2026-05-16 07:38:23 CET1344SMARAPIDTEST650A PLUS DIAGNOSTICS LAB.SAN.TIC.A.S.Turkeywww.aplustbd.comYesCommercialisedNoNoNear POC / POCAntibodyAntigenNasal swabSaliva2022-08-24 09:08:01 CET1111Immuno-AntigenYesNoImmunoassayQualitative15LOD15False positives52 out of 40 samples of Gold standard reagent False negatives2.52 out of 80 samples of Gold standard reagent Accuracy96%Clinical Sensitivity95%1112Immuno-AntibodyYesNoImmunoassayQualitative15LOD0.10.1CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives1.47%1 out of 68 samples of Gold standard reagent False negatives10.1%10 out of 99 samples of Gold standard reagentPrecisionNot evaluatedAccuracy98% IgGAccuracy93% IgMReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity97% IgGClinical Sensitivity87% IgM2985SMARTTEST SARS-COV-2 NASOPHARYNGEAL ANTIGEN RAPID TEST1320A PLUS DIAGNOSTICS LAB.SAN.TIC.A.S.Turkeywww.aplusıvd.comYesCommercialisedNoNoManualAntigenNasal swabNasopharyngeal swabSARS-CoV1032B.1.351Beta1495P.1Gamma1321B.1.617.2Delta678B.1.1.529Omicronnucleocapsid proteinThe test was approved by BFARM2022-08-24 09:08:01 CET2691Immuno-AntigenYesImmunoassayQualitativeMembrane-based15LOD100TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.99%9 out of 452 samples were found falsely positive comparing with the PCR testFalse negatives0.95%5 out of 523 samples were found falsely negative comparing with the PCR testPrecisionEvaluatedAccuracy98.3%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.26%Clinical Specificity99.05%Type of antigenNucleocapsid protein1004A&B RAPID TEST COVID-19 IGG/IGM CASSETTA535A&B ProfessionalItalywww.aebrapidtest.com/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2022-08-24 09:08:01 CET777Immuno-AntibodyNoImmunoassayQualitative10Accuracy99.6% IgGAccuracy97.8% IgMAccuracy98.2%IgG+IgMClinical Sensitivity94.1%IgG+IgMClinical Sensitivity100% IgGClinical Sensitivity91.8% IgMClinical Specificity99.2%IgG+IgMClinical Specificity99.5% IgGClinical Specificity99.2% IgM1608ANTIGEN RAPID TEST CASSETTE SARS-COV-2 (SWAB)713A. Menarini DiagnosticsItalywww.menarinidiagnostics.comYesCommercialisedNoNoCardNear POC / POCAntigenNasopharyngeal swabnucleocapsid protein2022-08-24 09:08:01 CET1288Immuno-AntigenYesNoImmunoassayQualitative15Accuracy98.74%95%CI: 96.80%-99.66%Clinical Sensitivity96.72%95%CI: 88.65%-99.60%Clinical Specificity99.22%95%CI: 97.21%-99.91%Type of antigennucleocapside protein964Covid PRESTO Test rapide COVID-19 IgG/IgM519AAZFrancewww.covid19aaz.com/en/covid-19-aaz-2/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood https://drive.google.com/open?id=1IYwO5TKn5M0TnyOFlPDuq5de7x-HRT5V https://www.youtube.com/watch?v=ggugEocCscg; This company has reconverted its production (HIV tests) into COVID kits production2022-08-24 09:08:01 CET865Immuno-AntibodyYesImmunoassayQualitativeNot found10Rapid diagnostic test cassette Not found 1834COV-QUANTO837AAZ-LMBFrancehttps://www.covid19aaz.com/en/autotest-covid-viro-all-in/YesCommercialisedNoNoSemi-automatedAntigenPlasmaSerumNA2022-08-24 09:08:01 CET1513Immuno-AntigenYesELISAQuantitativeSandwich, Double210LOD2.97AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives1.6%False negatives7%PrecisionEvaluatedAccuracy85%CI: range: 85-115 (Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93%Clinical Specificity98.4%1835COVID-PRESTO837AAZ-LMBFrancehttps://www.covid19aaz.com/en/autotest-covid-viro-all-in/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2022-08-24 09:08:01 CET1514Immuno-AntibodyNoImmunochromatographyQualitativeMembrane-based11LOD1AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy100% IgGAccuracy100% IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100% IgGClinical Sensitivity100% IgMClinical Specificity100% IgGClinical Specificity100% IgMType of antigenNucleoprotein1833COVID-VIRO837AAZ-LMBFrancehttps://www.covid19aaz.com/en/autotest-covid-viro-all-in/YesCommercialisedYesYesNear POC / POCAntigenNasal swabNasopharyngeal swab2022-08-24 09:08:01 CET1512Immuno-AntigenYesNoImmunochromatographyQualitativeMembrane-based16LOD1.15AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives3.4%PrecisionEvaluatedAccuracy98.74ReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity96.6%Clinical Specificity100%Type of antigenNucleoprotein3037COVID-VIRO ALL IN837AAZ-LMBFrancehttps://www.covid19aaz.com/en/autotest-covid-viro-all-in/YesCommercialisedYesYesNear POC / POCAntigenNasal swabMERS-CoV678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1223B.1.525Eta1224B.1.526Iota1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu2041C.37Lambda1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid proteinAll-in-one device suitable for children.2022-10-05 13:51:27 CET3926Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwichColorimetry15LOD0TCID50/ml1×10^2.4 TCID50/mLCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives5.61%PrecisionEvaluatedAccuracy99%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.39%Clinical Specificity100%Type of antigenNucleocapsid protein3975COVID-VIRO ALL IN TRIPLEX837AAZ-LMBFrancehttps://www.covid19aaz.com/en/autotest-covid-viro-all-in/YesCommercialisedNoNoNear POC / POCAntigenNasal swabInfluenza AInfluenza BRespiratory Syncytial V (RSV)SARS-CoV678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1223B.1.525Eta1224B.1.526Iota1320B.1.617.1Kappa1321B.1.617.2Delta1323B.1.621Mu2041C.37Lambda1495P.1Gammanucleocapsid protein2022-08-24 09:08:01 CET3640Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD251.18TCID50/mlAnalytical Sensitivity94.39%Analytical Specificity100%False positives0%False negatives5.61%Accuracy99%Clinical Sensitivity94.39%Clinical Specificity100%913abia SARS-CoV- IgG/IgM320AB Dianostic Systems GmbHGermanywww.ab-ds.de/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerum2022-08-24 09:08:01 CET739Immuno-AntibodyNoYesImmunoassayQualitativeFluorescence120Clinical Sensitivity100%Clinical Specificity95.31%505abia SARS-CoV-2 Ab320AB Dianostic Systems GmbHGermanywww.ab-ds.de/NoIn developmentNoNoAutomatedManualAntibody2022-08-24 09:08:01 CET424Immuno-AntibodyImmunoassay1032BasePoint Covid-19 IgG/IgM Rapid test Device6AbbottUnited Stateswww.abbott.com/NoCommercialisedNoNoNear POC / POCAntibodyIgGIgM2022-08-24 09:08:01 CET825Immuno-AntibodyYesImmunoassay754COVID-19 LAB TEST TO DETECT ANTIBODIES6AbbottUnited Stateswww.abbott.com/NoCommercialisedNoNoLab-basedAntibody2022-08-24 09:08:01 CET609Immuno-AntibodyImmunoassay 701SARS-CoV-2 IgG6AbbottUnited Stateswww.abbott.com/YesCommercialisedNoNoAutomatedManualAntibodyIgGPlasmaSerum2022-08-24 09:08:01 CET584Immuno-AntibodyNoImmunoassayQualitativeNot found29False positivesFour false positives out of a total of 1070 negative specimens.False negativesZero false negatives for specimens collected from positive subjects >/=14 days post-symptom onset. PrecisionEvaluatedAccuracy99.45% IgGReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity100% IgGClinical Specificity99%181/1822773SARS-CoV-2 IgG II Quant1246Abbott Ireland Diagnostics DivisionIrelandwww.corelaboratory.abbottYesCommercialisedNoNoAutomatedAntibodyIgGPlasmaSerum689B.1.1.7AlphaSARS-CoV-2 IgG II Quant (also referred to as CoV-2 IgG II or SARS-CoV-2 IgG II on the reagent bottle/cartridge label). The SARS-CoV-2 IgG II Quant assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative and quantitative determination of IgG antibodies to SARS-CoV-2 in human serum and plasma2022-08-24 09:08:01 CET2478Immuno-AntibodyNoImmunoassayQuantitative29LOD6.8AU/mLCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.45%Nine false positives out of a total of 1999 negative specimensFalse negativesOne false negative for specimens collected from positive subjects >/=15 days post-symptom onset.PrecisionEvaluatedAccuracy99.37% IgGReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.37% IgGClinical Specificity99.55% IgGType of antigenSpike protein2774SARS-CoV-2 IgM1246Abbott Ireland Diagnostics DivisionIrelandwww.corelaboratory.abbottYesCommercialisedNoNoAutomatedAntibodyIgMPlasmaSerumSARS-CoV-2 IgM (also referred to as CoV-2 IgM). The SARS-CoV-2 IgM assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of IgM antibodies to SARS-CoV-2 in human serum and plasma2022-08-24 09:08:01 CET2479Immuno-AntibodyNoImmunoassayQualitative29CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.44%13 false positives out of a total of 2952 negative specimensFalse negatives3 false negatives for specimens collected from positive subjects 15-30 days post-symptom onset.PrecisionEvaluatedAccuracy96.67% IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.67% IgMClinical Specificity99.56% IgMType of antigenSpike protein1232Panbio Covid-19 Ag Rapid Test628Abbott Rapid DiagnosticsGermanyhttps://www.globalpointofcare.abbott/en/index.htmlYesCommercialisedYesYesManualNear POC / POCAntigenNasal swabNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.2678B.1.1.529Omicron1518P.2Zetanucleocapsid proteinAvailable for Professional use (Nasal and Nasopharyngeal) and Self-Test (Nasal)2022-08-24 09:08:01 CET1015Immuno-AntigenYesYesNoImmunochromatographyQualitative15LOD0AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0AUPrecisionEvaluatedAccuracy100%ReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity98%Clinical Specificity99%Type of antigenOther1992AbC-19 Rapid Test913Abingdon Health PlcUnited Kingdomhttps://www.abingdonhealth.com/YesCommercialisedNoNoNear POC / POCIgGWhole bloodRapid diagnostic test cassette2022-08-24 09:08:01 CET1668Immuno-AntibodyNoImmunoassayQualitative20LOD0AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracy99.4% IgGReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.03% IgGClinical Specificity99.56% IgGType of antigenOther2879AbC-19 Semi-Q Rapid Test913Abingdon Health PlcUnited Kingdomhttps://www.abingdonhealth.com/YesCommercialisedNoNoNear POC / POCIgGPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2Zetaspike proteinThe AbC-19 Semi-Q Rapid Test is a single use, in vitro immunochromatographic sandwich assay for the semi-quantitative detection of IgG antibodies against the full trimeric SARS-CoV-2 spike protein in capillary whole blood, serum and plasma (EDTA) samples.2022-08-24 09:08:01 CET2584Immuno-AntibodyNoImmunochromatographySemiquantitativeSandwich20CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.44%2/450False negatives1.97%4/203PrecisionEvaluatedAccuracy99.4% IgGReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.03% IgGClinical Specificity99.56% IgG2975IVD CAPSULE COVID-19-NP1314Abionic SASwitzerlandwww.abionic.comYesCommercialisedYesYesNear POC / POCSemi-automatedAntigenNasopharyngeal swabSalivaSARS-CoV-2678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1321B.1.617.2Deltanucleocapsid proteinIVD CAPSULE COVID-19-NP is a very rapid SARS-CoV-2 antigen test giving results in under 2 minutes for nasopharyngeal specimens (the collection NP swab is included). It is suitable for point-of-care environments. Optionally (with another accessory saliva swab), it can also be used with saliva specimen with specifically tested performance as given in the IFU. 2023-02-17 08:44:03 CET21056Immuno-AntigenYesNoYesImmunoassayQualitativeOtherImmunofluorescence2LOD755TCID50/mlNasopharyngealCalibrationNot evaluatedAnalytical Sensitivity100%For samples with a viral load at the indicated LOD (or higher)Analytical Specificity100%Based on tested interference substancesAnalysis of cross reactivityEvaluatedFalse positivessamples0 out of 326 negative samplesFalse negatives31samples31 out of 105 positive samplesPrecisionNot evaluatedAccuracy100%RobustnessEvaluatedClinical Sensitivity93%Nasopharyngeal: for Ct≤30Clinical Specificity100%Nasopharyngeal: for 326 negative samples2993IVD CAPSULE COVID-19-SS1314Abionic SASwitzerlandwww.abionic.comYesCommercialisedNoNoNear POC / POCSemi-automatedAntigenSaliva689B.1.1.7Alpha1032B.1.351Beta1321B.1.617.2Delta678B.1.1.529Omicronnucleocapsid proteinThe product is a very rapid SARS-CoV-2 antigen test giving results in under 2 minutes for saliva specimens (the collecting saliva swab is included). It is suitable for point-of-care environments.2022-08-24 09:08:01 CET2699Immuno-AntigenNoYesImmunoassayQualitative2LODTCID50/ml4x10E3 TCID50/mLCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%0 out of 309False negatives0%0 out of 12 for Ct<25False negatives14.8%11 out of 74 for Ct<30False negatives30.8%33 out of 107 for Ct<35False negatives34.7%totally 40 out of 115PrecisionNot evaluatedAccuracy100%ReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity100%for Ct<25Clinical Specificity100%Type of antigenNucleocapsid protein2374Cora Gentest-191100Abioteq GmbHGermanywww.abioteq.deYesCommercialisedYesYesManualNear POC / POCAntigenAnterior nasal swabNasal swabNasopharyngeal swabOropharyngeal swabThroat swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2Zetanucleocapsid proteinThe product is intended for in vitro diagnosis only. The test result must not be used as the sole index to evaluate the patient's condition, and the patient's clinical manifestation and other laboratory tests must be combined to perform a comprehensive analysis of the condition. Inspection of the product packaging and seal and expiration date is required before performing the test. The test should be performed as soon as possible. Exposure of the test to air and moisture for an extended period of time will result in invalid results. Overloading the specimen may cause unexpected results, such as false positives. The accuracy of the test may be affected by ambient temperature (40°C) and relative humidity (>80%).2022-08-24 09:08:01 CET2076Immuno-AntigenYesNoImmunoassayQualitative10LOD1231AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives231AUFalse negatives1000AUPrecisionEvaluatedAccuracy99.6%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.7%Clinical Specificity99.8%Type of antigenNucleocapsid protein9The non-invasive MEGA test of SARS-CoV-27Absea Biotechnology Ltd.Chinawww.absea-antibody.com/NoIn developmentNoNoNear POC / POCAntibodyAMP Rapid Test SARS-CoV-2 Ag 2022-08-24 09:08:01 CET9Immuno-AntibodyYesImmunoassay1982Absoludy COVID-19 Ag909Absology Co. Ltd.South Koreawww.absology.co.krYesCommercialisedYesYesNear POC / POCSemi-automatedAntigenNasopharyngeal swabnucleocapsid proteinAbsoludy COVID-19 Ag for use in conjunction with ABSOL instrument, is an in vitro diagnostic medical device based on microfluidic fluorescent immunoassay (FIA) for measurement of SARS-CoV-2 antigen.2022-08-24 09:08:01 CET2880Immuno-AntigenYesImmunoassaySemiquantitativeFluorescence5MicrofluidicLOD1.25AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.63%(3/184)False negatives3%(3/100)PrecisionEvaluatedAccuracy97.9%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97%Clinical Specificity98.37%Type of antigenNucleocapsid protein1981Absoludy COVID-19 Ag Rapid909Absology Co. Ltd.South Koreawww.absology.co.krYesCommercialisedNoNoManualNear POC / POCAntigenNasopharyngeal swabOropharyngeal swabnucleocapsid proteinAbsoludy COVID-19 Ag Rapid is based on immunochromatography for the qualitative determination of SARS-CoV-2 virus specific antigens in human Nasopharyngeal and Oropharyngeal swab specimen.2022-08-24 09:08:01 CET1657Immuno-AntigenYesNoImmunochromatographyQualitativeMembrane-based15LOD125AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives12%(12/100)PrecisionEvaluatedAccuracy95.8%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity88%(100/100)Clinical Specificity100%(184/184)Type of antigenNucleoprotein1302Absoludy COVID-19 IgM/IgG Combo601Absology Co. Ltd.South Koreawww.absology.co.kr/YesCommercialisedNoNoAutomatedLab-basedNear POC / POCAntibodyIgGIgMPlasmaSerum2022-08-24 09:08:01 CET1072Immuno-AntibodyYesImmunoassayQualitative10Analytical Specificity96% IgGAnalytical Specificity97% IgGAccuracy93.48%Clinical Sensitivity91.67%Type of antigenNucleoprotein1151Absoludy COVID-19 IgM/IgG Rapid601Absology Co. Ltd.South Koreawww.absology.co.kr/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood other website http://www.absology.co.kr/2022-08-24 09:08:01 CET923Immuno-AntibodyYesNoImmunoassayQualitativeMagnetic Electrochemical15Accuracy95%Clinical Sensitivity90.24%Clinical Specificity97.82%1983Absoludy COVID-19 NAb909Absology Co. Ltd.South Koreawww.absology.co.krYesCommercialisedNoNoNear POC / POCSemi-automatedAntibodySerum689B.1.1.7Alpha1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.320A.23.1OtherAbsoludy COVID-19 NAb is intended for detection of nuetralizing antobody to SARS-CoV-2 virus (COVID-19) in human serum specimens. This product is for professional use.2022-08-24 09:08:01 CET1659Immuno-AntibodyYesYesImmunoassaySemiquantitativeNeutralization Antibody (NAb)6LOD20AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracy95%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96%Clinical Specificity100%Type of antigenOther1984Absoludy COVID-19 NAb & TAb909Absology Co. Ltd.South Koreawww.absology.co.krNoIn developmentNoNoNear POC / POCSemi-automatedAntibodyIgGIgMSerumAbsoludy COVID-19 NAb & TAb is a single-use only, fluorescent nanoparticle immunoassay designed for in vitro measurement of COVID-19 neutralizing antibody and COVID-19 total antibody. Human serum can be used as specimen for the test. Absoludy COVID-19 NAb & TAb is intended to be used by a healthcare professional who is sufficiently trained in clinical skills like specimen handling and medical instrument usage. Absoludy COVID-19 NAb & TAb is designed for use only with the ABSOL(ABSOL-001), fluorescent immunoassay reading instrument manufactured by Absology Co., Ltd.2022-08-24 09:08:01 CET1660Immuno-AntibodyYesImmunoassaySemiquantitativeNeutralization Antibody (NAb)Fluorescence10LOD20AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positivesEvaluation ongoingFalse negativesEvaluation ongoingPrecisionEvaluatedAccuracy95%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96%Clinical Specificity98%Type of antigenOther1985Absoludy COVID-19 NAb Rapid909Absology Co. Ltd.South Koreawww.absology.co.krNoIn developmentNoNoManualAntibodySerumAbsoludy COVID-19 NAb Rapid is intended for detection of neutralizing antibody to SARS-CoV-2 virus (COVID-19) in human serum.2022-08-24 09:08:01 CET1661Immuno-AntibodyNoImmunochromatographyQualitativeNeutralization Antibody (NAb)15LOD20AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positivesEvaluation ongoingFalse negativesEvaluation ongoingPrecisionEvaluatedAccuracy90%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90%Clinical Specificity95%Type of antigenNucleoprotein10RabWiz Ultra Sensitive COIV-19 Viral Antigen Test Kit (ELISA)8Abwiz BioUnited Stateswww.abwizbio.com/NoIn developmentNoNoAutomatedManualAntigen2022-08-24 09:08:01 CET10Immuno-AntigenELISAManual or automated 11Anti-SARS-CoV-2 nucleocapsid protein human IgM/IgG rapid detection kit9Academia SinicaTaiwan ROCwww.sinica.edu.tw/enNoIn developmentNoNoNear POC / POCAntibodyIgGIgMnucleocapsid protein2022-08-24 09:08:01 CET11Immuno-AntibodyYesImmunoassayRapid diagnostic test Type of antigenNucleocapside12SARS-CoV-2 Nucleocapsid Protein Rapid Detection Kit9Academia SinicaTaiwan ROCwww.sinica.edu.tw/enNoIn developmentNoNoNear POC / POCAntigennucleocapsid protein2022-08-24 09:08:01 CET12Immuno-AntigenYesImmunoassayRapid diagnostic test Type of antigenNucleocapsid506CareStart COVID-19 IgM/IgG321Access Bio Inc.United Stateswww.accessbio.net/NoCommercialisedNoNoNear POC / POCAntibodyIgGIgM2022-08-24 09:08:01 CET425Immuno-AntibodyYesImmunoassayRapid diagnostic test Not found Not found 2572CareStart(TM) COVID-19 Antigen1173Access Bio Inc.United Stateswww.accessbiodiagnostics.comYesCommercialisedNoNoManualNear POC / POCAntigenAnterior nasal swabNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.32041C.37LambdaReference number: RCMM-02072 Kit contents - 20, test device - 20, extraction buffer vial and cap - 20, anterior nasal swab - 1, positive control swab - 1, negative control swab - 1, instructions for use2022-08-24 09:08:01 CET2277Immuno-AntigenNoImmunochromatographyQualitativeSandwich10CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2AU(NP swab)False positives5AU(Anterior nasal swab)False negatives1AU(NP swab)False negatives0AU(Anterior nasal swab)PrecisionEvaluatedAccuracy98.33% (NP swab)Accuracy94.57 (Anterior nasal swab)ReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity93.75% (NP swab)Clinical Sensitivity87.18% (Anterior nasal swab)Clinical Specificity99.32% (NP swab)Clinical Specificity100%(Anterior nasal swab)Type of antigenNucleocapsid protein2573CareStart(TM) COVID-19 IgM/IgG1173Access Bio Inc.United Stateswww.accessbiodiagnostics.comYesCommercialisedNoNoManualNear POC / POCAntibodyIgGIgMPlasmaSerumWhole bloodWhole blood with anti-coagulantsThe kit contains the following items - 25 test devices - 1 assay buffer vial - 25 blood transfer pipettes - 1 instructions for use2022-08-24 09:08:01 CET2278Immuno-AntibodyNoImmunochromatographyQualitative10CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives6AU (IgG-/IgM-)False negatives0AU (IgG+/IgM+)False negatives1AU(IgG+/IgM-)False negatives1AU(IgG-/IgM+)PrecisionEvaluatedAccuracy94.2%ReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity91.2%Clinical Specificity97.1%Type of antigenOther2578Accu-Tell COVID-19 Antigen Cassette (Nasal Swab)1176AccuBioTech Co. Ltd.Chinawww.accubiotech.comYesCommercialisedNoNoNear POC / POCAntigenNasal swab1321B.1.617.2Deltanucleocapsid proteinACCU-TELL ® COVID-19 Antigen Cassette(Nasal Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS- CoV-2 antigen in Nasal swab. The identification is based on monoclonal antibodies specific to the Nucleocapsid（N）protein of SARS-CoV-2. It is intended to aid in the rapid differential diagnosis of COVID-19 infection2022-08-24 09:08:01 CET2283Immuno-AntigenYesNoImmunochromatographyQualitativeOther10LOD1000TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.8%2/250False negatives6.79%7/103PrecisionEvaluatedAccuracy97.5%(Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.2%(Antigen)Clinical Specificity99.2%(Antigen)Type of antigenNucleocapsid protein2580Accu-Tell COVID-19 Antigen Cassette (Saliva)1176AccuBioTech Co. Ltd.Chinawww.accubiotech.comYesCommercialisedNoNoNear POC / POCAntigenSaliva1321B.1.617.2DeltaACCU-TELL® COVID-19 Antigen Cassette (Saliva) is a rapid chromatographic immunoassay for the qualitative detection of COVID-19 antigen in Saliva. The identification is based on the monoclonal antibodies specific for the Nucleocapsid（N）protein of SARS-CoV-2. It is intended to aid in the rapid differential diagnosis of COVID-19 infections.2022-08-24 09:08:01 CET2285Immuno-AntigenNoImmunochromatographyQualitativeOther10LOD1000TCID50/ml CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%No False positiveFalse negatives8.21%12/146PrecisionEvaluatedAccuracy96.1%(Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity91.8%(Antigen)Clinical Specificity99.9%>99.9%(Antigen)Type of antigenNucleocapsid protein14Accu-Tell COVID-19 IgG/IgM Cassette11AccuBioTech Co. Ltd.Chinawww.accubiotech.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMSerumWhole blood1321B.1.617.2DeltaACCU-TELL® COVID-19 IgG/IgM Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to SARS-CoV-2 in human whole blood, serum, or plasma as an aid in the diagnosis of SARS-COV-2 infections.2022-08-24 09:08:01 CET14Immuno-AntibodyYesNoImmunochromatographyQualitativeOther10CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracy95.5% IgGAccuracy95.5% IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.5% IgGClinical Sensitivity93.5% IgMClinical Specificity97.5% IgGClinical Specificity97.5% IgM2579Accu-Tell SARS-CoV-2 Ag Cassette1176AccuBioTech Co. Ltd.Chinawww.accubiotech.comYesCommercialisedYesYesNear POC / POCAntigenNasopharyngeal swab1321B.1.617.2Deltanucleocapsid proteinACCU-TELL® SARS-CoV-2 Ag Cassette (Nasopharyngeal Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 antigen in Nasopharyngeal swab. The identification is based on the monoclonal antibodies specific for the Nucleocapsid （N）protein of SARS-CoV-2. It is intended to aid in the rapid differential diagnosis of COVID-19 infections.2022-08-24 09:08:01 CET2284Immuno-AntigenYesNoImmunochromatographyQualitativeOther10LOD1000TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.82%3/363False negatives4.27%5/117PrecisionEvaluatedAccuracy98.3%(Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.7%(Antigen)Clinical Specificity99.2%(Antigen)Type of antigenNucleocapsid protein2581ACCU-TELL® SARS-CoV-2 Neutralizing Antibody Cassette1176AccuBioTech Co. Ltd.Chinawww.accubiotech.comYesCommercialisedNoNoNear POC / POCAntibodySerumWhole blood1321B.1.617.2DeltaACCU-TELL® SARS-CoV-2 Neutralizing Antibody Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of neutralizing antibodies to SARS-CoV-2 in human whole blood, serum, or plasma as an aid in the diagnosis of the presence of neutralizing antibodies to SARS-CoV-22022-08-24 09:08:01 CET2286Immuno-AntibodyNoImmunochromatographyQualitativeOther10CalibrationNot evaluatedAnalysis of cross reactivityNot evaluatedFalse positives0%No False positive ( using Elisa kit as the comparator method)False negatives0%No False positive ( using Elisa kit as the comparator method)PrecisionEvaluatedAccuracy100%(Neutralizing Antibody)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%(Neutralizing Antibody)Clinical Specificity100%(Neutralizing Antibody)762COVID-19 RAPID IgG/IgM test kit452Accuster Technologies Pvt Ltd.Indiawww.accuster.com/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2022-08-24 09:08:01 CET618Immuno-AntibodyYesNoImmunoassayQualitative15Clinical Sensitivity98%Clinical Specificity97%1669FIAflex SARS-CoV-2 Antigen FIA1117Acon Biotech (Hangzhou) Co. Ltd.Chinahttps://www.aconbio.com/YesCommercialisedNoNoLab-basedNear POC / POCAntigenNasal swabNasopharyngeal swabSARS-CoV689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda70AT.11224B.1.526Iota678B.1.1.529Omicron1518P.2Zetanucleocapsid protein2022-08-24 09:08:01 CET1348Immuno-AntigenYesNoYesImmunoassayQualitativeMembrane-based15LOD95TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.48%2 out of 411 - Nasal SwabFalse positives0%0 out of 156 - Nasopharyngeal SwabFalse negatives2.54%4 out of 157 - Nasal SwabFalse negatives2.17%3 out of 138 - Nasopharyngeal SwabPrecisionEvaluatedAccuracy98.9Nasal SwabAccuracy99%Nasopharyngeal SwabReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.5%Nasal SwabClinical Sensitivity97.8Nasopharyngeal SwabClinical Specificity99.5Nasal SwabClinical Specificity100Nasopharyngeal SwabType of antigenNucleocapsid protein2951Flowflex Anti-SARS-CoV-2 S Antibody Rapid Test1117Acon Biotech (Hangzhou) Co. Ltd.Chinahttps://www.aconbio.com/YesCommercialisedNoNoLab-basedNear POC / POCAntibodyPlasmaSerumVenous whole bloodWhole bloodWhole blood with anti-coagulantsspike protein2022-08-24 09:08:01 CET2657Immuno-AntibodyNoNoImmunochromatographyQualitativeMembrane-based15CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.96%2 out of 208False negatives1.37%2 out of 145PrecisionEvaluatedAccuracy98.87%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.65%Clinical Specificity99.04%4054Flowflex SARS-CoV-2 & Flu A/B & RSV & Adenovirus Antigen Combo Rapid Test565Acon Biotech (Hangzhou) Co. Ltd.Chinahttps://www.aconbio.com/YesCommercialisedNoNoLab-basedNear POC / POCAntigenNasal swabNasopharyngeal swabSARS-CoVSARS-CoV-220A.23.170AT.1678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526IotaB.1.526.1B.1.526.23939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu1439C.362041C.37LambdaOther1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid proteinN.A2022-09-20 13:35:47 CET3817Immuno-AntigenYesNoNoImmunochromatographyQualitativeMembrane-basedN.A.15LOD160TCID50/mlfor SARS-CoV-2CalibrationNot evaluatedAnalytical Sensitivity100%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives0.49%False negatives3.88%PrecisionEvaluatedAccuracy98.82%for SARS-CoV-2 (Nasal swab)RobustnessEvaluatedClinical Sensitivity96.12%for SARS-CoV-2 (Nasal swab)Clinical Specificity99.51%for SARS-CoV-2 (Nasal swab)1457Flowflex SARS-CoV-2 Antigen Rapid Test565Acon Biotech (Hangzhou) Co. Ltd.Chinahttps://www.aconbio.com/YesCommercialisedYesYesLab-basedNear POC / POCAntigenNasal swabNasopharyngeal swabSARS-CoVSARS-CoV-220A.23.170AT.1678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526IotaB.1.526.1B.1.526.23939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu1439C.362041C.37LambdaOther1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid proteinN/A2022-10-20 10:15:02 CET5223Immuno-AntigenYesNoNoImmunochromatographyQualitativeMembrane-basedOther15LOD160TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.45%2 out of 435 (Nasal Swab)False positives0.56%1 out of 176 (Nasopharyngeal Swab)False negatives2.94%5 out of 170 (Nasal Swab)False negatives2.43%3 out of 123 (Nasopharyngeal Swab)PrecisionEvaluatedAccuracy98.8%Nasal SwabAccuracy98.7%Nasopharyngeal SwabReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.1%Nasal SwabClinical Sensitivity97.6%Nasopharyngeal SwabClinical Specificity99.5%Nasal SwabClinical Specificity99.4% Nasopharyngeal SwabType of antigenNucleocapsid protein4057Flowflex SARS-CoV-2 Antigen Rapid Test (Nasal/Nasopharyngeal/Saliva)565Acon Biotech (Hangzhou) Co. Ltd.Chinahttps://www.aconbio.com/YesCommercialisedYesYesNear POC / POCAntigenNasal swabNasopharyngeal swabSalivaSARS-CoVSARS-CoV-220A.23.170AT.1678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526IotaB.1.526.1B.1.526.23939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu1439C.362041C.37LambdaOther1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid proteinN.A2022-09-20 13:50:51 CET5370Immuno-AntigenYesNoNoImmunochromatographyQualitativeMembrane-basedN.A.15LOD160TCID50/mlCalibrationNot evaluatedAnalytical Sensitivity100%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives0.46%for nasal swabFalse negatives2.94%for nasal swabPrecisionEvaluatedAccuracy98.8%RobustnessEvaluatedClinical Sensitivity97.1%Clinical Specificity99.5%1865Flowflex SARS-CoV-2 Antigen Rapid Test (Nasal/Saliva)565Acon Biotech (Hangzhou) Co. Ltd.Chinahttps://www.aconbio.com/YesCommercialisedYesYesLab-basedNear POC / POCAntigenNasal swabSalivaSARS-CoVSARS-CoV-220A.23.170AT.1678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526IotaB.1.526.1B.1.526.23939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu1439C.362041C.37LambdaOther1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid proteinNo2022-09-20 17:45:54 CET3845Immuno-AntigenYesNoNoImmunochromatographyQualitativeMembrane-basedN.A.15LOD160TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.45%2 out of 435 - Nasal SwabFalse positives0.23%1 out of 429 - SalivaFalse negatives2.94%5 out of 170 - Nasal SwabFalse negatives8.46%11 out of 130 - SalivaPrecisionEvaluatedAccuracy98.8%Nasal SwabAccuracy97.9%SalivaReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.1%Nasal SwabClinical Sensitivity91.5%SalivaClinical Specificity99.5%Nasal SwabClinical Specificity99.8%SalivaType of antigenNucleocapsid protein4050Flowflex SARS-CoV-2 Antigen Rapid Test Lollipop (Saliva)565Acon Biotech (Hangzhou) Co. Ltd.Chinahttps://www.aconbio.com/YesCommercialisedNoNoLab-basedNear POC / POCAntigenSalivaSARS-CoVSARS-CoV-220A.23.170AT.1678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526IotaB.1.526.1B.1.526.23939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu1439C.362041C.37LambdaOther1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid proteinN.A2022-09-20 13:26:33 CET3813Immuno-AntigenYesNoNoImmunochromatographyQualitativeMembrane-basedN.A.15LOD320TCID50/mlCalibrationNot evaluatedAnalytical Sensitivity100%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives0%0/450False negatives18.2%20/110PrecisionEvaluatedAccuracy96.4%RobustnessEvaluatedClinical Sensitivity81.8%Clinical Specificity100%4053Flowflex SARS-CoV-2 Antigen Rapid Test Slim565Acon Biotech (Hangzhou) Co. Ltd.Chinahttps://www.aconbio.com/YesCommercialisedYesYesNear POC / POCAntigenNasal swabNasopharyngeal swabSARS-CoVSARS-CoV-220A.23.170AT.1678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526IotaB.1.526.1B.1.526.23939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu1439C.362041C.37LambdaOther1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid proteinN.A2022-10-31 09:34:57 CET5369Immuno-AntigenYesNoNoImmunochromatographyQualitativeMembrane-basedN.A.15LOD160TCID50/mlCalibrationNot evaluatedAnalytical Sensitivity100%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives%False negatives2.7%PrecisionEvaluatedAccuracy99%for nasal swabRobustnessEvaluatedClinical Sensitivity97.3%for nasal swabClinical Specificity100%for nasal swab4052Flowflex SARS-CoV-2 Antigen Rapid Test Slim(Self-Testing)565Acon Biotech (Hangzhou) Co. Ltd.Chinahttps://www.aconbio.com/YesCommercialisedNoNoOtherAntigenAnterior nasal swabSARS-CoVSARS-CoV-220A.23.170AT.1678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526IotaB.1.526.1B.1.526.23939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu1439C.362041C.37LambdaOther1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid proteinN.A2022-09-20 13:30:30 CET3814Immuno-AntigenYesYesNoImmunochromatographyQualitativeMembrane-basedN.A.15LOD160TCID50/mlCalibrationNot evaluatedAnalytical Sensitivity100%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives0%False negatives11.8%PrecisionEvaluatedAccuracy97.7%RobustnessEvaluatedClinical Sensitivity88.2%Clinical Specificity100%4051Flowflex SARS-CoV-2 Antigen Saliva Rapid Test Lollipop (Self-Testing)565Acon Biotech (Hangzhou) Co. Ltd.Chinahttps://www.aconbio.com/YesCommercialisedNoNoOtherAntigenSalivaSARS-CoVSARS-CoV-220A.23.170AT.1678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526IotaB.1.526.1B.1.526.23939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu1439C.362041C.37LambdaOther1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid proteinN.A2022-09-20 13:32:38 CET3816Immuno-AntigenYesYesNoImmunochromatographyQualitativeMembrane-basedN.A.15LOD320TCID50/mlCalibrationNot evaluatedAnalytical Sensitivity100%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives0%False negatives18.2%PrecisionEvaluatedAccuracy96.4%RobustnessEvaluatedClinical Sensitivity81.8%Clinical Specificity100%1424Foresight SARS-CoV-2 IgG565Acon Biotech (Hangzhou) Co. Ltd.Chinahttps://www.aconbio.com/YesCommercialisedNoNoFingertipLab-basedAntibodyIgGPlasmaSerum https://www.aconlabs.com.cn/en/ACON/687.html2022-08-24 09:08:01 CET1183Immuno-AntibodyYesImmunoassayQualitativeMagnetic Electrochemical75Accuracy99.6%Clinical Sensitivity99.9%Clinical Specificity99.4%1425Foresight SARS-CoV-2 IgM565Acon Biotech (Hangzhou) Co. Ltd.Chinahttps://www.aconbio.com/YesCommercialisedNoNoLateral flowLab-basedAntibodyIgMPlasmaSerum https://www.aconlabs.com.cn/en/ACON/687.html2022-08-24 09:08:01 CET1184Immuno-AntibodyYesImmunoassayQualitativeMagnetic Electrochemical75Accuracy96.1%Clinical Sensitivity88.6%Clinical Specificity97.8%2595SARS-CoV-2 & Influenza A/B Ag Combo FIA1117Acon Biotech (Hangzhou) Co. Ltd.Chinahttps://www.aconbio.com/YesCommercialisedNoNoLab-basedNear POC / POCAntigenNasal swabNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda70AT.11224B.1.526Iota1518P.2Zeta2022-08-24 09:08:01 CET2300Immuno-AntigenYesImmunoassayQualitativeFluorescence15CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.19%1/502 (COVID)False positives0%0/592 (Influ.B)False positives0.76%4/592 (Influ.A)False negatives2%3/150 (COVID)False negatives3.33%2/60 (Influ.B);False negatives1.66%1/60 (Influ.A)PrecisionEvaluatedAccuracy99.4% (SARS-CoV-2)Accuracy99.7%(Influ.B)Accuracy99.2%(Influ.A)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98% (SARS-CoV-2)Clinical Sensitivity98.3% (Influ.A)Clinical Sensitivity96.7% (Influ.B)Clinical Specificity99.3%(Influ.A)Clinical Specificity100%(Influ.B)Clinical Specificity99.8% (SARS-CoV-2)Type of antigenNucleocapsid protein2594SARS-CoV-2 & Influenza A/B Ag Combo Rapid Test565Acon Biotech (Hangzhou) Co. Ltd.Chinahttps://www.aconbio.com/YesCommercialisedNoNoLab-basedNear POC / POCAntigenNasal swabNasopharyngeal swabInfluenza AInfluenza A H1N1Influenza A H3N2Influenza A H5N1Influenza BInfluenza B VictoriaSARS-CoVSARS-CoV-220A.23.170AT.1678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526IotaB.1.526.1B.1.526.23939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu1439C.362041C.37LambdaOther1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid proteinN/A2022-09-20 17:48:08 CET3846Immuno-AntigenYesNoNoImmunochromatographyQualitativeMembrane-basedOther15LOD160TCID50/mlfor SARS-CoV-2CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.29%NP swab:1/335(Influ.B)False positives0.23%Nasal swab:1/430(COVID)False positives0.59%NP swab: 2/335(Influ.A)False positives0.38%NP swab:1/257(COVID)False positives0.19%Nasal swab: 1/505((Influ.B)False positives0.39%Nasal swab 2/505(Influ.A)False negatives4%Nasal swab 3/75((Influ.B)False negatives1.66%NP swab:1/60(Influ.B)False negatives1.66%NP swab:1/60(Influ.A)False negatives2.17%NP swab:3/138(COVID)False negatives2.66%Nasa swab 2/75(Influ.A)False negatives2.66%Nasal swab :4/150 (COVID)PrecisionEvaluatedAccuracy99.24%NP swab: (Influ.A)Accuracy99.31%Nasal swab (Influ.A)Accuracy99.31%Nasal swab (Influ.B)Accuracy99.49%NP swab:(Influ.B)Accuracy98.99%NP swab:(SARS-CoV-2)Accuracy99.14%Nasal swab:(SARS-CoV-2)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.33%Nasal swab: (Influ.A)Clinical Sensitivity98.33%NP swab:(Influ.B)Clinical Sensitivity98.33%NP swab:(Influ.A)Clinical Sensitivity97.83%NP swab:(SARS-CoV-2)Clinical Sensitivity96%Nasal swab: (Influ.B)Clinical Sensitivity97.33%Nasal swab:(SARS-CoV-2)Clinical Specificity99.77%Nasal swab:(SARS-CoV-2)Clinical Specificity99.6%Nasal swab: (Influ.A)Clinical Specificity99.8%Nasal swab: (Influ.B)Clinical Specificity99.61%NP swab:(SARS-CoV-2)Clinical Specificity99.4%NP swab:(Influ.A)Clinical Specificity99.7%NP swab:(Influ.B)Type of antigenNucleocapsid protein2451SARS-CoV-2 Antigen Rapid Test (Self-Testing)1117Acon Biotech (Hangzhou) Co. Ltd.Chinahttps://www.aconbio.com/YesCommercialisedNoNoAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2Zeta2022-08-24 09:08:01 CET2154Immuno-AntigenYesNoImmunochromatographyQualitativeMembrane-based15LOD160AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.46%2 out of 435False negatives2.94%5 out of 170PrecisionEvaluatedAccuracy98.8%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.1%Clinical Specificity99.5%Type of antigenNucleoprotein4045SARS-CoV-2 Antigen Rapid Test Strip565Acon Biotech (Hangzhou) Co. Ltd.Chinahttps://www.aconbio.com/YesCommercialisedNoNoLab-basedNear POC / POCAntigenNasal swabNasopharyngeal swabSARS-CoVSARS-CoV-220A.23.170AT.1678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526IotaB.1.526.1B.1.526.23939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu1439C.362041C.37LambdaOther1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid proteinN.A.2022-09-21 09:43:16 CET3855Immuno-AntigenYesNoNoImmunochromatographyQualitativeMembrane-basedOther15LOD160TCID50/mlAnalysis of cross reactivityEvaluatedFalse positives0.24%(1 out of 410)False negatives2.59%(3 out of 116)PrecisionEvaluatedAccuracy99.2%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.4%Clinical Specificity99.8%Type of antigenNucleoprotein828SARS-CoV-2 IgG/IgM Rapid Test (CE-IVD)565Acon Biotech (Hangzhou) Co. Ltd.Chinahttps://www.aconbio.com/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2022-08-24 09:08:01 CET1548Immuno-AntibodyImmunoassay2603SARS-CoV-2 Neutralizing Antibody Rapid Test1117Acon Biotech (Hangzhou) Co. Ltd.Chinahttps://www.aconbio.com/YesCommercialisedNoNoLab-basedNear POC / POCAntibodyPlasmaSerumVenous whole bloodWhole bloodWhole blood with anti-coagulantsNA2022-08-24 09:08:01 CET2308Immuno-AntibodyNoImmunochromatographyQualitativeNeutralization Antibody (NAb)10CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives1%False positives1.33%(Fingertip Blood)False negatives4.35%False negatives2.63%(Fingertip Blood)PrecisionEvaluatedAccuracy97.78%Accuracy98.23%(Fingertip Blood)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.65%Clinical Sensitivity97.37%(Fingertip Blood)Clinical Specificity99%Clinical Specificity98.67%(Fingertip Blood)Type of antigenOther1675ACON SARS-CoV-2 IgG/IgM Rapid Test683ACON Laboratories Inc.United Stateswww.aconlabs.comYesCommercialisedNoNoMicrotiter plateNear POC / POCIgGIgMPlasmaSerumWhole blood2022-08-24 09:08:01 CET1354Immuno-AntibodyYesNoImmunoassayQualitative15LOD1AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracy98.3%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.89%1670FIAflex SARS-CoV-2 Antigen FIA683ACON Laboratories Inc.United Stateswww.aconlabs.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabnucleocapsid protein2022-08-24 09:08:01 CET1349Immuno-AntigenYesNoImmunochromatographyQualitative15LOD95%CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracy98.9%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.5%Type of antigennucleoprotein1468Flowflex SARS-CoV-2 Antigen rapid test683ACON Laboratories Inc.United Stateswww.aconlabs.comYesCommercialisedYesYesNear POC / POCAntigenNasal swabnucleocapsid protein2022-08-24 09:08:01 CET1219Immuno-AntigenYesNoImmunochromatographyQualitative15LOD160U/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.5%False negatives3.1%PrecisionEvaluatedAccuracy98.8%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.9%Type of antigenNucleoprotein1671Foresight SARS-CoV-2 IgG EIA Test Kit683ACON Laboratories Inc.United Stateswww.aconlabs.comYesCommercialisedNoNoAutomatedManualAntibodyIgGPlasmaSerum2022-08-24 09:08:01 CET1350Immuno-AntibodyYesImmunoassayQualitativeOther30LOD0.67AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracy97.21%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity91.64%1672Foresight SARS-CoV-2 IgM EIA Test Kit683ACON Laboratories Inc.United Stateswww.aconlabs.comYesCommercialisedNoNoAutomatedManualAntibodyIgMPlasmaSerum2022-08-24 09:08:01 CET1351Immuno-AntibodyYesImmunoassayQualitativeOther30Manual or automated other LOD1AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracy97.72%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90.14%1908SARS-CoV-2 Antigen Rapid Test (Nasal/Saliva)683ACON Laboratories Inc.United Stateswww.aconlabs.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabSalivanucleocapsid proteinN.A.2022-08-24 09:08:01 CET1583Immuno-AntigenYesImmunoassayMembrane-based15LOD160AUFalse positives0.462 out of 435(Nasal Swab); 1 out of 236(Saliva)False negatives2.945 out of 170(Nasal Swab); 9 out of 105(Saliva)PrecisionEvaluatedAccuracy98.8%98.8%(Nasal Swab); 97.1%(Saliva)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.1%97.1%(Nasal Swab); 91.4%(Saliva); Clinical Specificity99.5%99.5%(Nasal Swab); 99.6%(Saliva); Type of antigenNucleoprotein2452SARS-CoV-2 Antigen Rapid Test (Self-Testing)1118ACON Laboratories Inc.United Stateshttps://www.aconlabs.com/YesCommercialisedNoNoAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaN.A.2022-08-24 09:08:01 CET2155Immuno-AntigenYesNoImmunochromatographyQualitativeMembrane-based15LOD160AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.46%2 out of 435False negatives2.94%5 out of 170PrecisionEvaluatedAccuracy98.8%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.1%Clinical Specificity99.5%Type of antigenNucleoprotein1907SARS-CoV-2 Antigen Rapid Test Strip683ACON Laboratories Inc.United Stateswww.aconlabs.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabNasopharyngeal swabN.A.2022-08-24 09:08:01 CET1582Immuno-AntigenNoImmunochromatographyQualitativeMembrane-based15LOD160CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.24%(1 out of 410)False negatives2.59%(3 out of 116)PrecisionEvaluatedAccuracy99.2%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.4%Clinical Specificity99.8%Type of antigenNucleoprotein16962019-nCoV IgG/IgM Rapid Test Cassette890Acro Biotech Inc.United Stateswww.acrobiotech.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2022-08-24 09:08:01 CET1375Immuno-AntibodyYesNoImmunoassayQualitative10LOD0AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives2% IgGFalse positives4% IgMFalse positives3.7%IgG, IgMFalse negatives15% IgMFalse negatives0% IgGFalse negatives3.1%IgG, IgMPrecisionEvaluatedAccuracy92.9% IgMAccuracy96.4%IgG, IgMAccuracy98.6% IgGReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100% IgGClinical Sensitivity85% IgMClinical Sensitivity96.9%IgG, IgM24342019-nCoV IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)890Acro Biotech Inc.United Stateswww.acrobiotech.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThe 2019-nCoV IgG/IgM Rapid Test Cassette is a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to 2019-nCoV in human whole blood, serum or plasma specimen.2022-08-24 09:08:01 CET2137Immuno-AntibodyImmunoassayQualitativeSandwich10LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0AU(IgG);False positives0.031AU(2019-nCoV IgG/IgM )False positives0.15AU(IgM);False negatives0.02AU(IgG);False negatives0.04AU(IgM);0.037(2019-nCoV IgG/IgM )False negatives0.04AU(IgM);0.037(2019-nCoV IgG/IgM )PrecisionEvaluatedAccuracy98.6%(IgG/IgM)(IgG);Accuracy96.4%(IgG/IgM)(2019-nCoV IgG/IgM )Accuracy92.9%(IgG/IgM)(IgM);ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%(IgG/IgM)(IgG);Clinical Sensitivity85%(IgG/IgM)(IgM);Clinical Sensitivity96.9%(IgG/IgM)(2019-nCoV IgG/IgM )Clinical Specificity96%(IgG/IgM)(IgM);Clinical Specificity96.3%(IgG/IgM)(2019-nCoV IgG/IgM )Clinical Specificity98%(IgG/IgM)(IgG);Type of antigenNucleoprotein2391COVID-19 and Influenza A+B Antigen Combo Rapid Test (Nasopharyngeal Swab)890Acro Biotech Inc.United Stateswww.acrobiotech.comYesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThe COVID-19 and Influenza A+B Antigen Combo Rapid Test (Nasopharyngeal Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2, Influenza A and Influenza B virus antigens in nasopharyngeal swab specimens from individuals with suspected SARS-CoV-2/Influenza infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2 and Influenza A+B Antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2/Influenza A+B infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19/Influenza A+B. The COVID-19 and Influenza A+B Antigen Combo Rapid Test is intended for use by trained clinical laboratory personnel.2022-08-24 09:08:01 CET2093Immuno-AntigenNoImmunoassayQualitativeSandwich15LODAU100CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.023AU(COVID-19 Test);False positives0.054AU(Influenza Type B).False positives0.03AU(Influenza Type A);False negatives0.01AU(COVID-19 Test);False negatives0.006AU(Influenza Type B).False negatives0.006AU(Influenza Type A);PrecisionEvaluatedAccuracy98.6%(Antigen)(COVID-19 Test)Accuracy99%(Antigen)(Influenza Type B).Accuracy99.2%(Antigen)(Influenza Type A);ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.7%(Antigen)(COVID-19 Test);Clinical Sensitivity97%(Antigen)(Influenza Type A);.Clinical Sensitivity94.6%(Antigen)(Influenza Type B)Clinical Specificity99.4%(Antigen)(Influenza Type A);Clinical Specificity99.4%(Antigen)(Influenza Type B).Clinical Specificity99%(Antigen)(COVID-19 Test);Type of antigenNucleoprotein1698COVID-19 and M.pneumoniae IgG Combo Rapid Test890Acro Biotech Inc.United Stateswww.acrobiotech.comYesCommercialisedNoNoStripNear POC / POCAntibodyIgGPlasmaSerumWhole blood2022-08-24 09:08:01 CET1377Immuno-AntibodyYesNoImmunoassayQualitative10LOD0CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives2False negatives0PrecisionEvaluatedAccuracy100% IgGReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100% IgG2420COVID-19 and M.pneumoniae IgG Combo Rapid Test (Whole Blood/Serum/Plasma) Package Insert890Acro Biotech Inc.United Stateswww.acrobiotech.comYesCommercialisedNoNoNear POC / POCAntibodyIgGPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1132B.1.427Epsilon1223B.1.525Eta1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThe COVID-19 and M.pneumoniae IgG Combo Rapid Test (Whole Blood/ Serum/Plasma) is a lateral flow chromatographic immunoassay for the qualitative detection of IgG antibodies to SARS-COV-2 and Mycoplasma pneumoniae in human whole blood, serum or plasma specimen. The COVID-19 and M.pneumoniae IgG Combo Rapid Test is for professional use only and is intended to be used as an aid in the diagnosis of patients with suspected SARS-CoV2/M.pneumoniae infection in conjunction with clinical presentation and the results of other laboratory tests. The product is intended to be used by trained laboratory personnel. Negative results will not preclude SARS-COV-2/M.pneumoniae infection and they cannot be used as the sole basis for treatment or other management decision. False positive results for IgG antibodies may occur due to cross-reactivity from preexisting antibodies or other possible causes.2022-08-24 09:08:01 CET2122Immuno-AntibodyNoImmunoassayQualitativeSandwich15LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0AU(COVID-19 IgG),False positives0.078AU(Mycoplasma pneumoniae IgG)False negatives0.02AU(COVID-19 IgG),False negatives0.054AU(Mycoplasma pneumoniae IgG)PrecisionEvaluatedAccuracy98.6% IgG(COVID-19 IgG);Accuracy93.7% IgG(Mycoplasma pneumoniae IgG).ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100% IgG(COVID-19 IgG);Clinical Sensitivity92.2% IgG(Mycoplasma pneumoniae IgG).Clinical Specificity98% IgG(COVID-19 IgG);Clinical Specificity94.6% IgG(Mycoplasma pneumoniae IgG).Type of antigenNucleoprotein1697COVID-19 and M.pneumoniae IgG/IgM Combo Rapid Test890Acro Biotech Inc.United Stateswww.acrobiotech.comYesCommercialisedNoNoN.A.Near POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2022-08-24 09:08:01 CET1376Immuno-AntibodyYesNoImmunoassayQualitative10LOD0AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives2AU(IgG)False positives4AU(IgM)False negatives0AU(IgG)False negatives15AU(IgM)PrecisionEvaluatedAccuracy98.6% IgG98.6 (COVID-Accuracy92.9% IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100% IgGClinical Sensitivity85% IgM2412COVID-19 and M.pneumoniae IgG/IgM Combo Rapid Test (Whole Blood/Serum/Plasma)890Acro Biotech Inc.United Stateswww.acrobiotech.comYesCommercialisedNoNoNear POC / POCIgGIgMPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThe COVID-19 and M.pneumoniae IgG/IgM Combo Rapid Test (Whole Blood/Serum/Plasma) is a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to SARS-COV-2 and Mycoplasma pneumoniae in human whole blood, serum or plasma specimen. The COVID-19 and M.pneumoniae IgG/IgM Combo Rapid Test is for professional use only and is intended to be used as an aid in the diagnosis of patients with suspected SARSCoV-2/M.pneumoniae infection in conjunction with clinical presentation and the results of other laboratory tests. The product is intended for use by trained laboratory personnel. The test provides preliminary test results. Negative results will not preclude SARS-COV2/ M.pneumoniae infection and they cannot be used as the sole basis for treatment or other management decision. False positive results for IgM and IgG antibodies may occur due to cross-reactivity from pre-existing antibodies or other possible causes.2022-08-24 09:08:01 CET2114Immuno-AntibodyNoImmunoassayQualitativeSandwich15LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives% IgG0(COVID-19 IgG ),False positives0.085% IgM(Mycoplasma pneumoniae IgM)False positives0.78% IgG(Mycoplasma pneumoniae IgG),False positives0.15% IgM(COVID-19 IgM),False negatives% IgG0.02(COVID-19IgG )False negatives0.052% IgM(Mycoplasma pneumoniae IgM)False negatives0.054% IgG(Mycoplasma pneumoniae IgG)False negatives0.04% IgM(COVID-19 IgM)PrecisionEvaluatedAccuracy93.7% IgG(Antigen)(Mycoplasma pneumoniae IgG),Accuracy93.7% IgM(Antigen)(Mycoplasma pneumoniae IgM)Accuracy98.6% IgG(Antigen)(COVID-19 IgG )Accuracy92.9% IgM(Antigen)(COVID-19 IgM),ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100% IgG(Antigen)(COVID-19 IgG ),Clinical Sensitivity85% IgM(Antigen)(COVID-19 IgM),Clinical Sensitivity92.2% IgG(Antigen)(Mycoplasma pneumoniae IgG),Clinical Sensitivity91.5% IgM(Antigen)(Mycoplasma pneumoniae IgM)Clinical Specificity98% IgG(Antigen)(COVID-19 IgG ),Clinical Specificity96% IgMAntigen)(COVID-19 IgM),Clinical Specificity94.6% IgG(Antigen)(Mycoplasma pneumoniae IgG),Clinical Specificity94.8% IgM(Antigen)(Mycoplasma pneumoniae IgM)Type of antigenNucleoprotein1688COVID-19 Antigen Rapid Test890Acro Biotech Inc.United Stateswww.acrobiotech.comYesCommercialisedNoNoNot foundNear POC / POCAntigenNasal swabOther2022-08-24 09:08:01 CET1367Immuno-AntigenYesNoImmunoassayQualitative15LOD0CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives1AUFalse negatives2.3AUPrecisionEvaluatedAccuracy98.6%(Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.7%(Antigen)1702COVID-19 Antigen Rapid Test (For Reader)890Acro Biotech Inc.United Stateswww.acrobiotech.comYesCommercialisedNoNoOtherNear POC / POCAntigenNasal swabnucleocapsid protein2022-08-24 09:08:01 CET1382Immuno-AntigenYesYesImmunoassayQualitative15LOD0AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2.3AUFalse negatives1AUPrecisionEvaluatedAccuracy98.6%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.7%Type of antigennucleoprotein2432COVID-19 Antigen Rapid Test (Nasopharyngeal Swab)890Acro Biotech Inc.United Stateswww.acrobiotech.comYesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThe COVID-19 Antigen Rapid Test (Nasopharyngeal Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 antigens in nasopharyngeal swab specimens from individuals with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2 Antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19. The COVID-19 Antigen Rapid Test is intended for use by trained clinical laboratory personnel.2022-08-24 09:08:01 CET2135Immuno-AntigenYesImmunoassayQualitativeSandwich15LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.023AUFalse negatives0.01AUPrecisionEvaluatedAccuracy98.6%(Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.7%(Antigen)Clinical Specificity99%(Antigen)Type of antigenNucleoprotein2417COVID-19 Antigen Rapid Test (Nasopharyngeal Swab)1057Acro Biotech Inc.United Stateswww.acrobiotech.comYesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThe COVID-19 Antigen Rapid Test (Nasopharyngeal Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 antigens in nasopharyngeal swab specimens from individuals with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2 Antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19. The COVID-19 Antigen Rapid Test is intended for use by trained clinical laboratory personnel.2022-08-24 09:08:01 CET2119Immuno-AntigenNoImmunoassayQualitativeSandwich15LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.023AUFalse negatives0.01AUPrecisionEvaluatedAccuracy98.6%(Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.7%（Antigen）Clinical Specificity99%（Antigen）Type of antigenNucleoprotein1949COVID-19 Antigen Rapid Test (Oral Fluid)890Acro Biotech Inc.United Stateswww.acrobiotech.comYesCommercialisedNoNoNear POC / POCAntigenSaliva689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2Zetanucleocapsid proteinThe COVID-19 Antigen Rapid Test (Oral Fluid) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in oral fluid specimens from individuals with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2 nucleocapsid protein antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.2022-08-24 09:08:01 CET1625Immuno-AntigenYesNoImmunoassayQualitativeSandwich15LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.007AUFalse negatives0.097AUPrecisionEvaluatedAccuracy96.8%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90.3%Clinical Specificity99.3%Type of antigenNucleoprotein1700COVID-19 Antigen Test Cassette (For Analyzer)890Acro Biotech Inc.United Stateswww.acrobiotech.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabnucleocapsid protein2022-08-24 09:08:01 CET1380Immuno-AntigenYesYesImmunoassayQualitative10LOD0AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives6.7AUFalse negatives1.6AUPrecisionEvaluatedAccuracy96.2(Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.3%(Antigen)Type of antigennucleoprotein1695COVID-19 IgG Rapid Test890Acro Biotech Inc.United Stateswww.acrobiotech.comYesCommercialisedNoNoNear POC / POCAntibodyIgGPlasmaSerumWhole blood2022-08-24 09:08:01 CET1374Immuno-AntibodyYesNoImmunoassayQualitative10LOD0AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives4.7AUFalse negatives5.7AUPrecisionEvaluatedAccuracy95% IgGReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.3% IgG2427COVID-19 IgG Rapid Test (Whole Blood/Serum/Plasma)890Acro Biotech Inc.United Stateswww.acrobiotech.comYesCommercialisedNoNoNear POC / POCAntibodyIgGPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThe COVID-19 IgG Rapid Test (Whole Blood/Serum/Plasma) is a lateral flow chromatographic immunoassay for the qualitative detection of IgG antibodies to SARS-CoV-2 spike (S) protein receptor binding domain (RBD) in human whole blood, serum or plasma specimen. The COVID-19 IgG Rapid Test (Whole Blood/Serum/Plasma) is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2. False positive results may occur due to cross-reactivity from pre-existing antibodies or other possible causes. Due to the risk of false positive results, confirmation of positive results should be considered using second, different IgG assay.2022-08-24 09:08:01 CET2130Immuno-AntibodyNoImmunoassayQualitativeSandwich10LOD100CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.071AU(SARS-CoV-2);False positives0.015AU(vaccination)False negatives0AU(SARS-CoV-2);False negatives0.001AU>0.001(vaccination)PrecisionEvaluatedAccuracy97.4% IgG(SARS-CoV-2);Accuracy98.9% IgG(vaccination).ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.9% IgG(SARS-CoV-2);Clinical Sensitivity98.5% IgG(vaccination).Clinical Specificity100% IgG(SARS-CoV-2);Clinical Specificity99.9% IgG(vaccination)Type of antigenNucleoprotein1677COVID-19 IgG/IgM Rapid Test (For Reader)890Acro Biotech Inc.United Stateswww.acrobiotech.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2022-08-24 09:08:01 CET1356Immuno-AntibodyYesYesImmunoassayQualitative10LOD0AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives5.6AUFalse negatives5AUPrecisionEvaluatedAccuracy94.9% (IgG/IgM)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.4%2433COVID-19 IgG/IgM Rapid Test (Whole Blood/Serum/Plasma)890Acro Biotech Inc.United Stateswww.acrobiotech.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThe COVID-19 IgG/IgM Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to SARS-CoV-2 in human whole blood, serum or plasma specimen from patients suspected of COVID-19 infection by a healthcare provider. The COVID-19 IgG/IgM Rapid Test is an aid in the diagnosis of patients with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results from the COVID-19 IgG/IgM Rapid Test should not be used as the sole basis for diagnosis. Results are for the detection of SARS-CoV-2 antibodies. IgM antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, although levels over the course of infection are not well characterized. IgG antibodies to SARS-CoV-2 become detectable later following infection. Positive results for both IgG and IgM could occur after infection and can be indicative of acute or recent infection. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. IgM antibodies may not be detected in the first few days of infection; the sensitivity of the COVID-19 IgG/IgM Rapid Test early after infection is unknown. False positive results for IgM and IgG antibodies may occur due to cross-reactivity from pre-existing antibodies or other possible causes. At this time, it is unknown for how long IgM or IgG antibodies may persist following infection.2022-08-24 09:08:01 CET2136Immuno-AntibodyYesImmunoassayQualitativeSandwich10LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.056AUFalse negatives0.05AUPrecisionEvaluatedAccuracy94.9%(IgG/IgM)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.4%(IgG/IgM)Clinical Specificity95%(IgG/IgM)Type of antigenNucleoprotein465COVID-19 IgG/IgM Rapid Test Cassette890Acro Biotech Inc.United Stateswww.acrobiotech.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2022-08-24 09:08:01 CET712Immuno-AntibodyYesNoImmunoassayQualitativeColloidal gold10False positivesEvaluatedFalse negativesEvaluatedAccuracy98.6% IgGAccuracy92.9% IgMRobustnessEvaluatedClinical Sensitivity100% IgGClinical Sensitivity85% IgMClinical Specificity98% IgGClinical Specificity96% IgM1694COVID-19 IgG/IgM Rapid Test Dipstick890Acro Biotech Inc.United Stateswww.acrobiotech.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2022-08-24 09:08:01 CET1373Immuno-AntibodyYesNoImmunoassayQualitative10LOD0AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives2AU(IgG)False positives3AU(IgM)False negatives0.1AU(IgG)False negatives9.1AU(IgM)PrecisionEvaluatedAccuracy98.4% IgGAccuracy95.9% IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.9% IgGClinical Sensitivity90.9% IgM1676COVID-19 IgG/IgM Test Cassette (for Analyzer)890Acro Biotech Inc.United Stateswww.acrobiotech.comYesCommercialisedNoNoNear POC / POCIgGIgMPlasmaSerumWhole blood2022-08-24 09:08:01 CET1355Immuno-AntibodyYesNoImmunoassayQualitative15LOD0AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives3.1AUFalse negatives3.3AUPrecisionEvaluatedAccuracy96.9%(IgG, IgM)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.7%(IgG/IgM)2267SARS-CoV-2 Antigen Rapid Test (Nasal Swab)890Acro Biotech Inc.United Stateswww.acrobiotech.comYesCommercialisedYesYesNear POC / POCAntigenNasal swab20A.23.170AT.1689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526IotaB.1.526.1B.1.526.23939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu1439C.362041C.37Lambda1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid proteinThe ACRO SARS-CoV-2 Antigen Rapid Test (Nasal Swab) is a lateral flow immunoassay for the qualitative detection of Nucleocapsid protein antigens of SARS-CoV-2 in swab specimens from individuals suspected of COVID-19 by their healthcare provider. The SARS-CoV-2 antigen is able to be detected in the upper respiratory tract during the acute phase of infection. The ACRO SARS-CoV-2 Antigen Rapid Test (Nasal Swab) tests for the SARS-CoV-2 nucleocapsid protein antigen in upper respiratory specimens. While a positive result indicates the existence of the viral antigen, further evaluation of patient history and diagnostics are necessary to confirm these results. A patient may experience concurrent infection with other viruses or a bacterial infection which are not ruled out by a positive SARS-CoV-2 antigen result. Detection of the antigen does not surely certify it as the cause of the disease. Negative results should be treated as presumptive and confirmation with a molecular assay may be necessary for patient management. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.2023-05-17 17:26:51 CET21057Immuno-AntigenYesNoImmunoassayQualitativeSandwich15LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.054AUFalse negatives0.006AUPrecisionEvaluatedAccuracy98.1%(Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.6%(Antigen)Clinical Specificity99.4%(Antigen)Type of antigenNucleoproteins1948SARS-CoV-2 Antigen Rapid Test (Swab)890Acro Biotech Inc.United Stateswww.acrobiotech.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabOropharyngeal swabThe ACROTM SARS-CoV-2 Antigen Rapid Test (Swab) is a lateral flow immunoassay for the qualitative detection of Nucleocapsid protein antigens of SARS-CoV-2 in swab specimens from individuals suspected of COVID-19 by their healthcare provider. The SARS-CoV-2 antigen is able to be detected in the upper respiratory tract during the acute phase of infection. The ACROTM SARS-CoV-2 Antigen Rapid Test (Swab) tests for the SARS-CoV-2 nucleocapsid protein antigen in upper respiratory specimens. While a positive result indicates the existence of the viral antigen, further evaluation of patient history and diagnostics are necessary to confirm these results. A patient may experience concurrent infection with other viruses or a bacterial infection which are not ruled out by a positive SARS-CoV-2 antigen result. Detection of the antigen does not surely certify it as the cause of the disease. Negative results should be treated as presumptive and confirmation with a molecular assay may be necessary for patient management. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.2022-08-24 09:08:01 CET1624Immuno-AntigenImmunoassayQualitative15LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.006AUFalse negatives0.063AUPrecisionEvaluatedAccuracy96.7%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.7%Clinical Specificity99.4%Type of antigenNucleocapside2397SARS-CoV-2/Influenza A+B/RSV Antigen Combo Rapid Test (Nasopharyngeal Swab)890Acro Biotech Inc.United Stateswww.acrobiotech.comYesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThe SARS-CoV-2/Influenza A+B/RSV Antigen Combo Rapid Test (Nasopharyngeal Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2, Influenza A, Influenza B and Respiratory Syncytial Virus(RSV) antigens in nasopharyngeal swab specimens from individuals with suspected SARS-CoV-2/Influenza/RSV infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2, Influenza A+B and RSV Antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out other bacterial/viral infection. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2/Influenza A+B/RSV infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19, Influenza A+B and RSV. The SARS-CoV-2/Influenza A+B/RSV Antigen Combo Rapid Test is intended for use by trained clinical laboratory personnel.2022-08-24 09:08:01 CET2099Immuno-AntigenImmunoassayQualitativeSandwich15LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.023AU(SARS-CoV-2 Test);False positives0.051AU(RSV Test).False positives0.054AU(Influenza Type B);False positives0.03AU(Influenza Type A);False negatives0.01AU(SARS-CoV-2 Test);False negatives0.016AU(RSV Test).False negatives0.006AU(Influenza Type B);False negatives0.006AU(Influenza Type A);PrecisionEvaluatedAccuracy99%(Antigen)(Influenza Type B);Accuracy99.2%(Antigen)(Influenza Type A);Accuracy98.6%(Antigen)(SARS-CoV-2 Test);Accuracy97.9%(Antigen)(RSV Test).ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.7%(Antigen)(SARS-CoV-2 Test);Clinical Sensitivity97%(Antigen)(Influenza Type A);Clinical Sensitivity94.6%(Antigen)(Influenza Type B);Clinical Sensitivity94.9%(Antigen)(RSV Test).Clinical Specificity99%(Antigen)(SARS-CoV-2 Test);9Clinical Specificity9.4%(Antigen)(Influenza Type A);Clinical Specificity99.4%(Antigen)(Influenza Type B);Clinical Specificity98.4%(Antigen)(RSV Test).Type of antigenNucleoprotein2409SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test (Nasopharyngeal Swab)890Acro Biotech Inc.United Stateswww.acrobiotech.comYesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1519P.3Theta1137B.1.429Epsilon3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThe SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test (Nasopharyngeal Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2, Influenza A, Influenza B, Respiratory Syncytial Virus(RSV) and Adenovirus antigens in nasopharyngeal swab specimens from individuals with suspected SARS-CoV-2/ Influenza/ RSV/Adenovirus infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2, Influenza A+B, RSV and Adenovirus antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out other bacterial/viral infection. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2/ Influenza A+B/RSV/Adenovirus infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19, Influenza A+B ,RSV and Adenovirus. The SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test is intended for use by trained clinical laboratory personnel.2022-08-24 09:08:01 CET2111Immuno-AntigenNoImmunoassayQualitativeSandwich15LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.032AU(Adenovirus)False positives0.023AU(SARS-CoV-2),False positives0.051AU(RSV),False positives0.054AU(Influenza Type B),False positives0.03AU(Influenza Type A),False negatives0.006AU(Influenza Type A),False negatives0.015AU(Adenovirus)False negatives0.016AU(RSV),False negatives0.006AU(Influenza Type B),False negatives0.01AU(SARS-CoV-2),PrecisionEvaluatedAccuracy98.3%Antigen)(Adenovirus).Accuracy99.2%(Antigen)(Influenza Type A);Accuracy98.6%(Antigen)(SARS-CoV-2);Accuracy99%(Antigen)(Influenza Type B);Accuracy97.9%(Antigen)(RSV);ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.7%(Antigen)(SARS-CoV-2);Clinical Sensitivity97%(Antigen)(Influenza Type A);Clinical Sensitivity94.6%(Antigen)(Influenza Type B);Clinical Sensitivity94.9%(Antigen)(RSV);Clinical Sensitivity96.8%(Antigen)(Adenovirus).Clinical Specificity99%(Antigen)(SARS-CoV-2);Clinical Specificity99.4(Antigen)(Influenza Type A);Clinical Specificity99.4(Antigen)(Influenza Type B);Clinical Specificity98.4Antigen)(RSV);Clinical Specificity98.5(Antigen)(Adenovirus).Type of antigenNucleoprotein2411SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae Antigen Combo Rapid Test (Nasopharyngeal Swab)890Acro Biotech Inc.United Stateswww.acrobiotech.comYesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThe SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae Antigen Combo Rapid Test (Nasopharyngeal Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2, Influenza A, Influenza B, Respiratory Syncytial Virus(RSV), Adenovirus and M.pneumoniae antigens in nasopharyngeal swab specimens from individuals with suspected SARS-CoV-2/Influenza/RSV/Adenovirus/M.pneumoniae infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2, Influenza A+B, RSV, Adenovirus and M.pneumoniae antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of correlative antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out other bacterial/viral infection. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2/ Influenza A+B/RSV/Adenovirus/M.pneumoniae infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19, Influenza A+B,RSV, Adenovirus and M.pneumoniae. The SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae Antigen Combo Rapid Test is intended for use by trained clinical laboratory personnel.2022-08-24 09:08:01 CET2113Immuno-AntigenNoImmunoassayQualitativeSandwich15LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.071AU(M.pneumoniae)False positives0.023AU(SARS-CoV-2)False positives0.032AUAdenovirus)False positives0.051AU(RSV)False positives0.054AU((Influenza B)False positives0.03AU(Influenza A)False negatives0.006AU((Influenza BFalse negatives0.028AU(M.pneumoniae)False negatives0.015AU(Adenovirus)False negatives0.016AU(RSV)False negatives0.006AU(Influenza A)False negatives0.01AU(SARS-CoV-2)PrecisionEvaluatedAccuracy97.9%(Antigen)(RSV);Accuracy99.2%(Antigen)(Influenza A);Accuracy99%Antigen)((Influenza B);Accuracy98.3%(Antigen)(Adenovirus);Accuracy96.6%(Antigen)(M.pneumoniae)Accuracy98.6%(Antigen)(SARS-CoV-2);ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.6%(Antigen)((Influenza B);Clinical Sensitivity92.9%(Antigen)(M.pneumoniae)Clinical Sensitivity96.8%Antigen)(Adenovirus);Clinical Sensitivity94.9%(Antigen)(RSV);Clinical Sensitivity97%Antigen)(Influenza A);Clinical Sensitivity97.7%(Antigen)(SARS-CoV-2);Clinical Specificity99%(Antigen)(SARS-CoV-2);Clinical Specificity99.4%(Antigen)(Influenza A);Clinical Specificity99.4%(Antigen)((Influenza B);Clinical Specificity98.4%(Antigen)(RSV);Clinical Specificity98.5%(Antigen)(Adenovirus);Clinical Specificity97.2%(Antigen)(M.pneumoniae)Type of antigenAUNucleoprotein2245Actim SARS-CoV-21044Actim OyFinlandhttps://www.actimtest.com/YesCommercialisedNoNoManualAntigenNasopharyngeal swabSARS-CoV689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1132B.1.427Epsilon1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta678B.1.1.529Omicronnucleocapsid proteinInstructions for use available at: https://www.actimtest.com/wp-content/uploads/2021/06/Kayttoohje-Actim-SARS-CoV-2_AOACE35522_LR.pdf2022-08-24 09:08:01 CET1946Immuno-AntigenYesNoNoImmunochromatographyQualitativeMembrane-based15LOD200TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%0/149False negatives15%15/100PrecisionEvaluatedAccuracy99%Ct values < 33ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%Ct values < 25Clinical Sensitivity96%Ct < 30Clinical Specificity100%Type of antigenNucleocapsid protein2969Actim SARS-CoV-2 + Actim Influenza A&B1044Actim OyFinlandhttps://www.actimtest.com/YesCommercialisedNoNoManualNear POC / POCAntigenNasal swabNasopharyngeal swabnucleocapsid proteinFor performance data, please see the last pages of the IFU: https://www.actimtest.com/wp-content/uploads/2021/11/IFU-Actim-SARS-CoV-2-Influenza-AB-1.pdf2022-08-24 09:08:01 CET2675Immuno-AntigenYesNoNoImmunochromatographyQualitativeMembrane-based15LODSee IFU in additional information.CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positivesSee IFU in additional information.False negativesSee IFU in additional information.PrecisionEvaluatedAccuracy95%SARS-CoV-2 Nasal (Antigen)Accuracy94%SARS-CoV-2 Nasopharyngeal (Antigen), nasal 95(Antigen). Influenza A 97 (Antigen), Influenza B 98(Antigen).Accuracy97%Influenza A (Antigen)Accuracy98%Influenza B (Antigen)ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity85%SARS-CoV-2 Nasopharingeal (Antigen)Clinical Sensitivity89%SARS-CoV-2 Nasal (Antigen)Clinical Sensitivity86%Influenza A (Antigen)Clinical Specificity100%AntigenType of antigenNucleocapsid protein2459Acura Speichel-Test Diagnos COVID-19 Antigen Saliva Test Kit1122Acura Kliniken Baden-Baden GmbHGermanyhttps://acura-kliniken.com/YesCommercialisedNoNoManualAntibodyAntigenDeep (cough) sputumOropharyngeal swabOther biological fluidsSaliva689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2Zetanucleocapsid proteinPleas contact B.Grunberg: B.Grunberg@acura-kliniken.com2022-08-24 09:08:01 CET2162Immuno-AntigenYesNoImmunochromatographyQualitativeMembrane-basedColloidal gold15LOD0AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy98.2%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.1%Clinical Specificity99.33%Type of antigenNucleoprotein2896RAPiDgen SARS-CoV-2 Ag Test304ADALTIS srlItalywww.adaltis.net/YesCommercialisedNoNoLab-basedManualNear POC / POCAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1321B.1.617.2Delta678B.1.1.529Omicronnucleocapsid proteinFor all study participants the antigen rapid test correctly identified 91.87% of infected participants, and 99.04% of noninfected participants . For patients with a relatively high viral load (Ct≤30), the relative sensitivity was 95.74% (N=188). The RAPiDgenSARS-CoV-2 Ag Test detects SARS-CoV-2 nucleoprotein (N). This protein has 419 amino acids. The RAPiDgenSARS-CoV-2 Ag Test detects the C-terminal end of this protein (specifically AA247-364)2022-08-24 09:08:01 CET2601Immuno-AntigenYesNoImmunochromatographyQualitative20LOD400TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.95%4 on 418 negative samples tested during the clinical trialFalse negatives8.12%16 on 197 positive samples tested during the clinical trialPrecisionEvaluatedAccuracy96.75%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity91.87%AntigenClinical Specificity0.04%AntigenType of antigenNucleocapsid protein2448SARS-CoV-2 Antigen Rapid Test Kit (Fluorescence Immunochromatography)1115ADS Biotec Inc.United Stateswww.adsbiotec.comYesCommercialisedNoNoManualAntigenNasopharyngeal swabOropharyngeal swabSerum689B.1.1.7Alpha1032B.1.351Betahttp://4ffkhs61xjo3g7q3l6b7s61t.wpengine.netdna-cdn.com/wp-content/uploads/YIG-AR-0010-SARS-CoV-2-Antigen-Rapid-Test-CE-IVD-declaration.pdf Note: additional materials required that are not supplied include UV flashlight with a wavelength of 365 nm, vortex mixer and timer. LOD; Serum - 3.5 pg/mL Swabs - 7.0 pg/mL2022-08-24 09:08:01 CET2151Immuno-AntigenNoImmunochromatographyQualitativeMembrane-basedFluorescence15LOD7AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1% (serum) False positives0.4% (swab)False negatives4% (serum) False negatives3% (swab)PrecisionEvaluatedAccuracy97.72%(95.54%-99.23%).ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.12% antigen (swab); Clinical Sensitivity96.04%(serum)Clinical Specificity99.6% antigen (swab) Clinical Specificity98.9%(serum)Type of antigenNucleoprotein2736ADTech COVID-19 Ag RAPID KIT1241ADTech Co. Ltd.South Koreawww.adtchip.comNoCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1320B.1.617.1KappaADTech COVID-19 Ag RAPID KIT is based on immunochromatography for the qualitative determination of SARS-CoV-2 virus specific antigens in human Nasopharyngeal swab specimen.2022-08-24 09:08:01 CET2441Immuno-AntigenNoImmunochromatographyQualitativeSandwich20LOD339TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.33%1 out of 300False negatives8%8 out of 100PrecisionEvaluatedAccuracy95%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92%Clinical Specificity99.67%Type of antigenNucleocapsid protein818COVID-19 IgG/IgM LF485Advagen Biotech Ltd.Brazilwww.advagen.com.br/NoCommercialisedNoNoLab-basedAntibodyIgGIgM2022-08-24 09:08:01 CET674Immuno-AntibodyImmunoassay2676COVID-19 Antigen Rapid Test Kit (Colloidal Gold)1222AEHEALTH LIMITEDUnited KingdomYesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swabOropharyngeal swabSaliva689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaRapid diagnostic test cassette without reader.2022-08-24 09:08:01 CET2381Immuno-AntigenColloidal gold15CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives1AUPrecisionEvaluatedAccuracy97.71%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.88%Clinical Specificity99.21%Type of antigenNucleocapsid protein1091AESKULISA SARS-CoV-2 NP IgA586Aesku.DiagnosticsGermanywww.aesku.comYesCommercialisedNoNoAutomatedManualAntibodyIgA Additional info: http://en.diagreat.com/Private/Files/20200402/6372142236666949104672720.pdf https://www.aesku.com/index.php/diagnostics/aeskulisa-elisa-test-kits/infectious-serology-elisa/item/3972022-08-24 09:08:01 CET871Immuno-AntibodyYesImmunoassayQuantitativeMagnetic ElectrochemicalClinical Sensitivity98.3%Clinical Specificity99%1092AESKULISA SARS-CoV-2 NP IgG586Aesku.DiagnosticsGermanywww.aesku.comYesCommercialisedNoNoAutomatedManualAntibodyIgG Additional info: http://en.diagreat.com/Private/Files/20200402/6372142198788930846626315.pdf https://www.aesku.com/index.php/diagnostics/aeskulisa-elisa-test-kits/infectious-serology-elisa/item/3982022-08-24 09:08:01 CET872Immuno-AntibodyYesImmunoassayQuantitativeMagnetic ElectrochemicalClinical Sensitivity95.2%Clinical Specificity99%1093AESKULISA SARS-CoV-2 NP IgM586Aesku.DiagnosticsGermanywww.aesku.comYesCommercialisedNoNoAutomatedManualAntibodyIgMPlasmaSerumhttps://www.aesku.com/index.php/diagnostics/aeskulisa-elisa-test-kits/infectious-serology-elisa/item/3992022-08-24 09:08:01 CET873Immuno-AntibodyYesImmunoassayQuantitativeMagnetic Electrochemical2108AESKU.RAPID SARS-CoV-2976AESKU.DIAGNOSTICS GmbH & Co. KGGermanywww.aesku.comYesCommercialisedYesYesNear POC / POCAntigenNasal swabThroat swab689B.1.1.7AlphaIntended use: The AESKU.RAPID SARS-CoV-2 rapid test is an immunochromatographic sandwich method with two specific antibodies for the qualitative detection of the N-protein antigen in human nasal swab samples. The point-of- care test is designed to detect SARS-CoV-2 N-protein antigens detectable during the acute phase of infection. The test should be performed by healthcare professionals familiar with in vitro diagnostic methods and appropriate infection control procedures. Test principle: The AESKU.RAPID SARS-CoV-2 rapid test is based on immunochromatographic polymer technology combined with the sandwich principle for the qualitative detection of the nucleocapsid protein antigen in human nasal swab samples. The sample is mixed with colored polymer-labeled SARS-CoV-2 monoclonal antibody 1 in the test device's sample well and chromatographed along the nitrocellulose membrane. If SARS-CoV-2 antigens are present in the sample, they will bind to SARS-CoV-2 antibody 1, and the mixture will bind to immobilized SARS-CoV-2 antibody 2 on the nitrocellulose membrane. The resulting complex of antibody 1, antigen, and antibody 2 forms the colored test line. The test device's control line is coated with secondary antibodies, resulting in a colored result during a standard test procedure.2022-10-17 12:52:06 CET5203Immuno-AntigenYesNoImmunoassayQualitativeSandwich, Double15LOD50AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives1.8%4 false positives out of 222 negative samplesFalse negatives3.66%4 false negatives out of 109 positive samplesPrecisionEvaluatedAccuracy0%(Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96% (Antigen)Clinical Specificity98% (Antigen)Type of antigenNucleoprotein2136InfectCheck® - COVID-19 IgG/IgM Test987Affimedix Inc.United Stateswww.affimedix.comYesCommercialisedNoNoNear POC / POCIgGIgMPlasmaSerumWhole blood1132B.1.427Epsilon1137B.1.429EpsilonDigital result reading with a Reader2022-08-24 09:08:01 CET1826Immuno-AntibodyNoImmunochromatographyQuantitativeSandwich15LOD0AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracy99.8%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.3%Clinical Specificity99.7%Type of antigenNucleoprotein2137InfectCheck® COVID-19 NAb Test987Affimedix Inc.United Stateswww.affimedix.comYesCommercialisedNoNoNear POC / POCIgGPlasmaSerumWhole blood1132B.1.427Epsilon1137B.1.429EpsilonInfectCheck® COVID-19 NAb Test is an in vitro Rapid “Sandwich” immunochromatography test for the “Quantitative” detection of circulating functional Neutralizing Antibodies (NAb) Titer post COVID-19 Vaccination or after SARS-CoV-2 Infection using a Reader. InfectCheck® COVID-19 NAb Test is a Point-Of-Care finger-prick whole blood Quantitative test for checking the efficacy of COVID-19 vaccines and monitoring the levels of NAb Titer longitudinally to help determine duration of immunity. InfectCheck® COVID-19 NAb Test uses Receptor Binding Domain (RBD) of the viral Spike Protein (S), and it detects Neutralizing Antibodies (NAb) that neutralize the RBD-ACE2 interaction. RBD is the major neutralizing determinant for SARS-CoV-2. Clinical study has shown that serum IgG against RBD best correlates with virus-neutralizing activity and disease severity (https://www.jimmunol.org/content/206/10/2393) InfectCheck® COVID-19 NAb Test has been standardized against “First WHO International Standard for anti-SARS-CoV-2 Immunoglobulins” (NIBSC Code: 20/136) with excellent Correlation Coefficient (R2 = 0.99). Limit of Detection (LOD): 25 – 50 BAU/ml (Test Lot dependent).2022-08-24 09:08:01 CET1827Immuno-AntibodyYesImmunochromatographyQuantitativeSandwich15NAb testLOD0CalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracy98.97%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.17%Clinical Specificity98.67%Type of antigenOther2130TestNOW® - COVID-19 Antigen Test987Affimedix Inc.United Stateswww.affimedix.comYesCommercialisedYesYesNear POC / POCAntigenAnterior nasal swabNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1321B.1.617.2Deltanucleocapsid proteinDigital Result option available with a Reader.2022-08-24 09:08:01 CET1820Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich15LOD126TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.6%False negatives3.9%PrecisionEvaluatedAccuracy98.4%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.1%Anterior Nasal SwabClinical Sensitivity95%Nasopharyngeal SwabClinical Specificity100%Anterior Nasal SwabClinical Specificity99.2%Nasopharyngeal SwabType of antigenNucleocapsid protein2132TestNOW® - COVID-19 IgG/IgM Test987Affimedix Inc.United Stateswww.affimedix.comYesCommercialisedNoNoNear POC / POCIgGIgMPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429EpsilonDigital Result reading with a Reader2022-08-24 09:08:01 CET1822Immuno-AntibodyNoImmunochromatographyQualitativeSandwich15LOD0AU0CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positivesN.A.False negativesN.A.PrecisionEvaluatedAccuracy96.8%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.3%Clinical Specificity99.8%Type of antigenNucleoprotein2134TestNOW® - COVID-19 NAb Quantitative Test987Affimedix Inc.United Stateswww.affimedix.comYesCommercialisedNoNoNear POC / POCIgGPlasmaSerumWhole blood1132B.1.427Epsilon1137B.1.429EpsilonTestNOW® - COVID-19 NAb Quantitative Test is an in vitro Rapid “Sandwich” immunochromatography test for the “Quantitative” detection of circulating functional Neutralizing Antibodies (NAb) Titer post COVID-19 Vaccination or after SARS-CoV-2 Infection using a Reader. TestNOW® - COVID-19 NAb Quantitative Test is a Point-Of-Care finger-prick whole blood Quantitative test for checking the efficacy of COVID-19 vaccines and monitoring the levels of NAb Titer longitudinally to help determine duration of immunity. TestNOW® - COVID-19 NAb Quantitative Test uses Receptor Binding Domain (RBD) of the viral Spike Protein (S), and it detects Neutralizing Antibodies (NAb) that neutralize the RBD-ACE2 interaction. RBD is the major neutralizing determinant for SARS-CoV-2. Clinical study has shown that serum IgG against RBD best correlates with virus-neutralizing activity and disease severity (https://www.jimmunol.org/content/206/10/2393) TestNOW® - COVID-19 NAb Quantitative Test has been standardized against “First WHO International Standard for anti-SARS-CoV-2 Immunoglobulins” (NIBSC Code: 20/136) with excellent Correlation Coefficient (R2 = 0.99). Limit of Detection (LOD): 25 – 50 BAU/ml (Test Lot dependent).2022-08-24 09:08:01 CET1824Immuno-AntibodyYesImmunochromatographyQuantitativeSandwich15LODAU0CalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracy98.97%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.17%Clinical Specificity98.67%994Acro 2019-nCoV IgG/IgM pikatesti594AIDIANFinlandwww.aidian.eu/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2022-08-24 09:08:01 CET902Immuno-AntibodyYesNoImmunoassayQualitative203036Novel Coronavirus (2019-nCoV) Antigen Detection Kit (AIE Fluorescence Immunochromatography)1351AIETech Co. Ltd.ChinaYesCommercialisedNoNoNear POC / POCAntigenAnterior nasal swabCoronaviruses (HCoV)689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1321B.1.617.2Delta1323B.1.621Mu2041C.37Lambda678B.1.1.529Omicronnucleocapsid proteinfrist application2022-08-24 09:08:01 CET2742Immuno-AntigenNoYesImmunochromatographyQualitativeSandwichFluorescence15LOD140TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.48AUFalse negatives10.68AUPrecisionEvaluatedAccuracy96.15%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity89.32%Clinical Specificity99.52%Type of antigenNucleocapsid protein3022COVID-19 Antigen Rapid Test Kit (Colloidal Gold)1341Aikang Diagnostics Co. Ltd.Chinahttp://www.aikang-medical.comYesCommercialisedNoNoNear POC / POCAntigenSaliva1321B.1.617.2Delta678B.1.1.529Omicronnucleocapsid proteinUsed for the in vitro qualitative detection of the novel coronavirus (COVID-19) N protein antigen in human saliva samples from posterior oropharynx.2022-08-24 09:08:01 CET2728Immuno-AntigenImmunochromatographyColloidal gold15LOD300TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives3.54%False negatives0.62%PrecisionEvaluatedAccuracy98.62%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.46%Clinical Specificity99.38%Type of antigenNucleocapsid protein3016COVID-19 Antigen Test Kit (Immunochromatography)1341Aikang Diagnostics Co. Ltd.Chinahttp://www.aikang-medical.comYesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swabSARS-CoV1321B.1.617.2Delta678B.1.1.529Omicronnucleocapsid proteinThe kit is used for in vitro qualitative detection of the novel coronavirus (COVID-19) N protein antigen in human nasopharyngeal swabs.2022-08-24 09:08:01 CET2722Immuno-AntigenImmunochromatography15LOD100TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives4.26%False negatives0.72%PrecisionEvaluatedAccuracy98.38%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.74%Clinical Specificity99.28%Type of antigenNucleocapsid protein3023COVID-19 Antigen Test Kit (Saliva)1341Aikang Diagnostics Co. Ltd.Chinahttp://www.aikang-medical.comYesCommercialisedNoNoNear POC / POCAntigenSaliva1321B.1.617.2Delta678B.1.1.529Omicronnucleocapsid proteinUsed for the in vitro qualitative detection of the novel coronavirus (COVID-19) N protein antigen in human saliva samples2022-08-24 09:08:01 CET2729Immuno-AntigenImmunochromatographyQualitative15LOD600TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives5%False negatives0.75%PrecisionEvaluatedAccuracy98.15%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95%Clinical Specificity99.25%Type of antigenNucleocapsid protein3017COVID-19 Antigen Test Kit(Immunochromatography)1341Aikang Diagnostics Co. Ltd.Chinahttp://www.aikang-medical.comYesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swabAdenovirusAlpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)MERS-CoVSARS-CoVInfluenza AInfluenza A H1N1Influenza BMycoplasma PneumoniaeParainfluenza Virus Type 1Parainfluenza Virus Type 2Parainfluenza Virus Type 3Parainfluenza Virus Type 4Respiratory Syncytial V (RSV)Rhinovirus1321B.1.617.2Delta678B.1.1.529Omicronnucleocapsid proteinThe kit is used for in vitro qualitative detection of the novel coronavirus (COVID-19) N protein antigen in human nasopharyngeal swabs.2022-08-24 09:08:01 CET2723Immuno-AntigenYesNoImmunochromatography15LOD100TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives4.26%False negatives0.72%PrecisionEvaluatedAccuracy98.38%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.74%Clinical Specificity99.28%Type of antigenNucleocapsid protein3024COVID-19 Antigen Test Kit(Nasal/Nasopharyngeal/Oropharyngeal/Saliva)1341Aikang Diagnostics Co. Ltd.Chinahttp://www.aikang-medical.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabSaliva1321B.1.617.2Delta678B.1.1.529Omicronnucleocapsid proteinThe kit is used for in vitro qualitative detection of the novel coronavirus (COVID-19) N protein antigen in human nasopharyngeal swabs, nasal swabs, oropharyngeal swabs or saliva samples.2022-08-24 09:08:01 CET2730Immuno-AntigenImmunochromatographyQualitative15LOD100TCID50/mlNasal swabLOD300TCID50/mlSaliva swabLOD300TCID50/mlOropharyngeal swabLOD100TCID50/mlNasopharyngeal swabCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.94%Nasopharyngeal swabFalse positives0.94%Nasal swabsFalse positives0.94%Oropharyngeal swabFalse positives0.94%SalivaFalse negatives0.48%Nasal swabFalse negatives0.72%Nasopharyngeal swabFalse negatives0.48%Oropharyngeal swabFalse negatives0.72%SalivaPrecisionEvaluatedAccuracy99.43%Nasal swabAccuracy99.05%SalivaAccuracy99.43%Oropharyngeal swabAccuracy99.24%Nasopharyngeal swabReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.06%Nasal swabClinical Sensitivity99.06%Nasopharyngeal swabClinical Sensitivity99.06%Oropharyngeal swabClinical Sensitivity98.11%SalivaClinical Specificity99.52%Nasal swabClinical Specificity99.28%Nasopharyngeal swabClinical Specificity99.52%Oropharyngeal swabClinical Specificity99.28%SalivaType of antigenNucleocapsid protein18COVID-19 IgG/IgM Rapid Test (colloidal gold-based)14AIVD Biotech Inc.Chinawww.aivdbiotech.cn/NoIn developmentNoNoNear POC / POCAntibodyIgGIgMWhole blood http://en.keweidiagnostic.com/uploadfile/2020/0702/20200702085141757.pdf 2022-08-24 09:08:01 CET1847Immuno-AntibodyImmunoassayQualitativeColloidal gold1510022019nCoV IgG/IgM Rapid test Device534AkralabSpainwww.akralab.es/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole bloodnucleocapsid protein http://en.keweidiagnostic.com/uploadfile/2020/0721/20200721032246798.pdf 2022-08-24 09:08:01 CET776Immuno-AntibodyYesNoImmunoassayQualitative15Type of antigennucleocapsid protein from SARS-CoV-2 COVID-1921DrivenFlow COVID-1917Alfa Scientific Designs Inc.United Stateswww.alfascientific.com/YesCommercialisedNoNoNear POC / POCAntibody2022-08-24 09:08:01 CET21Immuno-AntibodyYesImmunoassay958Instant-view PLUS COVID-19 Test17Alfa Scientific Designs Inc.United Stateswww.alfascientific.com/YesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET754Immuno-AntibodyYesNoImmunoassayQualitative7Analysis of cross reactivityEvaluatedAccuracy96.7%1678Instant-view® PLUS COVID-19 Antigen Test17Alfa Scientific Designs Inc.United Stateswww.alfascientific.com/YesCommercialisedNoNoNear POC / POCAntigenNasal swabnucleocapsid protein2022-08-24 09:08:01 CET1357Immuno-AntigenYesNoImmunoassayQualitative3LOD2800AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives3 out of 171False negatives3 out of 40PrecisionNot evaluatedAccuracy97.2%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity92.5Type of antigennucleoprotein1427SARS-CoV-2 (COVID-19) serological test671ALIMETRIX Inc.United Stateswww.alimetrix.com/NoIn developmentNoNoLab-basedAntibodySerum https://www.alimetrix.com/images/Alimetrix-COVID-19.pdf2022-08-24 09:08:01 CET1186Immuno-AntibodyImmunoassayQuantitativeMicroarray microarray 1852DAILY TAMPON846ALLUM SRLItalywww.allumbiotech.comYesCommercialisedNoNoCassetteManualAntigenNasal swabThe performance of the kit was established with 600 direct nasal swabs2022-08-24 09:08:01 CET1532Immuno-AntigenNoImmunoassayQualitativeColorimetry15LOD1.6AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1%False negatives1%PrecisionEvaluatedAccuracy99%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99%Clinical Specificity99%Type of antigenNucleoprotein900AlphaBiolabs IgM-IgG Combined Antibody Rapid Test581AlphaBiolabsUnited Kingdomwww.alphabiolabs.co.ukYesCommercialisedNoNoAutomatedManualAntibodyIgGIgMWhole blood2022-08-24 09:08:01 CET856Immuno-AntibodyNoImmunoassayQualitative15Type of antigenNucleocapsid (N) antigen1803Alphadia805AlphadiaBelgiumwww.alphadia.beYesCommercialisedNoNoAutomatedIgGSerum2022-08-24 09:08:01 CET1482Immuno-AntibodyNoImmunoassaySemiquantitativeMicroarray65LOD5U/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1AUFalse negatives0AUPrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99% IgGClinical Specificity99% IgG3965SARS-CoV-2 Antigen Test Kit1402Alphagen Bio-Technology Co.,LtdChinahttp://www.alphagen-bio.com/YesIn developmentNoNoNear POC / POCAntigenNasopharyngeal swabOropharyngeal swabSARS-CoV20A.23.170AT.1678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526IotaB.1.526.1B.1.526.23939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu1439C.362041C.37LambdaOther1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid protein2022-08-24 09:08:01 CET3630Immuno-AntigenYesNoNoImmunochromatographyN.A.N.A.Colloidal gold15LOD250TCID50/mlAnalytical Sensitivity97%Analytical Specificity100%False positives0.01%False negatives0.13%Accuracy95%Clinical Sensitivity87%Clinical Specificity98%3265SARS-CoV-2 Antigen Test Kit(Colloidal Gold)1402Alphagen Bio-Technology Co.,LtdChinahttp://www.alphagen-bio.com/YesCommercialisedNoNoNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabAdenovirus 3Alpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Epstein-Barr Virus (EBV)Influenza A H1N1Influenza A H3N2Influenza A H5N1Influenza BInfluenza B VictoriaInfluenza B YamagataMERS-CoVMumps Virus (MuV)Parainfluenza Virus Type 2Respiratory Syncytial V (RSV) Type ARhinovirus20A.23.170AT.1678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526IotaB.1.526.1B.1.526.23939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu1439C.362041C.37LambdaOther1495P.1Gamma1518P.2Zeta1519P.3Thetamembrane proteinnucleocapsid protein2022-08-24 09:08:01 CET3029Immuno-AntigenYesNoNoImmunochromatographyOtherMembrane-basedColloidal gold152075COVID-19 Antigen Sealing Tube Test Strip (Colloidal Gold)960Amazing Biotech (Shanghai) Co. Ltd.ChinaYesCommercialisedYesYesNear POC / POCAntigenNasal swabNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gammanucleocapsid proteinIt is an in vitro lateral flow immunochromatographic assay for qualita-tive detection of nucleocapsid protein of SARS-CoV-2 virus in human nasopharyngeal, nasal secretion specimens directly collected from individuals suspected of COVID-19 within the first seven days after the onset of symptoms. It’s a quick and easy-to-use test in the diag-nosis of SARS-CoV-2 infection to humans. The results should not be used as the sole basis for diagnosis. The innovative design of test strip packed in a sealing tube can minimize potential biological risks of pathogen contamination to users and the environment. The test is for professional use only and can be used by medical profes-sionals, laboratory personnel or individuals trained for point-of-care test.2023-03-15 16:33:18 CET20268Immuno-AntigenYesNoImmunochromatographyQualitativeSandwichColloidal gold15LOD312TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives3.382% (Nasal Swab)False negatives0.713% (Nasal Swab)PrecisionEvaluatedAccuracy98.407% (Antigen) (Nasal Swab)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.618% (Antigen) (Nasal Swab)Clinical Specificity99.287%(Antigen) (Nasal Swab)Type of antigenNucleocapsid protein1304AMP Rapid Test SARS-CoV-2 Ag531AMEDA Labordiagnostik GmbHAustriawww.amp-med.com/YesCommercialisedYesYesNear POC / POCAntigenNasal swabNasopharyngeal swabnucleocapsid protein2022-08-24 09:08:01 CET1076Immuno-AntigenYesNoImmunochromatographyQualitative15Analysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessEvaluatedRobustnessEvaluatedClinical Sensitivity97.3%Type of antigenNucleoproteinType of antigenNucleoprotein993AMP Rapid Test SARS-CoV-2 IgG/IgM531AMEDA Labordiagnostik GmbHAustriawww.amp-med.com/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2022-08-24 09:08:01 CET1551Immuno-AntibodyImmunoassay1602Rapid Test SARS-CoV-2 Ag531AMEDA Labordiagnostik GmbHAustriawww.amp-med.com/YesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swabnucleocapsid protein2022-08-24 09:08:01 CET1283Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15Rapid diagnostic test cassette colloidal gold LOD115TCID50/mlAnalysis of cross reactivityno cross reaction with RSV type A, RSV type B, novel influenza A H1N1,, Influenza A H3N2, Influenza A H5N1, Influenza B yamagata, Influenza B Victoria, Rhinovirus, Adenovirus 3, Adenovirus 7, EV-A71, Mycobacterium tuberculosis, Micoplasma pneumoniae, MumFalse positives2.7%3 of 111False negatives0%0 of 139Accuracy98.8%Clinical Sensitivity97.3%Clinical Specificity100%Type of antigennucleocapside protein829Amela Covid-19 Antigen test478Amedica SANetherlandswww.amedicagroup.com/YesCommercialisedNoNoAutomatedManualAntigen2022-08-24 09:08:01 CET680Immuno-AntigenImmunoassay830Amela Covid-19 IgM IgG Combo test kit478Amedica SANetherlandswww.amedicagroup.com/YesCommercialisedNoNoAutomatedManualAntibodyIgGIgMWhole blood Name from the website is "Rapid SARS-CoV-2 Antibody (IgM/IgG) Test"2022-08-24 09:08:01 CET830Immuno-AntibodyNoImmunoassayQualitativeColorimetryManual or automated cassette Colloidal Gold 2936AMPER COVID-19 Antigen Rapid Testing Kit (Colloidal Gold)1275AMPER Inc.United Stateshttp://www.amperbio.comYesCommercialisedYesYesManualNear POC / POCAntigenAnterior nasal swabSARS-CoV678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1321B.1.617.2Delta1495P.1Gammanucleocapsid proteinNA2022-10-05 14:04:25 CET3932Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD625TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives6%PrecisionEvaluatedAccuracy93.64%(103/110) [95% CI, 87.44% – 96.88%]ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.64%AntigenClinical Specificity100%Type of antigenNucleocapsid protein2873AMPER COVID-19 Neutralizing Antibody Rapid Testing kit (Colloidal Gold)1275AMPER Inc.United Stateshttp://www.amperbio.comYesCommercialisedNoNoManualNear POC / POCAntibodySerumangiotensin-converting enzyme 2See IFU2022-08-24 09:08:01 CET2578Immuno-AntibodyYesYesImmunochromatographyQualitativeNeutralization Antibody (NAb)Colloidal gold30LODNot evaluatedCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives5%False negatives6%PrecisionEvaluatedAccuracy93.5%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90%Clinical Specificity97%2870AMPER RSV Antigen Rapid Test (Colloidal Gold)1275AMPER Inc.United Stateshttp://www.amperbio.comYesCommercialisedNoNoManualNear POC / POCAntigenNasal swabNasopharyngeal swabnucleocapsid proteinSee IFU, we will apply for a CE registration2022-08-24 09:08:01 CET2575Immuno-AntigenNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD156TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives3%PrecisionEvaluatedAccuracy100%RSV antigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%RSV antigenClinical Specificity100%RSV antigenType of antigenNucleocapsid protein3579Quadruple Fast Test Pen (Latex) For SARS-CoV-2 & influenza A/B antigens and COVID-19 Neutralizing antibody1275AMPER Inc.United Stateshttp://www.amperbio.comYesCommercialisedNoNoManualNear POC / POCAntigenAnterior nasal swabSalivaAdenovirusAdenovirus 3Adenovirus 7Adenovirus Subtype BAdenovirus Subtype CAlpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Anti-Nuclear AntibodyBeta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Bordetella PertussisChlamydia PneumoniaeCoronaviruses (HCoV)Cytomegalovirus (CMV)Enterovirus A71 (EV-A71)Epstein-Barr Virus (EBV)Hemophilus InfluenzaeHepatitis A Virus (HAV)Hepatitis B Virus (HBV)Hepatitis C Virus (HCV)Herpes Simplex (HSV)Human Immunodeficiency Virus (HIV)Human Metapneumovirus (HMPV)Influenza AInfluenza A H1N1Influenza A H3N2Influenza A H5N1Influenza BInfluenza B VictoriaInfluenza B YamagataMERS-CoVMumps Virus (MuV)Mycobacterium TuberculosisMycoplasma PneumoniaeOtherParainfluenza Virus TypeParainfluenza Virus Type 1Parainfluenza Virus Type 2Parainfluenza Virus Type 3Parainfluenza Virus Type 4Respiratory Syncytial V (RSV)Respiratory Syncytial V (RSV) Type ARespiratory Syncytial V (RSV) Type BRhinovirusRhinovirus ARhinovirus BSARS-CoVVaricella Zoster Virus (VZV)678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1321B.1.617.2Deltanucleocapsid protein2022-08-24 09:08:01 CET3297Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD156TCID50/mlFalse positives4.76%False negatives1.67%5799RSV-SC2-Flu Quadruplex Fast Test (Colloidal Gold) For RSV SARS-CoV-2 & Influenza A/B antigens1275AMPER Inc.United Stateshttp://www.amperbio.comYesCommercialisedNoNoManualNear POC / POCAntigenAnterior nasal swabInfluenza AInfluenza A H1N1Influenza A H3N2Influenza A H5N1Influenza BInfluenza B VictoriaInfluenza B YamagataRespiratory Syncytial V (RSV)Respiratory Syncytial V (RSV) Type ARespiratory Syncytial V (RSV) Type BSARS-CoV-220A.23.170AT.1678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526IotaB.1.526.1B.1.526.23939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu1439C.362041C.37LambdaOther1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid protein2022-12-13 10:56:49 CET5382Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD625TCID50/mlfor RSV, COVID, Flu A/BCalibrationEvaluatedAnalytical Sensitivity95%for RSV, COVID, Flu A/BAnalytical Specificity100%for RSV, COVID, Flu A/BAnalysis of cross reactivityEvaluatedFalse positives%for RSV, COVID, Flu A/BFalse negatives9%for RSV, COVID, Flu A/BPrecisionEvaluatedAccuracy98%for RSV, COVID, Flu A/BRobustnessEvaluatedClinical Sensitivity90%for RSV, COVID, Flu A/BClinical Specificity100%for RSV, COVID, Flu A/B2872SC2Flu Triplex Fast Test (Colloidal Gold) For SARS-CoV-2 & influenza A/B antigens1275AMPER Inc.United Stateshttp://www.amperbio.comYesCommercialisedNoNoManualNear POC / POCAntigenNasal swabNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1321B.1.617.2Delta2041C.37Lambda678B.1.1.529Omicronnucleocapsid proteinSee IFU2022-08-24 09:08:01 CET2577Immuno-AntigenNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD78TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives3%PrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.12%SARS-CoV-2 antigenClinical Sensitivity96.88%influenza A antigenClinical Sensitivity97.5%Influenza B antigenClinical Specificity100%SARS-CoV-2 antigenClinical Specificity100%influenza A antigenClinical Specificity100%Influenza B antigenType of antigenNucleocapsid protein12032019-nCoV Antigen Device561AMS UK (NI) Ltd.United Kingdomwww.amslabs.co.ukYesCommercialisedNoNoNear POC / POCAntigenNasal swabSaliva2022-08-24 09:08:01 CET989Immuno-AntigenYesNoImmunochromatographyQualitative15Rapid diagnostic test Lateral flow False positives0.9%False negatives9.1%Accuracy97.5%Clinical Sensitivity90.9%26052019-nCoV Antigen Device (Anterior Nasal Swab)561AMS UK (NI) Ltd.United Kingdomwww.amslabs.co.ukYesCommercialisedNoNoLab-basedManualNear POC / POCAntigenAnterior nasal swab689B.1.1.7AlphaThe 2019-nCoV Antigen Device (Anterior Nasal Swab) is a rapid chromatographic immunoassay for the qualitative detection of nucleocapsid antigen of SARS-CoV-2 in anterior nasal swab samples.2022-08-24 09:08:01 CET2310Immuno-AntigenNoImmunochromatographyQualitativeSandwich, Double15LOD625TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.5%False negatives3.7%PrecisionEvaluatedAccuracy98.1%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.3%Clinical Specificity99.5%Type of antigenNucleocapsid protein10482019-nCoV IgG/IgM Device561AMS UK (NI) Ltd.United Kingdomwww.amslabs.co.ukYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2022-08-24 09:08:01 CET819Immuno-AntibodyYesNoImmunoassayQualitative10Analysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracy95% IgGAccuracy96.7% IgMClinical Sensitivity91.8% IgGClinical Sensitivity95.7% IgMClinical Specificity96.4% IgGClinical Specificity97.3% IgM22252019-nCoV Neutralising Antibody561AMS UK (NI) Ltd.United Kingdomwww.amslabs.co.ukYesCommercialisedNoNoLab-basedManualNear POC / POCAntibodyPeripheral bloodPlasmaSerumVenous whole bloodWhole bloodWhole blood with anti-coagulantsThe 2019-nCoV Neutralization Antibody device is a rapid chromatographic immunoassay intended for the qualitative detection of neutralization antibodies against viral spike glycoprotein.2022-08-24 09:08:01 CET1926Immuno-AntibodyNoImmunochromatographyQualitativeNeutralization Antibody (NAb)15LOD500AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2.29%(3/131)False negatives2.27%(2/88)PrecisionEvaluatedAccuracy97.7%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.6%Clinical Specificity98.5%Type of antigenOther1280COVID-19 Antigen ELISA561AMS UK (NI) Ltd.United Kingdomwww.amslabs.co.ukYesCommercialisedNoNoAutomatedManualAntigen2022-08-24 09:08:01 CET1055Immuno-AntigenNoYesELISASandwich32COVID-19 Hybrid Capture Fluorescence Immunoassay Test17319Anbang (Xiamen) Biotechnology Co. Ltd.ChinaNoCommercialisedNoNoNear POC / POCAntibodyWhole bloodSARS-CoV-2678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351BetaOther2023-06-20 13:33:41 CET21076Immuno-AntibodyYesNoNoImmunoassayQualitativeN.A.Colorimetry15LOD40N.A.CalibrationNot evaluatedAnalytical Sensitivity97.7%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives100%False negatives97.7%PrecisionEvaluatedAccuracy99.2%RobustnessNot evaluatedClinical Sensitivity97.7%Clinical Specificity100%2604Rapid COVID-19 Antigen Test (Colloidal Gold )/ Saliva307Anbio (Xiamen) Biotechnology Co. Ltd.Chinawww.anbio.comYesCommercialisedNoNoManualNear POC / POCAntigenNasopharyngeal swabCoronaviruses (HCoV)678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1321B.1.617.2Delta1495P.1Gammanucleocapsid proteinCertified CE1434 by Notified Body of POLISH CENTRE FOR TESTING AND CERTIFICATION (POLSKIE CENTRUM BADAN I CERTYFIKACJI)2022-08-24 15:42:41 CET3708Immuno-AntigenYesNoNoImmunoassayQualitativeSandwich, DoubleColloidal gold15LOD150TCID50/mlCalibrationNot evaluatedAnalytical Sensitivity98.33%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives0%False negatives1.67%PrecisionEvaluatedAccuracy99.52%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.06%Clinical Specificity100%Type of antigenNucleocapsid protein1822Rapid COVID-19 Antigen Test (Colloidal Gold)307Anbio (Xiamen) Biotechnology Co. Ltd.Chinawww.anbio.comYesCommercialisedYesYesNear POC / POCAntigenNasal swabNasopharyngeal swabThroat swabCoronaviruses (HCoV)689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1321B.1.617.2Delta678B.1.1.529Omicronnucleocapsid protein2022-08-24 09:08:01 CET1732Immuno-AntigenYesNoNoImmunoassayQualitativeSandwich, DoubleColloidal gold15LOD150TCID50/mlAnalysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracy99.5%Nasopharyngeal SwabAccuracy99.3%Nasal SwabAccuracy99.2%Throat SwabReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.33%Nasopharyngeal SwabClinical Sensitivity97.33%Nasal SwabClinical Sensitivity97.67%Throat SwabClinical Specificity100%Nasopharyngeal SwabClinical Specificity100%Nasal SwabClinical Specificity100%Throat SwabType of antigenNucleocapsid protein2239Rapid COVID-19 Antigen Test（Colloidal Gold）1040Anbio (Xiamen) Biotechnology Co. Ltd.Chinawww.anbio.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabSalivaThroat swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaApproved by Germany Approved by Paul-Ehrlich-Institut，list on BfArm self test list，the number is 5640-S-058（saliva）and 5640-S-310（Nasal Swab）.According to the evaluation report of PacGenomics Clinical Genetics Laboratory in the United States, the sensitivity and specificity of Anbio's Rapid COVID-19 Antigen test kit （Colloidal Gold） are 98.51% and 99.63%.2022-08-24 09:08:01 CET1940Immuno-AntigenNoImmunochromatographyQuantitativeSandwichColloidal gold15LOD150AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives1AUPrecisionEvaluatedAccuracy99.52%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.18%Clinical Specificity100%Type of antigenNucleoprotein4142COVID- 19 Antigen Rapid Test Kit3179Anhui Bessie Biological Technology Co. ，Ltd.Chinawww.bessiebio.comYesCommercialisedNoNoManualIgMAntigenNasopharyngeal swabAdenovirusAdenovirus 3Adenovirus 7Adenovirus Subtype BAdenovirus Subtype CAlpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Anti-Nuclear AntibodyBeta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Bordetella PertussisChlamydia PneumoniaeCoronaviruses (HCoV)Cytomegalovirus (CMV)Enterovirus A71 (EV-A71)Epstein-Barr Virus (EBV)Hemophilus InfluenzaeHepatitis A Virus (HAV)Hepatitis B Virus (HBV)Hepatitis C Virus (HCV)Herpes Simplex (HSV)Human Immunodeficiency Virus (HIV)Human Metapneumovirus (HMPV)Influenza AInfluenza A H1N1Influenza A H3N2Influenza A H5N1Influenza BInfluenza B VictoriaInfluenza B YamagataMERS-CoVMumps Virus (MuV)Mycobacterium TuberculosisMycoplasma PneumoniaeOtherParainfluenza Virus TypeParainfluenza Virus Type 1Parainfluenza Virus Type 2Parainfluenza Virus Type 3Parainfluenza Virus Type 4Respiratory Syncytial V (RSV)Respiratory Syncytial V (RSV) Type ARespiratory Syncytial V (RSV) Type BRhinovirusRhinovirus ARhinovirus BSARS-CoVSARS-CoV-2Varicella Zoster Virus (VZV)20A.23.170AT.1678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526IotaB.1.526.1B.1.526.23939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu1439C.362041C.37LambdaOther1495P.1Gamma1518P.2Zeta1519P.3Thetanon-structural protein NS10non-structural protein NS3a2022-10-18 15:13:13 CET5212Immuno-AntigenYesNoNoChromatographyQualitativeSandwich, DoubleColloidal gold15LOD175TCID50/mlCalibrationNot evaluatedAnalytical Sensitivity96.03%Analytical Specificity98.83%Analysis of cross reactivityEvaluatedFalse positives1.3%False negatives3.4%PrecisionEvaluatedAccuracy97.5%RobustnessEvaluatedClinical Sensitivity96.03%Clinical Specificity98.83%34Colloidal gold strip for SARS-CoV-2 IgG & IgM24Anhui Deep Blue Medical Technology Co. Ltd.Chinawww.dbluemedical.comNoCommercialisedNoNoNear POC / POCAntibodyIgGIgM2022-08-24 09:08:01 CET28Immuno-AntibodyYesImmunoassayColloidal goldRapid diagnostic test 1736COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold)24Anhui Deep Blue Medical Technology Co. Ltd.Chinawww.dbluemedical.comYesCommercialisedYesYesNear POC / POCAntigenAnterior nasal swabNasopharyngeal swabOropharyngeal swabSARS-CoV689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.2678B.1.1.529Omicron1518P.2Zetanucleocapsid protein1. Passed the UK Department of Health and Social Care (DHSC) Phase 3B validation. - Only 4 to 5 manufacturers all over the world have passed Phase 3B. 2. Germany PEI Eveluation. 3. Delta and Omicron variants clinical validation in EU countries.2022-08-24 09:08:01 CET1415Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich, DoubleColorimetry15Other pathogens tested for cross-reactivity: Streptococcus pneumoniae, Streptococcus pyogenes, Candida albicans, Pneumocystis jirovecii, Legionella pneumophila, Pseudomonas Aeruginosa, Staphylococcus Epidermidis, Streptococcus SalivariusLOD80TCID50/mlAnalysis of cross reactivityEvaluatedFalse positives0.2%False negatives3.6%PrecisionEvaluatedAccuracy99.03%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.4%Clinical Specificity99.8%Type of antigenNucleocapsid protein1589COVID-19 (Sars-CoV-2) Antigen Test Kit (Colloidal Gold) - (Nasal swab/saliva)24Anhui Deep Blue Medical Technology Co. Ltd.Chinawww.dbluemedical.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabSalivanucleocapsid protein website not accessible (considered suspicious for the EC) 2022-08-24 09:08:01 CET1269Immuno-AntigenYesNoImmunoassayQualitativeColorimetry20Rapid diagnostic test cassette LOD320AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0False negatives3.6PrecisionEvaluatedAccuracy99.03%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.4%Type of antigennucleoprotein1815COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold) - Nasal Swab24Anhui Deep Blue Medical Technology Co. Ltd.Chinawww.dbluemedical.comYesCommercialisedYesYesNear POC / POCAntigenAnterior nasal swabNasal swabnucleocapsid proteinPlease check attached UK national systematic evaluation report with the detailed data from UK government validation, performed by University of Oxford. Public Health England Porton Down. 132 brands were tested and only 4 suppliers have passed all of the Phase 3B validation, including ANHUI DEEPBLUE MEDICAL. The link of this report: https://www.medrxiv.org/content/10.1101/2021.01.13.21249563v1.full-text Please check attached UK national systematic evaluation report with the detailed data from UK government validation, performed by University of Oxford. Public Health England Porton Down. 132 brands were tested and only 4 suppliers have passed all of the Phase 3B validation, including ANHUI DEEPBLUE MEDICAL. The link of this report: https://www.medrxiv.org/content/10.1101/2021.01.13.21249563v1.full-text And we have attached the MHRA registration certificate. Also the registration in Germany, registration in Italy, registration in Portugal and so on.2022-08-24 09:08:01 CET1493Immuno-AntigenYesNoImmunochromatographyQualitativeColorimetry20LOD320AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.2%False negatives3.6%PrecisionEvaluatedAccuracy99.03%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.4%Clinical Specificity99.8%Type of antigenNucleoprotein2750COVID-19 (SARS-CoV-2) Antigen Test Kit (self-testing)24Anhui Deep Blue Medical Technology Co. Ltd.Chinawww.dbluemedical.comYesCommercialisedNoNoNear POC / POCAntigenAnterior nasal swabNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaWe obtained CE1434 self-test certificate and the registration in Germany, registration in Italy, registration in Portugal and so on.Also we have attached the MHRA registration certificate. Please check attached UK national systematic evaluation report with the detailed data from UK government validation, performed by University of Oxford. Public Health England Porton Down. 132 brands were tested and only 4 suppliers have passed all of the Phase 3B validation, including ANHUI DEEPBLUE MEDICAL. The link of this report: https://www.medrxiv.org/content/10.1101/2021.01.13.21249563v1.full-text Please check attached UK national systematic evaluation report with the detailed data from UK government validation, performed by University of Oxford. Public Health England Porton Down. 132 brands were tested and only 4 suppliers have passed all of the Phase 3B validation, including ANHUI DEEPBLUE MEDICAL. The link of this report: https://www.medrxiv.org/content/10.1101/2021.01.13.21249563v1.full-text2022-08-24 09:08:01 CET2455Immuno-AntigenYesImmunochromatographyQualitativeColloidal gold15LOD80AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.2%False negatives3.6%PrecisionEvaluatedAccuracy99.03%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.4%Clinical Specificity99.8%Type of antigenNucleocapsid protein2651COVID-19 (SARS-CoV-2) Antigen Test Midstream — Saliva1020Anhui Deep Blue Medical Technology Co. Ltd.Chinawww.dbluemedical.comYesCommercialisedNoNoNear POC / POCAntigenSaliva689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThis product is used for in vitro qualitative detection of the antigen of SARS-CoV-2 in human saliva specimen. It finished registration in Germany and also in German BfArM List.2022-08-24 09:08:01 CET2356Immuno-AntigenImmunochromatography15LOD80TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.05%False negatives2.5%PrecisionEvaluatedAccuracy98.8%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.5%Clinical Specificity99.5%Type of antigenNucleocapsid protein510COVID-19 (SARS-CoV-2) IgG/IgM Antibody Test Kit24Anhui Deep Blue Medical Technology Co. Ltd.Chinawww.dbluemedical.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2022-08-24 09:08:01 CET404Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15Rapid diagnostic test Strip Colloidal Gold 2189COVID-19 (SARS-CoV-2) Neutralizing Antibody (Double Antigen Sandwich) Test Kit (Colloidal Gold)1020Anhui Deep Blue Medical Technology Co. Ltd.Chinawww.dbluemedical.comYesCommercialisedNoNoManualAntibodyPlasmaSerumVenous whole bloodWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThis product is used for in vitro qualitative detection of novel coronavirus(COVID-19)(Sars-CoV-2) neutralizing antibody in human serum, plasma, whole blood and/or fingertip blood. This product uses double antigen sandwich method for detection. The gold label pad is marked with S-RBD-mFc C-terminal, and the detection line is coated with S-RBD-mFc N-terminal. When the sample contains neutralizing antibody, it will bind to S-RBD-mFc C-terminal, then the complex will be captured by pre-coated S-RBD-mFc N-terminal and the T line will show color. When the sample does not contain neutralizing antibodies, the T line will not show color. The quality control line is coated with goat anti-mouse polyclonal antibody. The C line will show color regardless of whether the sample contains neutralizing antibody.2022-08-24 09:08:01 CET1890Immuno-AntibodyImmunochromatographyQualitativeNeutralization Antibody (NAb)Colloidal gold15LOD20AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives3%False negatives7%PrecisionEvaluatedAccuracy95%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93%Clinical Specificity97%Type of antigenOther2198COVID-19 (SARS-CoV-2) Neutralizing Antibody IgG Test Kit (Colloidal Gold)1020Anhui Deep Blue Medical Technology Co. Ltd.Chinawww.dbluemedical.comYesCommercialisedNoNoManualIgGPlasmaSerumVenous whole bloodWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThis product is used for in vitro qualitative detection of novel coronavirus(COVID-19)(Sars-CoV-2) neutralizing antibody IgG in human serum, plasma, whole blood and/or fingertip blood. This product uses capture method for detection. The gold label pad is marked with S-RBD protein, and the detection line is coated with mouse-anti-human IgG. When the sample contains neutralizing antibody IgG, it will bind to the S-RBD protein, then the complex will be captured by pre-coated mouse anti-human IgG and the T line will show color. When the sample does not contain neutralizing antibodies IgG, the T line will not show color. The quality control line is coated with goat anti-mouse polyclonal antibody. The C line will show color regardless of whether the sample contains neutralizing antibody IgG.2022-08-24 09:08:01 CET1899Immuno-AntibodyNoImmunochromatographyQualitativeCaptureColloidal gold15LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives4.2%False negatives7.8%PrecisionEvaluatedAccuracy94%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.2%Clinical Specificity95.7%Type of antigenOther2089New Coronavirus (COVID-19) Antigen Rapid Test967Anhui Formaster Biosci Co. Ltd.Chinawww.for-master.comYesCommercialisedYesYesManualAntigenNasopharyngeal swabOropharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2Zetanucleocapsid proteinCE certified2022-08-24 09:08:01 CET1772Immuno-AntigenYesNoImmunochromatographyQualitativeMembrane-based15LOD1250AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.5%3 of 200False negatives4.848%8 of 165PrecisionEvaluatedAccuracy96.99%(Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.15%(Antigen)Clinical Specificity98.5%(Antigen)Type of antigenNucleocapsid protein2480New Coronavirus (COVID-19) Antigen Rapid Test (saliva)967Anhui Formaster Biosci Co. Ltd.Chinawww.for-master.comYesCommercialisedNoNoManualAntigenSaliva689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2Zetano2022-08-24 09:08:01 CET2183Immuno-AntigenNoImmunochromatographySandwich, Double20LOD1250AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.02%False negatives3.76%PrecisionEvaluatedAccuracy98.81% (Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.24% (Antigen)Clinical Specificity99.8% (Antigen)Type of antigenNucleoprotein2375COVID-19 Virus Antigen Detection Kit（Fluorescence Immunochromatography Assay）1101Anhui Hua Pei Biotechnology Co. Ltd.ChinaNoCommercialisedNoNoNear POC / POCSemi-automatedAntigenBronchoalveolar lavage fluidNasopharyngeal swabOropharyngeal swabSerum689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1321B.1.617.2Deltanucleocapsid protein1,the antibodies used in the test kit can recognize COVID-19 virus Nucleocapsid protein(Wide type). 2, The false positive will occur if some saliva present in the sample, the tester should be trained to know how to take swab sample and avoid saliva contamination is recommended.2022-08-24 09:08:01 CET2077Immuno-AntigenYesYesImmunochromatographySemiquantitativeSandwichFluorescence15LOD0.016ng/mLCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives4.4%False negatives2.2%PrecisionEvaluatedAccuracy97%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.01%Clinical Specificity97.9%Type of antigenNucleoprotein914SARS-CoV IgG ELISA512Ansh LabsUnited Stateswww.anshlabs.com/YesCommercialisedNoNoLab-basedAntibodyIgGPlasmaSerum2022-08-24 09:08:01 CET740Immuno-AntibodyNoYesELISAQualitativeFluorescence120Analysis of cross reactivityEvaluatedClinical Sensitivity95%Clinical Specificity98.3%915SARS-CoV IgM ELISA512Ansh LabsUnited Stateswww.anshlabs.com/YesCommercialisedNoNoLab-basedAntibodyIgMPlasmaSerum2022-08-24 09:08:01 CET741Immuno-AntibodyNoYesELISAQualitativeFluorescence120Analysis of cross reactivityEvaluatedClinical Sensitivity100%Clinical Specificity98.5%1451COVID-19 Antigen Rapid Test (Vstrip)676AnTaimmu BioMedTaiwan ROCwww.antaimmu.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabnucleocapsid protein2022-08-24 09:08:01 CET1203Immuno-AntigenYesNoImmunoassayQualitativeColorimetry10LOD1.571035AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives92.31%Positive predictive value: % (95%CI: 62.97%- 98.83%) False negatives96.49%Negative predictive value: 96.49% (95%CI: 88.40%-99.00%) PrecisionEvaluatedAccuracy95.71%CI95%:: 87.98%-99.11%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity85.71%CI95%: 57.19%- 98.22%Type of antigennucleoprotein1289Novel SARS-CoV-2 Coronavirus Spike Glycoprotein Detection Kit (S Protein-ACE2 receptor)642Apollo Biomedical LLCUnited Stateswww.apollobiomedical.comYesCommercialisedNoNoNear POC / POCAntigenSputumStoolThroat swabOther2022-08-24 09:08:01 CET1063Immuno-AntigenYesN.A.ImmunoassayQualitativeRapid diagnostic test Type of antigenACE2 receptor917GenomeCov9 IgM/IgG Rapid Test Kit504Applied Biological Materials Inc.Canadawww.abmgood.com/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2022-08-24 09:08:01 CET743Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15Rapid diagnostic test Lateral flow Colloidal Gold PrecisionCV < 5%Clinical Sensitivity91%Clinical Specificity99%767Confidence COVID-19 Rapid Test462Applied Biomedical LLCUnited Stateswww.appliedbiomedical.comNoCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET637Immuno-AntibodyYesNoImmunoassayQualitative20663Adx SARS Cp V-2 Virus Antigen Rapid Point of Care Test404Aptamer Group Ltd.United Kingdomwww.aptamergroup.comNoIn developmentNoNoNear POC / POCAntigen2022-08-24 09:08:01 CET556Immuno-AntigenYesImmunoassay2079mariPOC Quick Flu+454ArcDia International Ltd.Finlandwww.arcdia.comYesCommercialisedYesYesAutomatedNear POC / POCAntigenNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1321B.1.617.2Deltanucleocapsid proteinNo crossreactivity with MERS, seasonal coronaviruses (229E, HKU1, NL63, OC43) or other common respiratory tract pathogens or normal bacterial flora. The test is designed to escape SARS-CoV strain variations. It detects so conserved epitope that it is shared also by SARSCoV(-1) from year 2003. Please update the link of the scientific publication in the online database to https://www.nature.com/articles /s41598-021-99886-6 since the article has now been peer reviewed and published.2022-08-24 09:08:01 CET1761Immuno-AntigenYesYesImmunoassaySemiquantitativeSandwich20https://www.nature.com/articles /s41598-021-99886-6 LOD5.4AUAnalysis of cross reactivityEvaluatedFalse positives0%No false positivesFalse negatives0%No false negativesPrecisionEvaluatedAccuracy100% (Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%Clinical Specificity100%Type of antigenNucleocapsid protein2078mariPOC Respi+454ArcDia International Ltd.Finlandwww.arcdia.comYesCommercialisedYesYesAutomatedNear POC / POCAntigenNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1321B.1.617.2Deltanucleocapsid proteinNo crossreactivity with MERS, seasonal coronaviruses (229E, HKU1, NL63, OC43) or other common respiratory tract pathogens or normal bacterial flora. The test is designed to escape SARS-CoV strain variations. It detects so conserved epitope that it is shared also by SARSCoV(-1) from year 2003. Most positive results are reported in 20 minutes. Low positive and negatives are reported in 120 minutes. Please update the link of the scientific publication in the online database to https://www.nature.com/articles/s41598-021-99886-6 since the article has now been peer reviewed and published.2022-08-24 09:08:01 CET1760Immuno-AntigenYesYesImmunoassaySemiquantitativeSandwich120https://www.nature.com/articles/s41598-021-99886-6 LOD2.7AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%No false positivesFalse negatives0%No false negativesPrecisionEvaluatedAccuracy100%(Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100% (Antigen)Clinical Specificity100% (Antigen)Type of antigenNucleocapsid protein768mariPOC SARS-CoV-2454ArcDia International Ltd.Finlandwww.arcdia.comYesCommercialisedYesYesAutomatedNear POC / POCAntigenNasopharyngeal swabOther689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1321B.1.617.2Deltanucleocapsid proteinNo crossreactivity with MERS, seasonal coronaviruses (229E, HKU1, NL63, OC43) or other common respiratory tract pathogens or normal bacterial flora. The test is designed to escape SARS-CoV strain variations. It detects so conserved epitope that it is shared also by SARS-CoV(-1) from year 2003.2022-08-24 09:08:01 CET622Immuno-AntigenYesYesImmunoassaySemiquantitativeSandwich20https://www.nature.com/articles/s41598-021-99886-6LOD2.7AUAnalysis of cross reactivityEvaluatedFalse positives0%noFalse negatives0%noPrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%Clinical Specificity100%Type of antigenNucleocapsid protein3568CoVard Covid-19 Nasal Antigen Test Kit1424ARDİ MEDİKAL ARAŞTIRMA VE DİAGNOSTİK ÜRÜNLERİ SAN. TİC. LTD. ŞTİ.Turkeywww.ardimed.comNoCommercialisedNoNoManualNear POC / POCAntigenNasal swabSARS-CoV678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1321B.1.617.2Delta1495P.1Gammanucleocapsid protein2022-08-24 09:08:01 CET3286Immuno-AntigenYesYesNoImmunoassayQualitativeMembrane-basedColloidal gold154000CoVard Covid-19 Rapid Antigen Test Kit1424ARDİ MEDİKAL ARAŞTIRMA VE DİAGNOSTİK ÜRÜNLERİ SAN. TİC. LTD. ŞTİ.Turkeywww.ardimed.comNoCommercialisedNoNoManualNear POC / POCAntigenNasopharyngeal swabSARS-CoV678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1321B.1.617.2Delta1495P.1Gammanucleocapsid protein2022-08-24 09:08:01 CET3665Immuno-AntigenYesNoNoImmunoassayQualitativeMembrane-basedColloidal gold152633Anti-SARS-CoV-2-Multi-Antikörper IgG/Nab-Test (IgG-Antikörper/neutralisierende Antikörper) (LFIA)1011Aripa Biotec GmbHGermanywww.aripa-biotec.comYesCommercialisedNoNoAutomatedManualAntibodyIgGPlasmaSerumVenous whole bloodWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThe anti-SARS-CoV-2 multi-antibody IgG/Nab Tests (IgG antibody/neutralising antibody) is suitable for the qualitative in vitro detection of SARS-CoV-2 neutralising antibodies and nucleocapsid protein IgG antibodies in human serum, plasma or whole blood. for vaccinated persons and recovered persons.2022-08-24 09:08:01 CET2338Immuno-AntibodyYesImmunochromatographyQuantitativeNeutralization Antibody (NAb)15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracy98.34%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.67%Clinical Specificity98.01%Type of antigenSpike protein2169COVID-19-N-Antigen Schnelltest SARS-CoV-21011Aripa Biotec GmbHGermanywww.aripa-biotec.comYesCommercialisedNoNoManualNear POC / POCAntigenNasal swabNasopharyngeal swabSARS-CoV-220A.23.170AT.1678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526IotaB.1.526.1B.1.526.23939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu1439C.362041C.37LambdaOther1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid proteinPositive coincidence rate(Ct value < 25)（Sensitivity）：99.33%(95% CI: 94.55%~99.82%) Negative coincidence rate（Specificity）：99.20%(95%CI: 96.32%~99.87%) Total coincidence rate: 99.25% (95%CI: 97.15%~99.78%)2022-11-23 08:41:09 CET5337Immuno-AntigenYesYesNoImmunochromatographyQualitativeCaptureColloidal gold10LOD28.75AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1AUFalse negatives1AUPrecisionEvaluatedAccuracy99.25%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.33% IgGClinical Specificity99.2cqType of antigenNucleoprotein1926ARISTA™ COVID-19 Antigen Rapid Test879ARISTA Biotech Pte. Ltd.Singaporewww.aristabio.comYesCommercialisedYesYesManualNear POC / POCAntigenNasopharyngeal swabSARS-CoV689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.32041C.37Lambda1439C.361323B.1.621Mu1224B.1.526Iota678B.1.1.529Omicronnucleocapsid proteinARISTA has conducted a verification study using recombinant nucleocapsid protein of the Omicron variant (B.1.1.529) and B.1.640. The results show that ARISTA™ COVID-19 Antigen Rapid Test remain fully capable in detecting the N-protein of the Omicron variant as well as the wildtype SARS-CoV-2 and the Delta Variant with similar sensitivity (LoD: 100 pg/ml).2022-08-24 09:08:01 CET1602Immuno-AntigenYesNoNoImmunoassayQualitativeMembrane-based15LOD100TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0.6%PrecisionEvaluatedAccuracy99.82%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.4%Clinical Specificity100%Type of antigenNucleocapsid protein5779Artron COVID-19 Antigen Self Test721Artron Laboratories Inc.Canadahttp://www.artronlab.com/YesCommercialisedNoNoOtherAntigenNasal swabSARS-CoV-2678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1321B.1.617.2Delta1495P.1Gammanucleocapsid protein2022-11-21 09:03:12 CET5335Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD1000TCID50/mlCalibrationNot evaluatedAnalytical Sensitivity95%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives1sampleswithin 126 negative samplesFalse negativessampleswithin 47 positive samplesPrecisionEvaluatedAccuracy99.4%RobustnessEvaluatedClinical Sensitivity100%Clinical Specificity99.2%1618Artron COVID-19 Antigen Test721Artron Laboratories Inc.Canadahttp://www.artronlab.com/YesCommercialisedYesYesNear POC / POCAntigenNasal swabNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1321B.1.617.2Delta678B.1.1.529Omicronnucleocapsid proteinArtron COVID-19 Antigen Test is a rapid and convenient immunochromatographic assay for the qualitative detection of COVID-19 antigen (viral nucleoprotein) from nasopharyngeal/nasal swab obtained from patient with signs and symptoms of respiratory infection. This test is for administration by healthcare workers and labs only, as an aid to early diagnosis of SARS-CoV-2 infection in patient with clinical symptoms of SARS-CoV-2 infection.2022-08-24 09:08:01 CET1298Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich15Rapid diagnostic test cassette LOD1000TCID50/mlAnalysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracy99.67%NasalAccuracy98.25%NasopharyngealReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity91.59%NasalClinical Sensitivity91.67%NasopharyngealClinical Specificity100%NasopharyngealClinical Specificity100%NasalType of antigenNucleoproteinType of antigenNucleocapsid protein1729Artron COVID-19 IgM/IgG Antibody Test721Artron Laboratories Inc.Canadahttp://www.artronlab.com/YesCommercialisedNoNoAutomatedManualNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2022-08-24 09:08:01 CET1409Immuno-AntibodyNoImmunoassayQualitative30Manual or automated lateral flow LOD0AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.72% IgMcombined data from 6 centersFalse positives0.22% IgGcombined data from 6 centersFalse negatives14.83% IgMcombined data from 6 centersFalse negatives6.01% IgGcombined data from 6 centersPrecisionEvaluatedAccuracy93.64% IgMcombined data from 6 centersAccuracy94.2% IgGcombined data from 6 centersReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity85.17% IgMcombined data from 6 centersClinical Sensitivity83.99% IgGcombined data from 6 centers1410Immuno-AntibodyYesNoImmunoassayQualitative15rapid diagnostic test lateral flow LOD0CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives1.87%26 false positives out of a total of 1393 RT-PCR confirmed non-COVID-19 specimensFalse negatives7.7%59 false negatives out of a total of 762 RT-PCR confirmed COVID-19 specimensPrecisionEvaluatedAccuracy96.06 (IgG+IgM)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.49 (IgG+IgM) 14 days post infection1654Asan Easy Test COVID-19 Ag741Asan Pharmaceutical Co. Ltd.South Koreawww.asanpharm.comYesCommercialisedYesYesNear POC / POCAntigenNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1132B.1.427Epsilon1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta1224B.1.526Iota1518P.2Zetanucleocapsid proteinThe Asan Easy Test® COVID-19 Ag is an in vitro diagnostic medical device that diagnoses COVID-19 by qualitatively testing SARS-CoV-2 nucleocapsid protein antigen in nasopharyngeal swab by immunochromatographic assay (ICA).2022-08-24 09:08:01 CET1733Immuno-AntibodyYesNoNoImmunochromatographyQualitativeMembrane-based15LOD590TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracy97.6%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.7%Clinical Specificity97.7%Type of antigenNucleocapsid protein1760Asan Easy Test COVID-19 IgG/IgM741Asan Pharmaceutical Co. Ltd.South Koreawww.asanpharm.comYesCommercialisedNoNoManualIgGIgMSerumWhole bloodnucleocapsid protein2022-08-24 09:08:01 CET1438Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15LOD0.2U/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives13AUFalse negatives12AUPrecisionEvaluatedAccuracy95.38%RobustnessNot evaluatedClinical Sensitivity95%Type of antigenNucleoprotein1761Asan Easy Test Flu/COVID-19 Ag Combo741Asan Pharmaceutical Co. Ltd.South Koreawww.asanpharm.comYesCommercialisedNoNoManualAntigenNasal swab2022-08-24 09:08:01 CET1440Immuno-AntigenYesNoImmunochromatographyQualitativeColorimetry15LOD1230U/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity94.7%Clinical Specificity97.4%2535KNAX-SMART SARS-CoV-2 Ag1049Asan Pharmaceutical Co. Ltd.South Koreahttp://www.asapharm.comYesCommercialisedNoNoManualNear POC / POCAntigenNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1519P.3Theta.2022-08-24 09:08:01 CET2240Immuno-AntigenNoImmunochromatographyQualitativeSandwich15LOD590AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives2.29%8/350False negatives5.33%8/150PrecisionEvaluatedAccuracy96.8%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.7%Clinical Specificity97.7%Type of antigenNucleocapsid protein2537KNAX-SMART SARS-CoV-2 IgM/IgG1049Asan Pharmaceutical Co. Ltd.South Koreahttp://www.asapharm.comYesCommercialisedNoNoManualIgGIgMSerumWhole blood.2022-08-24 09:08:01 CET2242Immuno-AntibodyNoImmunoassayQualitative15LOD0.2U/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives13AUFalse negatives12AUPrecisionEvaluatedAccuracy95.38%ReproducibilityNot evaluatedRobustnessNot evaluatedClinical Sensitivity95%Clinical Specificity-Type of antigenNucleocapsid protein2571KNAX-SMART SARS-CoV-2 IgM/IgG (N)1049Asan Pharmaceutical Co. Ltd.South Koreahttp://www.asapharm.comYesCommercialisedNoNoManualIgGIgMPlasmaSerumWhole blood2022-08-24 09:08:01 CET2276Immuno-AntibodyNoImmunochromatographyQualitativeNeutralization Antibody (NAb)15CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives3AUFalse negatives15AUPrecisionEvaluatedAccuracy100% IgGAccuracy100% IgMReproducibilityNot evaluatedRobustnessNot evaluatedClinical Sensitivity88.7%Clinical Specificity98.1%Type of antigenNucleocapsid protein2536KNAX-SMART SARS-CoV2 Influenza A&B Ag combo1049Asan Pharmaceutical Co. Ltd.South Koreahttp://www.asapharm.comYesCommercialisedNoNoManualAntigenNasal swab.2022-08-24 09:08:01 CET2241Immuno-AntigenNoImmunochromatographyQualitative15LOD1230U/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives-False negatives-PrecisionEvaluatedAccuracy-ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity94.7%Clinical Specificity97.4%1371COVID-19 & Influenza A/B Antigen Combo Test Device455Assure Tech (Hangzhou) Co. Ltd.Chinawww.diareagent.comYesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swabInfluenza AInfluenza A H1N1Influenza A H3N2Influenza BInfluenza B VictoriaInfluenza B YamagataSARS-CoV678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526Iota1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu2041C.37Lambda1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid protein2022-11-03 08:54:25 CET20276Immuno-AntigenYesNoNoImmunoassayQualitativeMembrane-basedColorimetry15False positives%False negatives3.8%Accuracy98.2%(COVID-19:98.2%, Influenza A:99.9%, Influenza B:99.7%)Clinical Sensitivity96.2%(COVID-19:96.2%, Influenza A:99.9%, Influenza B:96.0%)2280COVID-19 & Influenza A/B Antigen Nasal Test Kit455Assure Tech (Hangzhou) Co. Ltd.Chinawww.diareagent.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabInfluenza AInfluenza A H1N1Influenza A H3N2Influenza BInfluenza B VictoriaInfluenza B YamagataSARS-CoV678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526Iota1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu2041C.37Lambda1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid proteinNone2022-10-31 09:23:23 CET20275Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich, DoubleOther15LOD251TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.3%A total of 310 SARS-CoV-2 negative samples were tested, 1 samples were positive by this test.False negatives3.6%A total of 140 SARS-CoV-2 positive samples were tested, 5 samples were negative by this test.PrecisionEvaluatedAccuracy98.7%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.4%Clinical Specificity99.7%Type of antigenNucleoprotein3106COVID-19 & Influenza A/B Antigen Nasal Test Kit455Assure Tech (Hangzhou) Co. Ltd.Chinawww.diareagent.comYesCommercialisedNoNoManualNear POC / POCAntigenNasal swabSARS-CoVInfluenza AInfluenza A H1N1Influenza A H3N2Influenza BInfluenza B VictoriaInfluenza B Yamagata689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu2041C.37Lambda1224B.1.526Iota678B.1.1.529Omicron1518P.2Zetanucleocapsid proteinThe COVID-19&Influenza A/B Antigen Nasal Test Kit is an in vitro immunoassay. The assay is for the direct and qualitative detection of viral nucleocapsid proteins of SARS-CoV-2, Influenza A virus, and Influenza B virus from nasal secretions. The test is for self-testing use. Children aged between 2 and 18 years old, must be supervised or aided by an adult when carrying out the test. Negative results do not preclude these viral infections. Testing results should not be the sole basis for treatment or other management decisions. This test is intended for asymptomatic and people who with symptoms of COVID-19 within the first 7 days of symptom onset.2022-08-24 09:08:01 CET2812Immuno-AntigenYesYesNoImmunoassayQualitative15LOD251.2TCID50/ml1×10^2.4 TCID 50/mL (for SARS-CoV-2)CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.3%1/396 - Flu BFalse positives0.5%2/377 - Flu AFalse positives0.3%1/310 - COVID-19False negatives3.6%5/140 - COVID-19False negatives4.1%3/73 - Flu AFalse negatives5.6%3/54 - Flu BPrecisionEvaluatedAccuracy99.1%446/450 - Flu BAccuracy98.7%444/450 COVID-19Accuracy98.9%445/450 - Flu AReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.4%51/54 - Flu BClinical Sensitivity95.9%70/73 - Flu A Clinical Sensitivity96.4%135/140 - COVID-19Clinical Specificity99.7%309/310 - COVID-19Clinical Specificity99.5%375/377 - Flu AClinical Specificity99.7%395/396 - Flu BType of antigenNucleocapsid protein1373COVID-19 & Influenza A/B Nucleic Acid Combo Test455Assure Tech (Hangzhou) Co. Ltd.Chinawww.diareagent.comYesCommercialisedNoNoNear POC / POCAntigenOther this kit needs to be checked, in the name states nucleic acid but it is submitted as immuno-antigen2022-08-24 09:08:01 CET1137Immuno-AntigenNoNoImmunoassayQualitative120LOD500AUType of antigennucleoprotein5803COVID-19 & Influenza A/B& RSV Antigen Nasal Test Kit455Assure Tech (Hangzhou) Co. Ltd.Chinawww.diareagent.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabInfluenza AInfluenza A H1N1Influenza A H3N2Influenza BInfluenza B VictoriaInfluenza B YamagataRespiratory Syncytial V (RSV)Respiratory Syncytial V (RSV) Type ARespiratory Syncytial V (RSV) Type BSARS-CoV678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526Iota1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu2041C.37Lambda1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid protein2022-12-22 08:48:45 CET20277Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich, DoubleOther15LOD251TCID50/mlCalibrationEvaluatedAnalytical Sensitivity97%Analytical Specificity99.3%Analysis of cross reactivityEvaluatedFalse positives0.7%A total of 450 SARS-CoV-2 negative samples were tested, 3 samples were positive by this test.False negatives3%A total of 101 SARS-CoV-2 positive samples were tested, 3 samples were negative by this test.PrecisionEvaluatedAccuracy98.9%RobustnessEvaluatedClinical Sensitivity97%Clinical Specificity99.3%1372COVID-19 & M. pneumoniae Antigen Combo Test Device455Assure Tech (Hangzhou) Co. Ltd.Chinawww.diareagent.comYesCommercialisedNoNoNear POC / POCAntigenOther immunochromatography?2022-08-24 09:08:01 CET1146Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15Rapid diagnostic test colloidal gold LOD0AUAccuracy87.8%(COVID-19:87.8%; M. pneumoniae:96.6%)Clinical Sensitivity75.8%(COVID-19:75.8%, M. pneumoniae:91.4%)2277COVID-19 Antigen Nasal Test Kit455Assure Tech (Hangzhou) Co. Ltd.Chinawww.diareagent.comYesCommercialisedYesYesNear POC / POCAntigenNasal swabSARS-CoV678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526Iota1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu2041C.37Lambda1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid protein2022-09-20 17:14:49 CET5469Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich, DoubleColorimetry15LOD251TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.2%A total of 413 SARS-CoV-2 negative samples were tested, 1 samples were positive by this test.False negatives3.9%A total of 203 SARS-CoV-2 positive samples were tested, 8 samples were negative by this test.PrecisionEvaluatedAccuracy98.5%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.1%Clinical Specificity99.8%Type of antigenNucleocapsid protein2933COVID-19 Antigen Nasal Test Kit455Assure Tech (Hangzhou) Co. Ltd.Chinawww.diareagent.comYesCommercialisedNoNoManualNear POC / POCAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.3678B.1.1.529Omicronnucleocapsid proteinCE1434 certification has been completed2022-08-24 09:08:01 CET2639Immuno-AntigenYesImmunoassay15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives4.1%8 out of 195False negatives0.24%1 out of 412PrecisionEvaluatedAccuracy98.5%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.1%Clinical Specificity99.8%Type of antigenNucleocapsid protein24760COVID-19 Antigen Rapid Test Device455Assure Tech (Hangzhou) Co. Ltd.Chinawww.diareagent.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabSARS-CoV678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526Iota1320B.1.617.1Kappa1321B.1.617.2Delta1323B.1.621Mu2041C.37Lambda1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid protein2023-03-27 17:03:45 CET21039Immuno-AntigenYesNoNoImmunoassayQualitativeMembrane-basedColorimetry15LOD502TCID50/ml2×10^2.4 TCID50/mLCalibrationEvaluatedAnalytical Sensitivity92.3%Analytical Specificity99%Analysis of cross reactivityEvaluatedFalse positives0.97%A total of 309 SARS-CoV-2 negative samples were tested, 3 samples were positive by this test.False negatives7.69%A total of 104 SARS-CoV-2 positive samples were tested, 8 samples were negative by this test.PrecisionEvaluatedAccuracy97.3%RobustnessEvaluatedClinical Sensitivity92.3%Clinical Specificity99%2270COVID-19 Antigen Rapid Test Device1059Assure Tech (Hangzhou) Co. Ltd.Chinawww.diareagent.comYesCommercialisedNoNoManualNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.3678B.1.1.529Omicronnucleocapsid protein2022-08-24 09:08:01 CET1971Immuno-AntigenYesNoNoImmunoassayQualitative15LOD502AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.86%A total of 1036 SARS-CoV-2 negative samples were tested, 9 samples were positive by this test.False negatives2.34%A total of 128 SARS-CoV-2 positive samples were tested, 3 samples were negative by this RDT.PrecisionEvaluatedAccuracy99%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.7%Clinical Specificity99.1%Type of antigenNucleoproteinType of antigenNucleocapsid protein2076COVID-19 Antigen Rapid Test Device (Nasal Swab)455Assure Tech (Hangzhou) Co. Ltd.Chinawww.diareagent.comYesCommercialisedNoNoNear POC / POCAntigenNasal swab689B.1.1.7Alpha1321B.1.617.2DeltaNot available2022-08-24 09:08:01 CET1758Immuno-AntigenNoImmunoassayQualitative15LOD0AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positivesNot availableFalse negativesNot availablePrecisionEvaluatedAccuracy97.4%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity91.4%Clinical Specificity100%Type of antigenOther1579COVID-19 Antigen Saliva Test Kit455Assure Tech (Hangzhou) Co. Ltd.Chinawww.diareagent.comYesCommercialisedNoNoNear POC / POCAntigenSalivaSARS-CoV678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526Iota1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu2041C.37Lambda1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid proteinN/A2022-11-03 08:58:57 CET5279Immuno-AntigenYesNoNoImmunoassayQualitativeMembrane-basedColorimetry15LOD31.4TCID50/ml1.25×10^1.4 TCID50/mLAnalysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracy95.3%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90%Clinical Specificity97%2037COVID-19 Antigen Saliva Test Kit455Assure Tech (Hangzhou) Co. Ltd.Chinawww.diareagent.comYesCommercialisedNoNoManualNear POC / POCAntigenSalivaSARS-CoV689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526Iota1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu2041C.37Lambda1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid protein2023-01-09 10:11:42 CET5425Immuno-AntigenYesYesNoImmunoassayQualitativeMembrane-basedColorimetry15LOD31.4TCID50/ml1.25×10^1.4 TCID50/mLCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.6%False negatives13.6%PrecisionEvaluatedAccuracy94.1%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity86.4%Clinical Specificity99.4%664COVID-19 IgG/IgM Rapid Test Device455Assure Tech (Hangzhou) Co. Ltd.Chinawww.diareagent.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2022-08-24 09:08:01 CET799Immuno-AntibodyYesNoImmunoassayQualitativeNot found15Rapid diagnostic test cassette Not found 1577COVID-19 Neutralizing Antibody FIA455Assure Tech (Hangzhou) Co. Ltd.Chinawww.diareagent.comYesCommercialisedNoNoLab-basedAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET1256Immuno-AntibodyYesYesImmunoassayQualitativeFluorescence15LOD0CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positivesNot availableFalse negativesNot availablePrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%5824COVID-19& Influenza A/B& RSV Antigen Combo Rapid Test455Assure Tech (Hangzhou) Co. Ltd.Chinawww.diareagent.comYesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swabInfluenza AInfluenza A H1N1Influenza A H3N2Influenza BInfluenza B VictoriaInfluenza B YamagataRespiratory Syncytial V (RSV)Respiratory Syncytial V (RSV) Type ARespiratory Syncytial V (RSV) Type BSARS-CoV678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526Iota1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu2041C.37Lambda1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid protein2023-01-09 10:11:18 CET5424Immuno-AntigenYesNoNoImmunoassayQualitativeMembrane-basedColorimetry15LOD502TCID50/ml2×10^2.4 TCID50/mLCalibrationEvaluatedAnalytical Sensitivity96.7%Analytical Specificity99.5%Analysis of cross reactivityEvaluatedFalse positives0.52%False negatives3.31%PrecisionEvaluatedAccuracy98.8%COVID-19:98.8%, Influenza A:99.0%, Influenza B:98.8%,RSV:98.4%RobustnessEvaluatedClinical Sensitivity96.7%COVID-19:96.7%, Influenza A:95.3%, Influenza B:91.5%,RSV:90.0%Clinical Specificity99.5%COVID-19:99.5%, Influenza A:99.5%, Influenza B:99.6%,RSV:99.0%770ECOTEST COVID-19 Antigen Rapid Test Device (Nasal swab, Nasopharyngeal swab, Oropharyngeal swab)455Assure Tech (Hangzhou) Co. Ltd.Chinawww.diareagent.comYesCommercialisedYesYesManualNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabSARS-CoV689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta1323B.1.621Mu2041C.37Lambda1224B.1.526Iota678B.1.1.529Omicron1518P.2Zetanucleocapsid proteinupdate Variants detected information2022-08-24 09:08:01 CET623Immuno-AntigenYesNoNoImmunoassayQualitativeColorimetry15LOD2×10^2.4 TCID50/mLCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.75%A total of 1190 SARS-CoV-2 negative samples were tested, 9 samples were positive by this test.False negatives7.5%A total of 160 SARS-CoV-2 positive samples were tested, 12 samples were negative by this RDT.PrecisionEvaluatedAccuracy98.5%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.5%Clinical Specificity99.2%Type of antigenNucleocapsid protein2350ECOTEST COVID-19 Antigen Rapid Test Device (Nasopharyngeal swab, Oropharyngeal swab)1059Assure Tech (Hangzhou) Co. Ltd.Chinawww.diareagent.comYesCommercialisedYesYesManualNear POC / POCAntigenNasopharyngeal swabOropharyngeal swabSARS-CoV689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu2041C.37Lambda1224B.1.526Iota678B.1.1.529Omicron1518P.2Zetanucleocapsid proteinupdate Variants detected information2022-08-24 09:08:01 CET2051Immuno-AntigenYesNoNoImmunoassayQualitative15LOD2×10^2.4 TCID50/mLCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.86%A total of 1036 SARS-CoV-2 negative samples were tested, 9 samples were positive by this testFalse negatives2.3%A total of 128 SARS-CoV-2 positive samples were tested, 3 samples were negative by this RDTPrecisionEvaluatedAccuracy99%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.7%Clinical Specificity99.1%Type of antigenNucleocapsid protein4075ECOTEST COVID-19 Antigen Rapid Test Device455Assure Tech (Hangzhou) Co. Ltd.Chinawww.diareagent.comYesCommercialisedYesYesNear POC / POCAntigenNasopharyngeal swabSARS-CoV678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526Iota1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu2041C.37Lambda1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid protein2022-09-20 14:49:27 CET5372Immuno-AntigenYesNoNoImmunoassayQualitativeMembrane-basedColorimetry15LOD251.2TCID50/ml2×10^2.4 TCID50/mLCalibrationEvaluatedAnalytical Sensitivity92.3%Analytical Specificity99%Analysis of cross reactivityEvaluatedFalse positives0.97%A total of 309 SARS-CoV-2 negative samples were tested, 3 samples were positive by this test.False negatives7.69%A total of 104 SARS-CoV-2 positive samples were tested, 8 samples were negative by this test.PrecisionEvaluatedAccuracy97.3%RobustnessEvaluatedClinical Sensitivity92.3%Clinical Specificity99%2469FaStep COVID-19 Antigen Nasal Test Kit1059Assure Tech (Hangzhou) Co. Ltd.Chinawww.diareagent.comYesCommercialisedNoNoNear POC / POCAntigenOther689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.3None2022-08-24 09:08:01 CET2172Immuno-AntigenNoImmunochromatographyQualitativeSandwich, Double15LOD251AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%none, 100% specificFalse negatives0%no false negatives occurred on antigen level at 370 pg/mL or virus level at 1×10 2.4 TCID50/mLPrecisionEvaluatedAccuracy98.7%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.1%Clinical Specificity99.8%Type of antigenNucleoprotein2364FASTEP COVID-19 Antigen Rapid Test Device1059Assure Tech (Hangzhou) Co. Ltd.Chinawww.diareagent.comYesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swabOropharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.3nucleocapsid proteinPEI EVALUATED2022-08-24 09:08:01 CET2065Immuno-AntigenYesNoImmunoassayQualitative15LOD501AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.86%A total of 1036 SARS-CoV-2 negative samples were tested, 9 samples were positive by this testFalse negatives2.3%A total of 128 SARS-CoV-2 positive samples were tested, 3 samples were negative by this RDTPrecisionEvaluatedAccuracy99%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.7%Clinical Specificity99.1%Type of antigenNucleocapsid protein1370FLUA-FLUB-RSV-ADV-COVID-19 Combo Test Device455Assure Tech (Hangzhou) Co. Ltd.Chinawww.diareagent.comYesCommercialisedNoNoNear POC / POCAntigenOther immunochromatography?2022-08-24 09:08:01 CET1141Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15Rapid diagnostic test colloidal gold LOD2102.4AUFalse positivesNot availableFalse negativesNot availableAccuracy98.5%(COVID-19:98.5%; Influenza A:88.4%, Influenza B:88.9%, RSV:97.4%, Adenovirus:96.3%)Clinical Sensitivity97.3%(COVID-19:97.3%; Influenza A:83.3%, Influenza B:82.4%, RSV:96.2%, Adenovirus:95.2%)2932SARS-CoV-2 Antigen Rapid Tests for Self-Testing455Assure Tech (Hangzhou) Co. Ltd.Chinawww.diareagent.comYesCommercialisedNoNoManualNear POC / POCAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.3678B.1.1.529Omicronnucleocapsid proteinCE0197 certification has been completed.2022-08-24 09:08:01 CET2638Immuno-AntigenYesImmunoassay15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives5.88%6 out of 102False negatives0%on 243PrecisionEvaluatedAccuracy98.3%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.1%Clinical Specificity100%Type of antigenNucleocapsid protein1584SARS-CoV-2 Neutralizing Antibody Rapid Test455Assure Tech (Hangzhou) Co. Ltd.Chinawww.diareagent.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood no info on website about preformance (LOD=0) 2022-08-24 09:08:01 CET1264Immuno-AntibodyYesYesImmunoassayQualitative15Rapid diagnostic test cassette LOD0CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positivesNot availableFalse negativesNot availablePrecisionEvaluatedAccuracy98.1%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.7%1036Covid-19 IgG/IgM RAPID TEST566Assut EuropeItalywww.assuteurope.com/NoCommercialisedNoNoNear POC / POCAntibody2022-08-24 09:08:01 CET829Immuno-AntibodyYesImmunoassay2195COVID-19 N.A.T. Neutralizing Antibodies Test1023ASSUT EUROPE SPAItalywww.assuteurope.comYesCommercialisedNoNoManualAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET1896Immuno-AntibodyYesOtherQuantitativeNeutralization Antibody (NAb)15LOD0.01AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives6AUFalse negatives4AUPrecisionEvaluatedAccuracy93.79%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.44%Clinical Specificity92.45%MAGLIANO DEI MARSI (AQ)Type of antigenOther2248SARS-CoV-2 Antigen Rapid Swab1023ASSUT EUROPE SPAItalywww.assuteurope.comYesCommercialisedNoNoManualAntigenNasopharyngeal swabOropharyngeal swabIVDD CE marked2022-08-24 09:08:01 CET1949Immuno-AntigenNoImmunoassayQualitativeSandwich, Double15LOD50AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2AUFalse negatives3AUPrecisionEvaluatedAccuracy99.3%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98%Clinical Specificity99.3%MAGLIANO DEI MARSI (AQ)Type of antigenNucleoprotein2454As-check1120Asterion Otel Ä°nÅŸaat BiliÅŸim Medikal Maden Tic. Ltd. Åžti.Turkeyhttp://www.asterion.com.tr/YesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31518P.2Zeta678B.1.1.529Omicronnucleocapsid proteinAs-check SARS-CoV-2 Antigen Rapid Test is intended for the qualitative detection of SARS-CoV-2 Antigen in nasopharyngeal swab specimens in vitro. The identification is based on the monoclonal antibodies specific for the Nucleocapsid （N）protein of SARS-CoV-2.2022-08-24 09:08:01 CET2157Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich15Measles virus, Bacillus pertussis, Escherichia coli, Neisseria meningococcus, Neisseria gonorrhoeae, Pseudomonas aeruginosa, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus salivariusLOD1.7U/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.008%3/363 with negative PCR result There 3 false positiv sample from the sampleFalse negatives0.042%5/117 positive PCR result 5 false negative samples did not come out of the samplePrecisionEvaluatedPrecisionEvaluatedAccuracy98.3%480 samplesReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.7%117 samplesClinical Specificity99.2%363 samplesType of antigenNucleocapsid protein2937FASPIT™ SARS-CoV-2 Antigen Saliva Test Kit924Atlas Link Technology Co. Ltd.Chinahttp://www.atlas-link.com/english/YesCommercialisedNoNoManualNear POC / POCAntigenSaliva689B.1.1.7Alpha1032B.1.351Beta1321B.1.617.2Delta2041C.37Lambda678B.1.1.529Omicronnucleocapsid proteinFASPIT™ SARS-CoV-2 Antigen Saliva Test Kit (Colloidal Gold Immunochromatography) is an immunochromatographic membrane assay that uses the double-antibody sandwich method to detect the SARS-CoV-2 nucleocapsid protein from saliva specimen from patients who are suspected of COVID-19 by a healthcare provider. Performance of the test is limited to certified laboratories that meet the requirements to perform moderate, high or waived complexity tests.2022-08-24 09:08:01 CET2643Immuno-AntigenNoImmunochromatographyQualitativeSandwich, Double15LOD50TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%Compared with PCR test, 154 individuals, 0 false positiveFalse negatives2.63%Compared with PCR test, 76 individuals, 2 false negativesPrecisionEvaluatedAccuracy99.1%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.4%AntigenClinical Specificity100%AntigenType of antigenNucleocapsid protein2956NOVA Test® SARS-CoV-2 Antigen Home Test Kit924Atlas Link Technology Co. Ltd.Chinahttp://www.atlas-link.com/english/YesCommercialisedNoNoManualNear POC / POCAntigenAnterior nasal swabAdenovirusBordetella PertussisChlamydia PneumoniaeCoronaviruses (HCoV)Alpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)MERS-CoVCytomegalovirus (CMV)Enterovirus A71 (EV-A71)Hemophilus InfluenzaeHepatitis B Virus (HBV)Hepatitis C Virus (HCV)Human Metapneumovirus (HMPV)Influenza AInfluenza BMycobacterium TuberculosisMycoplasma PneumoniaeParainfluenza Virus TypeParainfluenza Virus Type 1Parainfluenza Virus Type 2Parainfluenza Virus Type 3Parainfluenza Virus Type 4Respiratory Syncytial V (RSV)RhinovirusRhinovirus ARhinovirus B689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1321B.1.617.2Delta678B.1.1.529Omicronnucleocapsid proteinNOVA Test®SARS-CoV-2 Antigen Home Test Kit is intended for detection of SARS-CoV-2 Virus (COVID-19 Virus) for self-testing at home or near patient circumstance when someone was suspected COVID-19 infection within the first 7 days after symptom onset and non-symptomatic population especially for those who have recently been in contact with suspected or positive patients. This kit uses a nasal swab sample to reduce discomfort which can be applied to any person ranging from age 18 to 70. Adolescents or children can be tested under adult supervision or tested by an adult. For infants, very young children, or adults older than 70 please consult with your physician before use.2022-08-24 09:08:01 CET2830Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, Double15LOD50TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%Compared with PCR test, 419 individuals, 0 false positiveFalse negatives0.81%Compared with PCR test, 123 individuals, 1 false negativeAccuracy99.8%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity99.2Clinical Specificity100Type of antigenNucleocapsid protein2010NOVA Test® SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography)924Atlas Link Technology Co. Ltd.Chinahttp://www.atlas-link.com/english/YesCommercialisedNoNoManualNear POC / POCAntigenNasal swabOropharyngeal swabSARS-CoVCoronaviruses (HCoV)Alpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)MERS-CoVCytomegalovirus (CMV)Enterovirus A71 (EV-A71)Hemophilus InfluenzaeHepatitis B Virus (HBV)Hepatitis C Virus (HCV)Human Metapneumovirus (HMPV)Influenza AInfluenza BMycobacterium TuberculosisMycoplasma PneumoniaeParainfluenza Virus TypeParainfluenza Virus Type 1Parainfluenza Virus Type 2Parainfluenza Virus Type 3Parainfluenza Virus Type 4Respiratory Syncytial V (RSV)RhinovirusRhinovirus ARhinovirus BAdenovirusBordetella Pertussis689B.1.1.7Alpha1032B.1.351Beta1321B.1.617.2Delta2041C.37Lambda678B.1.1.529Omicron1495P.1Gammanucleocapsid proteinNOVA Test®SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography) is an immunochromatographic membrane assay that uses the double-antibody sandwich method to detect the novel coronavirus (SARS-CoV-2) nucleocapsid protein from Nasopharyngeal swab (NPS) and Oropharyngeal swab (OP swab) from patients who are suspected of COVID-19 by a healthcare provider. Performance of the test is limited to professional use.2022-08-24 09:08:01 CET1688Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD50TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%Compared with PCR test, 419 individuals, 0 false positivesFalse negatives0.81%Compared with PCR test, 123 individuals, 1 false negativePrecisionNot evaluatedAccuracy99.8%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity99.2%Clinical Specificity100%Type of antigenNucleocapsid protein2959Atlas COVID-19 Antigen (Nasal Swab) Test Cassette1306Atlas Medical GmbHGermanywww.atlas-medical.comYesCommercialisedNoNoManualAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta1320B.1.617.1Kappa1321B.1.617.2Delta2041C.37Lambda1224B.1.526Iota678B.1.1.529Omicron1518P.2Zeta3939B.1.6161322B.1.617.31323B.1.621Mu20A.23.11439C.3670AT.1B.1.526.1B.1.526.2nucleocapsid proteinspike protein1) Intended use: Atlas COVID-19 Antigen Rapid Test (Nasal Swab) is a single-use test kit intended to detect the SARS-CoV-2 that causes COVID-19. This test is designed for nasal swab samples in symptomatic individuals who are suspected of COVID-19. The COVID-19 Antigen Rapid Test (Nasal Swab) gives a preliminary result only. The final confirmation should be based on clinical diagnostic results. 2) Test Principle: The Atlas Antigen Rapid Test (Nasal Swab) is a qualitative membrane-based immunoassay for the detection of SARS-CoV-2 Nucleocapsid protein Antigens in swab specimens. SARS-CoV-2 Nucleocapsid protein antibody is coated in the test line region. During testing, the specimen reacts with SARS-CoV-2 Nucleocapsid protein antibody-coated particles in the test. The mixture then migrates upward on the membrane by capillary action and reacts with the SARS-CoV-2 Nucleocapsid protein antibody in test line region. If the specimen contains SARS-CoV-2 Antigens, a colored line will appear in test line region as a result of this. If the specimen does not contain antigens to SARS-CoV-2, no colored line will appear in the test line region, indicating a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred. 2) Performance and Specification: Atlas Antigen Rapid Test (Nasal Swab) is a single-use test kit intended to detect the SARS-CoV-2 that causes COVID-19 with \collected nasal swab specimen. The test is intended for use in symptomatic individuals meeting the case definition for COVID-19, and to test asymptomatic individuals limited to contacts of confirmed COVID-19 cases or probable cases and to at-risk health workers. Results are for the detection of COVID-19 Nucleocapsid protein Antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results are indicative of the presence of SARS-CoV-2. Individuals who test positive should self-isolate and seek additional care from their healthcare provider. Positive results do not rule out bacterial infection or co-infection with other viruses. Negative results do not preclude SARSCoV-2 infection. Individuals who test negative and continue to experience COVID-like symptoms should seek follow up care from their healthcare provider. 3) Materials provided: • Atlas COVID-19 Antigen Rapid Test Cassette. • Sterilized swab. • Extraction tube. • Sample extraction buffer. • Instructions for use2022-08-24 09:08:01 CET2665Immuno-AntigenYesNoNoImmunoassayQualitativeMembrane-based15LOD100TCID50/mlThe LoD for Atlas COVID-19 Rapid Antigen Test (Nasal Swab) is 100 TCID50/ml of heat-inactivated virus, and 100pg/ml using a recombinant viral antigen.CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positivesThe reading of test after 20 minutes of sample application may lead false positive test resultFalse negativesThe using of open pouch after 2 hours from the opening time may lead false negative test resultPrecisionEvaluatedAccuracy98.4%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.8%Clinical Specificity99%Type of antigenNucleocapsid protein515Atlas COVID-19 IgG/IgM Test Cassette314Atlas Medical GmbHUnited Kingdomatlas-medical.com/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2022-08-24 09:08:01 CET415Immuno-AntibodyYesNoImmunoassayQualitative10773Atlas COVID-19 IgM Elisa Kit314Atlas Medical GmbHUnited Kingdomatlas-medical.com/YesCommercialisedNoNoAutomatedManualAntibodyIgMSerum2022-08-24 09:08:01 CET627Immuno-AntibodyYesELISAQualitative70Manual or automated 772Atlas COVID-19 S1-RBD IgG Elisa Kit314Atlas Medical GmbHUnited Kingdomatlas-medical.com/YesCommercialisedNoNoAutomatedManualAntibodyIgGSerum2022-08-24 09:08:01 CET626Immuno-AntibodyNoYesELISAQualitative70Manual or automated 771Atlas COVID-19 Total Antibody Elisa Kit314Atlas Medical GmbHUnited Kingdomatlas-medical.com/YesCommercialisedNoNoAutomatedManualAntibodySerum2022-08-24 09:08:01 CET625Immuno-AntibodyYesELISAQualitativeSandwich, Double70Manual or automated Sandwich, Double 2335Attana AVA SARS-CoV-2 IgG Immunoassay1086Attana ABSwedenwww.attana.comYesCommercialisedNoNoAutomatedLab-basedSemi-automatedAntibodyIgGSerumReceptor-binding domain (RBD) of the Spike protein. Attana AVA SARS-CoV-2 IgG Immunoassay for use with the Attana Cell 250 or Cell 200 systems to measure SARS-CoV-2 IgG in patient serum samples. CE-IVD registered. Ability to measure affinity of antibody interactions to RBD target2022-08-24 09:08:01 CET2036Immuno-AntibodyNoYesImmunoassayQuantitativeSandwich, Double17LOD1CalibrationEvaluatedAnalysis of cross reactivityNot evaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy100% IgGReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100% IgGClinical Specificity100% IgGType of antigenOther44Quantitative Immuno-kinetic assay for Covid-19 IgG+IgM+IgA for a multiantigen panel with CRP27Attomarker Ltd.United Kingdomwww.attomarker.com/NoIn developmentNoNoAutomatedManualAntibodyIgA2022-08-24 09:08:01 CET32Immuno-AntibodyImmunoassay665Anti-SARS-CoV-2 Rapid Test513Autobio Diagnostics Co. Ltd.Chinahttps://www.autobio.com.cn/YesCommercialisedNoNoManualAntibodyIgGIgMPlasmaSerumWhole bloodnucleocapsid proteinThis assay is based on a colloidal gold method for the rapid, qualitative determination of Anti-SARS-CoV-2 (IgG/IgM antibodies of Severe Acute Respiratory Syndrome Coronavirus 2) in human serum, plasma or whole blood. IgM Positive Percent Agreement of Anti-SARS-CoV-2 Rapid Test was 85.43% (346/405), (95%CI: 81.7% - 88.5%), IgM Negative Percent Agreement was 99.68% (311/312), (95%CI: 98.2% - 99.9%). IgG Positive Percent Agreement of Anti-SARS-CoV-2 Rapid Test was 86.17% (349/405), (95%CI: 82.5% - 89.2%), IgG Negative Percent Agreement was 99.36% (310/312), (95%CI: 97.7% - 99.8%).2022-08-24 09:08:01 CET800Immuno-AntibodyYesImmunoassayQualitativeCaptureColloidal gold15Analysis of cross reactivityEvaluatedPrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity88.15% (357/405) (95%CI: 84.6%-90.9%)Clinical Specificity99.04% (309/312), (95%CI: 97.2%-99.7%)Type of antigenSARS-CoV-2 nucleocapsid919SARS-CoV-2 IgG II CLIA Microparticles513Autobio Diagnostics Co. Ltd.Chinahttps://www.autobio.com.cn/YesCommercialisedNoNoAutomatedNear POC / POCAntibodyIgGPlasmaSerumNo cross-reaction with Influenza A, Influenza B,RSV, Adenovirus, Enterovirus 71, Coxsackie virus B, Chlamydia pneumonia, M. pneumoniae IgG, L. pneumophila, Toxo IgG, Rubella IgG, CMV IgG, HSV IgG, RF.2022-08-24 09:08:01 CET744Immuno-AntibodyNoCLIAQualitativeOtherChemiluminescence40Rapid diagnostic test Not found Chemiluminescence Analysis of cross reactivityEvaluatedPrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%≥15days after infection:100%(51/51), 8-14days after infection:79.3%(23/29),≤7days after infection:26.9%(7/26)Clinical Specificity99%(1063/1074)2429Anti-SARS-CoV-2 RBD CLIA Microparticles1038AUTOBIO DIAGNOSTICS. Ltd.Chinahttps://www.autobio.com.cn/YesCommercialisedNoNoAutomatedAntibodyPlasmaSerumThe unit of LOD is AU/mL.2022-08-24 09:08:01 CET2132Immuno-AntibodyCLIAQuantitativeSandwich17LOD3AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.22% from 1334 samples before the outbreak of COVID-19False negatives3.72% from 215 samples after inoculation from 15 to 75 daysPrecisionEvaluatedAccuracy99.29%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity79.49%Clinical Specificity99.78%Type of antigenOther2430Anti-SARS-CoV-2 RBD ELISA1038AUTOBIO DIAGNOSTICS. Ltd.Chinahttps://www.autobio.com.cn/YesCommercialisedNoNoManualAntibodyPlasmaSerumThe unit of LOD is AU/mL.2022-08-24 09:08:01 CET2133Immuno-AntibodyELISAQuantitativeSandwich40LOD2AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.29%from 686 samples before the outbreak of COVID-19False negatives1.47% from 68 samples after inoculation from 14 to 28 daysPrecisionEvaluatedAccuracy99.6%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.89%Clinical Specificity99.71%Type of antigenOther2538SARS-CoV-2 Ag Rapid Test1038AUTOBIO DIAGNOSTICS. Ltd.Chinahttps://www.autobio.com.cn/YesCommercialisedYesYesManualAntigenNasal swabnucleocapsid proteinThis assay is based on a colloidal gold method for the rapid, qualitative determination of SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2) nucleocapsid protein antigen in nasal swab specimens. This test kit shall not be used as a sole basis to diagnose or exclude SARS-CoV-2 infection.2022-10-05 14:12:13 CET3936Immuno-AntigenYesNoImmunoassayQualitativeSandwich15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives5.45%False negatives0%PrecisionEvaluatedAccuracy98.94%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.55%Clinical Specificity100%Type of antigenNucleocapsid protein3082SARS-CoV-2 Ag Rapid Test (self-test)1038AUTOBIO DIAGNOSTICS. Ltd.Chinahttps://www.autobio.com.cn/YesCommercialisedNoNoManualAntigenNasal swabChlamydia PneumoniaeHemophilus InfluenzaeHuman Metapneumovirus (HMPV)Mycoplasma Pneumoniaenucleocapsid proteinThis assay is based on a colloidal gold method for the rapid, qualitative determination of SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2) nucleocapsid protein antigen in anterior nasal swab specimens. This test kit is intended for self-testing at home for individuals with symptoms of SARS-CoV-2 infection. This test kit shall not be used as a sole basis to diagnose or exclude SARS-CoV-2 infection.2022-08-24 09:08:01 CET2788Immuno-AntigenYesYesImmunoassay15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives5.45%False negatives0%PrecisionEvaluatedAccuracy98.94%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.55%Clinical Specificity100%Type of antigenNucleocapsid protein2431SARS-CoV-2 NAb ELISA1038AUTOBIO DIAGNOSTICS. Ltd.Chinahttps://www.autobio.com.cn/YesCommercialisedNoNoManualAntibodyPlasmaSerumThe unit of LOD is AU/mL.2022-08-24 09:08:01 CET2134Immuno-AntibodyELISAQuantitativeNeutralization Antibody (NAb)40LOD10AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.29% from 680 samples before the outbreak of COVID-19False negatives4.6% from 87 samples after inoculation from 14 to 28 daysPrecisionEvaluatedAccuracy99.22%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.04%Clinical Specificity99.71%Type of antigenNucleoprotein2426AffiDX SARS-CoV-2 Antigen Lateral Flow Test1109Avacta Life Sciences Ltd.United Kingdomwww.avacta.comYesCommercialisedNoNoAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1321B.1.617.2Deltaspike protein antigen2022-08-24 09:08:01 CET2129Immuno-AntigenYesNoQualitative20LOD600AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives%1 out of 102 confirmed negativesFalse negatives%2 out of 98 confirmed positives (PCR Ct values up to 31)PrecisionEvaluatedAccuracy98.5%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98%Clinical Specificity99%Type of antigenOther1800Ksmart® SARS-COV2 Antigen Rapid Test820AVALUN SASFranceavalun.com/YesCommercialisedYesYesSemi-automatedAntigenNasopharyngeal swab2022-08-24 09:08:01 CET1479Immuno-AntigenYesImmunochromatographyQualitativeColorimetry20LOD30U/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.68%The specificity was tested using 441 negative specimens.3 False positives results vs the PCR assayFalse negatives6.81%The sensitivity was tested using 176 positive specimens.12 False negatives results vs the PCR assay.PrecisionEvaluatedAccuracy97.57%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity93.18%Clinical Specificity99.32%47Novel Coronavirus (2019-nCov)Antibody IgG/IgM Assay Kit (Colloidal Gold)30Avioq Bio-Tech Co. Ltd.Chinawww.avioqbio.comNoCommercialisedNoNoNear POC / POCAntibody2022-08-24 09:08:01 CET35Immuno-AntibodyYesImmunoassayColloidal gold1972Novel Coronavirus (SARS-CoV-2) Antigen Detection Kit(Colloidal Gold)30Avioq Bio-Tech Co. Ltd.Chinawww.avioqbio.comYesCommercialisedNoNoManualNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabSalivaSARS-CoV-2678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1321B.1.617.2Delta1495P.1Gammanucleocapsid proteinNone2022-09-20 14:57:20 CET3837Immuno-AntigenYesNoNoImmunochromatographyQualitativeMembrane-basedColloidal gold15LOD300TCID50/mlAnalytical Sensitivity100%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives0.44%False negatives6.36%PrecisionEvaluatedAccuracy98.41%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.64%Clinical Specificity99.56%Type of antigenNucleocapsid protein2101COVID-19 Antigen Rapid Test Card974AXIOM Gesellschaft für Diagnostica und Biochemica mbHYesCommercialisedYesYesNear POC / POCAntigenNasal swabNasopharyngeal swabThroat swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2Zetanucleocapsid proteinNone2022-08-24 09:08:01 CET1784Immuno-AntigenYesNoImmunoassay10LOD0.05AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy99%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98%Clinical Specificity100%Type of antigenNucleoprotein2476COVID-19 Antigen Saliva Test974AXIOM Gesellschaft für Diagnostica und Biochemica mbHYesCommercialisedNoNoNear POC / POCAntigenSaliva689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaNo additional information2022-08-24 09:08:01 CET2179Immuno-AntigenNoImmunoassay10LOD0.05AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0AUFalse negatives0AUPrecisionEvaluatedAccuracy98%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98%Clinical Specificity99%Type of antigenNucleoptotein775AxiumHealth COVID-19 IgG/IgM Antibody Test465Axium Bioresearch Inc.United Stateswww.axiumbioresearch.com/NoCommercialisedNoNoLab-basedAntibody2022-08-24 09:08:01 CET644Immuno-AntibodyImmunoassayType of antigenSARS-COV-2 nucleoprotein1906COVID-19 Antigen Rapid Test Device871Azure Biotech Inc.United Stateswww.azure.bioYesCommercialisedNoNoNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabOther2022-08-24 09:08:01 CET1672Immuno-AntigenYesImmunoassayAccuracy98.9%Clinical Sensitivity94.3%1682Immuno-AntigenYesNoImmunoassay15specimen = Nasal swabCalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracy98.7%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95%Clinical Specificity99.2%Type of antigenOther1911COVID-19 Antigen Saliva Test Kit871Azure Biotech Inc.United Stateswww.azure.bioYesCommercialisedNoNoManualNear POC / POCAntigenSalivaNot available2022-08-24 09:08:01 CET1586Immuno-AntigenNoImmunoassayQualitativeColorimetry15LOD0AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracy95.3%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90%Clinical Specificity97%Type of antigenOther1912COVID-19 IgG/IgM Rapid Test Device871Azure Biotech Inc.United Stateswww.azure.bioYesCommercialisedNoNoManualNear POC / POCAntibodyIgGIgMPlasmaSerumWhole bloodNot available2022-08-24 09:08:01 CET1587Immuno-AntibodyImmunoassayQualitativeColorimetry15Analysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracy98.7% IgGAccuracy97.7% IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.7% IgMClinical Sensitivity98.8% IgGClinical Specificity99.1% IgMClinical Specificity98.7% IgGType of antigenOther1910COVID-19 Neutralizing Antibody FIA871Azure Biotech Inc.United Stateswww.azure.bioYesCommercialisedNoNoManualNear POC / POCAntibodyPlasmaSerumWhole bloodNot available2022-08-24 09:08:01 CET1585Immuno-AntibodyYesImmunoassayQualitativeNeutralization Antibody (NAb)15Fluorescence detectionLOD0AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%Clinical Specificity100%Type of antigenOther2382Dia Sure COVID-19 Antigen Rapid Test Device871Azure Biotech Inc.United Stateswww.azure.bioYesCommercialisedNoNoNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.3Notes: Supplement the number of clinically naso- or oropharyngeal positive samples to more than 100 cases.2022-08-24 09:08:01 CET2084Immuno-AntigenNoImmunochromatographyQualitative15LOD502AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0% none, 100% specificFalse negatives0%no false negatives occurred on antigen level at 0.4 ng/mL or virus level at 2×10 2.4 TCID50/mLPrecisionEvaluatedAccuracy98.3%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.1%Clinical Specificity99.3%Type of antigenNucleoprotein2060Dia Sure COVID-19 Antigen Rapid Test Device950Azure Biotech Inc.United StatesYesCommercialisedNoNoNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swab689B.1.1.7AlphaLimit of detection (LOD):502.4 TCID50/ml Pathogens detected: SARS-CoV-22022-08-24 09:08:01 CET1740Immuno-AntigenNoImmunochromatographyQualitativeSandwich15LOD502.4AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.9%False negatives5.7%PrecisionEvaluatedAccuracy98.6%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.3%Clinical Specificity99.1%Type of antigenNucleoprotein1613ChekR™ COVID-19 IgM/IgG Rapid test717B-bio Co. Ltd.South Koreawww.b-bio.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2022-08-24 09:08:01 CET1293Immuno-AntibodyYesNoImmunoassayQualitative15LOD0CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positivesnot foundFalse negativesnot foundPrecisionEvaluatedAccuracy97.9%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity95.5%1615INNOGEN-B™ COVID-19 IgM/IgG Rapid test717B-bio Co. Ltd.South Koreawww.b-bio.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2022-08-24 09:08:01 CET1295Immuno-AntibodyYesNoImmunoassayQualitative15LOD1CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positivesnot foundPrecisionEvaluatedAccuracy97.9%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity95.5%2602SARS-CoV-2 Antigen Rapid Test1188Baicare(Tianjin) Biotechnology Co. Ltd.Chinahttp://www.bai-care.com/index.php?catid=27YesCommercialisedNoNoLab-basedManualAntigenNasal swabNasopharyngeal swabOropharyngeal swabnucleocapsid proteinSensitivity:nasal samples and oropharyngeal samples： 93.18% , nasopharyngeal samples：93.75% Specificity:nasal samples and oropharyngeal samples： 99.32%, nasopharyng99.32% Accuracy:nasal samples and oropharyngeal samples：97.57%, nasopharyngeal samples： 97.73%eal samples： 2022-08-24 09:08:01 CET2307Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich, Double15LOD30TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.7%A total of 617 clinical samples (176 positive and 441 negative), with 3 false positives.False negatives2.49%A total of 617 clinical samples (176 positive and 441 negative), with 11 false negatives.PrecisionEvaluatedAccuracy97.57%(Antigen) Nasal swabAccuracy97.73%Nasopharyngeal swabAccuracy97.57%Oropharyngeal swabReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.75%Nasopharyngeal swabClinical Sensitivity93.18%Oropharyngeal swabClinical Sensitivity93.18%(Antigen) Nasal swabClinical Specificity99.32%(Antigen) Nasal swabClinical Specificity99.32%Oropharyngeal swabClinical Specificity99.32%Nasopharyngeal swabType of antigenNucleocapsid protein50Baiya Rapid COVID-19 IgM/IgG test kit32Baiya Phytopharm Co. Ltd.Thailandbaiyaphytopharm.wixsite.com/baiyaNoIn developmentNoNoNear POC / POCAntibody2022-08-24 09:08:01 CET37Immuno-AntibodyYesImmunoassay1782Saligen798Bakter Medical s.r.o.Czechiawww.saligen.comYesCommercialisedNoNoNear POC / POCAntigenSaliva2022-08-24 09:08:01 CET1461Immuno-AntigenYesNoImmunochromatographyQualitativeColorimetry10LOD0.1AUCalibration0Analysis of cross reactivity0False positives0%False negatives1AUPrecision0Accuracy98.55%Robustness0Clinical Sensitivity97.1%Type of antigen02315MARK-B COVID-19 Ag1079BBB Inc.South Koreawww.bbbtech.comYesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1518P.2Zeta1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Deltanucleocapsid proteinUpdated the variants detected.2022-08-24 09:08:01 CET2016Immuno-AntigenYesYesImmunoassayQualitativeSandwich15LOD23.9TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives5%PrecisionEvaluatedAccuracy97.2 (Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.4%(Antigen)Clinical Specificity100% (Antigen)Type of antigenNucleocapsid protein1234MARK-B COVID-19 Ag S629BBB Inc. Obelis S.A.(BE)South Koreawww.bbbtech.com/YesCommercialisedNoNoOtherAntigenNasopharyngeal swab2022-08-24 09:08:01 CET1016Immuno-AntigenYesYesImmunoassayQualitativePhotonic ring resonance10Atomated Sandwich, Magnetic Electrochemical LOD24TCID50/mlClinical Sensitivity98.5%Clinical Specificity98.5%2996ACCESS SARS-CoV-2 IgG1325Beckman CoulterUnited Stateshttps://www.beckmancoulter.comYesCommercialisedNoNoAutomatedIgGPlasmaSerumspike proteinThe Access SARS-CoV-2 IgG assay is a paramagnetic particle, chemiluminescent immunoassay intended for the qualitative detection of IgG antibodies to SARS-CoV-2 in human serum and plasma using the Access Immunoassay Systems.2022-08-24 09:08:01 CET2702Immuno-AntibodyNoNoCLIAQualitativeSandwich31CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.21%Three false positive out of a total of 1,400 negative specimensFalse negativesOne false negative for specimens collected from positive subjects >/= 14days from PCR to collectionPrecisionNot evaluatedAccuracy99.1%ReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity99.1%95% CI: 95,0%-99,8%Clinical Specificity99.8%95% CI: 99,4%-99.9%Type of antigenSpike protein2994ACCESS SARS-CoV-2 IgG (1st IS)1325Beckman CoulterUnited Stateshttps://www.beckmancoulter.comYesCommercialisedNoNoAutomatedIgGPlasmaSerumspike proteinThe Access SARS-CoV-2 IgG (1st IS) assay is a paramagnetic particle, chemiluminescent immunoassay intended for the quantitative and qualitative detection of IgG antibodies to SARS-CoV-2 in human serum and plasma using the Access Immunoassay Systems.2022-08-24 09:08:01 CET2700Immuno-AntibodyNoNoCLIAQuantitativeSandwich30CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.21%three false positives out of a total of 1400 negative samplesFalse negatives0%Zero false negatve for specimens collectedfrom positive subjects >/= 14 days post symptom onsetPrecisionEvaluatedAccuracy100% IgGReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%95% CI: 92,7-100,0%Clinical Specificity99.8%95% CI: 99,4-99,9%Type of antigenSpike protein2995ACCESS SARS-CoV-2 IgG II1325Beckman CoulterUnited Stateshttps://www.beckmancoulter.comYesCommercialisedNoNoAutomatedIgGPlasmaSerumspike proteinThe Access SARS-CoV-2 IgG II assay is a paramagnetic particle, chemiluminescent immunoassay intended for the semi-quantitative and qualitative determination of IgG antibodies to SARS-CoV-2 in human serum and plasma using the Access Immunoassay Systems.2022-08-24 09:08:01 CET2701Immuno-AntibodyNoNoCLIASemiquantitativeSandwich30CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.13%Two false positive out of a total of 1448 negative specimensFalse negatives9 false negative for specimens collected from positive subjects >/= 15 days, 8 from >/= 60 daysPrecisionNot evaluatedAccuracy98.8%ReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity98.9%95% CI: 94,1%-99,8%Clinical Specificity99.9%95% CI: 99,5%-100,0%Type of antigenSpike protein2997ACCESS SARS-CoV-2 IgM1325Beckman CoulterUnited Stateshttps://www.beckmancoulter.comYesCommercialisedNoNoAutomatedIgMPlasmaSerumspike proteinThe Access SARS-CoV-2 IgM assay is a paramagnetic particle, chemiluminescent immunoassay intended for the qualitative detection of IgM antibodies to SARS-CoV-2 in human serum and plasma using the Access Immunoassay Systems.2022-08-24 09:08:01 CET2703Immuno-AntibodyNoNoCLIAQualitativeCapture37CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.21%Two false positives out of a total 1,400 negative specimensFalse negativesTwo false negatives for specimens collected from positive subjects >/= 14 days post symptom onsetPrecisionNot evaluatedAccuracy98.5% IgMReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity98.5% IgM(95% CI: 94,6%-99,6%) IgM >/= 14 days post symptom onsetClinical Specificity99.9%95% CI: 99,5%-100,0%Type of antigenSpike protein2282BD Kit For Rapid Detection of SARS-CoV-242Becton DickinsonUnited Stateshttps://www.bd.com/en-usYesCommercialisedYesYesManualAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1518P.2ZetaAs part of surveillance activities, BD is monitoring the emergence of new mutations of SARS-CoV-2. No impact of the mutations on the performance of the device has been observed so far.2022-08-24 09:08:01 CET1983Immuno-AntigenNoImmunoassayQualitative15LOD1400AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives1AUFalse negatives5AUPrecisionEvaluatedAccuracy98.1%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity91.1%Clinical Specificity99.6%Type of antigenNucleoprotein1065BD Veritor™ System for Rapid Detection of SARS CoV 242Becton DickinsonUnited Stateshttps://www.bd.com/en-usYesCommercialisedYesYesNear POC / POCAntigenNasal swabnucleocapsid protein2022-08-24 09:08:01 CET49Immuno-AntigenYesYesImmunochromatographyQualitativeMagnetic Electrochemical15LOD140TCID50/mlAnalysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracy98.1%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity91.1%Clinical Specificity99.6%Type of antigenNucleoproteinType of antigenNucleoprotein1281COVID-19 Viral Antigen Test Kit (Colloidal Gold Immunochromatography)640Beijing Abace Biology Co. Ltd.Chinawww.abace-biology.com/YesCommercialisedNoNoNear POC / POCAntigen2022-08-24 09:08:01 CET1056Immuno-AntigenYesImmunochromatographyRapid diagnostic test 1282COVID-19 Viral Antigen Test Kit (ELISA)640Beijing Abace Biology Co. Ltd.Chinawww.abace-biology.com/YesCommercialisedNoNoAutomatedManualAntigen2022-08-24 09:08:01 CET1057Immuno-AntigenNoN.A.ELISAManual or automated 30682019-nCoV Antigen Rapid Test Cassette1354Beijing Applied Biological Technologies Co. Ltd.Chinahttps://www.x-abt.com/YesCommercialisedNoNoNear POC / POCAntigenAnterior nasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta2041C.37Lambda70AT.1678B.1.1.529Omicronnucleocapsid proteinother pathogens tested for cross-reactivity: enterovirus, Measles virus, Human cytomegalovirus, Legionella, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes, Klebsiella pneumoniae, Aspergillus fumigatus, Candida albicans, Candida glabrata, Cryptococcus neoformans2022-08-24 09:08:01 CET2774Immuno-AntigenYesNoImmunoassayQualitativeSandwich15LOD200TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives5.53%False negatives9.9%PrecisionEvaluatedAccuracy94.47%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90.1%Clinical Specificity99.07%Type of antigenNucleocapsid protein30582019-nCoV Antigen Rapid Test Cassette Anterior Nasal Swab1354Beijing Applied Biological Technologies Co. Ltd.Chinahttps://www.x-abt.com/YesCommercialisedNoNoNear POC / POCAntigenAnterior nasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta2041C.37Lambda70AT.1678B.1.1.529Omicronnucleocapsid protein/2022-08-24 09:08:01 CET2764Immuno-AntigenYesNoImmunoassayQualitativeSandwich15LOD200TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.93%False negatives9.9%PrecisionEvaluatedAccuracy94.74%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90.1%Clinical Specificity99.07%Type of antigenNucleocapsid protein30622019-nCoV Antigen Rapid Test Cassette Nasopharyngeal and Oropharyngeal Swab1354Beijing Applied Biological Technologies Co. Ltd.Chinahttps://www.x-abt.com/YesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swabOropharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta2041C.37Lambda70AT.1678B.1.1.529Omicronnucleocapsid protein/2022-08-24 09:08:01 CET2768Immuno-AntigenYesNoNoImmunoassayQualitativeSandwich15LOD200TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives6.09%False negatives0%PrecisionEvaluatedAccuracy96.65%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%Clinical Specificity93.91%Type of antigenNucleocapsid protein30602019-nCoV Antigen Rapid Test Cassette Saliva1354Beijing Applied Biological Technologies Co. Ltd.Chinahttps://www.x-abt.com/YesCommercialisedNoNoNear POC / POCAntigenSaliva689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta2041C.37Lambda70AT.1678B.1.1.529Omicronnucleocapsid protein2022-08-24 09:08:01 CET2766Immuno-AntigenNoNoImmunoassayQualitativeSandwich15LOD200TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives9.71%PrecisionEvaluatedAccuracy95.26%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90.29%Clinical Specificity100%Type of antigenNucleocapsid protein30482019-nCoV Neutralization Antibody Rapid Test Cassette (Colloidal Gold Method)1354Beijing Applied Biological Technologies Co. Ltd.Chinahttps://www.x-abt.com/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta2041C.37Lambda70AT.1678B.1.1.529Omicronnucleocapsid protein/2022-08-24 09:08:01 CET2754Immuno-AntibodyYesNoNoImmunoassayQualitativeSandwich15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%Clinical Specificity100%Type of antigenNucleocapsid protein30476 Respiratory Pathogen Antigens Rapid Test Cassette (Colloidal Gold Method)1354Beijing Applied Biological Technologies Co. Ltd.Chinahttps://www.x-abt.com/YesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swabOropharyngeal swabAdenovirus 3Adenovirus 7SARS-CoVInfluenza AInfluenza A H1N1Influenza A H3N2Influenza A H5N1Influenza BInfluenza B VictoriaInfluenza B YamagataMycoplasma PneumoniaeRespiratory Syncytial V (RSV) Type ARespiratory Syncytial V (RSV) Type B689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta2041C.37Lambda70AT.1678B.1.1.529Omicronnucleocapsid protein/2022-08-24 09:08:01 CET2753Immuno-AntigenNoNoImmunoassayQualitativeSandwich15LOD10000TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%Clinical Specificity100%Type of antigenNucleocapsid protein3167SARS-CoV-2 and Influenza Viruses A/B Rapid Test Cassette For self-testing use only1354Beijing Applied Biological Technologies Co. Ltd.Chinahttps://www.x-abt.com/YesCommercialisedNoNoManualAntigenAnterior nasal swabInfluenza AInfluenza BSARS-CoV678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1320B.1.617.1Kappa2041C.37Lambda1495P.1Gammanucleocapsid protein2022-08-24 09:08:01 CET2930Immuno-AntigenYesNoImmunoassayQualitativeSandwichChemiluminescence20LOD200TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.01%False negatives18.18%PrecisionEvaluatedAccuracy96.43%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity81.82%Clinical Specificity99.99%Type of antigenNucleocapside protein3044SARS-CoV-2 Antigen Rapid Test Cassette1354Beijing Applied Biological Technologies Co. Ltd.Chinahttps://www.x-abt.com/YesCommercialisedNoNoManualNear POC / POCAntigenNasal swabSARS-CoV689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta2041C.37Lambda70AT.1678B.1.1.529Omicronnucleocapsid protein/2022-08-24 09:08:01 CET2750Immuno-AntigenYesNoImmunoassayQualitativeSandwich15LOD200TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives4.17%PrecisionEvaluatedAccuracy98.59%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.83%Clinical Specificity99.99%Type of antigenNucleocapsid protein2839SARS-CoV-2 Antigen Rapid Test Cassette34Beijing Applied Biological Technologies Co. Ltd.Chinahttps://www.x-abt.com/YesCommercialisedNoNoNear POC / POCAntigenAnterior nasal swabNasal swabSARS-CoV70AT.1678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1320B.1.617.1Kappa1321B.1.617.2Delta2041C.37Lambda1495P.1Gammanucleocapsid protein/2022-10-20 10:15:36 CET5224Immuno-AntigenYesNoNoImmunoassayQualitativeSandwichColloidal gold15LOD200TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives4.16%PrecisionEvaluatedAccuracy98.59%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.83%AntigenClinical Specificity100%AntigenType of antigenNucleocapsid protein3059SARS-CoV-2 Antigen Rapid Test Cassette Anterior Nasal Swab1354Beijing Applied Biological Technologies Co. Ltd.Chinahttps://www.x-abt.com/YesCommercialisedNoNoNear POC / POCAntigenAnterior nasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta2041C.37Lambda70AT.1678B.1.1.529Omicronnucleocapsid protein2022-08-24 09:08:01 CET2765Immuno-AntigenYesNoImmunoassayQualitativeSandwich15LOD200TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.93%False negatives9.9%PrecisionEvaluatedAccuracy94.74%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90.1%Clinical Specificity99.07%Type of antigenNucleocapsid protein3063SARS-CoV-2 Antigen Rapid Test Cassette Nasopharyngeal and Oropharyngeal Swab1354Beijing Applied Biological Technologies Co. Ltd.Chinahttps://www.x-abt.com/YesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swabOropharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta2041C.37Lambda70AT.1678B.1.1.529Omicronnucleocapsid protein2022-08-24 09:08:01 CET2769Immuno-AntigenYesNoNoImmunoassayQualitativeSandwich15LOD200TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives6.91%PrecisionEvaluatedAccuracy96.65%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.09%Clinical Specificity100%Type of antigenNucleocapsid protein3061SARS-CoV-2 Antigen Rapid Test Cassette Saliva1354Beijing Applied Biological Technologies Co. Ltd.Chinahttps://www.x-abt.com/YesCommercialisedNoNoNear POC / POCAntigenSaliva689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta2041C.37Lambda70AT.1678B.1.1.529Omicronnucleocapsid protein/2022-08-24 09:08:01 CET2767Immuno-AntigenNoNoImmunoassayQualitativeSandwich15LOD200TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives9.71%PrecisionEvaluatedAccuracy95.26%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90.29%Clinical Specificity100%Type of antigenNucleocapsid protein3064SARS-CoV-2 Neutralization Antibody Rapid Test Cassette (FIA)1354Beijing Applied Biological Technologies Co. Ltd.Chinahttps://www.x-abt.com/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta2041C.37Lambda70AT.1678B.1.1.529Omicronnucleocapsid protein2022-08-24 09:08:01 CET2770Immuno-AntibodyYesNoNoImmunoassayQualitativeSandwichFluorescence15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy100%100%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%Clinical Specificity100%Type of antigenNucleocapsid protein3065SARS-CoV-2 Neutralization Antibody Rapid Test Cassette (Lateral Flow Method)1354Beijing Applied Biological Technologies Co. Ltd.Chinahttps://www.x-abt.com/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumVenous whole bloodWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta2041C.37Lambda70AT.1678B.1.1.529Omicronnucleocapsid protein2022-08-24 09:08:01 CET2771Immuno-AntibodyYesNoNoImmunoassayQualitativeSandwich15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%Clinical Specificity100%Type of antigenNucleocapsid protein13592019-New Coronavirus IgM/IgG Rapid Test Cassette (WB/S/P)35Beijing Beier Bioengineering Co. Ltd.Chinahttps://www.beierbio.comYesCommercialisedNoNoManualAntibodyIgGIgMPlasmaSerumWhole blood2022-08-24 09:08:01 CET1130Immuno-AntibodyYesYesImmunoassayQualitativeColorimetry15Manual NAT cassette colloidal gold LOD131False positivesRequire clinical data comparisonFalse negativesRequire clinical data comparisonAccuracy96.77%Clinical Sensitivity94.12% IgMClinical Sensitivity95.1% IgG2769COVID-19 Antigen Rapid Test Kit35Beijing Beier Bioengineering Co. Ltd.Chinahttps://www.beierbio.comYesCommercialisedYesYesNear POC / POCAntigenNasal swabNasopharyngeal swabSARS-CoV-220A.23.170AT.1678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1321B.1.617.2Deltanucleocapsid proteinThis product was evaluated and approved by Paul-Ehrlich-Institute in Germany and Centralne Laboratorium Kliniczne Uniwersyteckie Centrurn Kliniczne, Poland2022-12-12 16:45:26 CET5373Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwichColloidal gold20LOD130TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives4%False negatives4%PrecisionEvaluatedAccuracy98.59%95% CI 97.23% to 99.39%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.36%95% CI 90.95% to 99%Clinical Specificity96.36%95% CI 97.77% to 99.76%Type of antigenNucleocapsid protein2326COVID-19 ANTIGEN RAPID TEST KIT1082Beijing Beier Bioengineering Co. Ltd.Chinahttp://www.beierbio.com/en/YesCommercialisedNoNoManualAntigenNasopharyngeal swabOropharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1323B.1.621Mu20A.23.12041C.37Lambda70AT.11518P.2ZetaPositiv evaluiert durch das PEI: https://www.pei.de/SharedDocs/Downloads/DE/newsroom/dossiers/evaluierung-sensitivitaet-sars-cov-2-antigentests-04-12-2020.pdf?__blob=publicationFile&v=46 https://handelshaus-lerch.de/wp-content/uploads/2021/05/COVID-19-Antigen-Schnelltestkit-Nasal-DE.pdf2022-08-24 09:08:01 CET2027Immuno-AntigenNoImmunoassayQualitative15LOD130AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.92%46 / 5000 Übersetzungsergebnisse 1 false positives in 166 people testedFalse negatives1.94%6 false negatives in 308 people testedPrecisionEvaluatedAccuracy98.5%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.5%Clinical Specificity99.7%Type of antigenNucleoprotein2667Covid-19 Antigen Rapid Test Kit (Colloidal Gold)1213Beijing Beier Bioengineering Co. Ltd.Chinahttps://www.beierbio.com/YesCommercialisedNoNoAntigenNasal swabNasopharyngeal swabOropharyngeal swabSaliva689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThe test is to be used as an aid in the diagnosis of coronavirus infection disease (COVID-19), which is caused by SARS-CoV-2.The COVID-19 Antigen Rapid Test Kit does not differentiate between SARS-CoV and SARS-CoV-2.2022-08-24 09:08:01 CET2372Immuno-AntigenYesImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD130TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.5%Clinical Specificity99.7%Type of antigenNucleocapsid protein1969MediPort Limited35Beijing Beier Bioengineering Co. Ltd.Chinahttps://www.beierbio.comYesCommercialisedNoNoManualNear POC / POCAntigenAnterior nasal swabNasal swabOtherType of antigens S1, S1-RBD, S2, N proteins2022-08-24 09:08:01 CET1645Immuno-AntigenNoImmunoassayQualitative15LOD130AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0AUFalse negatives0AUPrecisionNot evaluatedAccuracy98.5%ReproducibilityNot evaluatedRobustnessNot evaluatedClinical Sensitivity96.5%(95% CI: 93.7%~99.3%)Clinical Specificity99.8%Type of antigenNucleoprotein2055COVlD-19 IgM/IgG Antibodies Rapid Test(Colloidal GoId Method)946Beijing Bohui Innovation Biotechnology Co. Ltd.Chinahttp://www.bohui-tech.com/YesUnknownNoNoLab-basedAntibodyIgGIgMPlasmaSerumWhole blood1223B.1.525Eta2022-08-24 09:08:01 CET1735Immuno-AntibodyImmunochromatographyColloidal gold15LOD0AU/mLCalibrationNot evaluatedAnalysis of cross reactivityNot evaluatedFalse positives0%False negatives0%PrecisionNot evaluatedReproducibilityNot evaluatedRobustnessNot evaluatedClinical Sensitivity100% IgGClinical Sensitivity100% IgMClinical Specificity97.1% IgGClinical Specificity97.1% IgMType of antigenOther2046Anti-SARS-CoV-2 Neutralizing Antibody ELISA Kit943Beijing Bohui Innovative Biotechnology Co. Ltd.Chinahttp://www.bohui-tech.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerumWhole blood1223B.1.525EtaWe have CE marking, registered in Spanien. The products was registered in Spanish MOH with number RPS/294/2021.2022-08-24 09:08:01 CET1724Immuno-AntibodyImmunochromatographyNeutralization Antibody (NAb)120LOD20AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.47%Serum: 3/204;False positives1.98%Whole blood:4/202False positives1.47%Plasma: 3/203False negatives0.96%Plasma: 4/414False negatives1.44%Whole blood:6/415False negatives0.72%Serum: 3/413;PrecisionEvaluatedAccuracy97%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.06%Whole blood: (95% CI: 93.73%~98.65%)Clinical Sensitivity98.04%Plasma:(95% CI: 95.07%~99.23%) Clinical Sensitivity98.53%Serum: (95% CI: 95.77%~99.50%) Clinical Specificity99.27%Plasma: (95% CI: 97.89%~99.75%). Clinical Specificity99.03%Whole blood: (95% CI: 97.54%~99.62%).Clinical Specificity99.27%Serum: (95% CI: 97.89%~99.75%) Type of antigenOther2044Novel Coronavirus (SARS-CoV-2) Neutralizing Antibodies Test (Colloidal Gold)943Beijing Bohui Innovative Biotechnology Co. Ltd.Chinahttp://www.bohui-tech.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerumWhole blood1223B.1.525EtaWe have CE marking, registered in Spanien. The products was registered in Spanish MOH with number RPS/294/2021.2022-08-24 09:08:01 CET1722Immuno-AntibodyImmunochromatographyNeutralization Antibody (NAb)Colloidal gold15LOD20AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives3.41%serum:7/205False positives1.94%whoreblood:5/257False positives2.67%plasma:7/262False negatives1.45%serum:6/412False negatives1.81%plama:8/440False negatives2.47%whoreblood(11/445)PrecisionEvaluatedAccuracy98%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.82whoreblood: (95%CI: 92.67%-97.65%)Clinical Sensitivity96.96plasma: (95%CI: 94.11%-98.45%)Clinical Sensitivity97.06%serum:(95%CI: 93.73-98.65%)Clinical Specificity98.41plasma:(95% CI: 96.75%~99.23%)Clinical Specificity98.86whoreblood: (95% CI: 97.36%~99.51%).Clinical Specificity98.31%serum (95% CI:96.54%~99.18%)Type of antigen%Other2048Novel Coronavirus (SARS-CoV-2) Neutralizing Antibodies Test (Double Antigen Sandwich Colloidal Gold Immunochromatography)943Beijing Bohui Innovative Biotechnology Co. Ltd.Chinahttp://www.bohui-tech.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerumWhole blood1223B.1.525EtaWe have CE marking, registered in Spanien. The products was registered in Spanish MOH with number RPS/803/2021.2022-08-24 09:08:01 CET1726Immuno-AntibodyImmunochromatographyNeutralization Antibody (NAb)Colloidal gold15LOD20AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.76%Serum: 6/340False positives2.06%Whole blood:7/339False positives1.19%Plasma: 4/337False negatives1.04%Serum: 5/477False negatives1.25%Plasma: 6/480False negatives1.46%Whole blood:7/478PrecisionEvaluatedAccuracy99%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.94%Whole blood:(95%CI：95.80%~99.00%)Clinical Sensitivity98.23%Plasma:(95%CI：96.19%~99.19%) Clinical Sensitivity98.53%Serum: (95%CI：96.59%~99.37%) Clinical Specificity99.16%Plasma:(95%CI：97.87%~99.67%). Clinical Specificity98.54%Whole blood: (95%CI：97.01%~99.29%).Clinical Specificity98.74%Serum: (95%CI：97.29%~99.42%) . Type of antigenOther2047Novel Coronavirus (SARS-CoV-2) Neutralizing Antibodies Test (Quantum Dots Fluorescence Immunoassay)943Beijing Bohui Innovative Biotechnology Co. Ltd.Chinahttp://www.bohui-tech.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerumWhole blood1223B.1.525EtaWe have CE marking, registered in Spanien. The products was registered in Spanish MOH with number RPS/294/2021.2022-08-24 09:08:01 CET1725Immuno-AntibodyImmunochromatographyNeutralization Antibody (NAb)Fluorescence15LOD20AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.95%Serum：4/205False positives1.47%Whole blood:3/204False positives0.98%Plasma:2/204False negatives0.73%Serum：3/412False negatives0.48%Plasma:2/413False negatives0.72%Whole blood:3/413PrecisionEvaluatedAccuracy97%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.53%Whole blood: (95% CI: 95.77%~99.50%)Clinical Sensitivity99.02%Plasma:(95% CI: 96.50%~99.73%) Clinical Sensitivity98.53%Serum: (95% CI: 95.77%~99.50%) Clinical Specificity99.52%Plasma: (95% CI: 98.25%~99.87%). Clinical Specificity99.27%Whole blood: (95% CI:97.89%~99.75%)Clinical Specificity99.03%Serum: (95% CI:97.54%~99.62%) Type of antigenOther2045Novel Coronavirus (SARS-CoV-2) Neutralizing Antibody Detection Kit (Competitive ELISA)943Beijing Bohui Innovative Biotechnology Co. Ltd.Chinahttp://www.bohui-tech.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerumWhole blood1223B.1.525EtaWe have CE marking, registered in Spanien. The products was registered in Spanish MOH with number RPS/515/2021.2022-08-24 09:08:01 CET1723Immuno-AntibodyELISANeutralization Antibody (NAb)120LOD20AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2.4%Serum：5/208;False positives0.98%Plama:2/203False positives1.94%Whole blood:4/206False negatives0.49%Whole blood:2/411False negatives0.72%Plama:3/414False negatives0.24%Serum：1/409;PrecisionEvaluatedAccuracy98%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.51Serum:(95%CI：97.28%~99.91%) Clinical Sensitivity98.53Plasma:95%CI：95.77%~99.50%)Clinical Sensitivity99.02Whole blood:(95%CI：96.50%~99.73%)Clinical Specificity99.03Whole blood:(95%CI：97.54%~99.62%)Clinical Specificity99.52Plasma:(95%CI：98.25%~99.87%)Clinical Specificity98.79Serum: (95%CI：97.20%~99.48%)Type of antigenOther666Novel Coronavirus IgM/IgG Combo Rapid Test-Cassette551Beijing Decombio BiotechnologyChinawww.decombio-usa.com/NoCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2022-08-24 09:08:01 CET801Immuno-AntibodyYesNoImmunoassayQualitativeNot found15Rapid diagnostic test cassette Not found 12832019-nCoV Antigen Rapid Test Kit (colloidal gold assay)38Beijing Diagreat Biotechnologies Co. Ltd.Chinawww.diagreat.com/YesCommercialisedNoNoNear POC / POCAntigenNasal swabnucleocapsid protein2022-08-24 09:08:01 CET1093Immuno-AntigenYesImmunoassayQualitativeColorimetry15Type of antigenN protein632019-nCoV IgG Antibody Determination Kit38Beijing Diagreat Biotechnologies Co. Ltd.Chinawww.diagreat.com/YesCommercialisedNoNoNear POC / POCAntibodyIgGWhole blood2022-08-24 09:08:01 CET45Immuno-AntibodyYesYesImmunoassayQualitativeFluorescenceFluorescence15Analysis of cross reactivityEvaluated9602019-nCoV IgG/IgM Antibody Rapid Test Kit38Beijing Diagreat Biotechnologies Co. Ltd.Chinawww.diagreat.com/YesCommercialisedNoNoAutomatedManualAntibodyIgGIgMWhole blood2022-08-24 09:08:01 CET864Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15Manual or automated cassette Colloidal Gold Analysis of cross reactivityReported622019-nCoV IgM Antibody Determination Kit38Beijing Diagreat Biotechnologies Co. Ltd.Chinawww.diagreat.com/YesCommercialisedNoNoNear POC / POCAntibodyIgMWhole blood2022-08-24 09:08:01 CET44Immuno-AntibodyYesYesImmunoassayQualitativeFluorescence15Analysis of cross reactivityReported3622SARS-CoV-2 Antigen Rapid Test (Nasal Swab)1429Beijing Easy-Sweet Bio-medical Science and Technology Co., Ltd.ChinaYesCommercialisedNoNoManualAntigenNasal swabAdenovirus 3Adenovirus 7Alpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Hemophilus InfluenzaeInfluenza A H1N1Influenza A H3N2Influenza BMERS-CoV678B.1.1.529Omicronnucleocapsid protein2022-08-24 09:08:01 CET3334Immuno-AntigenYesYesNoImmunoassayQualitativeN.A.Colloidal gold15LOD115TCID50/mlAnalytical Sensitivity96%Analytical Specificity99.6%False positives96%False negatives99.6%Accuracy98.1%Clinical Sensitivity96%Clinical Specificity99.6%2292Coronavirus (2019-nCoV) -Antigentest1069Beijing Hotgen Biotech Co. Ltd.Chinawww.hotgen.com.cnNoCommercialisedNoNoNear POC / POCAntigenAnterior nasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThis product was evaluated by PEI with Ja（AT055/20）in Germany; Approval by BfArM GZ: 5640-S-057/212022-08-24 09:08:01 CET1993Immuno-AntigenNoImmunochromatographyQualitativeSandwich15LOD250CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy97.31%（Antigen）ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.37%（Antigen）Clinical Specificity99.13%（Antigen）Type of antigenNucleoprotein2293Coronavirus (2019-nCoV) -Antigentest-Speichel1069Beijing Hotgen Biotech Co. Ltd.Chinawww.hotgen.com.cnNoCommercialisedNoNoNear POC / POCAntigenSaliva689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThis product was evaluated by PEI with Ja（AT095/21）in Germany; Approval by BfArM GZ: 5640-S-080/212022-08-24 09:08:01 CET1994Immuno-AntigenNoImmunochromatographyQualitative15LOD250AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy97.76%（Antigen）ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.3%（Antigen）Clinical Specificity99.13%（Antigen）Type of antigenNucleoprotein2807Coronavirus (2019-nCoV)-Antigentest328Beijing Hotgen Biotech Co. Ltd.Chinawww.hotgen.com.cn/YesCommercialisedNoNoNear POC / POCAntigenAnterior nasal swab689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu2041C.37Lambda1495P.1GammaThe product has obtained the CE0123 certificate issued by the notified body, and has entered the German self-test whitelist, the French self-test whitelist and the Austrian self-test whitelist.2022-10-17 11:54:37 CET5303Immuno-AntigenYesNoNoImmunochromatographyQuantitativeSandwich15LOD79.2TCID50/mlLimit of detection is 5*10^1.2TCID50/mLCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives1.11%The 269 negative samples, 3 of them is false positives.False negatives3.05%The 131 positive samples, 4 of them should is false negativesPrecisionEvaluatedAccuracy98.25%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.95%AntigenClinical Specificity98.88%Antigen)Type of antigenNucleocapsid protein519Coronavirus disease (COVID-19) Antibody Test (Colloidal Gold)328Beijing Hotgen Biotech Co. Ltd.Chinawww.hotgen.com.cn/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerum2022-08-24 09:08:01 CET437Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15521Coronavirus disease (COVID-19) Antibody Test (Up-converting Phosphor Technology)328Beijing Hotgen Biotech Co. Ltd.Chinawww.hotgen.com.cn/YesCommercialisedNoNoNear POC / POCAntibody2022-08-24 09:08:01 CET451Immuno-AntibodyYesYesImmunoassayQualitative15Rapid diagnostic test card 2808Novel Coronavirus (SARS-CoV-2) Neutralizing Antibodies Test (Colloidal Gold)1069Beijing Hotgen Biotech Co. Ltd.Chinawww.hotgen.com.cnYesCommercialisedNoNoNear POC / POCAntibodyPeripheral bloodSerumVenous whole bloodWhole blood with anti-coagulants689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1132B.1.427Epsilon1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu2041C.37LambdaThere are acolorimetric cards in the product, and the user can judge the semi-quantitative result based on the colorimetric card.2022-08-24 09:08:01 CET2513Immuno-AntibodyYesNoImmunochromatographySemiquantitativeSandwichColloidal gold15LOD0.25AUThe cut off Novel Coronavirus (SARS-CoV-2) Neutralizing Antibodies in serum samples detected by this kit was determined to be 0.250(OCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.69%869 samples have 6 false positivesFalse negatives1.47%339 samples have 5 false negativesPrecisionEvaluatedAccuracy99.09% IgGReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.53% IgGClinical Specificity99.31% IgG2841Novel Coronavirus 2019-nCoV Antigen Test (Colloidal Gold)1069Beijing Hotgen Biotech Co. Ltd.Chinawww.hotgen.com.cnYesCommercialisedNoNoNear POC / POCAntigenAnterior nasal swabNasal swabThroat swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1132B.1.427Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu1439C.36The product can detect different types of sample.2022-08-24 09:08:01 CET2546Immuno-AntigenYesNoImmunochromatographyQuantitativeSandwichColloidal gold15LOD396.22TCID50/ml2.5×10^2.2 TCID50/mLCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives1.11%269 positive samples, 3 were false negative.False negatives3.05%131 positive samples, 4 were false negative.PrecisionEvaluatedAccuracy98.25%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.85%AntigenClinical Specificity98.88%AntigenType of antigenNucleocapsid protein1870Novel Coronavirus 2019-nCoV Antigen Test (Colloidal Gold)328Beijing Hotgen Biotech Co. Ltd.Chinawww.hotgen.com.cn/YesCommercialisedYesYesNear POC / POCAntigenNasal swabThroat swabSARS-CoV-2678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu2041C.37Lambda1495P.1Gammanucleocapsid proteinThis kit is used for in vitro qualitative determination of novel coronavirus antigen in human nasal swabs or throat swabs. It is used as rapid investigation for suspected cases of novel coronavirus, can also be used as a reconfirmation method for nucleic acid detection in discharged cases. A positive test result indicates that the samples contained novel coronavirus antigen. A negative test result does not rule out the possibility of infection. This product is only used for clinical and emergency reserve during the pneumonia outbreak of novel coronavirus infection, and can not be used as a routine in vitro diagnostic reagent for clinical application . The test results of this kit are for clinical reference only. It is recommended to conduct a comprehensive analysis of the condition based on the patient's clinical manifestations and other laboratory tests. For professional use only.2022-09-20 14:48:19 CET3834Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwichColloidal gold15LOD396.22TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives3.38%False negatives0.24%PrecisionEvaluatedAccuracy98.87%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.62%Clinical Specificity99.76%Type of antigenNucleocapsid protein1798Novel Coronavirus 2019-nCoV Antigen Test (Colloidal Gold) - Saliva328Beijing Hotgen Biotech Co. Ltd.Chinawww.hotgen.com.cn/YesCommercialisedNoNoNear POC / POCAntigenSalivaThis kit is used for in vitro qualitative determination of novel coronavirus antigen in human saliva samples from posterior oropharynx. It is used as rapid investigation for suspected cases of novel coronavirus, can also be used as a reconfirmation method for nucleic acid detection in discharged cases. A positive test result indicates that the samples contained novel coronavirus antigen. A negative test result does not rule out the possibility of infection. This product is only used for clinical and emergency reserve during the pneumonia outbreak of novel coronavirus infection, and can not be used as a routine in vitro diagnostic reagent for clinical application . The test results of this kit are for clinical reference only. It is recommended to conduct a comprehensive analysis of the condition based on the patient's clinical manifestations and other laboratory tests. For professional use only.2022-08-24 09:08:01 CET1477Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD250CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0False negatives0PrecisionEvaluatedAccuracy98.79ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96%Clinical Specificity99.78%2809Novel Coronavirus(SARS-CoV-2) Neutralizing AntibodiesTest (Up-converting Phosphor Immunochromatographic Technology)1256Beijing Hotgen Biotech Co. Ltd.ChinaYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumVenous whole bloodWhole bloodWhole blood with anti-coagulants689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.32041C.37LambdaProducts need to pass UPT instrument testing to obtain results.2022-08-24 09:08:01 CET2514Immuno-AntibodyYesImmunochromatographyQuantitativeNeutralization Antibody (NAb)Phosphor technology15LOD0.25AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.57%869 negative samples have 5 false positives.False negatives1.17%339 positive samples have 4 false negatives.PrecisionEvaluatedAccuracy99.25% IgGReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.82% IgGClinical Specificity99.42% IgG2811SARS-CoV-2 (S-RBD & NP) Antibody Test (Colloidal Gold)1069Beijing Hotgen Biotech Co. Ltd.Chinawww.hotgen.com.cnYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumVenous whole bloodWhole blood with anti-coagulants689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1132B.1.427Epsilon1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.32041C.37LambdaTwo test results can be obtained through this product test: S-RBD antibody and NP antibody.2022-08-24 09:08:01 CET2516Immuno-AntibodyNoImmunochromatographySemiquantitativeSandwichColloidal gold20LOD15AU/mL15BAU/mLCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%408 negative samples have no false positives.False negatives0.43%230 positive samples have 1 false negative.PrecisionEvaluatedAccuracy99.84% IgGReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.57% IgGClinical Specificity100% IgG2810SARS-CoV-2 and Flu A/B Antigen Combo Rapid Test (Colloidal Gold)1256Beijing Hotgen Biotech Co. Ltd.ChinaYesCommercialisedNoNoNear POC / POCAntigenNasal swabThroat swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1132B.1.427Epsilon1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.32041C.37LambdaAdd 1 sample to get 3 results: SARS-CoV-2, Flu A and Flu B .2022-08-24 09:08:01 CET2515Immuno-AntigenYesNoImmunochromatographyQuantitativeSandwichColloidal gold15LODLimit of detection is 2.5*10^2.2TCID50/mLCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.24%410 negative samples have 1 false positives.False negatives3.38%207 positive samples have 7 false negatives.PrecisionEvaluatedAccuracy98.7%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.62%AntigenClinical Specificity99.76%AntigenType of antigenNucleocapsid protein1725Jinwofu® Novel Coronavirus (SARS-CoV-2) Antigen-Rapid-Test765Beijing Jinwofu Bioengineering Technology Co. Ltd.Chinawww.jwfbio.com/en/YesCommercialisedNoNoNear POC / POCAntigenNasal swabOthernucleocapsid protein2022-08-24 09:08:01 CET1405Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD100CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0AUFalse negatives10AUPrecisionEvaluatedAccuracy98.82%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.88%Type of antigennucleoprotein2072Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test Kit958Beijing Jinwofu Bioengineering Technology Co. Ltd.Chinajwfbio.comYesCommercialisedYesYesNear POC / POCAntigenAnterior nasal swabNasal swabNasopharyngeal swabOropharyngeal swabSaliva689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma3939B.1.6161323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11518P.2Zetanucleocapsid protein)Do not use this kit beyond the expiration date printed on the outside carton. 2)This test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; 3)To avoid erroneous results, specimens must be processed as indicated in the test procedure section.Proper specimen collection, storage and transport are critical to the performance of this test 4)The used Jinwofu Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test cards should be treated as hazardous waste. 5)Our company's novel coronavirus detection kit is a product developed for novel coronavirus nucleoprotein, which only detects nucleoprotein, but cannot detect spike protein and its variation structure. Therefore, spike protein and UK variant do not affect the detection ability and accuracy (sensitivity and specificity) of our company's novel coronavirus antigen detection kit for novel coronavirus.2022-08-24 09:08:01 CET1754Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich, Double30LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives3.125%PrecisionEvaluatedAccuracy98.82%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity%96.88%Clinical Specificity100%Type of antigenNucleoprotein1778COVID19 Antigen Rapid Test Kit43Beijing Kewei Clinical Diagnostic Reagent Inc.Chinaen.keweidiagnostic.com/YesCommercialisedYesYesNear POC / POCAntigenNasal swab2022-08-24 09:08:01 CET1457Immuno-AntigenYesNoImmunochromatographyQualitativeColorimetry15LOD19.3U/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives3.82%PrecisionEvaluatedAccuracy98.56%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.18%707Genonto RapidTest10 COVID-19 IgG/IgM Antibody Rapid Test Kit43Beijing Kewei Clinical Diagnostic Reagent Inc.Chinaen.keweidiagnostic.com/NoCommercialisedNoNoNear POC / POCAntibodyIgGIgM Additional info: https://www.asiatechdaily.com/genbody-coronavirus-test-kit/ Not found in the company website2022-08-24 09:08:01 CET589Immuno-AntibodyYesImmunoassayRapid diagnostic test Not found Not found 1284Kewei COVID-19 Antigen Rapid Test Kit (Colloidal Gold)43Beijing Kewei Clinical Diagnostic Reagent Inc.Chinaen.keweidiagnostic.com/YesCommercialisedNoNoNear POC / POCAntigenNasal swabThroat swabnucleocapsid protein2022-08-24 09:08:01 CET1058Immuno-AntigenYesImmunoassayQualitativeColorimetry15Rapid diagnostic test Lateral Flow Clinical Sensitivity85%Clinical Specificity100%Type of antigennucleocapsid70Kewei COVID-19 Antigen Rapid Test Kit (FIA)43Beijing Kewei Clinical Diagnostic Reagent Inc.Chinaen.keweidiagnostic.com/YesCommercialisedNoNoNear POC / POCAntigenNasal swabOropharyngeal swab2022-08-24 09:08:01 CET390Immuno-AntigenYesYesImmunoassayQualitativeFluorescence15LOD140TCID50/mlAccuracy97.5%Clinical Sensitivity85%Clinical Specificity100%1285Kewei COVID-19 Antigen Rapid Test Kit (Fluorescence)43Beijing Kewei Clinical Diagnostic Reagent Inc.Chinaen.keweidiagnostic.com/YesCommercialisedNoNoNear POC / POCAntigenNasal swabThroat swabnucleocapsid protein2022-08-24 09:08:01 CET1059Immuno-AntigenYesImmunoassayQualitativeFluorescence15Rapid diagnostic test Lateral Flow fluorescence Clinical Sensitivity85%Clinical Specificity100%Type of antigennucleocapsid69Kewei COVID-19 IgG antibody ELISA Test Kit43Beijing Kewei Clinical Diagnostic Reagent Inc.Chinaen.keweidiagnostic.com/YesCommercialisedNoNoAutomatedManualAntibodyIgGPlasmaSerum2022-08-24 09:08:01 CET50Immuno-AntibodyNoYesELISAQualitativeMagnetic Electrochemical60Accuracy96% IgGClinical Sensitivity90.83% IgGClinical Specificity99.2% IgG71Kewei COVID-19 IgG/IgM antibody Rapid Test Kit (Colloidal Gold)43Beijing Kewei Clinical Diagnostic Reagent Inc.Chinaen.keweidiagnostic.com/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2022-08-24 09:08:01 CET1240Immuno-AntibodyYesNoImmunoassayQualitativeColloidal gold10Accuracy96%Clinical Sensitivity93.3%Clinical Specificity98.2%67Kewei COVID-19 IgM antibody ELISA Test Kit43Beijing Kewei Clinical Diagnostic Reagent Inc.Chinaen.keweidiagnostic.com/YesCommercialisedNoNoAutomatedManualAntibodyIgMPlasmaSerum2022-08-24 09:08:01 CET365Immuno-AntibodyNoYesELISAQualitativeCapture60Accuracy96% IgMClinical Sensitivity90.83% IgMClinical Specificity99.6% IgM1111Kewei COVID-19 total antibody ELISA Test Kit43Beijing Kewei Clinical Diagnostic Reagent Inc.Chinaen.keweidiagnostic.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum http://en.keweidiagnostic.com/index.php?m=content&c=index&a=show&catid=199&id=1752022-08-24 09:08:01 CET367Immuno-AntibodyNoYesELISAQualitativeSandwich, Double60Manual or automated microtiter plate Sandwich, Double Accuracy96%Clinical Sensitivity94.71%Clinical Specificity99.6%1112Kewei COVID-19 total antibody rapid test43Beijing Kewei Clinical Diagnostic Reagent Inc.Chinaen.keweidiagnostic.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerumWhole blood http://en.keweidiagnostic.com/uploadfile/2020/0704/20200704024137750.pdf2022-08-24 09:08:01 CET389Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry10Manual or automated Colloidal Gold Clinical Sensitivity93.33%Clinical Specificity99.6%17902019-nCoV Antigen Rapid Test Kit (Colloidal Gold Immunochromatography)319Beijing Lepu Medical Technology Co. Ltd.Chinahttps://www.lepumedical.com/YesCommercialisedNoNoOtherAntigenNasal swabOthernucleocapsid protein2022-08-24 09:08:01 CET1469Immuno-AntigenYesNoImmunochromatographyQualitativeColorimetry15LOD200IU/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.38%False negatives4.94%PrecisionEvaluatedPrecisionEvaluatedAccuracy97.44%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity95.06%Type of antigenNucleoprotein30782019-nCoV antigen, Influenza A virus antigen, Influenza B virus antigen detection kit (colloidal gold immunochromatography)1364Beijing Lepu Medical Technology Co. Ltd.Chinaen.lepumedical.comYesCommercialisedNoNoManualAntigenNasal swabNasopharyngeal swabSARS-CoVInfluenza AInfluenza A H1N1Influenza A H3N2Influenza A H5N1Influenza BInfluenza B Victoria689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1321B.1.617.2Delta678B.1.1.529Omicronnucleocapsid protein2022-08-24 09:08:01 CET2784Immuno-AntigenYesNoNoImmunochromatographyQualitativeColloidal gold15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy95%19/20ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.44%95%CI: 84.32%-97.42%Clinical Specificity99.38%95%CI: 96.55%-99.89%Type of antigenNucleocapsid protein523SARS-CoV-2 Antibody Test (colloidal gold immunochromatography)319Beijing Lepu Medical Technology Co. Ltd.Chinahttps://www.lepumedical.com/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerum2022-08-24 09:08:01 CET423Immuno-AntibodyYesImmunochromatographyColloidal goldLOD3.1U/ml1331SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography)319Beijing Lepu Medical Technology Co. Ltd.Chinahttps://www.lepumedical.com/YesCommercialisedYesYesNear POC / POCAntigenNasal swabNasopharyngeal swab2022-08-24 09:08:01 CET1100Immuno-AntigenYesNoImmunochromatographyQualitativeColloidal gold15Clinical Sensitivity95.06%Clinical Specificity99.62%2881SARS-CoV-2 Antigen Rapid Test Kits for Self-testing (Colloidal Gold Immunochromatography)319Beijing Lepu Medical Technology Co. Ltd.Chinahttps://www.lepumedical.com/YesCommercialisedNoNoManualAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1321B.1.617.2Delta678B.1.1.529Omicronnucleocapsid proteinN/A2022-08-24 09:08:01 CET2586Immuno-AntigenYesNoImmunochromatographyQualitativeColloidal gold15LOD200TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy97.8%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity95.9%Clinical Specificity100%Type of antigenNucleocapsid protein3009COVID-19 Antigen Rapid Test1334Beijing North Institute of Biotechnology Co. Ltd.YesCommercialisedNoNoNear POC / POCAntigenNasal swabBeta Coronavirus HKU1 (HCoV-HKU1)689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1321B.1.617.2Delta2041C.37Lambda678B.1.1.529Omicronnucleocapsid proteinThe COVID-19 Antigen Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of COVID-19 antigen in nasal swab.2022-08-24 09:08:01 CET2715Immuno-AntigenNoNoImmunochromatographyQualitativeSandwich, Double15LOD150TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives2.98AUFalse negatives2.19AUPrecisionEvaluatedAccuracy97.67%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90.74%Clinical Specificity99.33%Type of antigenNucleocapsid protein2733COVID-19 TEST RAPIDO ANTIGENE RICOV41240Beijing North Institute of Biotechnology Co. Ltd.Chinawww.bnibt.comYesCommercialisedNoNoNear POC / POCAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1320B.1.617.1Kappa1321B.1.617.2Delta2041C.37Lambda678B.1.1.529Omicronnucleocapsid protein2022.2.7 evaluated at Centralne Laboratorium Kliniczne Uniwersyteckie Centrum Kliniczne.2022-08-24 09:08:01 CET2438Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich, Double15LOD150TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.7%False negatives9.3%PrecisionEvaluatedAccuracy97.67%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90.74%Clinical Specificity99.33%Type of antigenNucleocapsid protein667Coronavirus disease (COVID-19) Total Antibody Rapid Test (Colloidal Gold)407Beijing O&D Biotech Co. Ltd.Chinawww.odbio.com/lxwmNoCommercialisedNoNoLab-basedAntibody No info on the webiste2022-08-24 09:08:01 CET561Immuno-AntibodyImmunoassayQualitative2494COVID-19 Antigen Rapid Test1135Beijing O&D Biotech Co. Ltd.Chinahttp://www.odbio.com/YesCommercialisedYesYesManualAntigenNasal swabNasopharyngeal swabOropharyngeal swabnucleocapsid proteinCOVID-19 Antigen Rapid Test is used for detection of COVID-19 specific antigens in human Nasal and Oropharyngeal Swab samples. It only detects the N protein and can’t detect the S protein and its mutation structure.2022-08-24 09:08:01 CET2197Immuno-AntigenYesNoNoImmunoassayQualitative15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.33%For Nasal Swab Sample -(4/300);False positives0.67%For Nasopharyngeal Swab Sample - (2/300)False positives1%For Oropharyngeal Swab Sample - (3/300); False negatives6.09%For Nasopharyngeal Swab Sample - (7/115)False negatives6.96%For Oropharyngeal Swab Sample - (8/115); False negatives7.83%For Nasal Swab Sample - (9/115); PrecisionEvaluatedAccuracy96.87%For Nasal Swab SampleAccuracy97.35%Accuracy97.83%For Nasopharyngeal Swab SampleAccuracy97.35%For Oropharyngeal Swab SampleReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.17%For Nasal Swab Sample - (95% CI: 85.26%-96.13% )Clinical Sensitivity93.04%For Oropharyngeal Swab Sample - (95% CI: 86.33%-96.73% )Clinical Sensitivity93.91%For Nasopharyngeal Swab Sample - (95% CI: 87.86%-97.52% )Clinical Specificity98.67%For Nasal Swab Sample - (95% CI: 96.39%-99.57%); Clinical Specificity99%For Oropharyngeal Swab Sample - (95% CI: 96.86%-99.74%); Clinical Specificity99.33%For Nasopharyngeal Swab Sample - (95% CI: 97.61%-99.92%)Type of antigenNucleocapsid protein76Coronavirus (SARS-Cov-2) N protein Detection Kit (Fluorescence immunochromatography)414Beijing Savant Biotechnology Co. Ltd.Chinawww.huaketai.com/YesCommercialisedNoNoAutomatedManualAntigenThroat swab2022-08-24 09:08:01 CET569Immuno-AntigenYesYesImmunochromatographyQualitativeFluorescence15LOD50ng/mLAnalysis of cross reactivityEvaluated1235SARS-Cov-2 Antigen Fluorescence Rapid Detection Kit414Beijing Savant Biotechnology Co. Ltd.Chinawww.huaketai.com/YesCommercialisedNoNoNear POC / POCAntigenOropharyngeal swab https://www.biorxiv.org/content/10.1101/2020.05.27.119255v1.full.pdf, http://www.huaketai.com/en/index.php?c=article&id=3152022-08-24 09:08:01 CET1017Immuno-AntigenYesNoImmunoassayQualitativeFluorescence15LOD50ng/mL3722SARS-CoV-2 Antigen Test1365Beijing Strong Biotechnologies Inc.Chinahttp://en.bsbe.com.cn/YesCommercialisedNoNoManualNear POC / POCAntigenNasopharyngeal swabAlpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)SARS-CoV678B.1.1.529Omicron1321B.1.617.2Deltanucleocapsid protein2022-08-24 09:08:01 CET3405Immuno-AntigenYesNoNoImmunoassayQualitativeSandwich, DoubleColloidal gold15LOD101TCID50/mlAnalytical Sensitivity81%Analytical Specificity99%False positives0samplesFalse negatives37samplesAccuracy88%Clinical Sensitivity81%Clinical Specificity100%1292Tigsun COVID-19 Antigen Rapid Test47Beijing Tigsun Diagnostics Co. Ltd.Chinawww.tigsun.com/YesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swabOropharyngeal swabnucleocapsid protein2022-08-24 09:08:01 CET1065Immuno-AntigenYesImmunoassayQualitativeType of antigenN protein1290Tigsun COVID-19 Antigen Saliva Rapid Test47Beijing Tigsun Diagnostics Co. Ltd.Chinawww.tigsun.com/YesCommercialisedNoNoNear POC / POCAntigenSalivanucleocapsid protein2022-08-24 09:08:01 CET1064Immuno-AntigenYesImmunoassayType of antigenN protein77Tigsun COVID-19 Combo IgM/IgG Rapid Test (Lateral Flow Method)47Beijing Tigsun Diagnostics Co. Ltd.Chinawww.tigsun.com/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2022-08-24 09:08:01 CET54Immuno-AntibodyYesNoImmunoassayQualitative3033Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test Kit (Colloidal Gold)1350Beijing Unidiag Technology Inc.Chinahttp://www.unidiaginc.com/YesCommercialisedNoNoManualNear POC / POCAntigenAnterior nasal swabSARS-CoV1495P.1Gamma1321B.1.617.2Delta678B.1.1.529Omicronnucleocapsid protein2022-08-24 09:08:01 CET2739Immuno-AntigenYesNoNoImmunochromatographyQualitativeMembrane-basedColloidal gold15LOD250TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%0 out of 460 samples were found falsely positive comparing with the PCR testFalse negatives7.3%8 out of 110 samples were found falsely negative comparing with the PCR testPrecisionEvaluatedAccuracy98.6%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.73%Clinical Specificity100%Type of antigenNucleocapsid protein833SARS-CoV-2 Total Ab ELISA49Beijing Wantai Biological Pharmacy Enterprise Co. Ltd.Chinawww.ystwt.cnYesCommercialisedNoNoAutomatedManualAntibodySerum2022-08-24 09:08:01 CET684Immuno-AntibodyNoYesELISAQualitativeFluorescence75Manual or automated Fluorescence Clinical Sensitivity94.36%Clinical Specificity100%82Wantai SARS-CoV-2 Ab Rapid Test49Beijing Wantai Biological Pharmacy Enterprise Co. Ltd.Chinawww.ystwt.cnNoCommercialisedNoNoNear POC / POCAntibody2022-08-24 09:08:01 CET58Immuno-AntibodyYesImmunoassayNot foundRapid diagnostic test Not found Not found 1485WANTAI SARS-CoV-2 Ag Rapid Test (Colloidal Gold)49Beijing Wantai Biological Pharmacy Enterprise Co. Ltd.Chinawww.ystwt.cnYesCommercialisedYesYesManualNear POC / POCAntigenNasal swabNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1320B.1.617.1Kappa1321B.1.617.2Delta1323B.1.621Mu2041C.37Lambda1224B.1.526Iotanucleocapsid proteinWe removed saliva from the specimen types.2022-08-24 09:08:01 CET1237Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD137TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.04%1.04/100False negatives6.78%6.78/100PrecisionEvaluatedAccuracy97.06%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.22%Clinical Specificity98.96%Type of antigenNucleocapsid protein1484WANTAI SARS-CoV-2 Ag Rapid Test (FIA)49Beijing Wantai Biological Pharmacy Enterprise Co. Ltd.Chinawww.ystwt.cnYesCommercialisedNoNoLab-basedManualNear POC / POCSemi-automatedAntigenNasopharyngeal swabOropharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1320B.1.617.1Kappa1321B.1.617.2Delta1323B.1.621Mu2041C.37Lambda1224B.1.526Iotanucleocapsid proteinID 1484 was deleted from RAT database, we now submit an application with new data again.2022-08-24 09:08:01 CET1236Immuno-AntigenYesYesOtherQualitativeSandwich, DoubleFluorescence15LOD60TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives3%3/100False negatives7%7/100PrecisionEvaluatedAccuracy96%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93%Clinical Specificity97%Type of antigenNucleocapsid protein834Wantai SARS-CoV-2 IgM ELISA49Beijing Wantai Biological Pharmacy Enterprise Co. Ltd.Chinawww.ystwt.cnYesCommercialisedNoNoAutomatedManualAntibodyIgMSerum2022-08-24 09:08:01 CET1792Immuno-AntibodyELISA1362Novel Coronavirus (2019-nCoV) Antigen Detection Kit (Quantum Dot-Based Fluorescence Immunochromatography)652Beijing WSWY Technology Co. Ltd.Chinawww.wswygs.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabnucleocapsid protein2022-08-24 09:08:01 CET1121Immuno-AntigenYesNoImmunoassayQualitativeFluorescence15LOD60AUFalse positives0%0False negatives8.43%Accuracy98.21%(Antigen)Clinical Sensitivity91.57%(Antigen)Type of antigennucleoprotein697SARS-CoV-2 IgG/igM Antibody Detection Kit425Beroni GroupAustraliawww.beronigroup.comYesCommercialisedNoNoLab-basedAntibodyIgGIgM2022-08-24 09:08:01 CET581Immuno-AntibodyImmunoassay2988SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method)1321BGI Europe A/Shttp://www.bgi.comYesCommercialisedNoNoNear POC / POCAntigenAnterior nasal swabNasal swabNasopharyngeal swabThroat swabSARS-CoV689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.3678B.1.1.529Omicronnucleocapsid protein2022-08-24 09:08:01 CET2694Immuno-AntigenNoImmunoassayQualitativeSandwich, DoubleColloidal gold15LOD200TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives4.26%4 out of 94 (Ct < 30)False negatives0%PrecisionEvaluatedAccuracy99.28%Ct values < 30Accuracy97.89%overallReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.74%Ct values <30Clinical Specificity100%Type of antigenNucleocapsid protein2122COVID-19 ANTIGEN RAPID TEST CASSETTE982BIO GROUP MEDICAL SYSTEMItalywww.biogms.itYesCommercialisedNoNoNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swab689B.1.1.7AlphaThe COVID-19 Antigen Rapid Test) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 antigens in nasopharyngeal/orophayngeal/nasal swab specimens from individuals with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests.2022-08-24 09:08:01 CET1812Immuno-AntigenNoImmunochromatographyQualitativeMembrane-based15LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positivesSee IFUFalse negativesSee IFUPrecisionEvaluatedAccuracy96.2% (95%CI*: 91.3%~98.7%)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.9% (95%CI*: 84.1%~97.6%)Clinical Specificity99.9%＞99.9% (95%CI*: 94.0%~100%)Type of antigenNucleoprotein756Platelia SARS-CoV-2 Total Ab Assay332Bio-Rad Laboratories Inc.United Stateswww.bio-rad.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET612Immuno-AntibodyYesImmunoassayQualitativeSandwich, DoubleMAnalysis of cross reactivityEvaluatedPrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity86.5%(73-100)Clinical Specificity100%85Ella / Simple Plex COVID-19 16×4 Standard Panel51Bio-TechneUnited Kingdomwww.bio-techne.com/NoCommercialisedNoNoAutomatedManualAntibody2022-08-24 09:08:01 CET59Immuno-AntibodyImmunoassayStandard panel2703(COVID-19) IgM/IgG Antibody Rapid Test Kit1236Bioantibody Biotechnology Co. Ltd.Chinahttp://www.baikangbiotech.com/index.php/product/49.htmlYesCommercialisedNoNoManualAntibodyIgGIgMPlasmaSerumWhole bloodnucleocapsid protein(COVID-19) IgM/IgG Antibody Rapid Test Kit (Latex Chromatography) is based on the principle of capture immunoassay for determination of COVID-19 IgG/IgM antibodies in human whole blood, serum and plasma. When the sample is added to the test device, the sample will be absorbed into the device by capillary action, mixing with SARS- CoV-2 recombinant antigen-color latex conjugate and flowing through the pre-coated membrane. When the COVID-19 IgG antibody or IgM antibody level in the specimen is at or above the target cutoff (the detection limit of the test), the antibodies bound to the antigen- color latex conjugate are captured by anti-human IgG antibody immobilized on the Test Region (G)of the device or anti-human IgMantibody immobilized on the Test Region(M), and This produces one or two color teststrips indicating a positive result. When theCOVID-19 IgG/IgM antibodies level in thespecimen is zero or below the target cutoff,there is not a visible colored band in the TestRegion (G M) of the device. This indicates anegative result. To serve as a procedure control, a colored linewill appear at the Control Region (C), if the testhas been performed properly.2022-08-24 09:08:01 CET2408Immuno-AntibodyYesChromatographyQualitativeSandwich15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives%0False negatives%0PrecisionEvaluatedAccuracy100% IgGAccuracy100% IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100% IgGClinical Sensitivity100% IgMClinical Specificity100% IgGClinical Specificity100% IgMType of antigenNucleocapsid protein2706(COVID-19) IgM/IgG Antibody Rapid Test Kit (Latex Chromatography)1236Bioantibody Biotechnology Co. Ltd.Chinahttp://www.baikangbiotech.com/index.php/product/49.htmlYesCommercialisedNoNoManualIgGIgMPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1321B.1.617.2Delta(COVID-19) IgM/IgG Antibody Rapid Test Kit (Latex Chromatography) is based on the principle of capture immunoassay for determination of COVID-19 IgG/IgM antibodies in human whole blood, serum and plasma. When the sample is added to the test device, the sample will be absorbed into the device by capillary action, mixing with SARS- CoV-2 recombinant antigen-color latex conjugate and flowing through the pre-coated membrane. When the COVID-19 IgG antibody or IgM antibody level in the specimen is at or above the target cutoff (the detection limit of the test), the antibodies bound to the antigen- color latex conjugate are captured by anti-human IgG antibody immobilized on the Test Region (G)of the device or anti-human IgMantibody immobilized on the Test Region(M), and This produces one or two color teststrips indicating a positive result. When theCOVID-19 IgG/IgM antibodies level in thespecimen is zero or below the target cutoff,there is not a visible colored band in the TestRegion (G M) of the device. This indicates anegative result. To serve as a procedure control, a colored linewill appear at the Control Region (C), if the testhas been performed properly.2022-08-24 09:08:01 CET2411Immuno-AntibodyImmunochromatographyQualitativeCapture15CalibrationEvaluatedAnalysis of cross reactivityNot evaluatedFalse positives0% IgGFalse positives1.1% IgMFalse negatives2.7% IgGFalse negatives0% IgMPrecisionEvaluatedAccuracy99% IgGAccuracy99% IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100% IgGClinical Sensitivity98.9% IgMClinical Specificity97.3% IgGClinical Specificity100% IgMType of antigenNucleocapsid protein3079SARS-CoV-2 Antigen Rapid Detection Kit1236Bioantibody Biotechnology Co. Ltd.Chinahttp://www.baikangbiotech.com/index.php/product/49.htmlYesCommercialisedNoNoNear POC / POCAntigenAnterior nasal swabAdenovirusCoronaviruses (HCoV)Alpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)MERS-CoVSARS-CoVInfluenza A689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1321B.1.617.2Delta678B.1.1.529Omicronnucleocapsid proteinSARS-CoV-2 nucleocapsid >sp|P0DTC9|1-419 MSDNGPQNQRNAPRITFGGPSDSTGSNQNGERSGARSKQRRPQGLPNNTASWFTALTQHG KEDLKFPRGQGVPINTNSSPDDQIGYYRRATRRIRGGDGKMKDLSPRWYFYYLGTGPEAG LPYGANKDGIIWVATEGALNTPKDHIGTRNPANNAAIVLQLPQGTTLPKGFYAEGSRGGS QASSRSSSRSRNSSRNSTPGSSRGTSPARMAGNGGDAALALLLLDRLNQLESKMSGKGQQ QQGQTVTKKSAAEASKKPRQKRTATKAYNVTQAFGRRGPEQTQGNFGDQELIRQGTDYKH WPQIAQFAPSASAFFGMSRIGMEVTPSGTWLTYTGAIKLDDKDPNFKDQVILLNKHIDAY KTFPPTEPKKDKKKKADETQALPQRQKKQQTVTLLPAADLDDFSKQLQQSMSSADSTQA2022-08-24 09:08:01 CET2785Immuno-AntigenNoYesImmunoassayMembrane-based15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives10%False negatives0%PrecisionEvaluatedAccuracy98.07%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90%Clinical Specificity100%Type of antigenNucleocapsid protein2704SARS-CoV-2 Antigen Rapid Detection Kit (Latex Chromatography)1236Bioantibody Biotechnology Co. Ltd.Chinahttp://www.baikangbiotech.com/index.php/product/49.htmlYesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swabSARS-CoV689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1321B.1.617.2Delta678B.1.1.529Omicronnucleocapsid proteinSARS-CoV-2 Antigen Rapid Detection Kit (Latex Chromatography) is a lateral flow chromatographic immunoassay. It has two pre-coated lines, “T” Test line and “C” Control line on the nitrocellulose membrane. Mouse monoclonal anti-SARS-CoV-2 antibodies are coated on the test line region and Goat anti-chicken IgY antibodies are coated on the control region. When the specimen is processed and added to the sample well, SARS-CoV-2 antigens in the sample interact with the SARS-CoV-2 Antibody-labeled conjugate forming antigen-antibody color particle complexs .The complexs migrate on the nitrocellulose membrane via capillary action until the test line, where they are captured by the mouse monoclonal anti-SARS-CoV-2 antibodies. A colored test line is visible in the result window if SARS-CoV-2 antigens are present in the specimen and the intensity depends upon the amount of SARS-CoV-2 antigen. When the SARS-CoV-2 antigens in the specimen does not exist or is below the detection limit, there is not a visible colored band in the Test line (T) of the device. This indicates a negative result. Neither the test line nor control line are visible in the result window prior to applying the specimen. A visible control line is required to indicate the result is valid.2022-08-24 09:08:01 CET2409Immuno-AntigenYesNoNoChromatographyQualitativeSandwich, Double15INTNSSP(74-80) clone2 binding site:GTRNPANN(147-154)LOD28.8pg/ml (Nucleocapsid protein Concentration)Analysis of cross reactivityEvaluatedFalse positives6AUFalse negatives2AUAccuracy98.4%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.9%AntigenClinical Specificity98.11%AntigenType of antigenNucleocapsid protein3081SARS-CoV-2 Antigen Rapid Detection Kit (Latex Chromatography) (anterior nasal swab)1236Bioantibody Biotechnology Co. Ltd.Chinahttp://www.baikangbiotech.com/index.php/product/49.htmlYesCommercialisedNoNoNear POC / POCAntigenAnterior nasal swabSARS-CoV689B.1.1.7Alpha1032B.1.351Beta1321B.1.617.2Delta678B.1.1.529Omicronnucleocapsid proteinno additional information2022-08-24 09:08:01 CET3135Immuno-AntigenYesNoYesImmunoassayQualitativeMembrane-based15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives10%PrecisionEvaluatedAccuracy98.07%antigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90%antigenClinical Specificity100%antigenType of antigenNucleocapsid protein2705SARS-CoV-2 Saliva Antigen Rapid Detection Kit (Latex Chromatography)1236Bioantibody Biotechnology Co. Ltd.Chinahttp://www.baikangbiotech.com/index.php/product/49.htmlYesCommercialisedNoNoManualAntigenSalivaSARS-CoV689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1321B.1.617.2Delta678B.1.1.529Omicronnucleocapsid proteinSARS-CoV-2 Saliva Antigen Rapid Detection Kit (Latex Chromatography) is a lateral flow chromatographic immunoassay. It has two pre-coated lines, “T” Test line and “C” Control line on the nitrocellulose membrane. Mouse monoclonal anti-SARS-CoV-2 antibodies are coated on the test line region and Goat anti-chicken IgY antibodies are coated on the control region.Mouse anti- SARS-CoV-2 antibodies conjuated with colored latex are used as detectors for SARS-CoV-2 antigen. When the specimen is processed and added to the sample well, SARS-CoV-2 antigens in the sample interact with the SARS-CoV-2 Antibody-labeled conjugate forming antigen-antibody color particle complexs .The complexs migrate on the nitrocellulose membrane via capillary action until the test line, where they are captured by the mouse monoclonal anti-SARS-CoV-2 antibodies. A colored test line is visible in the result window if SARS-CoV-2 antigens are present in the specimen and the intensity depends upon the amount of SARS-CoV-2 antigen. When the SARS-CoV-2 antigens in the specimen does not exist or is below the detection limit, there is not a visible colored band in the Test line (T) of the device. This indicates a negative result. Neither the test line nor control line are visible in the result window prior to applying the specimen. A visible control line is required to indicate the result is valid.2022-08-24 09:08:01 CET2410Immuno-AntigenYesNoChromatographyQualitativeSandwich15INTNSSP(74-80) clone2 binding site:GTRNPANN(147-154) LOD28.8 pg/ml (Nucleocapsid protein Concentration)CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives2.06%Saliva samples False positives1.46%Direct oral salivaFalse negatives3.77%Saliva samples False negatives2.61%Direct oral salivaPrecisionEvaluatedAccuracy97.26%Saliva samples Accuracy98.04%Direct oral salivaReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.23%Saliva samples Clinical Sensitivity97.39%Direct oral salivaClinical Specificity98.54%Direct oral salivaClinical Specificity97.94%Saliva samples Type of antigenNucleocapsid protein28952019-nCoV IgM/IgG Antibody Test Kit（Colloidal Gold）1272Biobase Biodustry（Shandong） Co. Ltd.Chinahttps://www.biobase.cc/YesCommercialisedNoNoLab-basedManualAntibodyIgGIgMOther689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1321B.1.617.2Delta678B.1.1.529Omicronenvelope proteinmembrane proteinnon-structural protein NSP1nucleocapsid proteinspike proteinThe SARS-COV-2 IgM/IgG Rapid Test Kit is used for the qualitative detection of IgM and IgG antibodies in human serum, plasma or whole blood.2022-08-24 09:08:01 CET2600Immuno-AntibodyYesYesImmunochromatographyQualitativeMembrane-basedColloidal gold15LOD5ng/mLIgG LOD25ng/mLIgMCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.67%False negatives1.85%PrecisionEvaluatedAccuracy98.33%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.15%Clinical Specificity98.44%Type of antigenNucleocapsid protein2864SARS-CoV-2 Antigen Test Kit (Colloidal Gold)1272Biobase Biodustry（Shandong） Co. Ltd.Chinahttps://www.biobase.cc/YesCommercialisedNoNoLab-basedManualAntigenNasopharyngeal swabOropharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1321B.1.617.2Delta678B.1.1.529OmicronNone2022-08-24 09:08:01 CET2569Immuno-AntigenYesImmunochromatographyQualitativeMembrane-basedColloidal gold15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.56%False negatives1.85%PrecisionEvaluatedAccuracy98.33%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.15%Clinical Specificity98.44%Type of antigenNucleocapsid protein3112BIOBASE COVID-19 Antigen Rapid Test (Self-testing)1358Biobase Diagnostic Technology (Shandong) Co. Ltd.Chinahttps://www.biobase.cc/YesCommercialisedNoNoManualNear POC / POCAntigenAnterior nasal swabCoronaviruses (HCoV)689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma678B.1.1.529Omicronnucleocapsid proteinThe Biobase COVID-19 Antigen Rapid Test is a lateral flow assay intended for the qualitative detection of nucleocapsid protein antigen from SARS-COV-2. The Test is intended for self-testing of anterior nasal (nares) swab samples from individuals aged 14 years or older, or adult collected anterior nasal swab samples from individuals aged 2 years or older.2022-08-24 09:08:01 CET2819Immuno-AntigenYesNoImmunochromatographyQualitativeMembrane-based15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives7.27%PrecisionEvaluatedAccuracy98.62%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.73%Clinical Specificity100%Type of antigenNucleocapsid protein3071BIOBASE COVID-19 Antigen Rapid Test（Self-Test）1358Biobase Diagnostic Technology (Shandong) Co. Ltd.Chinahttps://www.biobase.cc/YesCommercialisedNoNoManualNear POC / POCAntigenAnterior nasal swabSARS-CoV-2678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1321B.1.617.2Delta1495P.1Gammanucleocapsid proteinThis assay is based on a colloidal gold method for the rapid, qualitative determination of SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2) nucleocapsid protein antigen in anterior nasal swab specimens. This test kit is intended for self-testing at home for individuals with symptoms of SARS-CoV-2 infection. This test kit shall not be used as a sole basis to diagnose or exclude SARS-CoV-2 infection.2022-11-07 14:20:27 CET5288Immuno-AntigenYesYesNoImmunochromatographyQualitativeMembrane-basedColloidal gold15LOD115TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives%False negatives7.27%PrecisionEvaluatedAccuracy98.62%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.73%Clinical Specificity100%Type of antigenNucleocapsid protein2673Tell Me Fast COVID19 Antigen Test322Biocan Diagnostics Inc.Canadawww.rapidtest.caYesCommercialisedNoNoNear POC / POCAntigenAnterior nasal swabMid-turbinates swabNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta1323B.1.621Mu2041C.37Lambda1224B.1.526IotaB.1.526.2Please let us know what additional information is required by you.2022-08-24 09:08:01 CET2378Immuno-AntigenNoImmunochromatographyQualitativeSandwich10LOD140.6TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0AUFalse negatives5AUPrecisionEvaluatedAccuracy99.9%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95%Clinical Specificity100%Type of antigenNucleocapsid protein524Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Ab Test322Biocan Diagnostics Inc.Canadawww.rapidtest.caYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2022-08-24 09:08:01 CET426Immuno-AntibodyYesNoImmunoassayQualitative15Rapid diagnostic test Lateral Flow 1099Anti-SARS-CoV-2 IgG590Biocheck GmbHGermanywww.polycheck.deYesCommercialisedNoNoAutomatedManualAntibodyIgGPlasmaSerumhttps://polycheck.de/wp-content/uploads/2020/07/Polycheck-Anti-SARS-CoV-2-IgG-Flyer.pdf2022-08-24 09:08:01 CET880Immuno-AntibodyNoNoImmunoassayQuantitativeMagnetic Electrochemical105Manual or automated microblot colorimetry LOD0.2KU/lAnalysis of cross reactivityEvaluatedReproducibilityEvaluatedClinical Sensitivity98.6% IgGClinical Specificity98.7% IgG1687biocomma®COVID-19 Antigen Test Kit757Biocomma limitedChinawww.biocomma.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabnucleocapsid protein2022-08-24 09:08:01 CET1366Immuno-AntigenYesYesChromatographyQualitative15LOD312.5AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.55%False negatives17.9%PrecisionEvaluatedAccuracy97.13%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity82.14%Type of antigennucleoprotein1686Novel Coronavirus COVID-19 IgM/IgG Test Kit757Biocomma limitedChinawww.biocomma.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole bloodnucleocapsid protein2022-08-24 09:08:01 CET1365Immuno-AntibodyYesYesImmunoassayQualitativeColloidal gold15LOD312.5AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.35%False negatives0%PrecisionEvaluatedAccuracy99.26% IgGAccuracy99.26% IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100% IgGClinical Sensitivity100% IgMType of antigennucleoprotein3099RAPID SARS-COV-2 ANTIGEN TEST CARD1376BioDetect (Xiamen) Biotechnology Co. Ltd.Chinahttp://biodetect.cn/YesCommercialisedYesYesNear POC / POCAntigenNasal swabSARS-CoV20A.23.170AT.1678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526IotaB.1.526.1B.1.526.23939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu1439C.362041C.37Lambda1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid proteinOns kenmerk: CIBG-202110122023-05-11 11:30:37 CET21054Immuno-AntigenNoYesImmunochromatographyQualitativeSandwich, Double15LOD100pg/mLCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.248%False negatives10%PrecisionEvaluatedAccuracy96.523% IgGAntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90%AntigenClinical Specificity99.752%AntigenType of antigenNucleocapsid protein2902RAPID SARS-COV-2 ANTIGEN TEST CARD (self test)1376BioDetect (Xiamen) Biotechnology Co. Ltd.Chinahttp://biodetect.cn/YesCommercialisedNoNoNear POC / POCAntigenAnterior nasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.2678B.1.1.529Omicron1518P.2Zetanucleocapsid proteinEC Certificate No. 1434-IVDD-521/20212022-08-24 09:08:01 CET2607Immuno-AntigenYesYesYesImmunochromatographyQualitativeSandwich, Double15LOD100pg/mLCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.248%False negatives10%PrecisionEvaluatedAccuracy96.523%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90%AntigenClinical Specificity99.752%AntigenType of antigenNucleocapsid protein3504Biofeld Covid-19 Antigen Schnelltest1417Biofeld Diagnostic and Lab Solutions INC.Turkeywww.biofeld.com.trYesCommercialisedNoNoManualNear POC / POCAntigenNasopharyngeal swabSARS-CoV20A.23.170AT.1678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526IotaB.1.526.1B.1.526.23939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu1439C.362041C.37LambdaOther1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid protein2022-08-24 09:08:01 CET3223Immuno-AntigenYesNoNoImmunochromatographyQualitativeMembrane-basedOther15LOD120TCID50/mlAnalytical Sensitivity100%Analytical Specificity100%False positives4samplesFalse negatives8samples776COVID-19 IgG/IgM Ab Rapid Test457Biogate Laboratories Ltd.Canadawww.biogatelab.com/index.htmlNoCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2022-08-24 09:08:01 CET629Immuno-AntibodyYesNoImmunoassayQualitative15Rapid diagnostic test lateral flow Analysis of cross reactivityReportedAccuracy93.33% IgMAccuracy96.17% IgGClinical Sensitivity87.54% IgMClinical Sensitivity92.88% IgGClinical Specificity98.43% IgMClinical Specificity99.06% IgG777SARS CoV-2 IgG/IgM Ab Rapid Test466Biogenix Inc. Pvt Ltd.Indiawww.biogenixinc.com/NoCommercialisedNoNoNear POC / POCAntibodyIgGIgM2022-08-24 09:08:01 CET645Immuno-AntibodyYesImmunoassayRapid diagnostic test Not found Not found 2247CoviGnost AG Test Device 1x201046BioGnost Ltd.Croatiawww.biognost.hrYesCommercialisedYesYesManualAntigenNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1GammaThe Contract OEM manufacturer of the Test Device is Hangzhou Alltest Biotech CO., Ltd whose COVID-19 Antigen Rapid Test (Nasopharyngeal Swab) is allready on the Common list of rapid antigen tests, as agreed by Member States (May 10. pg.10) Our CoviGnost AG Test Device is validated at Croatian Institute of Public Health with excellent validation report. We sold CoviGnost AG Test Device in Croatia, Bulgaria, Italy and Greece, without any complaint.2022-08-24 09:08:01 CET1948Immuno-AntigenYesNoNoImmunochromatographyQualitativeMembrane-based15LOD0AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives2.44%3/123False negatives1.23%1/81PrecisionEvaluatedAccuracy98%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity96%Clinical Specificity99%2481CoviGnost AG test devices1046BioGnost Ltd.Croatiawww.biognost.hrYesCommercialisedNoNoManualAntigenNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma20A.23.1COVID-19 Antigen Rapid Test CoviGnost AG is a qualitative chromatographic immunoassay for detection of SARS-CoV-2 antigens in human nasopharyngeal swab specimens.2022-08-24 09:08:01 CET2184Immuno-AntigenNoImmunochromatographyQualitativeMembrane-based15LOD100TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2.4%Total 82 / 2 false positivesFalse negatives1.56%Total 192 / 3 false negativesPrecisionEvaluatedAccuracy98.2%ReproducibilityNot evaluatedRobustnessNot evaluatedClinical Sensitivity96.4%Clinical Specificity99%Type of antigenNucleoprotein2694BOH-180 Fluorescent Immunoassay Analyzer1037BIOHIT HealthCare (Hefei) Co. Ltd.Chinawww.biouhan.comYesCommercialisedNoNoNear POC / POCSemi-automatedAntibodyAntigenAnterior nasal swabAdenovirusChlamydia PneumoniaeCytomegalovirus (CMV)Enterovirus A71 (EV-A71)Epstein-Barr Virus (EBV)Hepatitis B Virus (HBV)Hepatitis C Virus (HCV)Herpes Simplex (HSV)Human Immunodeficiency Virus (HIV)Influenza AInfluenza BMycoplasma PneumoniaeParainfluenza Virus TypeRespiratory Syncytial V (RSV)Varicella Zoster Virus (VZV)689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta2041C.37Lambda1495P.1Gamma678B.1.1.529Omicronnucleocapsid proteinBOH-180 is a small bench top analyzer intended to be used with cassette-based immunofluorescent IVD assays manufactured by Biohit Healthcare (Hefei) Co., Ltd.2022-08-24 09:08:01 CET2399Immuno-AntigenYesNoNoImmunochromatographyQuantitativeOtherFluorescence1LOD12.69TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy98.71%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.12%Clinical Specificity99.6%Type of antigenNucleocapsid protein1293SARS-CoV-2 Antigen Quantitative Assay Kit (Enzyme-linked Immunoassay)1037BIOHIT HealthCare (Hefei) Co. Ltd.Chinawww.biouhan.comYesCommercialisedNoNoNear POC / POCAntigenPlasmaSerumAdenovirusChlamydia PneumoniaeCytomegalovirus (CMV)Enterovirus A71 (EV-A71)Epstein-Barr Virus (EBV)Hepatitis B Virus (HBV)Hepatitis C Virus (HCV)Herpes Simplex (HSV)Human Immunodeficiency Virus (HIV)Influenza AInfluenza BMycoplasma PneumoniaeParainfluenza Virus TypeRespiratory Syncytial V (RSV)Varicella Zoster Virus (VZV)689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1132B.1.427Epsilon1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta2041C.37Lambda678B.1.1.529Omicronnucleocapsid proteinThis kit is used for quantitative detection of SARS-CoV-2 nucleocapsid protein (N protein) in human serum or plasma. Antigen epitope information: N‐terminal domain (NTD; 46 –176 aa) C‐terminal domain (CTD; 247–364 aa)2022-08-24 09:08:01 CET1066Immuno-AntigenNoNoYesELISAQuantitativeSandwich, Double75LOD2.97pg/mLCalibrationEvaluatedCalibrationEvaluatedAnalysis of cross reactivityEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy99.33%Accuracy99.33%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.05%Clinical Specificity100%Type of antigenNucleocapsid protein2692SARS-CoV-2 Antigen Quantitative Test (Fluorescence Immunochromatography)-Anterior Nasal Swab1037BIOHIT HealthCare (Hefei) Co. Ltd.Chinawww.biouhan.comYesCommercialisedNoNoNear POC / POCSemi-automatedAntigenAnterior nasal swabAdenovirusChlamydia PneumoniaeCytomegalovirus (CMV)Enterovirus A71 (EV-A71)Hepatitis B Virus (HBV)Hepatitis C Virus (HCV)Herpes Simplex (HSV)Human Immunodeficiency Virus (HIV)Mycoplasma PneumoniaeParainfluenza Virus TypeRespiratory Syncytial V (RSV)Varicella Zoster Virus (VZV)689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta2041C.37Lambda1495P.1Gamma678B.1.1.529Omicronnucleocapsid proteinThis rapid kit is used for the semi-quantitative detection of SARS-CoV-2 nucleocapsid protein antigen in anterior nasal swab samples with the supporting Fluorescent Immunoassay Analyzer. Antigene epitope information: N‐terminal domain (NTD; 46–176 aa) C‐terminal domain (CTD; 247–364 aa)2022-08-24 09:08:01 CET2397Immuno-AntigenYesNoYesImmunochromatographySemiquantitativeSandwichImmunofluorescence15LOD12.69TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy98.71%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.12%Clinical Specificity99.6%Type of antigenNucleocapsid protein2693SARS-CoV-2 Antigen Quantitative Test (Fluorescence Immunochromatography)-Blood1037BIOHIT HealthCare (Hefei) Co. Ltd.Chinawww.biouhan.comYesCommercialisedNoNoNear POC / POCSemi-automatedAntigenPlasmaSerumWhole bloodAdenovirusChlamydia PneumoniaeAlpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus OC43 (HCoV-OC43)MERS-CoVCytomegalovirus (CMV)Enterovirus A71 (EV-A71)Epstein-Barr Virus (EBV)Hepatitis B Virus (HBV)Herpes Simplex (HSV)Human Immunodeficiency Virus (HIV)Influenza AInfluenza BMycoplasma PneumoniaeParainfluenza Virus TypeRespiratory Syncytial V (RSV)Varicella Zoster Virus (VZV)689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta2041C.37Lambda1495P.1Gamma678B.1.1.529Omicronnucleocapsid proteinThis rapid kit is used for the quantitative detection of SARS-CoV-2 nucleocapsid protein antigen in human serum, plasma (heparin, dipotassium EDTA, and sodium citrate), and fingertip blood with the supporting Fluorescent Immunoassay Analyzer. Antigen epitope information: N‐terminal domain (NTD; 46 –176 aa) C‐terminal domain (CTD; 247–364 aa).2022-08-24 09:08:01 CET2398Immuno-AntigenYesNoYesImmunochromatographySemiquantitativeSandwichFluorescence16LOD8.92pg/mLCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy98.69%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.63%Clinical Specificity99.72%Type of antigenNucleocapsid protein2230SARS-CoV-2 Antigen Rapid Test (Colloidal Gold Method)1037BIOHIT HealthCare (Hefei) Co. Ltd.Chinawww.biouhan.comYesCommercialisedYesYesNear POC / POCAntigenAnterior nasal swabAdenovirusChlamydia PneumoniaeEnterovirus A71 (EV-A71)Epstein-Barr Virus (EBV)Hepatitis B Virus (HBV)Hepatitis C Virus (HCV)Herpes Simplex (HSV)Human Immunodeficiency Virus (HIV)Influenza AInfluenza BParainfluenza Virus TypeRespiratory Syncytial V (RSV)Varicella Zoster Virus (VZV)689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta2041C.37Lambda678B.1.1.529Omicronnucleocapsid proteinAntiogen epitope information: N‐terminal domain (NTD)/RNA‐binding domain (46–176 aa) C‐terminal domain (CTD; 247–364 aa). This rapid kit is used for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in anterior nasal swab samples.2022-08-24 09:08:01 CET1931Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwichColloidal gold15LOD200TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy98.15%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.12%Clinical Specificity99.49%Type of antigenNucleoprotein1286SARS-CoV-2 Antigen Rapid Test Kit (Fluorescence Immunochromatography)53BIOHIT HealthCare (Hefei) Co. Ltd.Chinawww.biouhan.comYesCommercialisedYesYesManualNear POC / POCAntigenAnterior nasal swabAdenovirusChlamydia PneumoniaeCytomegalovirus (CMV)Enterovirus A71 (EV-A71)Epstein-Barr Virus (EBV)Hepatitis B Virus (HBV)Hepatitis C Virus (HCV)Herpes Simplex (HSV)Human Immunodeficiency Virus (HIV)Influenza AInfluenza BMycoplasma PneumoniaeParainfluenza Virus TypeRespiratory Syncytial V (RSV)Varicella Zoster Virus (VZV)689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1132B.1.427Epsilon1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta2041C.37Lambda678B.1.1.529Omicronnucleocapsid proteinThis test is used for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in anterior nasal swab samples. Antigen epitope information: N‐terminal domain (NTD; 46–176 aa) C‐terminal domain (CTD; 247–364 aa)2022-08-24 09:08:01 CET1060Immuno-AntigenYesNoYesImmunochromatographyQualitativeSandwichFluorescence15LOD40TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy98.71%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.12%Clinical Specificity99.6%Type of antigenNucleocapsid protein87SARS-CoV-2 IgM/IgG antibody test kit (Colloidal Gold Method)53BIOHIT HealthCare (Hefei) Co. Ltd.Chinawww.biouhan.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWash aspirate689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1132B.1.427Epsilon1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta2041C.37Lambdanucleocapsid proteinThe SARS-CoV-2 IgM/IgG antibody test kit is based on the immunochromatographic method. The SARS-CoV-2 IgM/IgG is detected by SARS-CoV-2 recombinant N protein.2022-08-24 09:08:01 CET61Immuno-AntibodyYesNoImmunoassayQualitativeColloidal gold15LOD10μg/mLCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy99.1% IgMAccuracy99.4% IgGReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.66% IgMClinical Sensitivity99.46% IgGClinical Specificity98.46% IgMClinical Specificity100% IgGType of antigenNucleocapsid protein2519COVID-19 Antigen Rapid Test (Colloidal Gold Method)835BIOLAN HEALTH S.L.Spainwww.biolanhealth.comYesCommercialisedYesYesNear POC / POCAntigenNasal swabnucleocapsid proteinBIOLAN HEALTH COVID-19 Antigen Rapid Test is a lateral flow immunochromatographic assay intended for the qualitative detection of the nucleoclapsid antigen of SARS-CoV-2 virus in nasal swab samples in only 15-20 minutes. The product is intended for use as an aid in the rapid diagnosis of COVID-19 in individuals who are suspected of COVID-19 within the first 7 days of symptoms onset or in asymptomatic individuals in line with the in existing national, regional, and local public health and occupational health regulations and recommendations , . This test provides preliminary test results. Positive results indicate the presence of viral antigens, but do not rule out a bacterial infection or co-infection with other viruses. Negative result does not preclude SARS-CoV-2 infection and it cannot be used as a sole basis for diagnosis or patient management decisions. Negative results must be combined with clinical findings, epidemiological information and if necessary, with a molecular test.2022-08-24 09:08:01 CET2223Immuno-AntigenYesNoImmunochromatographyQualitativeSandwichColloidal gold15LODTCID50/ml3,5 x 10(2,5) CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives1.7%False negatives3.5%(within 5 days of sympton onset). False negatives8.4%(7 days)PrecisionEvaluatedAccuracy97.4%(within 5 days of symptom onset). Accuracy94.4% (7 days)ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity96.5%(within 5 days of symptom onset). Clinical Sensitivity91.6%( 7 days)Clinical Specificity98.3%Type of antigenNucleocapsid protein1829COVID-19 IgG/IgM Rapid Test Cassette835BIOLAN HEALTH S.L.Spainwww.biolanhealth.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole bloodDetection of neutralizing antibodies. IgG and IgM antibodies against RBD of spike protein.2022-08-24 09:08:01 CET1507Immuno-AntibodyYesImmunoassay4972019-nCoV IgG/IgM Antibody Detection Kit316BiolidicsSingaporewww.biolidics.com/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2022-08-24 09:08:01 CET418Immuno-AntibodyYesNoImmunoassayQualitativeColloidal gold10Accuracy95%Clinical Sensitivity91.54%Clinical Specificity97.02%2639SARS-CoV-2 Total Ab ELISA1206BioMARICBelgiumwww.biomaric.beYesCommercialisedNoNoManualSemi-automatedAntibodyPlasmaSerumnone2022-08-24 09:08:01 CET2344Immuno-AntibodyYesELISAQualitativeSandwich95LOD1.637IU/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%no false positive detected in 352 negative samplesFalse negatives0.8%1 false negative observed in 126 PCR-positive samplesPrecisionEvaluatedAccuracy99.79% (Total Ab)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.2%total AbClinical Specificity100% Total AbType of antigenSpike protein882019-nCoV IgG/IgM Rapid Test Cassette52BioMaxima SAPolandwww.biomaxima.com/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2022-08-24 09:08:01 CET60Immuno-AntibodyYesNoImmunoassayQualitative10Analysis of cross reactivityReportedClinical Sensitivity100% IgGClinical Sensitivity85% IgMClinical Specificity98% IgGClinical Specificity96% IgM2036COVID-19 Antigen Rapid Test937BioMaxima SAPolandwww.biomaxima.comYesCommercialisedNoNoManualNear POC / POCAntigenNasopharyngeal swabCat. No. 1-364-K020, the COVID-19 Antigen Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 antigens in nasopharyngeal swab specimens from individuals with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests.2022-08-24 09:08:01 CET1714Immuno-AntigenNoImmunochromatographyQualitativeCapture15LOD100AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives1AUFalse negatives3AUPrecisionEvaluatedAccuracy98%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96%Clinical Specificity99%Type of antigenNucleoprotein2035SARS-CoV-2 Ag Rapid Test937BioMaxima SAPolandwww.biomaxima.comYesCommercialisedYesYesManualNear POC / POCAntigenNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1321B.1.617.2Delta678B.1.1.529OmicronFollowing verification, BioMaxima's SARS-CoV-2 Ag Rapid Test antigen test effectively identifies variants: Alpha (B.1.1.7), Beta (B.1.351), Gamma (P1), Delta (B.1 .617.2) and Omicron (B.1.1.529) of the coronavirus.2022-08-24 09:08:01 CET1713Immuno-AntigenNoImmunochromatographyQualitativeCapture10LOD160AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives2AUFalse negatives5AUPrecisionEvaluatedAccuracy97%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95%Clinical Specificity99%Type of antigenNucleoprotein881VIDAS SARS-COV-2 IgG56bioMérieux SAFrancehttps://www.biomerieux-diagnostics.com/covid-19-r-geneYesCommercialisedNoNoAutomatedManualAntibodyIgG2022-08-24 09:08:01 CET718Immuno-AntibodyYesImmunoassayQualitative30Clinical Sensitivity99.6%Clinical Specificity100%957VIDAS SARS-COV-2 IgM56bioMérieux SAFrancehttps://www.biomerieux-diagnostics.com/covid-19-r-geneYesCommercialisedNoNoAutomatedManualAntibodyIgM2022-08-24 09:08:01 CET771Immuno-AntibodyYesImmunoassayQualitative3090COVID-19 IgM/IgG Rapid Test55BioMedomics Inc.United Stateswww.biomedomics.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumVenous whole bloodWhole bloodWhole blood with anti-coagulantsTHis is an update to the BioMedomics COVID-19 IgM-IgG Rapid Test2022-08-24 09:08:01 CET64Immuno-AntibodyYesNoImmunochromatographyQualitativeSandwich, DoubleColorimetry10LODnot applicableCalibrationEvaluatedAnalysis of cross reactivityReported as not possibleAnalysis of cross reactivityEvaluatedFalse positives0.125%1 out of 80 samples produced a false positiveFalse negatives0%(0 out of 26 samples produced false negatives)PrecisionEvaluatedAccuracy99.1%combinedReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%combinedClinical Specificity98.75%combined2520SARS-CoV-2 Antigen Test Kit (LFIA)1149BioMedomics Inc.United Stateswww.biomedomics.comYesCommercialisedNoNoNear POC / POCAntigenAnterior nasal swabNasal swabNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1320B.1.617.1KappaAlso tested versus a wide variety of endogenous and exogenous potential interferents and showed no interference at clinically relevants concentrations.2022-08-24 09:08:01 CET2224Immuno-AntigenNoImmunochromatographyQualitativeSandwich, Double15LOD2TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.49%2 out of 407 clinical specimens in clinical evaluation were false positivesFalse negatives2.27%5 out of 220 clinical specimens in clinical evaluation were false negativesPrecisionEvaluatedAccuracy98.88%antigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.73%antigenClinical Specificity99.51%antigenType of antigenNucleocapsid protein9210 Minutes COVID-19 IgG/IgM Rapid Test54BiomemeUnited Statesshop.biomeme.comNoCommercialisedNoNoNear POC / POCAntibodyIgGIgM2022-08-24 09:08:01 CET65Immuno-AntibodyYesImmunoassayRapid diagnostic test 1599Biomerica COVID-19 Antigen Rapid Test (nasopharyngeal swab)708Biomerica Inc.United Statesbiomerica.com/index.aspYesCommercialisedYesYesNear POC / POCAntigenNasal swabNasopharyngeal swabnucleocapsid protein data available upon request 2022-08-24 09:08:01 CET1280Immuno-AntigenYesNoImmunoassayQualitative15Rapid diagnostic test lateral flow LOD0.0001AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1AUFalse negatives8AUPrecisionEvaluatedAccuracy98%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.7%Type of antigennucleoprotein1603Biomerica COVID-19 IgG/IgM Rapid Strip Test (1507B)708Biomerica Inc.United Statesbiomerica.com/index.aspYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole bloodnucleocapsid protein data available upon request2022-08-24 09:08:01 CET1284Immuno-AntibodyYesNoImmunoassayQualitative10LOD0AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives10AUFalse negatives2AUPrecisionEvaluatedAccuracy96.6%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.9%Type of antigennucleoprotein1601Biomerica COVID-19 IgG/IgM Rapid Test (1507A)708Biomerica Inc.United Statesbiomerica.com/index.aspYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole bloodnucleocapsid protein data available upon request (LOD=0) 2022-08-24 09:08:01 CET1282Immuno-AntibodyYesNoImmunoassayQualitative10Rapid diagnostic test lateral flow LOD0AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives4AUFalse negatives0AUPrecisionEvaluatedAccuracy96%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%Type of antigennucleoprotein2077Bioneovan COVID-19 Antigen Test Kit (Colloidal Gold)961Bioneovan Co. Ltd.Chinawww.bioneovan.comYesCommercialisedNoNoNear POC / POCAntigenNasal swab689B.1.1.7Alpha2022-08-24 09:08:01 CET1759Immuno-AntigenYesNoImmunochromatographyQualitativeSandwichColloidal gold15LOD95AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.75%False negatives2.86%PrecisionEvaluatedAccuracy97.89%ReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity98.33%Clinical Specificity97.56%Type of antigenNucleocapsid protein2206COVID-19 IgG Antibody Test Kit (Colloidal Gold)961Bioneovan Co. Ltd.Chinawww.bioneovan.comYesCommercialisedNoNoLab-basedNear POC / POCIgGPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351BetaNo2022-08-24 09:08:01 CET1907Immuno-AntibodyNoImmunochromatographyQualitativeCaptureColloidal gold15LOD1.1AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives1.3% IgGFalse negatives2.7% IgGPrecisionNot evaluatedAccuracy94.6% IgG(88%CI:92.9%-96.0%)ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity87.2% IgG(88%CI:82.9%-90.5%)Clinical Specificity98.7% IgG88% CI: 97.4%~99.4%）Type of antigenNucleoprotein2208COVID-19 IgM Antibody Test Kit (Colloidal Gold)961Bioneovan Co. Ltd.Chinawww.bioneovan.comYesCommercialisedNoNoLab-basedNear POC / POCIgMPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351BetaNo2022-08-24 09:08:01 CET1909Immuno-AntibodyNoImmunochromatographyQualitativeCapture15LOD1.1AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.9% IgMFalse negatives13.8% IgMPrecisionNot evaluatedAccuracy94.5% IgM (88%CI:92.8%-95.9%)ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity86.2% IgM(88%CI:81.8%-89.7%)Clinical Specificity99.1% IgM（88% CI: 97.9%~99.9%）2207COVID-19 IgM/IgG Antibody Test Kit (Colloidal Gold)961Bioneovan Co. Ltd.Chinawww.bioneovan.comYesCommercialisedNoNoLab-basedNear POC / POCIgGIgMPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351BetaNo2022-08-24 09:08:01 CET1908Immuno-AntibodyNoImmunochromatographyQualitativeCaptureColloidal gold15LOD1.1AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives2.2%False negatives5.1%PrecisionNot evaluatedAccuracy96.8%(93%CI:95.4%-97.8%)ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity94.9%(93%CI:91.8%-96.9%)Clinical Specificity97.8%（93% CI: 96.2%~98.7%）Type of antigenOther2205COVID-19 Neutralizing Antibody Test Kit (Colloidal Gold)961Bioneovan Co. Ltd.Chinawww.bioneovan.comYesCommercialisedNoNoLab-basedNear POC / POCAntibodyPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351BetaOtherThis kit is used for in-vitro semi-quantitative determination of novel corona virus neutralizing antibodies in human serum, plasma, venous whole blood or peripheral whole blood.2022-08-24 09:08:01 CET1906Immuno-AntibodyYesNoImmunochromatographySemiquantitativeCaptureColloidal gold15LOD1.1AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.9%False negatives1.3%PrecisionNot evaluatedAccuracy98.9%(95% CI: 98.0%~99.4%)ReproducibilityNot evaluatedRobustnessNot evaluatedClinical Sensitivity98.7%（95% CI: 96.6%~99.5%）Clinical Specificity99.1%（95% CI: 97.9%~99.6%）Type of antigenOther1242NowCheck COVID-19 Ag Test633Bionote Inc.South Koreabionote.co.krYesCommercialisedYesYesNear POC / POCAntigenNasal swabNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Deltahttps://www.finddx.org/wp-content/uploads/2021/03/Bionote_Nasal_Ag-Public-Report_20210330-v1.pdf2022-08-24 09:08:01 CET1023Immuno-AntigenYesNoImmunoassayQualitative15LOD247TCID50/mlAnalysis of cross reactivityEvaluatedFalse positives0.57%3/527False negatives9%2/22ReproducibilityEvaluatedClinical Sensitivity90.91%Clinical Specificity99.43%1016COVID-19 Rapid Antibody Test538Biopanda ReagentsUnited Kingdomwww.biopanda.co.ukYesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET781Immuno-AntibodyYesNoImmunoassayQualitative10Clinical Sensitivity69.4%CI: 69.4 - 100Clinical Specificity98.3% IgGClinical Specificity96.7% IgM2034COVID-19 Rapid Antigen Test936Biopanda ReagentsUnited Kingdomwww.biopanda.co.ukYesCommercialisedNoNoNear POC / POCAntigenAnterior nasal swabNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1321B.1.617.2Deltanucleocapsid proteinTest has been validated by the UK Department of Health and has passed the full validation process.2022-08-24 09:08:01 CET1712Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich15LOD100RNA-copiesRNA copies/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.3%False negatives5.9%PrecisionEvaluatedAccuracy97.7%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.2%Clinical Specificity99.6%Type of antigenNucleocapsid protein2858Novel Coronavirus (2019-nCoV) Antigen Rapid Detection kit1197Bioscience(Tianjin) Diagnostic Technology Co. Ltd.Chinahttps://www.bioscience-tj.comYesCommercialisedYesYesNear POC / POCAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.2678B.1.1.529Omicron1518P.2ZetaProduct is positively evaluated by PEI with the bfarm number AT805/212022-08-24 09:08:01 CET2872Immuno-AntigenNoRT-PCROtherSandwich20LOD1000TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives3.4%4 out of 120False negatives0%2 out of 250PrecisionEvaluatedAccuracy98.38%95%CI：96.52-99.41%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.67%95%CI：91.31%-98.94%Clinical Specificity99.2%95%CI:96.83%-99.86Type of antigenNucleocapsid protein2623Novel Coronavirus (2019-nCoV) Antigen Rapid Test1197Bioscience(Tianjin) Diagnostic Technology Co. Ltd.Chinahttps://www.bioscience-tj.comYesCommercialisedNoNoNear POC / POCAntigenAnterior nasal swabThis kit is used for in vitro qualitative detection of novel coronavirus (2019-CoV) antigens in human anterior nasal swab samples, and is used for clinical auxiliary diagnosis of novel coronavirus infection. For professional IVD use only.2022-08-24 09:08:01 CET2328Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich15LOD1000TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives1.73%False negatives1.59%PrecisionEvaluatedAccuracy98.38ReproducibilityNot evaluatedRobustnessNot evaluatedClinical Sensitivity96.67%Clinical Specificity99.2%Type of antigenNucleocapsid protein778SARS-COV-2 Antibody Test467Biosino Bio-Technology and Science Inc.Chinawww.sinobio.com.cn/YesCommercialisedNoNoLab-basedAntibody2022-08-24 09:08:01 CET646Immuno-AntibodyImmunoassay2856SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Immunochromatographic Assay)467Biosino Bio-Technology and Science Inc.Chinawww.sinobio.com.cn/YesCommercialisedNoNoLab-basedManualNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabSalivaThroat secretionThroat swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1321B.1.617.2Delta1323B.1.621Mu2041C.37Lambda678B.1.1.529OmicronThis product is a lateral flow chromatographic immunoassay intend for in vitro qualitative detection of SARS-CoV-2 nucleocapsid(N) protein antigen in human nasal swab specimens directly from individuals within 7 days of symptom onset or without symptom or other epidemiological reasons to suspect COVID-19 infection. The SARS-CoV-2 belongs to a novel coronavirus of genus β. It has an envelope, the particles are round or oval, often polymorphic, and its diameter is 60-140 nm. Its genetic characteristics are significantly different from SARSr-CoV and MERSr-CoV. SARS-CoV-2 nucleocapsid(N) protein antigen detection is generally used in the acute infection period, and used for sample testing within 7 days of the onset of symptoms in suspected populations. Antigen detection should be used in combination with diagnostic information such as nucleic acid assay and imaging data, and medical history and exposure history to determine the infection status. This product is applicable to the detection of SARS-CoV-2 nucleocapsid(N) protein antigen for people suspected of SARS-CoV-2 infection, and not applicable to the screening of general populations. Regardless of negative or positive test results, further nucleic acid detection should be performed.2022-08-24 09:08:01 CET2561Immuno-AntigenNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD0.1ng/mLCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy98.6%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity95%nasal swabClinical Specificity100%nasal swabType of antigenNucleocapsid protein2865SARS-CoV-2 Neutralizing antibody Test KIT (Colloidal gold)467Biosino Bio-Technology and Science Inc.Chinawww.sinobio.com.cn/YesCommercialisedNoNoLab-basedManualNear POC / POCAntibodyPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1321B.1.617.2Delta1323B.1.621Mu2041C.37LambdaThis product with Colloidal Gold is used in the qualitative analysis of SARS-CoV-2 Neutralizing antibody in the samples about serum, plasma and whole blood. It is also used to monitor the process of different immune stages and evaluate the effect after vaccination. If there is a positive result, it indicates that there may be neutralizing antibody in the sample, but it cannot rule out the false positive caused by inhibitory peptides or small molecule inhibitors. If there is negative result, it indicates that the amount of neutralizing antibody is lower than the detection limit. The negative result can not rule out the possibility that there is neutral antibody in subjects.2022-08-24 09:08:01 CET2570Immuno-AntibodyNoImmunochromatographyQualitativeColloidal gold15LOD0.1ng/mLCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy95%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90%Clinical Specificity98%Type of antigenSpike protein2857SARS-CoV-2 Neutralizing antibody Test Kit (ELISA)467Biosino Bio-Technology and Science Inc.Chinawww.sinobio.com.cn/YesCommercialisedNoNoLab-basedManualSemi-automatedAntibodyPlasmaSerum689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1321B.1.617.2Delta1323B.1.621Mu2041C.37Lambda678B.1.1.529OmicronThe SARS-CoV-2 Neutralizing Antibody Test Kit (Enzyme-Linked Immunosorbent Assay，ELISA) is intended for in vitro concentration quantification of total neutralizing antibodies to SARS-CoV-2 in human serum or plasma. The kit is only intended for testing people who have received SARS-CoV-2 vaccine, cannot be used as the basis for the confirmation and exclusion of infectious SARS-CoV-2 pneumonia, and is not applicable for general population screening.2022-08-24 09:08:01 CET2562Immuno-AntibodyNoYesELISAQuantitativeNeutralization Antibody (NAb)120LOD0.1µg/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy98.75%serumReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity96.25%serumClinical Specificity100%serumType of antigenSpike protein2381BioSpeedia COVID19 Nasal Antigen Test BSD_5061024BioSpeedia InternationalFrancewww.biospeedia.comYesCommercialisedNoNoManualNear POC / POCAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2Zetanucleocapsid protein.2022-08-24 09:08:01 CET2083Immuno-AntigenYesNoImmunochromatographyQualitativeMembrane-based15LOD4510.6851CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives8.7%False negatives0.5%PrecisionEvaluatedAccuracy97.5%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity91.3%Clinical Specificity99.5%Type of antigenNucleoprotein2379BioSpeedia COVID19 Non-Invasive Antigen Test BSD_5041024BioSpeedia InternationalFrancewww.biospeedia.comYesCommercialisedNoNoManualNear POC / POCAntigenNasal swabThroat swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.11518P.2Zetanucleocapsid protein.2022-08-24 09:08:01 CET2081Immuno-AntigenYesNoImmunochromatographyQualitativeMembrane-based15LOD4510.6851AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives5.26%False negatives0.5%PrecisionEvaluatedAccuracy98.3%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95%Clinical Specificity99%Type of antigenNucleoprotein2503BioSpeedia® Covid-19 Nasal AG test BSD_5211024BioSpeedia InternationalFrancewww.biospeedia.comYesCommercialisedNoNoManualNear POC / POCAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2Zeta.2022-08-24 09:08:01 CET2207Immuno-AntigenNoImmunochromatographyQualitativeMembrane-based15CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives5%False negatives0.4%PrecisionEvaluatedAccuracy97.8%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95%Clinical Specificity99.6%Type of antigenMembrane protein2380COVID19Speed-Antigen Test BSD_05031024BioSpeedia InternationalFrancewww.biospeedia.comYesCommercialisedYesYesManualNear POC / POCAntigenNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2Zetanucleocapsid protein.2022-08-24 09:08:01 CET2082Immuno-AntigenYesNoImmunochromatographyQualitativeMembrane-based15LOD4510.6851AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives2.5%False negatives0.7%PrecisionEvaluatedAccuracy98.3%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.5%Clinical Specificity99.3%Type of antigenNucleoprotein2965BIOSYNEX AUTOTEST ANTIGENIQUE COVID-19 Ag651BIOSYNEX S.A.Switzerlandwww.biosynex.comYesCommercialisedNoNoManualAntigenNasal swabSARS-CoV1032B.1.351Beta1495P.1Gamma1321B.1.617.2Delta1323B.1.621Mu2041C.37Lambda678B.1.1.529OmicronN/A2022-08-24 09:08:01 CET2671Immuno-AntigenNoImmunochromatography15CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives00 false positive out of 140 tested negative samples confirmed by RT-PCRFalse negatives2.75%3 false negative out of 109 tested positive samples confirmed by RT-PCRPrecisionEvaluatedAccuracy98.4%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.2%AntigenClinical Specificity100%AntigenType of antigenNucleocapsid protein2964BIOSYNEX AUTOTEST ANTIGENIQUE COVID-19 Ag+651BIOSYNEX S.A.Switzerlandwww.biosynex.comYesCommercialisedNoNoManualAntigenNasal swabSARS-CoV689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1132B.1.427Epsilon1137B.1.429Epsilon1321B.1.617.2Delta678B.1.1.529Omicronnucleocapsid proteinN/A2022-08-24 09:08:01 CET2670Immuno-AntigenYesNoImmunochromatographyQualitative10CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.25%1 false positive out of 405 negative samples confirmed by RT-PCRFalse negatives4.62%6 false negative out of 130 positive samples confirmed by RT-PCRPrecisionEvaluatedAccuracy98.7%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.4%AntigenClinical Specificity99.8%AntigenType of antigenNucleocapsid protein1223BIOSYNEX COVID-19 Ag BSS651BIOSYNEX S.A.Switzerlandwww.biosynex.comYesCommercialisedYesYesManualAntigenNasal swabNasopharyngeal swab1032B.1.351Beta1495P.1Gamma1321B.1.617.2Delta1323B.1.621Mu2041C.37Lambdanucleocapsid protein/2022-08-24 09:08:01 CET1007Immuno-AntigenYesNoImmunochromatographyQualitativeMembrane-basedColorimetry15LOD115TCID50/mlAnalysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracy98%NasopharyngealAccuracy98.8%NasalReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96%NasopharyngealClinical Sensitivity97.2%NasalClinical Specificity100%NasopharyngealClinical Specificity100%NasalType of antigenNucleocapsid protein1494BIOSYNEX COVID-19 Ag+ BSS651BIOSYNEX S.A.Switzerlandwww.biosynex.comYesCommercialisedYesYesManualNear POC / POCAntigenNasal swabNasopharyngeal swabnucleocapsid proteinPlease note the update consists in: - Correction of the legal manufacturer which is BIOSYNEX SWISS SA (it has been incorrectly entered on the database) - Type of specimens = nasopharyngeal and nasal swabs2022-08-24 09:08:01 CET1244Immuno-AntigenYesNoImmunochromatographyQualitative10LOD750TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%Clinical data: 0 false positive result out of 583 negative samples confirmed by RT-PCRFalse negatives2.53%Clinical data: 2 false negative results out of 79 positive samples confirmed by RT-PCRPrecisionEvaluatedAccuracy99.7%NasopharyngealAccuracy98.7%NasalReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.5%NasopharyngealClinical Sensitivity95.4%NasalClinical Specificity100%NasopharyngealClinical Specificity99.8%NasalType of antigenNucleocapsid protein779BIOSYNEX COVID-19 BSS651BIOSYNEX S.A.Switzerlandwww.biosynex.comYesCommercialisedNoNoLab-basedAntibodyWhole blood2022-08-24 09:08:01 CET821Immuno-AntibodyYesNoImmunoassayQualitative10Not found cassette Not found 2947BIOSYNEX COVITOP651BIOSYNEX S.A.Switzerlandwww.biosynex.comYesNoNoManualNear POC / POCAntigenNasal swabNasopharyngeal swabSARS-CoV689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526Iota678B.1.1.529Omicron1518P.2Zeta2022-08-24 09:08:01 CET2653Immuno-AntigenYesNoNoImmunochromatographyQualitative15LODTCID50/ml22,7 TCID50/mLCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.31%1 false positive among 321 tested samplesFalse negatives6.02%5 false negative among 83 tested samples - Nasopapharyngeal swabFalse negatives18.07%15 false negative among 83 tested - Nasal swabPrecisionEvaluatedAccuracyNot evaluatedReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.98%Antigen - Nasopharyngeal sampleClinical Sensitivity81.93%Antigen - Nasal sampleClinical Specificity99.69%AntigenType of antigenNucleocapsid protein3113KSMART COVITOP651BIOSYNEX S.A.Switzerlandwww.biosynex.comYesIn developmentNoNoAntigenNasopharyngeal swabSARS-CoV689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526Iota678B.1.1.529Omicron1518P.2Zetanucleocapsid proteinNA2022-08-24 09:08:01 CET2820Immuno-AntigenNoYesImmunochromatography20LOD22.7AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.29%1 false positive among 341 tested samples (nasopharyngeal swab)False negatives0.57%6 false negative among 1041 tested samples (nasopharyngeal swab)PrecisionEvaluatedAccuracynot availableReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.2%Clinical Specificity99.7%Type of antigenNucleocapsid protein5827Multiple Respiratory Multipathogen Antigen Test Kit (immunochromatographic assay)955BIOTEKE CORPORATION (WUXI) Co. Ltd.Chinahttps://www.bioteke.cn/YesCommercialisedYesYesNear POC / POCAntigenAnterior nasal swabInfluenza AInfluenza BRespiratory Syncytial V (RSV)SARS-CoV-2678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1321B.1.617.2Deltanucleocapsid protein2023-03-30 10:55:36 CET21087Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich, DoubleOther15LOD200TCID50/mlCalibrationNot evaluatedAnalytical Sensitivity90.29%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives%False negatives9.71%PrecisionEvaluatedAccuracy97.4%RobustnessEvaluatedClinical Sensitivity91.67%Clinical Specificity99.42%25541Multiple Respiratory Multipathogen Antigen Test Kit (immunochromatographic assay)955BIOTEKE CORPORATION (WUXI) Co. Ltd.Chinahttps://www.bioteke.cn/YesCommercialisedNoNoNear POC / POCAntigenAnterior nasal swabInfluenza AInfluenza BRespiratory Syncytial V (RSV)SARS-CoV-2678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1321B.1.617.2Deltanucleocapsid protein2023-04-03 10:07:12 CET21045Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich, DoubleOther15LOD200TCID50/mlCalibrationNot evaluatedAnalytical Sensitivity91.67%Analytical Specificity99.42%Analysis of cross reactivityEvaluatedFalse positives0.58%False negatives8.33%PrecisionEvaluatedAccuracy97.4%RobustnessEvaluatedClinical Sensitivity91.67%Clinical Specificity99.42%25545Multiple Respiratory Multipathogen Antigen Test Kit (immunochromatographic assay)955BIOTEKE CORPORATION (WUXI) Co. Ltd.Chinahttps://www.bioteke.cn/YesCommercialisedNoNoNear POC / POCAntigenAnterior nasal swabInfluenza AInfluenza BRespiratory Syncytial V (RSV)SARS-CoV-2678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1321B.1.617.2Deltanucleocapsid protein2023-04-03 10:10:06 CET21048Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich, DoubleOther15LOD200TCID50/mlCalibrationNot evaluatedAnalytical Sensitivity90.29%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives%False negatives9.71%PrecisionEvaluatedAccuracy97.4%RobustnessEvaluatedClinical Sensitivity91.67%Clinical Specificity99.42%3487SARS-CoV-2 Antigen Test Kit 955BIOTEKE CORPORATION (WUXI) Co. Ltd.Chinahttps://www.bioteke.cn/YesCommercialisedNoNoNear POC / POCAntigenAnterior nasal swabAdenovirusAdenovirus 3Adenovirus 7Alpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Bordetella PertussisChlamydia PneumoniaeCytomegalovirus (CMV)Enterovirus A71 (EV-A71)Epstein-Barr Virus (EBV)Influenza AInfluenza A H1N1Influenza A H3N2Influenza A H5N1Influenza BInfluenza B VictoriaInfluenza B YamagataMERS-CoVMumps Virus (MuV)Mycoplasma PneumoniaeParainfluenza Virus TypeParainfluenza Virus Type 1Parainfluenza Virus Type 2Parainfluenza Virus Type 3Parainfluenza Virus Type 4Respiratory Syncytial V (RSV) Type ARhinovirus ARhinovirus BVaricella Zoster Virus (VZV)678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1321B.1.617.2Delta1495P.1Gammanucleocapsid protein2022-08-24 09:08:01 CET3209Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, DoubleOther15LOD1250TCID50/mlAnalytical Sensitivity96.36%Analytical Specificity100%False positives0%False negatives3.64%Accuracy99.29%Clinical Sensitivity96.36%Clinical Specificity100%5853SARS-CoV-2 Antigen Test Kit955BIOTEKE CORPORATION (WUXI) Co. Ltd.Chinahttps://www.bioteke.cn/YesCommercialisedYesYesNear POC / POCAntigenAnterior nasal swabSARS-CoV-220A.23.170AT.1678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526IotaB.1.526.1B.1.526.23939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu1439C.362041C.37LambdaOther1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid protein2023-02-13 08:48:31 CET21088Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich, DoubleN.A.15LOD1250TCID50/mlCalibrationNot evaluatedAnalytical Sensitivity100%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives8.65%False negatives0.27%PrecisionEvaluatedAccuracy97.91%RobustnessEvaluatedClinical Sensitivity91.35%Clinical Specificity99.73%5852SARS-CoV-2 Antigen Test Kit (anterior nasal swab)955BIOTEKE CORPORATION (WUXI) Co. Ltd.Chinahttps://www.bioteke.cn/YesCommercialisedNoNoLab-basedNear POC / POCAntigenAnterior nasal swabSARS-CoV-220A.23.170AT.1678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526IotaB.1.526.1B.1.526.23939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu1439C.362041C.37LambdaOther1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid protein2023-02-13 08:48:10 CET20244Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich, DoubleN.A.15LOD1250TCID50/mlCalibrationNot evaluatedAnalytical Sensitivity100%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives8.65%False negatives0.27%PrecisionEvaluatedAccuracy97.91%RobustnessEvaluatedClinical Sensitivity91.35%Clinical Specificity99.73%2067SARS-CoV-2 Antigen Test Kit (colloidal gold method)955BIOTEKE CORPORATION (WUXI) Co. Ltd.Chinahttps://www.bioteke.cn/YesCommercialisedYesYesNear POC / POCAntigenNasopharyngeal swabOropharyngeal swabAdenovirusAdenovirus 3Adenovirus 7Alpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Enterovirus A71 (EV-A71)Human Metapneumovirus (HMPV)Influenza A H1N1Influenza A H3N2Influenza B VictoriaInfluenza B YamagataMERS-CoVParainfluenza Virus Type 1Parainfluenza Virus Type 2Parainfluenza Virus Type 3Parainfluenza Virus Type 4Respiratory Syncytial V (RSV)RhinovirusSARS-CoV678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1321B.1.617.2Delta1495P.1Gammanucleocapsid proteinhttps://www.bioteke.cn/2022-09-29 09:39:11 CET3898Immuno-AntigenYesNoNoImmunoassayQualitativeSandwich, DoubleColloidal gold15LOD175TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.72%False negatives3.51%PrecisionEvaluatedAccuracy98.47%(95%CI: 96.70%～99.44%)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.49%(95%CI: 91.26%～99.04%)Clinical Specificity99.28%(95%CI: 97.43%～99.91%)Type of antigenNucleoprotein2068SARS-CoV-2 Antigen Test Kit (colloidal gold method) nasal swab955BIOTEKE CORPORATION (WUXI) Co. Ltd.Chinahttps://www.bioteke.cn/YesCommercialisedNoNoNear POC / POCAntigenNasal swabAlpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Enterovirus A71 (EV-A71)Human Metapneumovirus (HMPV)Influenza A H1N1Influenza A H3N2Influenza B VictoriaInfluenza B YamagataMERS-CoVParainfluenza Virus Type 1Parainfluenza Virus Type 2Parainfluenza Virus Type 3Parainfluenza Virus Type 4Respiratory Syncytial V (RSV)RhinovirusSARS-CoV678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1321B.1.617.2Delta1495P.1Gammanucleocapsid proteinhttps://www.bioteke.cn/2022-09-29 09:38:43 CET3896Immuno-AntigenYesNoNoImmunoassayQualitativeSandwich, DoubleColloidal gold15LOD575AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.61%False negatives4.23%PrecisionEvaluatedAccuracy95.77%(95%CI: 92.87%～97.73%)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity91.61%(95%CI: 85.80%～95.59%)Clinical Specificity99.39%(95%CI: 96.65%～99.98%)Type of antigenNucleoprotein2146SARS-CoV-2 Antigen Test Kit (colloidal gold method) saliva955BIOTEKE CORPORATION (WUXI) Co. Ltd.Chinahttps://www.bioteke.cn/YesCommercialisedNoNoNear POC / POCAntigenSaliva689B.1.1.7Alpha1032B.1.351Beta1495P.1Gammahttps://www.bioteke.cn/2022-08-24 09:08:01 CET1836Immuno-AntigenNoImmunoassayQualitativeSandwich, DoubleColloidal gold15LOD175AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives2.5%False negatives7.2%PrecisionEvaluatedAccuracy95.42%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.8%Clinical Specificity97.5Type of antigenNucleoprotein14882019-nCoV IgM/IgG Antibody Test Kit (colloidal gold method)848Bioteke Taizhou Biotechnology Co. Ltd.Chinawww.bioteke.cn/YesCommercialisedNoNoAutomatedManualAntibodyIgGIgMPlasmaSerumnucleocapsid protein2022-08-24 09:08:01 CET1231Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15LOD176AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1 for serum specimens, 2 for plasma specimensFalse negatives5 for serum specimens, 4 for plasma specimensPrecisionEvaluatedAccuracy98.35%serum specimensAccuracy98.3%plasma specimensReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.1%serum specimensClinical Sensitivity95.92%plasma specimensType of antigennucleoprotein1487SARS-CoV-2 Antigen Test Kit (colloidal gold method)848Bioteke Taizhou Biotechnology Co. Ltd.Chinawww.bioteke.cn/YesCommercialisedNoNoNear POC / POCAntigenNasal swabSalivanucleocapsid protein2022-08-24 09:08:01 CET1230Immuno-AntigenYesNoImmunoassayQualitativeColloidal gold15Rapid diagnostic test colloidal gold LOD175CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2False negatives3PrecisionEvaluatedAccuracy98.58%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.95%Type of antigennucleoprotein2013biotical SARS-CoV-2 Ag Card925Biotical Health S.L.U.Spainhttps://biotical.es/es/YesCommercialisedYesYesManualNear POC / POCAntigenNasopharyngeal swabnucleocapsid protein2022-08-24 09:08:01 CET1691Immuno-AntigenYesNoImmunochromatographyQualitative10LOD1000TCID50/mlLOD1ng/mLCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives3%PrecisionEvaluatedAccuracy99%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96%Clinical Specificity99%Type of antigenNucleoprotein335BIOCREDIT COVID-19 Ag480BioVendorCzechiawww.biovendor.com/YesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swab2022-08-24 09:08:01 CET665Immuno-AntigenYesNoImmunoassayQualitativeColorimetry8Clinical Sensitivity90.2%Clinical Specificity100%1991COVID-19 Antigen Rapid Test Cassette (Oral Fluid)912Biozek MedicalNetherlandswww.biozek.comYesCommercialisedNoNoNear POC / POCAntigenSaliva689B.1.1.7Alpha1032B.1.351BetaPlease contact for more information: Robyn White Robyn.white@medusa19.com Data Summary With Additional Information Below: LOD: 100 TCID50/mL COVID-19 Variants: This test has been tested on the UK/South Africa and Kent Strain - all variants are detectable using this device. Sensitivity: 91.67%（95%CI*:85.90%~95.62%） Specificity: 99.72%（95%CI*:98.44%~＞99.99%） Accuracy: 97.39%（95%CI*:94.94%~98.87%）2022-08-24 09:08:01 CET1667Immuno-AntigenNoImmunoassayQuantitative15This test has been tested on the UK/South Africa and Kent StrainLOD100AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.28%(1/354)False negatives8.33%(12/144)PrecisionNot evaluatedAccuracy97.39%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity91.67%Clinical Specificity99.72%Type of antigenNucleoprotein1012Covid-19 IgG/IgM Rapid Test912Biozek MedicalNetherlandswww.biozek.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood this website redirects to another company (Biozek); http://biozek.com/corona-virus-covid-rapid-test/2022-08-24 09:08:01 CET780Immuno-AntibodyYesNoImmunoassayQualitative10Accuracy92.9%464COVID-19 IgG/IgM Rapid Test Cassette912Biozek MedicalNetherlandswww.biozek.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2022-08-24 09:08:01 CET374Immuno-AntibodyYesNoImmunoassayQualitative10Rapid diagnostic test Lateral flow False positivesReportedFalse negativesReportedAccuracy98.6% IgGAccuracy92.9% IgMRobustnessReportedClinical Sensitivity100% IgGClinical Sensitivity85% IgMClinical Specificity98% IgGClinical Specificity96% IgM3008BHM COVID-19 Antigen Rapid Test1333Birmingham Biotech Ltd.United Kingdomhttps://www.birminghambiotech.co.ukYesCommercialisedNoNoNear POC / POCAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1321B.1.617.2Delta2041C.37Lambda678B.1.1.529Omicronnucleocapsid proteinThe BHM® COVID-19 Antigen Rapid Test is intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 from individuals with or without symptoms or other epidemiological reasons to suspect COVID-19. Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in nasal and oral specimens during the acute phase of infection. Individuals who test negative and continue to experience COVID-19 like symptoms of fever, cough and/or shortness of breath may still have SARSCoV-2 infection and should seek follow up care with their general practitioner or healthcare provider.2022-08-24 09:08:01 CET2714Immuno-AntigenYesYesNoImmunoassayQualitativeSandwich, Double15LOD150TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives5.3%False negatives1%PrecisionEvaluatedAccuracy97.4%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.7%Clinical Specificity99%Type of antigenNucleocapsid protein3007BHM COVID-19 Antigen Sealing Tube Test Strip1333Birmingham Biotech Ltd.United Kingdomhttps://www.birminghambiotech.co.ukYesCommercialisedNoNoNear POC / POCAntigenNasal swabThroat swabSARS-CoV1321B.1.617.2Delta678B.1.1.529Omicronnucleocapsid proteinThe BHM® COVID-19 Antigen Sealing Tube Test Strip is for the qualitative detection of SARS-associated coronavirus (SARS-CoV-2) antigens from the human nose to assist in the diagnosis of a coronavirus (Covid-19) infection. Since the strip detects the nucleocapsid protein antigen, the spike protein mutations have no effect on the function of the test. This unique design combines the test strip and diluent together in the same tube, which provides the concept: To combine sampling and testing into one. It also seals the sample swab and clinical sample in the tube to avoid potential biosecurity substances (such as the virus from the nasal or oral swab sample) spreading to the operator and the environment. The test is helpful to identify SARS-CoV-2 among symptomatic & asymptomatic people.2022-08-24 09:08:01 CET2713Immuno-AntigenYesNoNoImmunoassayQualitativeSandwich15LOD612TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1%False negatives1.5%PrecisionEvaluatedAccuracy98.8%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.5%Clinical Specificity99%Type of antigenNucleocapsid protein2627COVID-19 Antigen Test1198Blue Cross Bio-Medical（Beijing） Co. Ltd.Chinawww.bcbmo.comYesCommercialisedNoNoManualAntigenNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.3COVID-19 Antigen Test is the chromatographic assay used for qualitative detection of the COVID-19 antigen in human nasopharyngeal or pharyngeal swab specimens.2022-08-24 09:08:01 CET2332Immuno-AntigenYesImmunoassay15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives8.33%False negatives1.63%PrecisionEvaluatedAccuracy97.05%(Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity91.67%(Antigen)Clinical Specificity98.37%(Antigen)Type of antigenNucleocapsid protein103ViroTrack Sero COVID-19 IgA+IgM/IgG Ab60BluSense Diagnostics ApSDenmarkhttps://www.blusense-diagnostics.com/YesNoNoAutomatedNear POC / POCAntibodyIgGIgMIgAPlasmaSerumWhole bloodPatented IMA technology2022-08-24 09:08:01 CET73Immuno-AntibodyYesNoYesImmunoassaySemiquantitativeOther13Patented IMA technology CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.15%1 false positive in a cohort of 87 negative samplesFalse negatives17.14%6 false negatives in a cohort of 35 positive samplesPrecisionEvaluatedAccuracy93.4%IgA+IgMAccuracy93.4% IgGAccuracy93.4%IgA+IgM/IgGReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity80%IgA+IgMClinical Sensitivity77.1% IgGClinical Sensitivity82.9%IgA+IgM/IgG2906ViroTrack Sero COVID-19 Total Ab60BluSense Diagnostics ApSDenmarkhttps://www.blusense-diagnostics.com/YesCommercialisedNoNoAutomatedAntibodyPlasmaSerumVenous whole bloodWhole bloodWhole blood with anti-coagulants689B.1.1.7Alphaspike proteinViroTrack Sero COVID-19 Total Ab is an in vitro diagnostic (IVD) immunomagnetic (IMA) assay intended for the quantitative detection of anti-SARS-CoV-2 total human antibodies in human whole blood, serum or plasma as an aid at identifying individuals with an adaptive immune response to SARS-CoV-2 indicating recent or prior infection. The cartridge is single-use and intended to be used exclusively in combination with the BluBox reader (Ref.: 60BB01). The system is automated. The assay kit is intended to be used by Healthcare Professionals in a laboratory environment and by Healthcare Professionals in office-like near-patient testing environments, for example in hospitals, clinics, pharmacies, long-term care facilities, primary care settings, or General Practitioners offices with the purpose of testing patients of both genders in all age classes. Results must be confirmed by clinical assessment by an expert physician and/or using another marketed test method.2022-08-24 09:08:01 CET2611Immuno-AntibodyNoYesImmunoassayQuantitative7LOD9.1BAU/mLCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.28%2 FP out of 699 samplesFalse negatives0.55%1 FN out of 179 samples ( Detected as equivocal)PrecisionEvaluatedAccuracy99.7%(875/878) [99.0%;99.9%]ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.4%(178/179) [96.9%;100.0%]Clinical Specificity99.7%(697/699) [99.0%;100.0%]Type of antigenSpike protein1168Lab-On-Time 2019-nCoV IgG/IgM Rapid Test611BMT DiagnosticsIsraelwww.bmtdiagnostics.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerum2022-08-24 09:08:01 CET945Immuno-AntibodyYesNoImmunoassayQualitative10Rapid diagnostic test Lateral Flow Accuracy94.9%Clinical Sensitivity94.4%1605Lab-On-Time COVID-19 Antigen Rapid Test Device (Integrated Throat Swab)611BMT DiagnosticsIsraelwww.bmtdiagnostics.comYesCommercialisedNoNoNear POC / POCAntigenOtherThroat swabnucleocapsid protein no info on website about preformance 2022-08-24 09:08:01 CET1286Immuno-AntigenYesNoImmunoassayQualitative15Rapid diagnostic test Dipstick LOD1000AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2.43%3 of 123False negatives1.23%1 of 81PrecisionEvaluatedAccuracy98%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.4%Type of antigennucleoprotein1830COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold)834BN SantéFrancewww.biogyne.frYesIn developmentNoNoManualAntigenNasal swabSalivaNo additional information2022-08-24 09:08:01 CET1506Immuno-AntigenImmunoassayColloidal gold20LOD320AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives3False negatives1PrecisionEvaluatedAccuracy99.22%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.1%Clinical Specificity99.8%Type of antigenNucleoprotein1828Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold)834BN SantéFrancewww.biogyne.frYesCommercialisedNoNoNear POC / POCAntigenNasal swabNasopharyngeal swabnucleocapsid proteinNo additional information to update.2022-08-24 09:08:01 CET1505Immuno-AntigenYesNoImmunoassayQualitativeColloidal gold15LOD0.5AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1False negatives8PrecisionEvaluatedAccuracy97.81%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity95%Clinical Specificity99.6%Type of antigenNucleoprotein1964SARS-CoV-2 Antigen Rapid test834BN SantéFrancewww.biogyne.frYesCommercialisedNoNoAntigenNasal swabnucleocapsid protein2022-08-24 09:08:01 CET1640Immuno-AntigenYesNoImmunochromatographyQualitative15LOD160AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.5%False negatives2.9%PrecisionEvaluatedAccuracy98.8%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.1%Clinical Specificity99.5%Type of antigenNucleoprotein2194SARS-CoV-2 IgG/IgM Rapid Test834BN SantéFrancewww.biogyne.frYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole bloodNo additional information.2022-08-24 09:08:01 CET1895Immuno-AntibodyImmunoassay15LOD10AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives16AUFalse negatives4AUPrecisionEvaluatedAccuracy98% (97,38 % à 98,92 %)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98% (97,06 % à 99,67 %)Clinical Specificity98% (96,83 % à 98.82 %)Type of antigenOther836AFIAS COVID-19 Ab, IgM/IgG22Boditech Med Inc.South Koreahttps://www.boditech.co.kr/enYesCommercialisedNoNoAutomatedAntibodyIgGIgMWhole blood2022-08-24 09:08:01 CET686Immuno-AntibodyYesImmunoassayQualitativeFluorescence101989AFIAS COVID-19 Ag22Boditech Med Inc.South Koreahttps://www.boditech.co.kr/enYesCommercialisedYesYesNear POC / POCSemi-automatedAntigenNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1519P.3Theta1320B.1.617.1Kappa1321B.1.617.2Delta2041C.37Lambda1224B.1.526Iota678B.1.1.529Omicron1518P.2Zetanucleocapsid proteinIn the Link of Status validatie SARS-CoV-2 antigeen sneltesten, you can verify the clinical study, which shows that AFIAS COVID-19 Ag has a sensitivity of Ct <30: 96,4%.2022-08-24 09:08:01 CET1665Immuno-AntigenYesNoYesImmunoassayQualitativeMembrane-based12LOD35.15TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives1.25%2 false positive out of 160 tested negative samples confirmed by RT-PCRFalse negatives8.1%11 false negative out of 135 tested positive samples confirmed by RT-PCRPrecisionEvaluatedAccuracy95.6%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity91.9%95%CI: 86.0% ~ 95.4%Clinical Specificity98.8%95%CI: 95.6% - 99.7%Type of antigenNucleocapsid protein2399AFIAS COVID-19 nAb1104Boditech Med Inc.South Koreawww.boditech.co.kr/enYesCommercialisedNoNoAutomatedNear POC / POCAntibodyPlasmaSerumWhole bloodAFIAS COVID-19 nAb is a fluorescence Immunoassay (FIA) for the qualitative determination of neutralizing antibodies against SARS-CoV-2 that block the interaction between the receptor binding domain (RBD) of the viral spike glycoprotein with the ACE-2 cell surface receptor in human whole blood/serum/plasma. For in vitro diagnostic use only.2022-08-24 09:08:01 CET2101Immuno-AntibodyYesImmunoassayQualitativeSandwich20LOD10CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives2.7%PrecisionEvaluatedAccuracy98.8%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity97.3%Clinical Specificity100%Type of antigenOther2783AFIAS COVID-19 SP/NP IgG22Boditech Med Inc.South Koreahttps://www.boditech.co.kr/enYesCommercialisedNoNoNear POC / POCAntibodyIgGPlasmaSerumWhole bloodAFIAS COVID-19 SP/NP IgG is a fluorescence Immunoassay (FIA) for the qualitative determination of SP/NP IgG antibodies against of novel corona virus (SARS-CoV-2) in human whole blood/serum/plasma. It is helpful as an aid in the screening of early mild, asymptomatic or acute patients for identification of 'Novel Coronavirus (eg. SARS-CoV-2)' infection. For in vitro diagnostic use only.2022-08-24 09:08:01 CET2488Immuno-AntibodyYesYesImmunoassayQualitativeSandwich10LOD37AU/mLBAU/mL (NP IgG)LOD26AU/mLBAU/mL (SP IgG)CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.7%SP IgGFalse positives1.4%NP IgGFalse negatives1.4%SP IgGFalse negatives1.4%NP IgGPrecisionEvaluatedAccuracy97.9%SP IgGAccuracy97.2%NP IgGReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity98.8%SP IgGClinical Sensitivity96.1%NP IgGClinical Specificity96.7%SP IgGClinical Specificity97.8%NP IgG105AFIAS COVID-19, Viral Antigen22Boditech Med Inc.South Koreahttps://www.boditech.co.kr/enYesCommercialisedNoNoAutomatedAntigen2022-08-24 09:08:01 CET26Immuno-AntigenImmunoassaySemiquantitativeFluorescence1248AFIAS COVID-19, Viral Antigen (automated)22Boditech Med Inc.South Koreahttps://www.boditech.co.kr/enYesCommercialisedNoNoAutomatedManualAntigenNasopharyngeal swab2022-08-24 09:08:01 CET1026Immuno-AntigenYesImmunoassayQualitativeFluorescence15Clinical Sensitivity87.5%Clinical Specificity96.5%1449AFIAS COVID-19/Flu Ag Combo22Boditech Med Inc.South Koreahttps://www.boditech.co.kr/enYesCommercialisedNoNoNear POC / POCSemi-automatedAntigenNasopharyngeal swabInfluenza AInfluenza A H1N1Influenza A H3N2Influenza BInfluenza B VictoriaInfluenza B Yamagata689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta1518P.2Zeta1223B.1.525Eta1519P.3Theta2041C.37Lambda1224B.1.526Iota678B.1.1.529Omicronnucleocapsid proteinThe sens/spec of this kit can be compared with AFIAS COVID-19 Ag product (Device Identification number : 1989). https://covid-19-diagnostics.jrc.ec.europa.eu/devices/detail/19892022-08-24 09:08:01 CET1199Immuno-AntigenYesNoYesImmunoassayQualitativeMembrane-based20LOD35.15TCID50/mlSARS-CoV-2CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%0 false positive out of 117 tested negative samples confirmed by RT-PCRFalse negatives3.2%1 false negative out of 31 tested negative samples confirmed by RT-PCRPrecisionEvaluatedAccuracy99.3%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity96.8%95%CI:81.5% - 99.8%Clinical Specificity100%95%CI: 96.0% - 100%Type of antigenNucleocapsid protein2413Boditech Quick™ COIVD-19 Ag1104Boditech Med Inc.South Koreawww.boditech.co.kr/enYesCommercialisedNoNoManualNear POC / POCAntigenSalivaBoditech Quick™ COVID-19 Ag is a chromatographic Immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigen in human saliva. It is helpful as an aid in the screening of early mild, asymptomatic, or acute patients for identification of 'Novel Coronavirus' infection. For in vitro diagnostic use only.2022-08-24 09:08:01 CET2115Immuno-AntigenNoImmunochromatographyQualitativeSandwich10LOD177AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives20%PrecisionEvaluatedAccuracy91.2%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity80%Clinical Specificity100%Type of antigenNucleoprotein2785Boditech Quick™ COVID-19 Neutralizing Ab22Boditech Med Inc.South Koreahttps://www.boditech.co.kr/enYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole bloodBoditech Quick™ COVID-19 Neutralizing Ab is a chromatographic Immunoassay for the qualitative detection of Neutralizing antibodies against SARS-CoV-2 that block the interaction between the receptor binding domain (RBD) of the viral spike glycoprotein with the ACE-2 cell surface receptor in human whole blood/serum/plasma. For in vitro diagnostic use only.2022-08-24 09:08:01 CET2490Immuno-AntibodyNoImmunoassayQualitativeMembrane-based20LODPRNT50 1:27CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives1.1%1 false positive out of 90 PRNT negative samplesFalse negatives6.5%5 false negative out of 77 PRNT positive samplesPrecisionEvaluatedAccuracy96.4%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity93.5%95% C.I. 85.68~97.19%Clinical Specificity98.9%95% C.I. 93.97~99.80%1448ichroma COVID-19/Flu Ag Combo22Boditech Med Inc.South Koreahttps://www.boditech.co.kr/enYesCommercialisedNoNoAutomatedManualAntigenNasal swab2022-08-24 09:08:01 CET1198Immuno-AntigenYesImmunoassayQualitativeFluorescence20Accuracy: 98.1 (Flu A) 98.1 (Flu B). Clinical sensitivity 93.8 (Flu A) 93.8 (Flu B)LOD55IU/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracy98.6%(antigen) ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity100% (antigen)Type of antigennucleoprotein837Ichroma COVID-19 Ab, IgM/IgG22Boditech Med Inc.South Koreahttps://www.boditech.co.kr/enYesCommercialisedNoNoManualAntibodyIgGIgMWhole blood2022-08-24 09:08:01 CET687Immuno-AntibodyYesYesImmunoassayQualitativeFluorescence10107Ichroma COVID-19, viral Antigen22Boditech Med Inc.South Koreahttps://www.boditech.co.kr/enYesCommercialisedNoNoManualAntigen2022-08-24 09:08:01 CET75Immuno-AntigenImmunoassay1990ichroma™ COVID-19 Ag22Boditech Med Inc.South Koreahttps://www.boditech.co.kr/enYesCommercialisedNoNoManualNear POC / POCAntigenNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta20A.23.1nucleocapsid proteinIn the link I have attached, you may see that the sensitivity of iChroma COvid 19 Ag is "Ct ≤ 25" The clinical evaluation can be found on the website of FIND : https://www.finddx.org/wp-content/uploads/2021/02/iChroma_Ag-Public-Report_v1_20210223.pdf2022-08-24 09:08:01 CET1666Immuno-AntigenYesYesImmunochromatographySemiquantitativeSandwich12LOD35.15AUCalibrationEvaluatedCalibrationEvaluatedAnalysis of cross reactivityEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2AUFalse negatives12AUPrecisionEvaluatedAccuracy95.2%Accuracy95.2 %ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity90.9%Clinical Specificity98.7%Type of antigenNucleoprotein2398ichroma™ COVID-19 nAb1104Boditech Med Inc.South Koreawww.boditech.co.kr/enYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole bloodichroma™ COVID-19 nAb is a fluorescence Immunoassay (FIA) for the qualitative determination of neutralizing antibodies against SARS-CoV-2 that block the interaction between the receptor binding domain (RBD) of the viral spike glycoprotein with the ACE-2 cell surface receptor in human whole blood/serum/plasma. For in vitro diagnostic use only.2022-08-24 09:08:01 CET2100Immuno-AntibodyYesImmunoassayQualitativeSandwich15LOD10AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives1 (1 false positive out of 99 PRNT negative samples.)False negatives1(1 false negative out of 98 PRNT positive samples.)PrecisionEvaluatedAccuracy99 (Kappa = 0.97969)ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity99%(95% CI: 94.4 ~ 100%)Clinical Specificity99%(95% CI: 94.5 ~ 100%)Type of antigenOther2784ichroma™ COVID-19 SP/NP IgG22Boditech Med Inc.South Koreahttps://www.boditech.co.kr/enYesCommercialisedNoNoNear POC / POCAntibodyIgGPlasmaSerumichroma™ COVID-19 SP/NP IgG is a fluorescence Immunoassay (FIA) for the qualitative determination of SP/NP IgG antibodies against of novel corona virus (SARS-CoV-2) in human serum/plasma. It is helpful as an aid in the screening of early mild, asymptomatic or acute patients for identification of 'Novel Coronavirus (eg. SARS-CoV-2)' infection. For in vitro diagnostic use only.2022-08-24 09:08:01 CET2489Immuno-AntibodyYesImmunoassayQualitativeSandwichFluorescence10LOD37AU/mLBAU/mL (NP IgG)LOD26AU/mLBAU/mL (SP IgG)CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives4.3%SP IgGFalse positives8.3%NP IgGFalse negatives4%SP IgGFalse negatives0%NP IgGPrecisionEvaluatedAccuracy95.8%SP IgGAccuracy98.3%NP IgGReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity95.7%SP IgGClinical Sensitivity91.7%NP IgGClinical Specificity96%SP IgGClinical Specificity100%NP IgG109Rona 19 Screen Coronavirus (SARS-CoV-2) IgG/IgM Rapid Test61Bright Line ResearchUnited Stateswww.brightlineresearch.com/NoIn developmentNoNoNear POC / POCAntibodyIgGIgM2022-08-24 09:08:01 CET76Immuno-AntibodyYesImmunoassayRapid diagnostic test 1236Rapid Response COVID-19 Antigen Rapid Test62BTNX Inc.Canadawww.btnx.com/YesCommercialisedYesYesNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabnucleocapsid protein https://www.btnx.com/files/1110032811V5_COVID-19_Antigen_Rapid_Test_Device.pdf2022-08-24 09:08:01 CET1018Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich15LOD502.38TCID50/mlAnalysis of cross reactivityEvaluatedFalse positives0AUFalse negatives5AUPrecisionEvaluatedAccuracy97.2%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90.2%Clinical Specificity100%Type of antigenNucleoprotein1684Rapid Response COVID-19 Antigen Rapid Test Cassette (Oral Fluid)62BTNX Inc.Canadawww.btnx.com/YesCommercialisedNoNoNear POC / POCAntigenSalivanucleocapsid protein2022-08-24 09:08:01 CET1363Immuno-AntigenYesNoImmunoassayQualitative10LOD1000AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives5%PrecisionEvaluatedAccuracy99.5%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95%Type of antigennucleoprotein2033Rapid Response COVID-19 IgG/IgM Rapid Test Device62BTNX Inc.Canadawww.btnx.com/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole bloodThe Rapid Response COVID-19 IgG/IgM Rapid Test Device has been CE marked since April of 2020. Since then various independent evaluations have been completed at various EU member state organizations. The "COVID-19 In Vitro Diagnostic Medical Devices" mentions that the product is not CE marked. The name of the product has been slightly changed since the first CE marking which could be the cause of this being missed. Could you please check and update the list during the next meeting of JRC? Thank you, Khasim Technical Operations Manager khasim@btnnx.com2022-08-24 09:08:01 CET1711Immuno-AntibodyNoImmunochromatographyQualitativeSandwich15LOD210CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2% IgMFalse positives3% IgGFalse negatives5% IgMFalse negatives1% IgGPrecisionEvaluatedAccuracy97.7% IgMAccuracy98.7% IgGReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.7% IgMClinical Sensitivity98.8% IgGClinical Specificity99.1% IgMClinical Specificity98.7% IgGType of antigenOther110Rapid Response COVID-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma)62BTNX Inc.Canadawww.btnx.com/NoCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2022-08-24 09:08:01 CET77Immuno-AntibodyYesImmunoassayRapid diagnostic test 1647AllCheck COVID19 Ag738CALTH Inc.South Koreawww.thecalth.comYesCommercialisedYesYesNear POC / POCAntigenNasopharyngeal swabSARS-CoV689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1321B.1.617.2Delta678B.1.1.529Omicronnucleocapsid proteinN/A2022-08-24 09:08:01 CET3668Immuno-AntigenYesNoNoImmunochromatographyQualitativeOther10LOD250TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%Predict Postivie Value : 100.0% (95% CI : 97.2%~100.0%)False negatives1.1%Predict Negative Value : 98.9% (95% CI : 97.5%~99.6%))PrecisionEvaluatedAccuracy99.1%95% CI : 98.4%~99.8%, 650/656ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity95.6%95% CI : 90.6% ~98.4%, 130/136Clinical Specificity100%95% CI : 99.3%~100.0%, 520/520Type of antigenNucleocapsid protein2691AllCheck COVID19 Ag Nasal738CALTH Inc.South Koreawww.thecalth.comYesCommercialisedYesYesNear POC / POCAntigenNasal swabSARS-CoV689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1321B.1.617.2Delta678B.1.1.529Omicronnucleocapsid protein2022-08-24 09:08:01 CET3669Immuno-AntigenYesNoNoImmunochromatographyQualitative10LOD250TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.8%1 case - Predict Postivie Value : 99.2% (95% CI : 95.6% - 100.0%)False negatives1.1%6 cases - Predict Negative Value : 98.9% (95% CI : 97.5% - 99.6%)PrecisionEvaluatedAccuracy98.9%95% CI : 98.1% - 99.7%, 643/650ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity95.4%95% CI : 90.2% - 98.3% : 124/130Clinical Specificity99.8%95% CI : 98.9% - 100.0% : 519/520Type of antigenNucleocapsid protein1999See Now Coronavirus nCoV antigen test918CAMP MEDICA DISTRIBUTIONRomaniawww.campmedica.roYesCommercialisedNoNoLab-basedManualAntigenNasal swabNasopharyngeal swabOropharyngeal swabSaliva689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.2678B.1.1.529Omicron1518P.2Zetanucleocapsid proteinThe See Now -Coronavirus nCoV Antigen test is used for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 virus in nasal swabs, nasopharyngeal swabs, oropharyngeal swabs and/or saliva, from individuals suspected of COVID 19. See Now Coronavirus- nCoV Antigen test cannot be used as the basis to diagnose or exclude SARS-CoV-2 infection.2022-08-24 09:08:01 CET1676Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, Double10LOD1ng/mLAnalytical Sensitivity97%Analytical Specificity99%Analysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracy97.8%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.17%Clinical Specificity99.44%Type of antigenNucleocapside protein111Camtech COVID-19 Rapid Test Kit415CamtechSingaporecovid19-test.com/YesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET570Immuno-AntibodyYesNoImmunoassayQualitativeNot found10Analysis of cross reactivityReportedClinical Sensitivity87.5%Clinical Specificity100%1237COVID-19 Viral Antigen Test Kit415CamtechSingaporecovid19-test.com/YesCommercialisedNoNoNear POC / POCAntigenOropharyngeal swab Additional info available only upon request https://covid19-test.com/assets/Camtech_Covid19AntigenTestKit.pdf2022-08-24 09:08:01 CET1020Immuno-AntigenYesImmunoassayQualitativeFluorescence20Rapid diagnostic test cassette Fluorescence LODng/mL100 ng/mlAccuracy82.4%Clinical Sensitivity88.66%Clinical Specificity94.55%2283Pelican COVID-19 Ultra-Rapid Mobile Test1065Canary Global Inc.Canadawww.canarydetect.comYesCommercialisedNoNoNear POC / POCAntigenSaliva689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31518P.2Zetanucleocapsid proteinOur device is equipped with dual targeting system. One sensor is coated with monoclonal antibody to SARS-CoV-2 nucleocapsid protein and another with monoclonal antibody to SARS-CoV-2 spike protein. During testing SARS-CoV-2 antigens possibly present in the specimen react with the bio receptor antibody nanoparticles present in the test. . This immunological reaction results in a digital electrical signal that is recognized by the systems software on the mobile app which results in a plus (+) sign on mobile app indicating a positive result.. If the antigens are not present in the specimen, no digital electrical signal is generated which appears as a minus (-) sign on the app indicating a negative result.2022-08-24 09:08:01 CET1984Immuno-AntigenYesImmunoassayQualitativeOther2LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.83%When 120 negative samples were tested, 1 sample showed false positive resultFalse negatives1.8%When 111 positive samples were tested, 2 samples showed false negative resultPrecisionEvaluatedAccuracy98.7%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.2%Clinical Specificity99.17%Type of antigenNucleocapside protein2547SARS-CoV-2 Ultra Rapid Mobile Antigen Test1065Canary Global Inc.Canadawww.canarydetect.comYesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swabSaliva689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.3Our device is equipped with Sensor coated system having monoclonal antibody against SARS-CoV-2 nucleocapsid protein. During testing SARS-CoV-2 antigens possibly present in the Saliva and Nasopharyngeal specimens react with the bio receptor antibodies nanoparticles present in the test. The resulting complex results in a digital electrical signal that is recognized by the systems software on the mobile app, which results in a plus (+) sign on the mobile app indicating a positive result. If the antigens are not present in the specimens, no digital electrical signal is generated which appears as a minus (-) sign on the display of the app, indicating a negative result.2022-08-24 09:08:01 CET2252Immuno-AntigenImmunoassayQualitativeOther2LODAU100CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.83%Saliva: 1 False Positive out of 120 NegativeFalse positives0.83%Nasopharyngeal: 1 False Positive out of 120 NegativeFalse negatives3.6%Saliva: 4 False Negative out of 111 PositiveFalse negatives2.7%Nasopharyngeal: 3 False Negative out of 111 PositivePrecisionEvaluatedAccuracy99%Saliva: >99 (Antigen)Accuracy99%Nasopharyngeal: >99 (Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.4%Saliva: 96.4 (Antigen)Clinical Sensitivity97.3%Nasopharyngeal: 97.3 (Antigen)Clinical Specificity99.17%Saliva: 99.17 (Antigen)2788SARS-CoV-2 Neutralizing Antibodies Test Kit1253CAS-EnvisionChinawww.cas-envision.comYesCommercialisedNoNoManualAntibodyWhole blood2022-08-24 09:08:01 CET2493Immuno-AntibodyImmunochromatographyQualitativeNeutralization Antibody (NAb)15LOD10ng/mLCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.37%1/269False negatives2.59%3/116PrecisionEvaluatedAccuracy99%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.4%Clinical Specificity99.6%Type of antigenSpike protein838Smart COVID-19 IgM/IgG RDT488Cell ID Pte Ltd.Singaporewww.cid.com.sg/YesCommercialisedNoNoAutomatedManualAntibodyIgGIgM2022-08-24 09:08:01 CET688Immuno-AntibodyImmunoassayNot found116Cellex qSARS-CoV-2 IgGIgM Cassette Rapid Test416Cellex Inc.United Statescellex.us/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2022-08-24 09:08:01 CET571Immuno-AntibodyYesNoImmunoassayQualitativeNot found15Rapid diagnostic test cassette Not found Clinical Sensitivity93.75%Clinical Specificity96.4%1173CerTest SARS-CoV-2737CerTest BiotecSpainwww.certest.esYesCommercialisedYesYesManualNear POC / POCAntigenNasal swabNasopharyngeal swabThe buffer has SARS2 inactivation capability. The test detects equally the nucleo proteins from Alpha, Beta, Delta, Gamma and Omicrom variants.2022-09-05 16:45:10 CET3764Immuno-AntigenYes10Clinical Sensitivity93%Nasopharyngeal swabClinical Specificity99.8%Nasopharyngeal swab5817CHECK UP COVID19-INF A/B-RSV MULTI RAPID TEST KIT1232Cesna Biyoteknoloji AraÅŸtırma GeliÅŸtirme Laboratuvar Sist.Ä°nÅŸ.Müh.Dan.San.Tic.Ltd.Åžti.Turkeywww.cesnalaboratuvarsistemleri.comYesCommercialisedNoNoManualNear POC / POCAntigenNasal swabOther20A.23.170AT.1678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526IotaB.1.526.1B.1.526.23939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu1439C.362041C.37Lambda1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid proteinIn addition, our Covid19 test kit has been published by Common list with RAT number 2696. We were verified by PEI in 2021.2023-01-09 10:08:59 CET5421Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD3200TCID50/mlfor Covid19CalibrationEvaluatedAnalytical Sensitivity100%for Covid19Analytical Specificity100%for Covid19Analysis of cross reactivityEvaluatedFalse positives0.33%for Covid19False negatives0.49%for Covid19PrecisionEvaluatedAccuracy99.6%for Covid19RobustnessEvaluatedClinical Sensitivity99.3%for Covid19Clinical Specificity99.7%for Covid192696CHECK UP SARS-COV-2 NASAL ANTIGEN RAPID TEST1232Cesna Biyoteknoloji AraÅŸtırma GeliÅŸtirme Laboratuvar Sist.Ä°nÅŸ.Müh.Dan.San.Tic.Ltd.Åžti.Turkeywww.cesnalaboratuvarsistemleri.comYesCommercialisedYesYesManualAntigenNasal swab689B.1.1.7Alpha1495P.1Gamma1320B.1.617.1Kappanucleocapsid proteinThis test is for clinical laboratory use only or for immediate inspection by medical personnel, not for home testing, and cannot and is not intended to be used as a basis for diagnosing and ruling out pneumonia caused by a new Covid-19 infection Screening appropriate by the general population. A positive test result must be further confirmed. A negative test result cannot rule out an infection. The kit and test results are intended for clinical reference only. It is recommended to combine the patient's clinical manifestations and other laboratory tests for a comprehensive analysis of the condition.2022-08-24 09:08:01 CET2401Immuno-AntigenYesNoImmunoassayQualitativeOther15LOD100TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positivesIf you react later than 15 minutes, this can lead to a false positive resultFalse negativesReacting earlier than 15 minutes can lead to a false negative result.PrecisionEvaluatedAccuracy99.07%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.3%Clinical Specificity98.8%Type of antigenNucleocapsid protein2746CHECK UP SARS-COV-2 NASOPHARYNGEAL ANTIGEN TEST1232Cesna Biyoteknoloji AraÅŸtırma GeliÅŸtirme Laboratuvar Sist.Ä°nÅŸ.Müh.Dan.San.Tic.Ltd.Åžti.Turkeywww.cesnalaboratuvarsistemleri.comYesCommercialisedYesYesManualNear POC / POCAntigenNasopharyngeal swab689B.1.1.7Alpha1495P.1Gamma1320B.1.617.1KappaThis kit is used for in vitro qualitative detection of SARS-CoV-2 antigen. It is a lateral flow immunoassay designed for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 directly in the nose. This test is for clinical laboratory use only or for emergency examination by medical personnel, is not home tested and cannot and is not intended to be used as a basis for diagnosing and excluding pneumonia caused by a recent Covid-19 infection. general population. A positive test result should be further confirmed. A negative test result cannot rule out an infection. The kit and test results are for clinical reference only. It is recommended to combine the patient's clinical findings and other laboratory tests for a comprehensive analysis of the condition.2022-08-24 09:08:01 CET2451Immuno-AntigenNoImmunoassayQualitativeOther15LODTCID50/ml100 TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positivesIf you react later than 15 minutes, this can lead to a false positive resultFalse negativesReacting earlier than 15 minutes can lead to a false negative result.PrecisionEvaluatedAccuracy99.69%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.3%Clinical Specificity99.7%Type of antigenNucleocapsid protein5820CheckUp COVID-INF A/B-RSV COMBO RAPID NASAL TEST KIT1232Cesna Biyoteknoloji AraÅŸtırma GeliÅŸtirme Laboratuvar Sist.Ä°nÅŸ.Müh.Dan.San.Tic.Ltd.Åžti.Turkeywww.cesnalaboratuvarsistemleri.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabOther20A.23.170AT.1678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526IotaB.1.526.1B.1.526.23939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu1439C.362041C.37Lambda1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid proteinOur Covid19 clinical assessment was conducted by PEI in 2021. In addition, our Covid19 diagnostic kit is on the list with the number of HS common List RAT 2696.2023-01-09 10:10:16 CET5422Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD3200TCID50/mlfor Covid19CalibrationEvaluatedAnalytical Sensitivity100%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives0.32%1 out of 306False negatives0.49%2 out of 407PrecisionEvaluatedAccuracy98.98%RSVAccuracy98.18%INFBAccuracy98.09%INFAAccuracy98.98%Covid19RobustnessEvaluatedClinical Sensitivity98.04%InfAClinical Sensitivity98.13%INFBClinical Sensitivity99.3%Covid19Clinical Sensitivity99.03%RSVClinical Specificity99.01%INFAClinical Specificity99.7%Covid19Clinical Specificity99.04%INFBClinical Specificity98.04%RSV5832CHECKUP COVID-INF A/B-RSV-ADENO RAPID TEST KIT1232Cesna Biyoteknoloji AraÅŸtırma GeliÅŸtirme Laboratuvar Sist.Ä°nÅŸ.Müh.Dan.San.Tic.Ltd.Åžti.Turkeywww.cesnalaboratuvarsistemleri.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabAdenovirusAdenovirus 3Adenovirus 7Adenovirus Subtype BAdenovirus Subtype CAlpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Anti-Nuclear AntibodyBeta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Bordetella PertussisChlamydia PneumoniaeCoronaviruses (HCoV)Cytomegalovirus (CMV)Enterovirus A71 (EV-A71)Epstein-Barr Virus (EBV)Hemophilus InfluenzaeHepatitis A Virus (HAV)Hepatitis B Virus (HBV)Hepatitis C Virus (HCV)Herpes Simplex (HSV)Human Immunodeficiency Virus (HIV)Human Metapneumovirus (HMPV)Influenza AInfluenza A H1N1Influenza A H3N2Influenza A H5N1Influenza BInfluenza B VictoriaInfluenza B YamagataMERS-CoVMumps Virus (MuV)Mycobacterium TuberculosisMycoplasma PneumoniaeOtherParainfluenza Virus TypeParainfluenza Virus Type 1Parainfluenza Virus Type 2Parainfluenza Virus Type 3Parainfluenza Virus Type 4Respiratory Syncytial V (RSV)Respiratory Syncytial V (RSV) Type ARespiratory Syncytial V (RSV) Type BRhinovirusRhinovirus ARhinovirus BSARS-CoVSARS-CoV-2Varicella Zoster Virus (VZV)20A.23.170AT.1678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526IotaB.1.526.1B.1.526.23939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu1439C.362041C.37LambdaOther1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid protein2023-01-10 11:26:59 CET5436Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD3200TCID50/ml(for Covid19)CalibrationEvaluatedAnalytical Sensitivity100%Analytical Specificity100%Analytical Specificity99.01%ınfaAnalysis of cross reactivityEvaluatedFalse positives0.32%1 out of 306False negatives0.49%2 out of 407PrecisionEvaluatedAccuracy99.25%adenoAccuracy98.18%ınfbAccuracy98.09%ınfaAccuracy98.98%rsvAccuracy98.98%covid19RobustnessEvaluatedClinical Sensitivity99.03%rsvClinical Sensitivity98.04%ınfaClinical Sensitivity98.13%ınfbClinical Sensitivity99.3%covid19Clinical Sensitivity99.26%adenoClinical Specificity98.04%rsvClinical Specificity99.7%covid19Clinical Specificity99.04%ınfbClinical Specificity99.06%adeno2934COVID-19 Antigen Rapid Test1293Changchun WanCheng Bio Electron Co. Ltd.Chinahttps://jlwancheng.en.alibaba.comYesCommercialisedNoNoManualNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabSalivaThroat swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.2678B.1.1.529Omicron1518P.2Zetanucleocapsid proteinNone2022-08-24 09:08:01 CET2640Immuno-AntigenYesNoImmunochromatographyQualitativeMembrane-based15LOD100TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.7%No more than 0.7%False negatives1.5%No more than 1.5%PrecisionEvaluatedAccuracy99.6%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.8%AntigenClinical Specificity100%AntigenType of antigenNucleocapsid protein2990SARS-CoV-2 Antigen Rapid Test (Lateral Flow Method) 1323Changsha Sanji Bio-technology Co. Ltd.Chinawww.3gbio.com.cnYesCommercialisedNoNoNear POC / POCAntigenSalivaWash aspirateSARS-CoV689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.2678B.1.1.529Omicron1518P.2Zetanucleocapsid proteinNone2022-08-24 09:08:01 CET2696Immuno-AntigenYesN.A.ImmunoassayQualitative15LOD350TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%noneFalse negatives0%nonePrecisionEvaluatedAccuracy98%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95%AntigenClinical Specificity100%AntigenType of antigenNucleocapsid protein460SARS-CoV-2 Antibody Test Strip498Changsha Sinocare Inc.Chinawww.sinocare.com/web/about/index_enYesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET708Immuno-AntibodyYesNoImmunoassayQualitativeColloidal gold20Precision90%Reproducibility100%Clinical Sensitivity95%Clinical Specificity98.3%2365SARS-CoV-2 Antigen Test Kit (Colloidal Gold Method)1094Changsha Sinocare Inc.Chinawww.sinocareintl.comYesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1132B.1.427Epsilon1137B.1.429Epsilon1321B.1.617.2Delta1322B.1.617.3The LoD of this kit is 491TCID50/mL.2022-08-24 09:08:01 CET2066Immuno-AntigenYesImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD491AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives4AUFalse negatives0%PrecisionEvaluatedAccuracy98%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity96%(Antigen)Clinical Specificity100%(Antigen)Type of antigenNucleoprotein3148Biowin COVID-19 Antigen Nasal Test (Self-test)1181Changzhou Biowin Pharmaceutical Co. Ltd.Chinawww.czbiowin.cnYesCommercialisedNoNoManualNear POC / POCAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.32041C.37LambdaB.1.526.1B.1.526.2678B.1.1.529Omicron1518P.2Zetanucleocapsid protein[Warning and Precautions] 1. For in vitro diagnostic use. 2. This test has been authorized only for the detection of the nucleocapsid protein from SARS- CoV-2, not for any other viruses or pathogens. 3. Do not use this kit beyond the expiration date printed on the outside carton. 4. Test results are meant to be visually determined. 5. To avoid erroneous results, specimens must be processed as indicated in the assay procedure section. 6. Do not reuse any kit components. 7. Proper specimen collection is critical to the performance of this test. 8. Dispose of used test kits as biohazards waste in accordance with the local requirements.2022-08-24 09:08:01 CET2856Immuno-AntigenYesNoImmunochromatographyQualitativeN.A.30antigen_epi N protein antibody B2 ( MAB2) aa44-aa175 N protein antibody B3 ( MAB3) aa74-aa105LOD395TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives1.6%PrecisionEvaluatedAccuracy99.62%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.4%AntigenClinical Specificity100%AntigenType of antigenNucleocapsid protein2766Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold) (For Nasal)1181Changzhou Biowin Pharmaceutical Co. Ltd.Chinawww.czbiowin.cnYesCommercialisedNoNoManualAntigenNasal swab689B.1.1.7Alpha1495P.1Gamma3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta2041C.37LambdaStore extraction buffer at 2-30°C; Store the test cartridge at 2-30°C; After the aluminum foil bag is opened, it should be used within 15 minutes. Reagents and devices must be at room temperature (15–30 °C) when used for testing。2022-08-24 09:08:01 CET2471Immuno-AntigenImmunochromatographyColloidal gold30LOD170TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.97%False negatives4.35%PrecisionEvaluatedAccuracy98.41%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.65%AntigenClinical Specificity99.03%AntigenType of antigenNucleocapsid protein2641Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold)（For Nasal)1181Changzhou Biowin Pharmaceutical Co. Ltd.Chinawww.czbiowin.cnYesCommercialisedNoNoManualAntigenNasopharyngeal swab689B.1.1.7Alpha1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.32041C.37LambdaStore extraction buffer at 2-30°C;Store the test cartridge at 2-30°C; After the aluminum foil bag is opened, it should be used within 15 minutes. Reagents and devices must be at room temperature (15–30 °C) when used for testing。2022-08-24 09:08:01 CET2346Immuno-AntigenNoImmunochromatographyQualitativeColloidal gold30LOD170TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy100%(Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%(Antigen)Clinical Specificity100%(Antigen)Type of antigenNucleocapsid protein2749Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold)（For Saliva)）1181Changzhou Biowin Pharmaceutical Co. Ltd.Chinawww.czbiowin.cnYesCommercialisedNoNoManualAntigenSaliva689B.1.1.7Alpha1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.32041C.37Lambda1. Clinical performance was evaluated with frozen samples, and test performance may be different with fresh samples. 2. Users should test specimens as quickly as possible after specimen collection. 3. Positive test results do not rule out co-infections with other pathogens. 4.The test results should be correlated with the clinical history, epidemiological data, and other data available to the clinician evaluating the patient. 5. A false-negative test result may occur if the level of viral antigen in a sample is below the detection limit of the test or if the sample was collected or transported improperly; therefore, a negative test result does not eliminate the possibility of COVID-19 infection. 6.The amount of antigen in a sample may decrease as the duration of illness increases. Specimens collected after day 7 of illness are more likely to be negative compared to a RT-PCR assay. 7.Failure to follow the test procedure may adversely affect test performance and/or invalid the test result. 8.The contents of this kit are to be used for the qualitative detection of SARS- CoV-2 antigens from saliva swab specimens only2022-08-24 09:08:01 CET2454Immuno-AntigenImmunochromatographyQualitativeColloidal gold20CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives8.11%False negatives0.8%PrecisionEvaluatedAccuracy96%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity91.89%AntigenClinical Specificity99.2%AntigenType of antigenNucleocapsid protein2588Novel Coronavirus (COVID-19) Antigen Test Kit(Colloidal Gold)1181Changzhou Biowin Pharmaceutical Co. Ltd.Chinawww.czbiowin.cnYesCommercialisedYesYesLab-basedManualNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swab689B.1.1.7Alpha1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.32041C.37Lambdanucleocapsid protein1.. For in vitro diagnostic use. 2. This test has been authorized only for the detection of the nucleocapsid protein from SARS- CoV-2, not for any other viruses or pathogens. 3. Do not use this kit beyond the expiration date printed on the outside carton. 4. Test results are meant to be visually determined. 5. To avoid erroneous results, specimens must be processed as indicated in the assay procedure section. 6. Do not reuse any kit components. 7. Proper specimen collection, storage and transport are critical to the performance of this test 8. The SARS-CoV-2 external positive controls have been prepared from recombinant viral proteins and do not contain infectious material. 9. Dispose of used test kits as biohazards waste in accordance with the local requirements. 10. For additional information on hazard symbols, safety, handling and disposal of the components within this kit, please refer to the Safety Data Sheet (SDS). 11. Wear suitable protection when handling the contents of this kit if it is necessary.2022-08-24 09:08:01 CET2873Immuno-AntigenNoImmunochromatographyQualitativeColloidal gold30LOD170TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.7%False negatives4.4%PrecisionEvaluatedAccuracy97.2%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.6%Clinical Specificity98.3%Type of antigenNucleocapsid protein2871Novel Coronavirus(COVID-19) Antigen Test Kit (Colloidal Gold)1181Changzhou Biowin Pharmaceutical Co. Ltd.Chinawww.czbiowin.cnYesCommercialisedNoNoManualAntigenNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1321B.1.617.2Delta678B.1.1.529Omicronnucleocapsid proteinStore extraction buffer at 2-30°C;Store the test cartridge at 2-30°C; After the aluminum foil bag is opened, it should be used within 15 minutes. Reagents and devices must be at room temperature (15–30 °C) when used for testing。2022-08-24 09:08:01 CET2576Immuno-AntigenYesNoImmunochromatographyColloidal gold30CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy100%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%AntigenClinical Specificity100%AntigenType of antigenNucleocapsid protein3966COVID-19 Antigen Test Cassette16254Chastru Biotech LimitedChinaYesCommercialisedYesYesNear POC / POCAntigenAnterior nasal swabNasal swabNasopharyngeal swabOropharyngeal swabSalivaSARS-CoV678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1321B.1.617.2Delta1495P.1Gammanucleocapsid protein2023-03-15 16:34:32 CET20269Immuno-AntigenYesNoNoImmunochromatographyQualitativeMembrane-basedColloidal gold15LOD50TCID50/mlAnalytical Sensitivity97%Analytical Specificity100%False positives1%False negatives6%Accuracy99%Clinical Sensitivity97%Clinical Specificity99%669DPP COVID-19 IgM/IgG System408Chembio Diagnostic SystemsUnited Stateswww.chembio.comNoCommercialisedNoNoLab-basedAntibodyIgGIgMWhole blood2022-08-24 09:08:01 CET562Immuno-AntibodyYesImmunoassayQualitativeNot found15 Not found Not found 1098CHiL COVID-19 IgG/IgM Rapid Test cassette589CHIL Medical Supplies Ltd.Turkeyhttps://www.chil.com.tr/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgM2022-08-24 09:08:01 CET879Immuno-AntibodyYesNoImmunoassayQualitative10CalibrationPerformed (QCRSARSCoV-2QC1 - Anti-SARS-CoV-2 Quality Control 1 NIBSC code: 20/B764 is used)Analysis of cross reactivity0% (anti-influenza A (IgG), anti-influenza B (IgG), anti-HCV (IgG and IgM), anti-HBV (IgG and IgM), anti-229E (alpha coronavirus), anti-NL63 (alpha coronavirus), anti-OC43 (beta coronavirus), anti-HKU1 (beta coronavirus) , anti-respiratory syncytial viruFalse positives0.1% IgGFalse positives0.8% IgMFalse negatives0.5% IgGFalse negatives8% IgMPrecision100%Accuracy99.7% IgGAccuracy98% IgMReproducibility100%Robustness99%Clinical Sensitivity100% IgGClinical Sensitivity92% IgM3864CHIL COVID-19 Antigen Rapid Test1156Chil Tıbbi Malzeme Sanayi ve Ticaret Limited ÅžirketiTurkeyhttps://www.chil.com.trYesCommercialisedNoNoManualAntigenNasal swabSARS-CoV678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Betanucleocapsid protein2022-08-24 09:08:01 CET3530Immuno-AntigenYesYesNoImmunoassayQualitativeSandwichN.A.15LOD30TCID50/mlAnalytical Sensitivity100%Analytical Specificity100%False positives0.54%False negatives0.65%Accuracy99.67%Clinical Sensitivity98.75%Clinical Specificity99.72%1691CHIL COVID-19 Antigen Rapid Test (Nasal / Nasopharyngeal / Oropharyngeal Swab-Casette)1156Chil Tıbbi Malzeme Sanayi ve Ticaret Limited ÅžirketiTurkeyhttps://www.chil.com.trYesCommercialisedYesYesManualNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabSARS-CoV-2678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Betanucleocapsid proteinThe CHIL® COVID-19 antigen rapid test is an immunochromatographic in-vitro test for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct nasopharyngeal and oropharyngeal swabs directly from people. This product is intended exclusively for professional use in the laboratory and at the point of care.2022-08-24 15:42:41 CET3696Immuno-AntigenYesNoNoImmunoassayQualitativeSandwichN.A.15LOD30TCID50/mlCalibrationEvaluatedAnalytical Sensitivity100%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives0.49%2 False Positives out of 405False negatives0.85%4 False Negatives out of 466PrecisionEvaluatedAccuracy99.54%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.01%Clinical Specificity99.57%Type of antigenNucleocapsid protein2031Coronavirus Ag Rapid Test Cassette (Swab)934Chongqing iSIA BIO-Technology Co. Ltd.Chinawww.bio-rad.comYesCommercialisedYesYesManualNear POC / POCAntigenNasal swabNasopharyngeal swabProduct reference: 12015553 Packaging : 20 tests / box Storage : 2-30°C Total shelf life: 24 months2022-08-24 09:08:01 CET1709Immuno-AntigenNoImmunoassayQualitativeMembrane-based15LOD115AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.4%Nasopharyngeal Swab: 3/743False positives0%Nasal Swab: 0/128False negatives1.71%Nasopharyngeal Swab: 2/117False negatives2.83%Nasal Swab: 3/106PrecisionEvaluatedAccuracy99%Accuracy98.73%Nasal SwabAccuracy99%Nasopharyngeal SwabReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98%Clinical Sensitivity97.25%Nasal SwabClinical Sensitivity98.32%Nasopharyngeal SwabClinical Specificity99%Clinical Specificity100%Nasal SwabClinical Specificity99.6%Nasopharyngeal SwabType of antigenNucleoprotein1939COVID-19 Antibody Rapid Test Kit886Chongqing iSIA BIO-Technology Co. Ltd.Chinawww.isiabio.com.cnYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole bloodOther2022-08-24 09:08:01 CET1615Immuno-AntibodyYesImmunoassay15LOD0.8AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy98%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98%Clinical Specificity97%Type of antigenOther1944COVID-19 Antibody Rapid Test Kit (IgG)886Chongqing iSIA BIO-Technology Co. Ltd.Chinawww.isiabio.com.cnYesCommercialisedNoNoNear POC / POCIgGPlasmaSerumWhole bloodN/A2022-08-24 09:08:01 CET1620Immuno-AntibodyImmunochromatographyColloidal gold15LOD0.8AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy98% IgGReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity98% IgGClinical Specificity97% IgGType of antigenOther1941COVID-19 Antibody Rapid Test Kit (IgM)886Chongqing iSIA BIO-Technology Co. Ltd.Chinawww.isiabio.com.cnYesCommercialisedNoNoNear POC / POCIgMPlasmaSerumWhole bloodtest results good2022-08-24 09:08:01 CET1617Immuno-AntibodyImmunochromatographyColloidal gold15LOD0.8AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives1AUFalse negatives0AUPrecisionEvaluatedAccuracy97% IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97% IgMClinical Specificity97% IgMType of antigenOther1940COVID-19 Antibody Rapid Test Kit (QDs)886Chongqing iSIA BIO-Technology Co. Ltd.Chinawww.isiabio.com.cnYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blooduse instrument for test, quantum dots poct2022-08-24 09:08:01 CET1616Immuno-AntibodyImmunoassayImmunofluorescence15(Quantum Dots Immunofluorescence)LOD0.8AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy99%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99%Clinical Specificity99%Type of antigenOther1938COVID-19 Antigen Rapid Test Kit (Swab)886Chongqing iSIA BIO-Technology Co. Ltd.Chinawww.isiabio.com.cnYesCommercialisedNoNoNear POC / POCAntigennow sample in netherland for testing, result is good2022-08-24 09:08:01 CET1614Immuno-AntigenImmunoassayFluorescence15LOD0.9AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy99%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99%Clinical Specificity100%Type of antigenOther1937COVID-19 Antigen Rapid Test Kit(Swab)886Chongqing iSIA BIO-Technology Co. Ltd.Chinawww.isiabio.com.cnYesCommercialisedNoNoNear POC / POCAntigenNasal swabNasopharyngeal swabSaliva689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.2678B.1.1.529Omicron1518P.2ZetaOtherBefarm list PEI approved2022-08-24 09:08:01 CET1613Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich, Double15LOD10AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy97.57%ReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity97.06%Clinical Specificity98%Type of antigenOther2056iSIA947Chongqing iSIA BIO-Technology Co. Ltd.Chinawww.isiabio.com.cnYesCommercialisedNoNoNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabSaliva689B.1.1.7AlphaBfArM listed2022-08-24 09:08:01 CET1736Immuno-AntigenYesImmunoassaySandwich, Double10LOD0.1AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives12AUFalse negatives16AUPrecisionEvaluatedAccuracy97%ReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity96%Clinical Specificity97%Type of antigenNucleoprotein21502019-nCoV Antigen Test Kit995Chongqing M&D Biotechnology Co. Ltd.Chinawww.MDfastcheck.comYesCommercialisedYesYesNear POC / POCAntigenNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1GammaThe M&D 2019-nCoV Antigen Test Kit is a rapid and convenient lateral flow immunochromatographic assay for the qualitative detection of SARS-CoV-2 nucleocapsid protein from nasopharyngeal swab samples obtained from individuals suspected of COVID-19 by their healthcare provider within five-seven days of symptom onset and /or epidemiological criteria. The rapid test device is for professional use only and is intended to be used as an aid in the diagnosis of SARS-COV-2 infection.2022-08-24 09:08:01 CET1840Immuno-AntigenImmunochromatographyMembrane-based15LOD1AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives8.47%False negatives0%PrecisionEvaluatedAccuracy98.11%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity91.53%Clinical Specificity100%（Antigen）Type of antigenNucleoprotein1185Novegent COVID-19 Antibodies Rapid Test Kit620Chongqing Novegent Biotech Company LimitedChinawww.novegent.cnYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET969Immuno-AntibodyYesNoImmunoassayQuantitativeColorimetry15Rapid diagnostic test Colloidal Gold Analytical Sensitivity96% IgMAccuracy95.5% IgGAccuracy95.5% IgMClinical Sensitivity96% IgG1189Novegent COVID-19 Antigen Rapid Test Kit620Chongqing Novegent Biotech Company LimitedChinawww.novegent.cnYesCommercialisedNoNoNear POC / POCAntigenNasal swab http://www.novegent.eu/Antigen/2022-08-24 09:08:01 CET970Immuno-AntigenYesNoImmunoassayQuantitativeColloidal gold15LOD7AUAccuracy98.7%Clinical Sensitivity98.3%Clinical Specificity100%1978Suresign Professional 2019-nCoV IgG/IgM Rapid Test Cassette (Whole Blood, Serum, Plasma))905CIGA Healthcare Ltd.United Kingdomwww.cigahealthcare.com/YesCommercialisedNoNoNear POC / POCIgGIgMPlasmaSalivaWhole bloodthe product was registered with the MHRA on 9th September 20202022-08-24 09:08:01 CET1654Immuno-AntibodyNoImmunoassayQualitativeMembrane-based10LOD2.5AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.6%False negatives14%PrecisionEvaluatedAccuracy96.1%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity97.6%Clinical Specificity95.9%Type of antigenNucleoprotein1976Suresign Professional Covid-19 Antigen Rapid Test Cassette (Oral Fluid)905CIGA Healthcare Ltd.United Kingdomwww.cigahealthcare.com/YesCommercialisedNoNoNear POC / POCAntigenSalivaRegistered with MHRA 06 March 20212022-08-24 09:08:01 CET1652Immuno-AntigenNoImmunoassayQualitativeMembrane-based15LOD100AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives2%False negatives2%PrecisionEvaluatedAccuracy97%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity90.1%Clinical Specificity99.3%Type of antigenNucleoprotein13902019-nCoV IgG/IgM Rapid Test Cassette659CITEST DIAGNOSTICS Inc.Canadawww.citestdiagnostics.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2022-08-24 09:08:01 CET1156Immuno-AntibodyYesNoImmunoassayQualitative10LOD0CalibrationNot evaluatedFalse positives3.7%False negatives3.1%Accuracy96.4%Clinical Sensitivity96.9%24382019-nCoV IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)659CITEST DIAGNOSTICS Inc.Canadawww.citestdiagnostics.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThe 2019-nCoV IgG/IgM Rapid Test Cassette is a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to 2019-nCoV in human whole blood, serum or plasma specimen.2022-08-24 09:08:01 CET2141Immuno-AntibodyNoImmunoassayQualitativeSandwich10Ares(2021)4569376LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0% IgGFalse positives0.15% IgMFalse negatives0.02% IgGFalse negatives0.04% IgMPrecisionEvaluatedAccuracy98.6% IgGAccuracy92.9% IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100% IgGClinical Sensitivity85% IgMClinical Specificity98% IgGClinical Specificity96% IgMType of antigenNucleoprotein3142COVID-19 and Flu A/B Multiplex Panel for Home Use (Nasal Swab)659CITEST DIAGNOSTICS Inc.Canadawww.citestdiagnostics.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabInfluenza A H1N1Influenza A H3N2Influenza BSARS-CoV689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.2678B.1.1.529Omicron1518P.2Zetanucleocapsid proteinThe COVID-19 and Flu A/B Multiplex Panel for Home Use (Nasal Swab) is a single-use test kit intended to detect the SARS-CoV-2, Influenza A and Influenza B virus that causes COVID-19 and/or Influenza with self-collected nasal swab specimen. The test is intended for use in symptomatic/asymptomatic individuals who are suspected of being infected with SARS-CoV-2 and/or Influenza A+B. Results are for the detection of SARS-CoV-2 nucleocapsid protein, Influenza A and Influenza B nucleoproteins antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results are indicative of the presence of SARS-CoV-2 and/or Influenza A+B. Individuals who test positive should self-isolate and seek additional care from their healthcare provider. Positive results do not rule out bacterial infection or co-infection with other viruses. Negative results do not preclude SARS-CoV-2 and/or Influenza A+B infection. Individuals who test negative and continue to experience COVID-like or flu-like symptoms should seek follow up care from their healthcare provider. Test for children and young people should be used with an adult. Other pathogens tested for cross-reactivity: pathogens Human Rhinovirus 14,Human Rhinovirus 16,Measles2022-08-24 09:08:01 CET2850Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich10The current VOC including Alpha, Beta, Gamma, Delta, Omicron and Omicron BA.2 which will not influence the performance of the Test. antigen_epi NTD (44-180), N-CTD, 209-232a.LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.0285AUFalse negatives0.0046AUPrecisionEvaluatedAccuracy98.69%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.15%AntigenClinical Specificity99.56%AntigenType of antigenNucleocapsid protein2437COVID-19 and Influenza A+B Antigen Combo Rapid Test (Nasopharyngeal Swab)659CITEST DIAGNOSTICS Inc.Canadawww.citestdiagnostics.comYesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swab20A.23.170AT.1689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526IotaB.1.526.1B.1.526.21320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu1439C.362041C.37Lambda1518P.2Zeta1519P.3ThetaThe COVID-19 and Influenza A+B Antigen Combo Rapid Test (Nasopharyngeal Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2, Influenza A and Influenza B virus antigens in nasopharyngeal swab specimens from individuals with suspected SARS-CoV-2/Influenza infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2 and Influenza A+B Antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2/ Influenza A+B infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19/ Influenza A+B. The COVID-19 and Influenza A+B Antigen Combo Rapid Test is intended for use by trained clinical laboratory personnel.2023-03-31 09:02:14 CET21027Immuno-AntigenYesNoImmunoassayQualitativeSandwich15LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.0036AU(COVID-19),False positives0.071AU(Influenza B)False positives0.05AU (Influenza A),False negatives0.008AU(COVID-19), False negatives0.009AU(Influenza B)False negatives0.009AU(Influenza A), PrecisionEvaluatedAccuracy98%(Antigen COVID-19), Accuracy98.1%(Antigen Influenza B)Accuracy98.4%(Antigen Influenza A), ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.4%(Antigen COVID-19), Clinical Sensitivity95%(Antigen Influenza A), Clinical Sensitivity92.9%(Antigen Influenza B)Clinical Specificity99.1%(Antigen Influenza A), Clinical Specificity99.1%(Antigen Influenza B)Clinical Specificity99.2%(Antigen COVID-19), Type of antigenNucleoprotein1471COVID-19 and Influenza A+B Antigen Combo Rapid Test Cassette659CITEST DIAGNOSTICS Inc.Canadawww.citestdiagnostics.comYesCommercialisedNoNoNear POC / POCAntigenNasal swab no info in company website2022-08-24 09:08:01 CET1220Immuno-AntigenYesNoImmunoassayQualitative15Rapid diagnostic test lateral flow LOD0AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.08%(0.9% Influenza A); (0.9% Influenza B)False negatives3.6%(5.0% Influenza A); (7.1% Influenza B)PrecisionEvaluatedAccuracy98%(98.4 Influenza A); (98.1 Influenza B)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.4%(95.0 Influenza A); (92.9 Influenza B)2435COVID-19 and M.pneumoniae IgG Combo Rapid Test (Whole Blood/Serum/Plasma)659CITEST DIAGNOSTICS Inc.Canadawww.citestdiagnostics.comYesCommercialisedNoNoNear POC / POCAntibodyIgGPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.1B.1.526.11224B.1.526IotaB.1.526.21518P.2ZetaThe COVID-19 and M.pneumoniae IgG Combo Rapid Test (Whole Blood/ Serum/Plasma) is a lateral flow chromatographic immunoassay for the qualitative detection of IgG antibodies to SARS-COV-2 and Mycoplasma pneumoniae in human whole blood, serum or plasma specimen. The COVID-19 and M.pneumoniae IgG Combo Rapid Test is for professional use only and is intended to be used as an aid in the diagnosis of patients with suspected SARS-CoV-2/M.pneumoniae infection in conjunction with clinical presentation and the results of other laboratory tests. The product is intended to be used by trained laboratory personnel. Negative results will not preclude SARS-COV-2/M.pneumoniae infection and they cannot be used as the sole basis for treatment or other management decision. False positive results for IgG antibodies may occur due to cross-reactivity from pre-existing antibodies or other possible causes.2022-08-24 09:08:01 CET2138Immuno-AntibodyNoImmunoassayQualitativeSandwich10LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0AU(COVID-19 IgG)False positives0.078AU(Mycoplasma pneumoniae）False negatives0.02AU(COVID-19 IgG)False negatives0.054AU(Mycoplasma pneumoniae IgG）PrecisionEvaluatedAccuracy98.6% IgG(COVID-19)Accuracy93.7%（Mycoplasma pneumoniae IgG）ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100% IgG(COVID-19), Clinical Sensitivity92.2% IgG(Mycoplasma pneumoniae）Clinical Specificity98% IgG(COVID-19), Clinical Specificity94.6% IgG(Mycoplasma pneumoniae IgG）Type of antigenNucleoprotein2436COVID-19 and M.pneumoniae IgG/IgM Combo Rapid Test (Whole Blood/Serum/Plasma)659CITEST DIAGNOSTICS Inc.Canadawww.citestdiagnostics.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThe COVID-19 and M.pneumoniae IgG/IgM Combo Rapid Test (Whole Blood/Serum/Plasma) is a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to SARS-COV-2 and Mycoplasma pneumoniae in human whole blood, serum or plasma specimen. The COVID-19 and M.pneumoniae IgG/IgM Combo Rapid Test is for professional use only and is intended to be used as an aid in the diagnosis of patients with suspected SARS-CoV-2/M.pneumoniae infection in conjunction with clinical presentation and the results of other laboratory tests. The product is intended for use by trained laboratory personnel. The test provides preliminary test results. Negative results will not preclude SARS-COV-2/ M.pneumoniae infection and they cannot be used as the sole basis for treatment or other management decision. False positive results for IgM and IgG antibodies may occur due to cross- reactivity from pre-existing antibodies or other possible causes.2022-08-24 09:08:01 CET2139Immuno-AntibodyNoImmunoassayQualitativeSandwich10LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0AU(COVID19 IgG),False positives0.085AU(Mycoplasma pneumoniae IgM)False positives0.078AU(Mycoplasma pneumoniae IgG),False positives0.15AU(COVID19 IgM),False negatives0.02AU(COVID19 IgG),False negatives0.052AU(Mycoplasma pneumoniae IgM)False negatives0.054AU(Mycoplasma pneumoniae IgG),False negatives0.04(COVID19 IgM),PrecisionEvaluatedAccuracy93.7% IgG(Mycoplasma pneumoniae), Accuracy95% IgM(Mycoplasma pneumoniae)Accuracy98.6% IgG(COVID-19 )Accuracy92.9% IgM(COVID-19), ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100% IgG(COVID-19), Clinical Sensitivity85% IgM(COVID-19), Clinical Sensitivity92.2% IgG(Mycoplasma pneumoniae), Clinical Sensitivity91.5% IgM(Mycoplasma pneumoniae)Clinical Specificity98% IgG(COVID-19), Clinical Specificity96% IgM(COVID-19), Clinical Specificity94.6% IgG(Mycoplasma pneumoniae),Clinical Specificity94.8% IgM(Mycoplasma pneumoniae)Type of antigennucleoprotein1387COVID-19 Antigen Rapid Test659CITEST DIAGNOSTICS Inc.Canadawww.citestdiagnostics.comYesCommercialisedNoNoNear POC / POCAntigenNasal swab2022-08-24 09:08:01 CET1153Immuno-AntigenYesNoImmunoassayQualitative15LOD0AUCalibrationNot evaluatedFalse positives0.08%False negatives3.6%Accuracy98%Clinical Sensitivity96.4%1480COVID-19 Antigen Rapid Test (For Reader)659CITEST DIAGNOSTICS Inc.Canadawww.citestdiagnostics.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabnucleocapsid protein2022-08-24 09:08:01 CET1229Immuno-AntigenYesYesImmunoassayQualitative15LOD0AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.08%False negatives3.6%PrecisionEvaluatedAccuracy98%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.4%Type of antigennucleoprotein2447COVID-19 Antigen Rapid Test (Nasopharyngeal Swab)659CITEST DIAGNOSTICS Inc.Canadawww.citestdiagnostics.comYesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThe COVID-19 Antigen Rapid Test (Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 Nucleocapsid Protein antigens in swab specimens from individuals with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2 Antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.2022-08-24 09:08:01 CET2150Immuno-AntigenNoImmunoassayQualitativeSandwich15LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.036AUFalse negatives0.01AUPrecisionEvaluatedAccuracy98.2%(Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.4%(Antigen)Clinical Specificity99%(Antigen)Type of antigenNucleoprotein2386COVID-19 Antigen Rapid Test (Oral Fluid)659CITEST DIAGNOSTICS Inc.Canadawww.citestdiagnostics.comYesCommercialisedNoNoNear POC / POCAntigenSaliva689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThe COVID-19 Antigen Rapid Test (Oral Fluid) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in oral fluid specimens from individuals with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2 nucleocapsid protein antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co- infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.2022-08-24 09:08:01 CET2088Immuno-AntigenNoImmunoassayQualitativeSandwich15LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.099AUFalse negatives0.007AUPrecisionEvaluatedAccuracy97%(Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90.1%(Antigen)Clinical Specificity99.3%(Antigen)Type of antigenNucleoprotein2449COVID-19 Antigen Rapid Test (Swab)659CITEST DIAGNOSTICS Inc.Canadawww.citestdiagnostics.comYesCommercialisedYesYesNear POC / POCAntigenNasal swabNasopharyngeal swabAdenovirus 3Adenovirus 7Alpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Influenza AInfluenza A H1N1Influenza A H3N2Influenza BMERS-CoVMumps Virus (MuV)Parainfluenza Virus Type 2Parainfluenza Virus Type 3Respiratory Syncytial V (RSV)20A.23.170AT.1678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526IotaB.1.526.1B.1.526.23939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu1439C.362041C.37Lambda1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid proteinThe COVID-19 Antigen Rapid Test (Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 Nucleocapsid Protein antigens in swab specimens from individuals with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2 Antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.2022-09-20 17:34:01 CET3844Immuno-AntigenYesNoNoImmunoassayQualitativeSandwichImmunofluorescence15LOD100AUEvaluatedFalse positives0.01AUNasopharyngeal Swab(Antigen)False positives0.001AUNasal Swab(Antigen)False negatives0.036AUNasopharyngeal Swab(Antigen)False negatives0.039AUNasal Swab(Antigen)Accuracy98.2%Nasopharyngeal Swab(Antigen)Accuracy98.2%Nasal Swab(Antigen)Clinical Sensitivity96.4%Nasopharyngeal Swab(Antigen)Clinical Sensitivity96.1%Nasal Swab(Antigen)Clinical Specificity99%Nasopharyngeal Swab(Antigen)Clinical Specificity99.9%Nasal Swab(Antigen)2387COVID-19 Antigen Rapid Test(Nasopharyngeal Swab)659CITEST DIAGNOSTICS Inc.Canadawww.citestdiagnostics.comYesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThe COVID-19 Antigen Rapid Test (Nasopharyngeal Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 antigens in nasopharyngeal swab specimens from individuals with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2 Antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19. The COVID-19 Antigen Rapid Test is intended for use by trained clinical laboratory personnel.2022-08-24 09:08:01 CET2089Immuno-AntigenYesImmunoassayQualitativeSandwich15LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.036AUFalse negatives0.008AUPrecisionEvaluatedAccuracy98%(Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.4%(Antigen)Clinical Specificity99.2%(Antigen)Type of antigenNucleoprotein2388COVID-19 Antigen Test Cassette (Nasopharyngeal Swab)(FIA)659CITEST DIAGNOSTICS Inc.Canadawww.citestdiagnostics.comYesCommercialisedYesYesNear POC / POCAntigenNasopharyngeal swabAdenovirus 3Adenovirus 7Alpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Influenza AInfluenza A H1N1Influenza A H3N2Influenza BMERS-CoVMumps Virus (MuV)Parainfluenza Virus Type 2Parainfluenza Virus Type 3Respiratory Syncytial V (RSV)20A.23.170AT.1689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526IotaB.1.526.1B.1.526.23939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu1439C.362041C.37Lambda1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid proteinThe COVID-19 Antigen Test Cassette (Nasopharyngeal Swab) is based on fluorescence immunoassay for the qualitative detection of SARS-CoV-2 antigens in nasopharyngeal swab specimens from individuals with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2 Antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19, and confirmed with a molecular assay, if necessary for patient management. The COVID-19 Antigen Test Cassette is intended for use by trained clinical laboratory personnel.2022-09-20 10:40:16 CET5304Immuno-AntigenYesNoYesImmunoassayQualitativeSandwichImmunofluorescence10LOD100AUFalse positivesAUFalse negatives0.0144AUAccuracy99.54%(Antigen)Clinical Sensitivity98.56%EvaluatedClinical Specificity100%Evaluated1476COVID-19 Antigen Test for Self Testing659CITEST DIAGNOSTICS Inc.Canadawww.citestdiagnostics.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabAdenovirus 3Adenovirus 7Alpha Coronavirus 229E (HCoV-229E)20A.23.170AT.1678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526IotaB.1.526.1B.1.526.23939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu1439C.362041C.37Lambda1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid proteinThe COVID-19 Antigen Rapid Test (Swab) is a single-use test kit intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19 in self-collected nasal swab specimen from symptomatic / asymptomatic individuals who are suspected of being infected with COVID-19. This test is designed for the use by layperson. A positive result indicates the presence of SARS-CoV-2. Individuals whose test results are positive should self-isolate and seek help from relevant healthcare institutions. A positive result may also be caused by bacterial infection or co-infection with other viruses. A negative result may also be infected with SARS-CoV-2. Individuals whose test results are negative continue to experience COVID-like symptoms should seek follow-up help from relevant healthcare institutions.The COVID-19 Antigen Rapid Test (Swab) only indicates a preliminary result. The confirmation of the final result should be based on the clinical diagnosis.2022-11-07 14:09:37 CET5286Immuno-AntigenYesYesNoImmunoassayQualitativeSandwichImmunofluorescence15LOD100AUEvaluatedAnalytical Specificity99.9%EvaluatedFalse positives3%False negatives%Accuracy99.1%EvaluatedReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97%Evaluated1395COVID-19 IgG Rapid Test659CITEST DIAGNOSTICS Inc.Canadawww.citestdiagnostics.comYesCommercialisedNoNoNear POC / POCAntibodyIgGPlasmaSerumWhole blood2022-08-24 09:08:01 CET1161Immuno-AntibodyYesNoImmunoassayQualitative10LOD0CalibrationNot evaluatedFalse positives4.7%False negatives%5.70%Accuracy95% IgGClinical Sensitivity94.3% IgG2441COVID-19 IgG Rapid Test (Whole Blood/Serum/Plasma)659CITEST DIAGNOSTICS Inc.Canadawww.citestdiagnostics.comYesCommercialisedNoNoNear POC / POCAntibodyIgGPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThe COVID-19 IgG Rapid Test (Whole Blood/Serum/Plasma) is a lateral flow chromatographic immunoassay for the qualitative detection of IgG antibodies to SARS-CoV-2 spike (S) protein receptor binding domain (RBD) and/or Nucleocapsid protein in human whole blood, serum or plasma specimen. The COVID-19 IgG Rapid Test (Whole Blood/Serum/Plasma) is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2. False positive results may occur due to cross-reactivity from pre-existing antibodies or other possible causes. Due to the risk of false positive results, confirmation of positive results should be considered using second, different IgG assay.2022-08-24 09:08:01 CET2144Immuno-AntibodyNoImmunoassayQualitativeSandwich10LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.038AU( SARS-CoV-2 infection), False positives0.043AU(vaccination)False negatives0.001AU( SARS-CoV-2 infection), False negatives0AU(vaccination)PrecisionEvaluatedAccuracy97.7%( SARS-CoV-2 infection), Accuracy97.9%(vaccination)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.3%( SARS-CoV-2 infection), Clinical Sensitivity95.7%(vaccination)Clinical Specificity99%( SARS-CoV-2 infection), Clinical Specificity100%(vaccination)Type of antigenOther1389COVID-19 IgG/IgM Rapid Test (cassette)659CITEST DIAGNOSTICS Inc.Canadawww.citestdiagnostics.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2022-08-24 09:08:01 CET1155Immuno-AntibodyYesNoImmunoassayQualitative10Rapid diagnostic test lateral flow LOD0AUCalibrationNot evaluatedFalse positives5%False negatives5.6%Accuracy94.4%Clinical Sensitivity94.4%1479COVID-19 IgG/IgM Rapid Test (For Reader)659CITEST DIAGNOSTICS Inc.Canadawww.citestdiagnostics.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood no info in company website2022-08-24 09:08:01 CET1228Immuno-AntibodyYesYesImmunoassayQualitative10LOD0IU/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives5%False negatives5.6%PrecisionEvaluatedAccuracy94.9%(IgG/IgM)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.9%94.4(IgG/IgM)1394COVID-19 IgG/IgM Rapid Test (Strip)659CITEST DIAGNOSTICS Inc.Canadawww.citestdiagnostics.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2022-08-24 09:08:01 CET1160Immuno-AntibodyYesNoImmunoassayQualitative10Rapid diagnostic test Strip LOD0CalibrationNot evaluatedFalse positives5%False negatives5.6%Accuracy94.9%Clinical Sensitivity94.4%2439COVID-19 IgG/IgM Rapid Test (Whole Blood/Serum/Plasma)659CITEST DIAGNOSTICS Inc.Canadawww.citestdiagnostics.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2Zetanucleocapsid proteinThe COVID-19 IgG/IgM Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to SARS-CoV-2 in human whole blood, serum or plasma specimen from patients suspected of COVID-19 infection by a healthcare provider. The COVID-19 IgG/IgM Rapid Test is an aid in the diagnosis of patients with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results from the COVID-19 IgG/IgM Rapid Test should not be used as the sole basis for diagnosis. Results are for the detection of SARS-CoV-2 antibodies. IgM antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, although levels over the course of infection are not well characterized. IgG antibodies to SARS-CoV-2 become detectable later following infection. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. IgM antibodies may not be detected in the first few days of infection; the sensitivity of the COVID-19 IgG/IgM Rapid Test early after infection is unknown. False positive results for IgM and IgG antibodies may occur due to cross-reactivity from preexisting antibodies or other possible causes.2022-08-24 09:08:01 CET2142Immuno-AntibodyYesNoImmunoassayQualitativeSandwich10LOD100CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.037% IgGFalse positives0.05% IgMFalse negatives0.014% IgGFalse negatives0.02% IgMPrecisionEvaluatedAccuracy98.1% IgGAccuracy97.4% IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.3% IgGClinical Sensitivity95% IgMClinical Specificity98.6% IgGClinical Specificity98% IgMType of antigenNucleoprotein1475COVID-19 IgG/IgM Test Cassette659CITEST DIAGNOSTICS Inc.Canadawww.citestdiagnostics.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2022-08-24 09:08:01 CET1224Immuno-AntibodyYesYesImmunoassayQualitative15LOD0CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives3.3%False negatives3.1%PrecisionEvaluatedAccuracy96.9%(IgG/IgM)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.7%(IgG/IgM)2393COVID-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma)659CITEST DIAGNOSTICS Inc.Canadawww.citestdiagnostics.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1223B.1.525Eta1495P.1Gamma1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThe COVID-19 IgG/IgM Test Cassette is a fluorescence immunoassay for the qualitative detection of IgG and IgM antibodies to SARS-CoV-2 in human whole blood, serum or plasma specimen.The COVID-19 IgG/IgM Test is an aid in the diagnosis of patients with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results from the COVID-19 IgG/IgM Test should not be used as the sole basis for diagnosis. Results are for the detection of SARS-CoV-2 antibodies. IgM antibodies to SARS-CoV- 2 are generally detectable in blood several days after initial infection, although levels over the course of infection are not well characterized. IgG antibodies to SARS-CoV-2 become detectable later following infection. Positive results for both IgG and IgM could occur after infection and can be indicative of acute or recent infection. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. IgM antibodies may not be detected in the first few days of infection; the sensitivity of the COVID-19 IgG/IgM Test early after infection is unknown. False positive results for IgM and IgG antibodies may occur due to cross-reactivity from pre-existing antibodies or other possible causes. At this time, it is unknown for how long IgM or IgG antibodies may persist following infection.2022-08-24 09:08:01 CET2095Immuno-AntibodyYesImmunoassayQualitativeSandwich15LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.033AUFalse negatives0.031AUPrecisionEvaluatedAccuracy96.9%(IgG/IgM)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.7%(IgG/IgM)Clinical Specificity96.9%(IgG/IgM)Type of antigenNucleoprotein2394SARS-CoV-2 Neutralization Antibody Rapid Test (Whole Blood/Serum/Plasma)659CITEST DIAGNOSTICS Inc.Canadawww.citestdiagnostics.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThe SARS-CoV-2 Neutralization Antibody Rapid Test (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay intended for the qualitative detection of neutralization antibodies against SARS-CoV-2 that block the interaction between the receptor binding domain of the viral spike glycoprotein (RBD) with the cell surface receptor ACE2 in human whole blood, serum or plasma. It is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2. Results are for the detection of SARS-CoV-2 neutralization antibodies. Positive results indicate the presence of neutralization antibodies to SARS-CoV-2.2022-08-24 09:08:01 CET2096Immuno-AntibodyNoImmunoassayQualitativeNeutralization Antibody (NAb)10LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.034AUFalse negatives0.015AUPrecisionEvaluatedAccuracy97.7%(Neturalization Antibody)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.6%(Neturalization Antibody)Clinical Specificity98.5%(Neturalization Antibody)Type of antigenNucleoprotein2395SARS-CoV-2 S-RBD Antibody Rapid Test (Whole Blood/Serum/Plasma)659CITEST DIAGNOSTICS Inc.Canadawww.citestdiagnostics.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThe SARS-CoV-2 S-RBD Antibody Rapid Test (Whole Blood/Serum/ Plasma) is a rapid chromatographic immunoassay intended for the qualitative detection of antibodies to SARS-CoV-2 spike (S) protein receptor binding domain (RBD) in human serum, plasma, or whole blood. It is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2. Results are for the detection of antibodies to SARS-CoV-2 spike (S) protein receptor binding domain (RBD). Positive results indicate the presence of antibodies to SARS-CoV-2 spike (S) protein receptor binding domain (RBD)2022-08-24 09:08:01 CET2097Immuno-AntibodyNoImmunoassayQualitativeSandwich10LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.022AUFalse negatives0.015AUPrecisionEvaluatedAccuracy98.2%(Antibody)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.8%(Antibody)Clinical Specificity98.5%(Antibody)Type of antigenOther2400SARS-CoV-2 S-RBD IgG Antibody Rapid Test (Whole Blood/Serum/Plasma)659CITEST DIAGNOSTICS Inc.Canadawww.citestdiagnostics.comYesCommercialisedNoNoNear POC / POCAntibodyIgGPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThe SARS-CoV-2 S-RBD IgG Antibody Rapid Test (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay intended for the qualitative detection of IgG antibodies to SARS-CoV-2 spike (S) protein receptor binding domain (RBD) in human serum, plasma, or whole blood. It is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2. Results are for the detection of SARS-CoV-2 S-RBD IgG antibodies. Positive results indicate the presence of IgG antibodies to SARS-CoV-2.2022-08-24 09:08:01 CET2102Immuno-AntibodyNoImmunoassayQualitativeSandwich10LODAU100CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positivesAU0.022False negativesAU0.015PrecisionEvaluatedAccuracy98.2% IgG(IgG)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.8% IgG(IgG)Clinical Specificity98.5% IgG(IgG)Type of antigenOther1474SARS-CoV-2/Influenza A+B/RSV Antigen Combo Rapid Test659CITEST DIAGNOSTICS Inc.Canadawww.citestdiagnostics.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabnucleocapsid protein no info in company website2022-08-24 09:08:01 CET1223Immuno-AntigenYesNoImmunoassayQualitative15Rapid diagnostic test LOD0AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.8%(0.9% Influenza A; 0.9% Influenza B; 3.8% RSV)False negatives3.6%(5% Influenza A; 7.1% Influenza B; 5.7% RSV)PrecisionEvaluatedAccuracy98%(98.4 Influenza A; 98.1 Influenza B; 95.9 RSV)ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity96.4%(95 Influenza A; 92.9 Influenza B; 94.3 RSV)Type of antigennucleoprotein2410SARS-CoV-2/Influenza A+B/RSV Antigen Combo Rapid Test (Nasopharyngeal Swab)659CITEST DIAGNOSTICS Inc.Canadawww.citestdiagnostics.comYesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThe SARS-CoV-2/Influenza A+B/RSV Antigen Combo Rapid Test (Nasopharyngeal Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2, Influenza A, Influenza B and Respiratory Syncytial Virus(RSV) antigens in nasopharyngeal swab specimens from individuals with suspected SARS-CoV-2/Influenza/RSV infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2, Influenza A+B and RSV Antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out other bacterial/viral infection. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2/Influenza A+B/RSV infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with SARS-CoV-2, Influenza A+B and RSV. The SARS-CoV-2/Influenza A+B/RSV Antigen Combo Rapid Test is intended for use by trained clinical laboratory personnel.2022-08-24 09:08:01 CET2112Immuno-AntigenNoImmunoassayQualitativeSandwich15LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.036AU(SARS-CoV-2 Test), False positives0.057AU(RSV Test)False positives0.071AU(Influenza BTest), False positives0.05AU(Influenza A Test), False negatives0.008AU(SARS-CoV-2 Test), False negatives0.038AU(RSV Test)False negatives0.009AU(Influenza BTest), False negatives0.009AU(Influenza A Test), PrecisionEvaluatedAccuracy98.1% (Antigen-Influenza BTest), Accuracy95.9%(Antigen-RSV Test)Accuracy98%(Antigen-SARS-CoV-2 Test), Accuracy98.4%(Antigen-Influenza A Test), ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.4%(Antigen-SARS-CoV-2 Test), Clinical Sensitivity95%(Antigen-Influenza A Test), Clinical Sensitivity92.9%(Antigen-Influenza BTest)Clinical Sensitivity94.3%(Antigen-RSV Test)Clinical Specificity99.2%(Antigen-SARS-CoV-2 Test), Clinical Specificity99.1%(Antigen-Influenza A Test), Clinical Specificity99.1%(Antigen-Influenza BTest), Clinical Specificity96.2%(Antigen-RSV Test)Type of antigenNucleoprotein1472SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen659CITEST DIAGNOSTICS Inc.Canadawww.citestdiagnostics.comYesCommercialisedNoNoNear POC / POCAntigenNasal swab2022-08-24 09:08:01 CET1221Immuno-AntigenYesNoImmunoassayQualitative15LOD0CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.8%(S0.9% Influenza A; 0.9% Influenza B; 3.8% RSV; 1.4% Adenovirus)False negatives3.6%(5% Influenza A; 7.1% Influenza B; 5.7% RSV; 3.1% Adenovirus)PrecisionEvaluatedAccuracy98%(98.4 Influenza A; 98.1 Influenza B; 95.9 RSV; 98.4 Adenovirus)ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity96.4%(95 Influenza A; 92.9 Influenza B; 94.3 RSV; 96.9 Adenovirus)2440SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test (Nasopharyngeal Swab)659CITEST DIAGNOSTICS Inc.Canadawww.citestdiagnostics.comYesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.21518P.2ZetaThe SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test (Nasopharyngeal Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2, Influenza A, Influenza B, Respiratory Syncytial Virus(RSV) and Adenovirus antigens in nasopharyngeal swab specimens from individuals with suspected SARS-CoV-2/ Influenza/ RSV/Adenovirus infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2, Influenza A+B, RSV and Adenovirus antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out other bacterial/viral infection. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2/ Influenza A+B/RSV/Adenovirus infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with SARS-CoV-2, Influenza A+B ,RSV and Adenovirus. The SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test is intended for use by trained clinical laboratory personne2022-08-24 09:08:01 CET2143Immuno-AntigenNoImmunoassayQualitativeSandwich15LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.031AU(Adenovirus)False positives0.036AU(SARS-CoV-2),False positives0.057AU(RSV),False positives0.071AU(Influenza B),False positives0.05AU(Influenza A),False negatives0.009AU(Influenza A),False negatives0.014AU(Adenovirus)False negatives0.038AU(RSV),False negatives0.009AU(Influenza B),False negatives0.008AU(SARS-CoV-2),PrecisionEvaluatedAccuracy95.9%(Antigen RSV),Accuracy98.4%(Antigen Influenza A),Accuracy98%(Antigen SARS-CoV-2),Accuracy98.4%(Antigen Adenovirus)Accuracy98.1%(Antigen Influenza B),ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.4%(Antigen SARS-CoV-2),Clinical Sensitivity95%(Antigen Influenza A),Clinical Sensitivity92.9%(Antigen Influenza B),Clinical Sensitivity94.3%(Antigen RSV),Clinical Sensitivity96.9%(Antigen Adenovirus)Clinical Specificity99.2%(Antigen SARS-CoV-2),Clinical Specificity99.1%(Antigen Influenza A),Clinical Specificity99.1%(Antigen Influenza B),Clinical Specificity96.2%(Antigen RSV),Clinical Specificity98.6%(Antigen Adenovirus)1473SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae Antigen Combo Rapid Test659CITEST DIAGNOSTICS Inc.Canadawww.citestdiagnostics.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabnucleocapsid protein no info in company website2022-08-24 09:08:01 CET1222Immuno-AntigenYesNoImmunoassayQualitative15Rapid diagnostic test LOD0AU0CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.8%(0.9% Influenza A; 0.9% Influenza B; 3.8% RSV; 1.4% Adenovirus; 2% M.pneumoniae)False negatives3.6%(5% Influenza A; 7.1% Influenza B; 5.7% RSV; 3.1% Adenovirus;8.2% M.pneumoniae)PrecisionEvaluatedAccuracy98%(98.4 Influenza A; 98.1influenza B; 95.9 RSV; 98.4 Adenovirus; 97 M.pneumoniae)ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity96.4%(95 Influenza A; 92.9% Influenza B; 94.3 RSV; 96.9 Adenovirus; 91.8 M.pneumoniae)Type of antigennucleoprotein2401SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae Antigen Combo Rapid Test (Nasopharyngeal Swab)659CITEST DIAGNOSTICS Inc.Canadawww.citestdiagnostics.comYesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThe SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae Antigen Combo Rapid Test (Nasopharyngeal Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2, Influenza A, Influenza B, Respiratory Syncytial Virus(RSV), Adenovirus and M.pneumoniae antigens in nasopharyngeal swab specimens from individuals with suspected SARS-CoV-2/Influenza/RSV/Adenovirus/M.pneumoniae infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2, Influenza A+B, RSV, Adenovirus and M.pneumoniae antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of correlative antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out other bacterial/viral infection. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2/ Influenza A+B/RSV/Adenovirus/M.pneumoniae infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with SARS-CoV-2, Influenza A+B,RSV , Adenovirus and M.pneumoniae. The SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae Antigen Combo Rapid Test is intended for use by trained clinical laboratory personnel.2022-08-24 09:08:01 CET2103Immuno-AntigenNoImmunoassaySandwich15LODAU100CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.082AU(M.pneumoniae)False positives0.036AU(SARS-CoV-2),False positives0.031AU(Adenovirus),False positives0.057AU(RSV),False positives0.071AU(flu B),False positives0.05AU(flu A),False negatives0.009AU(flu B),False negatives0.002AU(M.pneumoniae)False negatives0.014AU(Adenovirus),False negatives0.038AU(RSV),False negatives0.009AU(flu A),False negatives0.008AU(SARS-CoV-2),PrecisionEvaluatedAccuracy95.9%(Antigen-RSV),Accuracy98.4%(Antigen-Influenza A)Accuracy98.4%(Antigen-Adenovirus),Accuracy98.1%(Antigen-Influenza B),Accuracy97%(Antigen-M.pneumoniae)Accuracy98%(Antigen-SARS-CoV-2),ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95%(Antigen-Influenza A),Clinical Sensitivity91.8%(Antigen-M.pneumoniae)Clinical Sensitivity96.9%(Antigen-Adenovirus),Clinical Sensitivity94.3%(Antigen-RSV),Clinical Sensitivity92.9%(Antigen-Influenza B),Clinical Sensitivity96.4%(Antigen-SARS-CoV-2),Clinical Specificity99.2%(Antigen-SARS-CoV-2),Clinical Specificity99.1%(Antigen-Influenza A),Clinical Specificity99.1%(Antigen-Influenza B),Clinical Specificity96.2%(Antigen-RSV),Clinical Specificity98.6%(Antigen-Adenovirus),Clinical Specificity98%(Antigen-M.pneumoniae)Type of antigenNucleoprotein3922CNAME1440CMANUItalyYesCommercialisedNoNoFully automated (robot)AntibodyBronchoalveolar lavage fluidAdenovirus20A.23.1angiotensin-converting enzyme 22022-08-24 09:08:01 CET3589Immuno-AntigenYesYesNoImmunoassayQualitativeSandwichColloidal gold12LOD12copies/sampleFalse positives12cpr/cpuFalse negatives12cpr/cpu2632SARS-CoV-2 Antigen Test Kit(Colloidal Gold Method)1202Cofoe Medical Technology Co. Ltd.China/YesCommercialisedNoNoManualAntigenNasopharyngeal swabnucleocapsid protein1.When the titer of the SARS-CoV-2 culture is 2.5×105TCID50/ml, the test result of this test card does not show a hook effect; when the concentration of the SARS-CoV-2 positive quality control product is within the range of 0.5mg/ml, the test result of this test card does not show a hook effect . 2.Nasopharyngeal swab specimens can be stored at 2℃-8℃ for at least 8h. 3.The loading volume of theSARS-CoV-2 antigen test strip is 50μl. 4.After opening the foil bag, the SARS-CoV-2 antigen test strip meets the requirements within 60 minutes. But the test result will fail after opening for 90 minutes. Therefore, the bag-opening stability is set at 60 minutes. 5.The general storage temperature of the kit is about 25°C. According to the Arrhenius formula, the logarithm of the expiration date and the reciprocal of the absolute temperature have a linear relationship. Accelerated at 37°C for 3 months (90 days), converted to approximately 12 months (360 days) stored at 25°C. Therefore, in the absence of real-time stability test results, it is temporarily assumed that the SARS-CoV-2 Antigen Test Kit (Colloidal Gold Method) is valid for 12 months.2022-08-24 09:08:01 CET2337Immuno-AntigenYesYesImmunochromatographyQualitativeColloidal gold15LOD0.1ng/mLCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives4%False negatives1%PrecisionNot evaluatedAccuracy98%(Antigen)ReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity96.04%(Antigen)Clinical Specificity99%(Antigen)Type of antigenNucleocapsid protein3937SARS-CoV-2 Antigen Test Kit(Colloidal Gold Method)3214Cofoe Medical Technology Co., Ltd.ChinaYesCommercialisedYesYesManualAntigenNasal swabAdenovirusAlpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus OC43 (HCoV-OC43)Bordetella PertussisChlamydia PneumoniaeHemophilus InfluenzaeInfluenza AInfluenza A H1N1Parainfluenza Virus TypeParainfluenza Virus Type 1Parainfluenza Virus Type 2Parainfluenza Virus Type 3Parainfluenza Virus Type 4Respiratory Syncytial V (RSV)Respiratory Syncytial V (RSV) Type ARhinovirus678B.1.1.529Omicronnucleocapsid protein2022-11-14 09:03:04 CET5308Immuno-AntigenYesNoNoImmunochromatographyQualitativeMembrane-basedColloidal gold15LOD900TCID50/mlAnalytical Sensitivity100%Analytical Specificity100%False positives0.99%False negatives9.901%Accuracy97.228%Clinical Sensitivity90.099%Clinical Specificity99.01%3011Q-Check COVID-19 Antigen Rapid Test1336Cold Spring Biotech Corp.Taiwan ROChttp://www.csbiotech.com.tw/YesCommercialisedNoNoManualNear POC / POCAntigenNasal swabNasopharyngeal swab689B.1.1.7Alpha1321B.1.617.2Delta678B.1.1.529Omicronnucleocapsid proteinQ-Check COVID-19 Antigen Rapid Test is a rapid immunochromatographic method intend for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct nasopharyngeal swab (NP)specimens from individuals who are suspected of COVID-19 by their healthcare provider within the first six days of symptom onset.2022-08-24 09:08:01 CET2717Immuno-AntigenNoImmunochromatographyQualitativeSandwich15LOD62.5TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives3%False negatives6.9%PrecisionEvaluatedAccuracy96.6%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.1%Clinical Specificity97%Type of antigenNucleocapsid protein131Instant COVID-19 “Coronavirus” Test418Confirm BioscienceUnited Stateswww.confirmbiosciences.com/YesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET573Immuno-AntibodyYesNoImmunoassayQualitative15Rapid diagnostic test cassette Not found 4068Convergys® COVID-19 Rapid Antigen Test769Convergent TechnologiesGermanywww.convergent-technologies.deYesCommercialisedNoNoManualNear POC / POCAntigenNasal swabNasopharyngeal swabSARS-CoV678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1223B.1.525Eta1224B.1.526Iota1320B.1.617.1Kappa1321B.1.617.2Delta1323B.1.621Mu2041C.37Lambda1495P.1Gamma1518P.2Zetanucleocapsid protein2022-09-20 14:36:35 CET3830Immuno-AntigenYesNoNoImmunochromatographyQualitativeMembrane-basedColloidal gold15LOD180TCID50/mlCalibrationNot evaluatedAnalytical Sensitivity95%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives0.98%False negatives4.97%PrecisionEvaluatedAccuracy97.15%RobustnessNot evaluatedClinical Sensitivity95.03%Clinical Specificity99.02%1594Antigen Rapid Test COVID-19 Coretests420Core Technology Co. Ltd.YesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swab2022-08-24 09:08:01 CET1274Immuno-AntigenYesNoImmunoassayQualitative152505Canea COVID-19 Antigen Speichel Selbsttest1142Core Technology Co. Ltd.Chinahttp://www.coretests.comYesCommercialisedNoNoManualAntigenSaliva689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31518P.2ZetaThis test kit uses COVID-19 monoclonal antibody and goat anti-mouse IgG polyclonal antibodies that are respectively immobilized on a nitrocellulose membrane. It uses colloidal gold to label the COVID-19 monoclonal antibody. Using nano-colloidal gold technology and applying highly specific antibody-antigen reaction and immunochromatographic analysis technology principle.2022-08-24 09:08:01 CET2209Immuno-AntigenYesImmunochromatographyQualitativeMembrane-based15LOD22.5TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives100%False negatives100%PrecisionEvaluatedAccuracy98.7%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.6%Clinical Specificity99.1%Type of antigenNucleocapsid protein1919Coretests COVID-19 Ag Test420Core Technology Co. Ltd.YesCommercialisedNoNoManualNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabAdenovirusAlpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Bordetella PertussisChlamydia PneumoniaeHemophilus InfluenzaeHuman Metapneumovirus (HMPV)Influenza A H1N1Influenza A H3N2Influenza A H5N1Influenza B VictoriaInfluenza B YamagataMERS-CoVMycobacterium TuberculosisMycoplasma PneumoniaeOtherParainfluenza Virus Type 1Parainfluenza Virus Type 2Parainfluenza Virus Type 3Parainfluenza Virus Type 4Respiratory Syncytial V (RSV) Type ARhinovirusSARS-CoV678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1137B.1.429Epsilon1223B.1.525Eta1224B.1.526Iota1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu2041C.37Lambda1495P.1Gamma1518P.2Zetanucleocapsid proteinCOVID-19 Ag Test is the chromatographic assay used for qualitative detection of the COVID-19 antigen in human nasopharyngeal swab / oropharyngeal swab / nasal swab specimen. This test kit uses COVID-19 monoclonal antibody and goat anti-mouse IgG polyclonal antibodies that are respectively immobilized on a nitrocellulose membrane. It uses colloidal gold to label sufficient COVID-19 monoclonal antibody, using nano-colloidal gold technology and applying highly specific antibody-antigen reaction and immunochromatographic analysis technology principle. When testing, the COVID-19 antigen in the sample combined with the colloidal gold-labeled COVID-19 monoclonal antibody to form a complex, which was then combined with the COVID-19 monoclonal antibody coated in the T line during chromatography, at this time there is one red line in the T area .When the samples do not contain COVID-19 antigen, colloidal gold-labeled COVID-19 monoclonal antibody cannot combined with COVID-19 monoclonal antibody in the T line region, so there is no red colored line in the T area. Regardless of the presence of COVID-19 antigen in the sample, a red line will form in the quality control area (C). The red line appears in the quality control area (C) serves as 1.verification that sufficient volume is added. 2.That proper flow is obtained 3. And as a control for the reagents.2022-10-31 09:12:45 CET5253Immuno-AntigenYesNoNoImmunochromatographyQualitativeMembrane-basedColloidal gold10LOD22.5TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives%False negatives18%PrecisionEvaluatedAccuracy91.09%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity82%Clinical Specificity100%Type of antigenNucleoprotein1923Coretests COVID-19 Neutralizing Ab Test420Core Technology Co. Ltd.YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole bloodCOVID-19 Neutralizing Ab Test is used for qualitative detection of the Neutralizing antibodies in patients who have recovered from Novel Coronavirus Pneumonia or those who have been vaccinated. The neutralizing antibody protects the host from infection by neutralizing the activity of the virus. It is a specific antibody that can block the virus from invading cells. The neutralizing antibody is produced by the immune response after a person is vaccinated or infected with a virus. Its titer will directly determine the body's ability to neutralize the virus, that is, the body's ability to avoid virus infection. Coretests® COVID-19 Neutralizing Ab Test can detect neutralizing antibodies faster, and the test only takes 10-15 minutes.2022-08-24 09:08:01 CET1599Immuno-AntibodyNoImmunoassayQualitativeSandwich15LODAU25CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives%0.7%False negatives%0.8%PrecisionEvaluatedAccuracy%99.3ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity%99.2Clinical Specificity%99.3Type of antigenOther3025Coretests ® COVID-19 Ag Test420Core Technology Co. Ltd.YesCommercialisedNoNoNear POC / POCAntigenNasal swab689B.1.1.7Alpha1495P.1Gamma1321B.1.617.2Deltanucleocapsid proteinCOVID-19 Ag Test is the chromatographic assay used for qualitative detection of the COVID-19 antigen in human nasal swab specimen.This test kit uses COVID-19 monoclonal antibody and goat anti-mouse IgG polyclonal antibodies that are respectively immobilized on a nitrocellulose membrane. It uses colloidal gold to label sufficient COVID-19 monoclonal antibody. Using nano-colloidal gold technology and applying highly specific antibody-antigen reaction and immunochromatographic analysis technology principle. When testing, the COVID-19 antigen in the sample combined with the colloidal gold-labeled COVID-19 monoclonal antibody to form a complex, which was then combined with the COVID-19 monoclonal antibody coated in the T line during chromatography, at this time there is one red line in the T area .When the samples do not contain COVID-19 antigen, colloidal gold-labeled COVID-19 monoclonal antibody cannot combined with COVID-19 monoclonal antibody in the T line region, so there is no red colored line in the T area .Regardless of the presence of COVID-19 antigen in the sample, a red line will form in the quality control area (C). The red line appears in the quality control area (C) serves as 1.verification that sufficient volume is added. 2.That proper flow is obtained 3. And as a control for the reagents.2022-08-24 09:08:01 CET2731Immuno-AntigenNoNoImmunochromatographyQualitativeMembrane-based15LOD22.5TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.1%False negatives1.3%PrecisionEvaluatedAccuracy98.8%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.1%AntigenClinical Specificity99.2%AntigenType of antigenNucleocapsid protein132COVID-19 IgM/IgG Ab Test420Core Technology Co. Ltd.YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2022-08-24 09:08:01 CET575Immuno-AntibodyYesNoImmunoassayQualitativeNot found15Rapid diagnostic test cassette Not found 1915COVID-19 Saliva Ag Test420Core Technology Co. Ltd.YesCommercialisedNoNoNear POC / POCAntigenSaliva2022-08-24 09:08:01 CET1592Immuno-AntigenNoImmunochromatographyQualitativeSandwich10LOD22.5AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.9%False negatives2.4%PrecisionEvaluatedAccuracy98.7%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.6%Clinical Specificity99.1%Type of antigenOther2648Covid-19 Ag K-SeT73Coris BioConceptBelgiumwww.corisbio.comYesCommercialisedNoNoManualNear POC / POCAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1519P.3Theta1321B.1.617.2DeltaB.1.526.2nucleocapsid proteinNew clinical validation on 174 samples (36 positives and 138 negatives versus PCR. 1 false negative observed.2022-08-24 09:08:01 CET2353Immuno-AntigenYesNoImmunochromatographyQualitativeCapture15LOD140TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives1%New clinical validation on 174 samples (36 positives and 138 negatives versus PCR. 1 false negative observedPrecisionEvaluatedAccuracy99.4%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.2%Clinical Specificity100%Type of antigenNucleocapsid protein133COVID-19 Ag Respi-Strip73Coris BioConceptBelgiumwww.corisbio.comYesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1321B.1.617.2Delta678B.1.1.529OmicronNew data is the positivity on OMICRON variant (real data, not bioinformatic)2022-08-24 09:08:01 CET92Immuno-AntigenYesNoImmunoassayQualitativeColorimetry30LOD5000TCID50/mlLOD0.25ng/mLCalibrationNot ReportedAnalysis of cross reactivityCross-reactivity: no cross-reactivity for bacteria and virus tested including seasonal Coronaviruses (HKU1, 229E, OC43, NL63), positive for SARS-CoVAccuracy97.9%Clinical Sensitivity91.2%Clinical Specificity99.4%2002COVID-19 Sero NP/RBD73Coris BioConceptBelgiumwww.corisbio.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumAssay evaluated with Anti-SARS-CoV-Verification Panel for Serology Assays (NIBSC code: 20/B770): 100% Accuracy. Test identifies antibodies against Nucleoprotein (NP Line) and against RBD domain of the spike protein (RBD line).2022-08-24 09:08:01 CET1679Immuno-AntibodyNoImmunochromatography15LOD10AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%No false positivity with seasonal coronaviruses HCoV-HKU1, -NL63, -OC43, and -229EFalse negatives1.47%(4 on 271 samples)PrecisionNot evaluatedAccuracy98.5%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity98.4%(combined NP and RBD)Clinical Specificity98.5%Type of antigenOther1810CORMAY RAPID SARS-CoV-2 ANTIGEN TEST KIT579CORMAYPolandcormay.pl/index.php?lang=_enYesCommercialisedNoNoManualAntigenNasopharyngeal swabOropharyngeal swabFully functional kit contains: cassettes, swabs, extraction buffers, extraction tubes, nozzles with filters and clear IFU.2022-08-24 09:08:01 CET1489Immuno-AntigenYesNoImmunochromatographyQualitativeCapture15LOD1.25AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives-False negatives-PrecisionEvaluatedAccuracy96%ReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity95%Clinical Specificity98%1074Cormay Rapid SARS-CoV-2 IgG/IgM Ab579CORMAYPolandcormay.pl/index.php?lang=_enYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2022-08-24 09:08:01 CET852Immuno-AntibodyYesNoChromatographyQualitative10Accuracy97.72% IgMAccuracy98.52% IgGClinical Sensitivity96.52% IgGClinical Sensitivity94.07% IgM341CoronaCide222CoronaCideUnited Stateswww.coronacide.com/NoCommercialisedNoNoNear POC / POCAntibody2022-08-24 09:08:01 CET284Immuno-AntibodyYesImmunoassayRapid diagnostic test 136SARS-CoV-2 (2019-nCoV) Nucleoprotein Protein ELISA Kit75Creative BiolabsUnited Statessars-cov-2.creative-biolabs.com/NoCommercialisedNoNoManualAntibody2022-08-24 09:08:01 CET95Immuno-AntibodyELISAQualitativeAbsorbance135SARS-CoV-2 (2019-nCoV) Spike Protein ELISA Kit75Creative BiolabsUnited Statessars-cov-2.creative-biolabs.com/NoCommercialisedNoNoManualAntibody Microarray based method 2022-08-24 09:08:01 CET94Immuno-AntibodyELISAQualitativeAbsorbance908ELISA: Anti-SARS-CoV-2 antibodies & NP antigen82Creative DiagnosticsUnited Stateswww.creative-diagnostics.com/NoCommercialisedNoNoAutomatedManualAntigen2022-08-24 09:08:01 CET722Immuno-AntigenELISA140SARS-CoV-2 Antigen ELISA Kit82Creative DiagnosticsUnited Stateswww.creative-diagnostics.com/NoCommercialisedNoNoAutomatedManualAntigenPlasmaSerum2022-08-24 09:08:01 CET105Immuno-AntigenYesELISAQuantitativeFluorescenceClinical Sensitivity98%Clinical Specificity98%138SARS-CoV-2 IgG ELISA Kit82Creative DiagnosticsUnited Stateswww.creative-diagnostics.com/NoCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET103Immuno-AntibodyELISAQualitativeFluorescenceClinical Sensitivity98%Clinical Specificity98%139SARS-CoV-2 IgM ELISA Kit82Creative DiagnosticsUnited Stateswww.creative-diagnostics.com/NoCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET104Immuno-AntibodyELISAQualitativeFluorescenceClinical Sensitivity98%Clinical Specificity98%137SARS-COV-2 Total Antibody ELISA Kit82Creative DiagnosticsUnited Stateswww.creative-diagnostics.com/NoCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET102Immuno-AntibodyYesELISAQualitativeFluorescenceClinical Sensitivity98%Clinical Specificity98%1853Aria COVID-19 Ag Rapid Test79CTK Biotech Inc.United Stateshttps://ctkbiotech.com/YesCommercialisedNoNoChipDipstickManualNear POC / POCAntigenNasal swabNasopharyngeal swabStudy has shown that the CTK Aria COVID-19 Ag Rapid Test can detect both the Sars-Cov-2 UK variant and South Africa variant. The test is registered Australia, Brazil, EU and 20 other additional countries.2022-08-24 09:08:01 CET1533Immuno-AntigenNoImmunochromatographyQualitativeColorimetry15LOD280AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives7.7%PrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.3%Clinical Specificity100%Type of antigenNucleoprotein1581OnSite COVID-19 Ag Rapid Test79CTK Biotech Inc.United Stateshttps://ctkbiotech.com/YesCommercialisedYesYesManualNear POC / POCAntigenNasal swabNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31224B.1.526Iotanucleocapsid proteinThis test is registered and for practical use in: Germany Bfarm https://antigentest.bfarm.de/ords/f?p=110:100:1379568298725:::::&tz=-7:00 Test ID AT390/21 Italy MOH https://www.salute.gov.it/interrogazioneDispositivi/RicercaDispositiviServlet?action=ACTION_MASCHERA Under CTK Biotech, Inc. Device registration number is 2095755 France ANSM https://covid-19.sante.gouv.fr/tests Denmark authorization: https://laegemiddelstyrelsen.dk/da/udstyr/covid-19-antigen-test-og-ivd/covid-19-antigen-test-til-selvtest/ Practical usage: To date, there are 11211460 tests that are in use or scheduled to be shipped to EU in the countries of Denmark, France, Germany, Italy, Ireland, Romania, Lithuania and the United Kingdom.2022-08-24 09:08:01 CET1260Immuno-AntigenYesNoImmunoassayQualitativeSandwich, DoubleColorimetry15LOD280%CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives7.7%PrecisionEvaluatedAccuracy100%Accuracy98.9%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.3%Clinical Specificity100%Type of antigennucleoprotein535OnSite COVID-19 IgG/IgM79CTK Biotech Inc.United Stateshttps://ctkbiotech.com/NoCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2022-08-24 09:08:01 CET459Immuno-AntibodyYesYesImmunoassayQualitative10Clinical Sensitivity96.9%Clinical Specificity99.4%902OnSite COVID-19 IgG/IgM Rapid Test79CTK Biotech Inc.United Stateshttps://ctkbiotech.com/YesCommercialisedNoNoAutomatedManualAntibodyIgGIgMWhole blood2022-08-24 09:08:01 CET857Immuno-AntibodyYesNoImmunoassayQualitativeNot found15Clinical Sensitivity98.2%Clinical Specificity97.8%2499COVID-19 Ag Rapid Test1138Cypress DiagnosticsBelgiumhttps://diagnostics.be/YesCommercialisedNoNoManualAntigenNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaPlease download our instructions for use2022-08-24 09:08:01 CET2203Immuno-AntigenNoImmunochromatographyQualitativeMembrane-based15LODAU50CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives7%PrecisionEvaluatedAccuracy95% (Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93%(Antigen)Clinical Specificity100% (Antigen)Type of antigenNucleoprotein1673COVID5GDIV-24749D-tek s.a.Belgiumwww.d-tek.beYesCommercialisedNoNoAutomatedManualAntibodyIgGSerum2022-08-24 09:08:01 CET1352Immuno-AntibodyNoNoImmunoassayQualitativeOther60 LOD5AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives5%False negatives5%PrecisionEvaluatedAccuracy100% IgGReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100% IgG1634DABLOOD COVID-19 IgM/IgG Rapid Antibody Test730Dablood pharmaceuticalChinawww.dabloodpharmaceutical.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2022-08-24 09:08:01 CET1314Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15rapid diagnostic test strip colloidal gold Accuracy98%145DART COVID-1981DART DiagnosticsPolandwww.dart-diagnostics.com/NoIn developmentNoNoAutomatedManualAntigen2022-08-24 09:08:01 CET101Immuno-AntigenImmunoassay1305Test Rapid Combo Covid-19/Influenza A+B Antigen577DDS DIAGNOSTIC SRLRomaniawww.ddsdiagnostic.comYesCommercialisedNoNoNear POC / POCAntigenNasal swab2022-08-24 09:08:01 CET1077Immuno-AntigenYesNoImmunoassayQualitative15False positives1AUFalse negatives3AUAccuracy99%Clinical Sensitivity98.77%Clinical Specificity99.03%1226Test Rapid Combo Covid-19/Influenza A+B Antigen (tampon nazofaringian))577DDS DIAGNOSTIC SRLRomaniawww.ddsdiagnostic.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabNasopharyngeal swab2022-08-24 09:08:01 CET1010Immuno-AntigenYesNoImmunoassayQualitative15Rapid diagnostic test cassette Accuracy98.95%Clinical Sensitivity98.77%Clinical Specificity99.03%2986Test Rapid Covid-19 Antigen (tampon nazal)1217DDS DIAGNOSTIC SRLRomaniawww.ddsdiagnostic.comYesCommercialisedNoNoManualAntigenNasal swabSARS-CoV689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1132B.1.427Epsilon1137B.1.429Epsilon1321B.1.617.2Delta678B.1.1.529Omicronnucleocapsid proteinThe performance evaluation of Covid-19 Antigen rapid test (Test Rapid Covid-19 Antigen (tampon nazal)), regarding the new variants is continuously updated according to DDS Diagnostic internal protocol.2022-08-24 09:08:01 CET2692Immuno-AntigenYesNoNoImmunochromatographyQualitativeMembrane-based15LOD2.4ng/mLCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.2%2 false negatives from 986 total samplesFalse negatives0.2%2 false positives from 986 total samplesPrecisionEvaluatedAccuracy99.59%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.17%AntigenClinical Specificity99.73%AntigenType of antigenNucleocapsid protein1225Test Rapid Covid-19 Antigen (tampon nazofaringian)577DDS DIAGNOSTIC SRLRomaniawww.ddsdiagnostic.comYesCommercialisedYesYesManualNear POC / POCAntigenNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1132B.1.427Epsilon1137B.1.429Epsilon1321B.1.617.2Delta678B.1.1.529Omicronnucleocapsid proteinThe performance evaluation of Covid-19 Antigen rapid test (Test Rapid Covid-19 Antigen (tampon nazofaringian)), regarding the new variants is continuously updated according to DDS Diagnostic internal Protocol.2022-08-24 09:08:01 CET1009Immuno-AntigenYesNoNoImmunochromatographyQualitativeMembrane-based15LOD1.25ng/mLAnalysis of cross reactivityEvaluatedFalse positives2AUFalse negatives1AUPrecisionEvaluatedAccuracy99.65%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.77%Clinical Sensitivity99.6%Clinical Specificity99.03%Clinical Specificity99.67%Type of antigenNucleocapsid protein1073Test Rapid IgG/IgM 2019-nCoV577DDS DIAGNOSTIC SRLRomaniawww.ddsdiagnostic.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood https://ddsdiagnostic.com/test-rapid-coronavirus-romania/2022-08-24 09:08:01 CET850Immuno-AntibodyYesNoImmunochromatographyQualitative10LOD0AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0AU0False negatives0AUPrecisionEvaluatedAccuracy98.82% IgGAccuracy98.88% IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100% IgGClinical Sensitivity100% IgMClinical Specificity98% IgGClinical Specificity97.96% IgM2453Dejavu COVİD-19 Antigen Rapit test (nazofaringeal/ orafaringel swap)1119Dejavu Medikal San. Tic.Ldt.ÅžtiTurkeywww.dejavumedikal.comYesCommercialisedNoNoManualNear POC / POCAntigenNasopharyngeal swabOropharyngeal swabThis product is used for in vitro diagnostic test for the qualitative detection of the antigen of SARS-CoV-2 (novel coronavirus) in human nasopharyngeal and/or oropharyngeal swabs. This instruction for use (IFU) must be read and followed carefully prior to use. The reliability of assay results cannot be guaranteed in case of any discrepancies from the instructions for use.2022-08-24 09:08:01 CET2156Immuno-AntigenNoImmunoassayQualitative15LOD30AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives2AUFalse negatives4AUPrecisionEvaluatedAccuracy99.54%ReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity99.01%Clinical Specificity99.57%Type of antigenNucleoprotein1007One check 2019-nCoV IgG/IgM536Delta Chemie Biotechnology SASItalywww.deltachemie.itYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2022-08-24 09:08:01 CET779Immuno-AntibodyYesNoImmunoassayQualitative20Rapid diagnostic test card Analysis of cross reactivityReportedAccuracy92.9%Clinical Sensitivity99.9%Clinical Specificity98%2088OneCheck Covid-19 Ag536Delta Chemie Biotechnology SASItalywww.deltachemie.itYesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swab689B.1.1.7AlphaNone2022-08-24 09:08:01 CET1771Immuno-AntigenImmunochromatographyQualitative15LOD100AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives3%False negatives0%PrecisionEvaluatedAccuracy98%ReproducibilityNot evaluatedRobustnessNot evaluatedClinical Sensitivity96%Clinical Specificity99%Type of antigenNucleoprotein2637OneCheck Covid-19 Ag Saliva536Delta Chemie Biotechnology SASItalywww.deltachemie.itYesCommercialisedNoNoNear POC / POCAntigenSaliva689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaOneCheck COVID-19 Ag Saliva is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in oral fluid specimens.2022-08-24 09:08:01 CET2342Immuno-AntigenNoImmunochromatographyQualitative15LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.7%False negatives9.9%PrecisionEvaluatedAccuracy97%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90.1%Clinical Specificity99.2%Type of antigenNucleocapsid protein2638OneCheck Covid-19 IgG Spike RBD536Delta Chemie Biotechnology SASItalywww.deltachemie.itYesCommercialisedNoNoNear POC / POCIgGPeripheral bloodPlasmaSerumVenous whole bloodWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaOneCheck COVID-19 IgG Spike RBD is a rapid chromatographic immunoassay for the qualitative detection of IgG antibodies to SARS-CoV-2 spike (S) protein receptor binding domain (RBD) in human serum, plasma, or whole blood.2022-08-24 09:08:01 CET2343Immuno-AntigenYesNoImmunochromatographyQualitative10LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.5%False negatives2.8%PrecisionEvaluatedAccuracy98%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.2%Clinical Specificity98.5%840COVID-19 (SARS-CoV-2) IgA ELISA489Demeditec Diagnostics GmbHGermanywww.demeditec.com/YesCommercialisedNoNoAutomatedManualAntibodyIgAPlasmaSerum2022-08-24 09:08:01 CET689Immuno-AntibodyN.A.YesELISAQualitativeFluorescenceAnalysis of cross reactivityEvaluatedClinical Sensitivity100%7.69 - 100Clinical Specificity98.26%841COVID-19 (SARS-CoV-2) IgG ELISA489Demeditec Diagnostics GmbHGermanywww.demeditec.com/YesCommercialisedNoNoAutomatedManualAntibodyIgGPlasmaSerum2022-08-24 09:08:01 CET690Immuno-AntibodyNoYesELISAQualitativeFluorescenceAnalysis of cross reactivityEvaluatedClinical Sensitivity100% IgGRange: 7.69 - 100Clinical Specificity99.24% IgG842COVID-19 (SARS-CoV-2) IgM ELISA489Demeditec Diagnostics GmbHGermanywww.demeditec.com/YesCommercialisedNoNoAutomatedManualAntibodyIgMPlasmaSerum2022-08-24 09:08:01 CET691Immuno-AntibodyNoYesELISAQualitativeFluorescenceAnalysis of cross reactivityEvaluatedClinical Sensitivity57.14% IgMClinical Specificity100% IgM780QuickNavi-COVID19468Denka Seiken Co. Ltd.Japandenka-seiken.com/NoIn developmentNoNoLab-basedAntibody2022-08-24 09:08:01 CET648Immuno-AntibodyImmunoassay Not found Not found 2190Dediatest 2019-nCoV Antigen Rapid Test1021Devidia GmbHGermanywww.devidia.deYesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swabOropharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaDer Dediatest 2019-nCoV Antigen Rapid Test aus Nasopharyngeal Abstrich wurde mit einem führenden kommerziellen RT-PCR-Test verglichen, die Korrelation zwischen beiden Systemen beträgt nicht weniger als 96 %2022-08-24 09:08:01 CET1891Immuno-AntigenNoImmunochromatographyQualitativeOther15LOD50AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives3%PrecisionEvaluatedAccuracy98%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96%Clinical Specificity99%Type of antigenNucleoprotein2574Dediatest 2019-nCoV Antigen Rapid Test (Nasopharyngeal)1021Devidia GmbHGermanywww.devidia.deYesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaNone2022-08-24 09:08:01 CET2279Immuno-AntigenNoImmunochromatographyQualitativeMembrane-based15LOD100TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positivesAU6False negativesAU1PrecisionEvaluatedAccuracy98.1%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.5%Clinical Specificity99.5%Type of antigenNucleocapsid protein2575Dediatest Frontnasal 2019-nCoV Antigen1021Devidia GmbHGermanywww.devidia.deYesCommercialisedNoNoNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaNone2022-08-24 09:08:01 CET2280Immuno-AntigenNoImmunochromatographyQualitativeMembrane-based15LOD1x102 tcid50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives5AUFalse negatives0%PrecisionEvaluatedAccuracy97.6%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.3%Clinical Specificity99.9%(>99,9)Type of antigenNucleocapsid protein2192Dediatest Frontnasal SARS-CoV Antigen Schnelltest 1021Devidia GmbHGermanywww.devidia.deYesCommercialisedNoNoNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaDer Dediatest Frontnasal SARS-CoV Antigen Schnelltest kann einen hitzeinaktivierten SARS-CoV-2-Virusstamm bereits bei einer 1x102 TCID 50/ml2022-08-24 09:08:01 CET1893Immuno-AntigenNoImmunochromatographyQualitativeOther15LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives5AUPrecisionEvaluatedAccuracy97%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95%Clinical Specificity99%Type of antigenNucleoprotein2193Dediatest IgG-Spike1021Devidia GmbHGermanywww.devidia.deYesCommercialisedNoNoNear POC / POCAntibodyIgGPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaDediatest IgG-Spike erfasst sowohl die Immunreaktion auf SARS-CoV-2-Infektionen als auch auf SARS-CoV-2-Impfungen. Bei der Immunreaktion auf Impfung ist die Sensitivität 95,7% Spezifität 100% Genauigkeit 97,9%. Der Vergleich erfolgte hier mit einem CLIA.2022-08-24 09:08:01 CET1894Immuno-AntibodyYesImmunochromatographyQualitativeNeutralization Antibody (NAb)10LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2AUFalse negatives6AUPrecisionEvaluatedAccuracy97%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96%Clinical Specificity99%Type of antigenOther2279Covid-19 (2019-nCoV) Antigen Rapid Test Cassette1064Dewei Medical Equipment Co. Ltd.ChinaYesCommercialisedNoNoNear POC / POCAntibodyIgGAntigenNasopharyngeal swabType of Antigen is N-Antigen LOD: See URL for additional information2022-08-24 09:08:01 CET1980Immuno-AntigenNoImmunochromatographyQualitativeSandwich, Double15LODAU0CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives2.94%(3 out of 102)False negatives2.58%(3 out of 116)PrecisionNot evaluatedAccuracy97.25% (Antigen)ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity97.06% (Antigen)Clinical Specificity97.41% (Antigen)Type of antigenNucleoprotein3144DSI COVID-19 Ag RAPID TEST1390Dia Sure Immunodiagnostic LLPIndiawww.dsillp.comYesCommercialisedNoNoLab-basedManualAntigenNasal swabNasopharyngeal swabnucleocapsid proteinThe positive outcomes are to be treated as Covid positive while negative outcomes can still considered and can go for RT-PCR testing based on the clinician judgement2022-08-24 09:08:01 CET2852Immuno-AntigenNoNoImmunochromatographyQualitativeMembrane-based15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%0/100False negatives10%10/100PrecisionEvaluatedAccuracy95%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90%AntigenClinical Specificity100%AntigenType of antigenNucleocapsid protein2462ACE2-RBD Neutralization Assay341DIA.PRO Diagnostic Bioprobes SrlItalywww.diapro.itYesCommercialisedNoNoAutomatedManualIgGPlasmaSerum689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaEnzyme ImmunoAssay (ELISA) for the determination of inhibition activity of RBD-ACE2 binding induced by antibodies to SARS-CoV-2 in human plasma and sera. The assay is intended for: (a) Confirmation of anti RBD antibodies neutralizing activity in patients positively recovered from COVID-19 showing antibodies to RBD/Spike; (b) Testing human donors, recovered from COVID-19 infection, positive for anti-RBD/Spike antibodies for the generation of hyperimmune plasma, as a possible immunotherapeutic approach to the disease; (c) Screening of vaccinated individuals to assure a reliable positive and efficient immunization with development of high titer neutralizing anti RBD/Spike IgG antibodies.2022-08-24 09:08:01 CET2165Immuno-AntibodyELISAQuantitative115LOD2AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%No false positive reactions were observedFalse negatives0%No false negative result was foundPrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%Clinical Specificity100%Type of antigenOther2455COVID-19 IgA341DIA.PRO Diagnostic Bioprobes SrlItalywww.diapro.itYesCommercialisedNoNoAutomatedManualIgAPlasmaSerum689B.1.1.7Alpha1032B.1.351Beta1223B.1.525Eta1495P.1Gamma1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.1B.1.526.1B.1.526.21518P.2ZetaEnzyme ImmunoAssay (ELISA) for the determination of IgA antibodies to COVID19 in human plasma and sera. The IgA assay is recommended, in addition to IgG and IgM, to: a) monitor the global immunological response of patients undergoing an acute infection and their follow-up to full recovery; b) test patients with symptoms of the gastro enteric form of COVID-19 infection, expected to generate IgA in a quite early stage of infection.2022-08-24 09:08:01 CET2158Immuno-AntibodyELISASemiquantitative105LOD2AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%Common autoantibodies in Autoimmune Diseases did not generate false positive resultsFalse negatives0%No false negative result was foundPrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%Clinical Specificity98%Type of antigenOther537COVID-19 IgG341DIA.PRO Diagnostic Bioprobes SrlItalywww.diapro.itYesCommercialisedNoNoAutomatedManualAntibodyIgGPlasmaSerum689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaMicroplates are coated with recombinant Nucleocapsid and Spike antigens specific to COVID-192022-08-24 09:08:01 CET453Immuno-AntibodyNoYesELISAQuantitativeFluorescence105CalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98%Clinical Specificity98%Type of antigenNucleocapside and Spike539COVID-19 IgG Confirmation341DIA.PRO Diagnostic Bioprobes SrlItalywww.diapro.itYesCommercialisedNoNoAutomatedManualAntibodyIgGPlasmaSerum689B.1.1.7Alpha1495P.1Gamma1032B.1.351Beta1223B.1.525Eta1137B.1.429Epsilon1132B.1.427Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaModule-based Enzyme-Immuno-Assay (ELISA) for the confirmation of samples positive for IgG antibodies to COVID-19 in first screening. The test can be used in addition to identify the specificity of antibodies to the major immunodominant COVID-19 antigens2022-08-24 09:08:01 CET455Immuno-AntibodyNoYesELISAQuantitativeFluorescence105CalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%Clinical Specificity100%2461COVID-19 IgG/IgM Confirmation and Typing341DIA.PRO Diagnostic Bioprobes SrlItalywww.diapro.itYesCommercialisedNoNoAutomatedManualIgGIgMPlasmaSerum689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaModule-based Enzyme-Immuno-Assay (ELISA) for the confirmation of samples positive for IgG and IgM antibodies to COVID-19 in first screening. The test is particularly useful in monitoring patients, infected by COVID-19, from the time of symptoms offset up to full recovery. The test can be used in addition to identify (a) the specificity (“typing”) of antibodies to the major immunodominant COVID-19 antigens and (b) identify those samples with a titer of “potentially” neutralizing IgG to Spike antigens such to select the donor as a candidate for immunotherapy, as well.2022-08-24 09:08:01 CET2164Immuno-AntibodyELISAQualitative105LOD2AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%No false positive reactions were observedFalse negatives0%No false negative result was foundPrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%Clinical Specificity100%Type of antigenOther538COVID-19 IgM341DIA.PRO Diagnostic Bioprobes SrlItalywww.diapro.itYesCommercialisedNoNoAutomatedManualAntibodyIgMPlasmaSerum689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThe kit is intended for the monitoring of the immune response to COVID-19 in the early stage of the infection as an additional marker to PCR2022-08-24 09:08:01 CET454Immuno-AntibodyNoYesELISASemiquantitativeFluorescence105CalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedRobustnessEvaluatedClinical Sensitivity98%Clinical Specificity98%2456COVID-19 Spike 1&2 IgG341DIA.PRO Diagnostic Bioprobes SrlItalywww.diapro.itYesCommercialisedNoNoAutomatedManualIgGPlasmaSerum689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaEnzyme ImmunoAssay (ELISA) for the determination of IgG antibodies to COVID-19 Spike antigens in human plasma and sera. The IgG assay is intended for testing: (a) health-care workers at risk of COVID-19 infection to verify whether or not they might be positive for potentially neutralizing anti Spike IgG; (b) normal population for epidemiology studies on presence of potential “protective” IgG to COVID-19 Spike antigens; (c) PCR-negative infected individuals, successfully recovered from infection, to assure presence of potentially neutralizing antibodies; (d) human donors, recovered from COVID-19 infection, positive for anti-Spike IgG for the generation of hyperimmune plasma, as a possible immunotherapeutic approach to the disease; (e) vaccinated individuals to assure a reliable positive immunization with development of anti Spike IgG antibodies2022-08-24 09:08:01 CET2159Immuno-AntibodyELISAQuantitative105LOD2AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%NoneFalse negatives0%NonePrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%Clinical Specificity98%Type of antigenSpike 1&22479DIA.CHEMILUX SARS-CoV-2 ACE2-RBD NEUTRALIZATION341DIA.PRO Diagnostic Bioprobes SrlItalywww.diapro.itYesCommercialisedNoNoFully automated (robot)IgGPlasmaSerum689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaChemi-Luminescence ImmunoAssay (CLIA) for the serological determination of the neutralization activity of antibodies to SARS-CoV-2, induced by natural infection and/or vaccination, able to block the interaction of Receptor Binding Domain (RBD) and ACE2 and thus the virus infection. The assay is intended for testing sera and plasma collected from: (a) PCR-negative Covid-19 individuals successfully recovered from infection, to assure presence of anti RBD neutralizing antibodies; (b) human donors, recovered from COVID-19 infection, positive for anti-RBD antibodies for the generation of hyperimmune plasma, as a possible immunotherapeutic approach to the disease; (c) vaccinated individuals to assure a reliable and efficient immunization with development of neutralizing antibodies able to block ACE2-RBD binding2022-08-24 09:08:01 CET2182Immuno-AntibodyCLIAQuantitativeChemiluminescence23CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%No false positive reaction was observedFalse negatives0%No false negative result was foundPrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99%Clinical Specificity98%Type of antigenOther (RDB)2477DIA.CHEMILUX SARS-CoV-2 NCP IgA341DIA.PRO Diagnostic Bioprobes SrlItalywww.diapro.itYesCommercialisedNoNoFully automated (robot)IgAPlasmaSerum689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon3939B.1.6161519P.3Theta1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThe kit is intended for monitoring of infected patients. In addition, the kit may be used when testing the population and health-care workers looking for potentially infective “pauci” or a-symptomatic individuals in the early phase of infection, in combination with SARS-COV-2 molecular tests. The device has been adapted for the use in exclusive combination with the Dia.Pro CLIA random access instrument named SARA.2022-08-24 09:08:01 CET2180Immuno-AntibodyCLIAChemiluminescence35LOD2AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positivesCommon autoantibodies in Autoimmune Diseases did not generate false positive resultsFalse negatives0%No false negative result was foundPrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98%Clinical Specificity99%Type of antigenOther2463DIA.CHEMILUX SARS-CoV-2 NCP IgG341DIA.PRO Diagnostic Bioprobes SrlItalywww.diapro.itYesCommercialisedNoNoFully automated (robot)AntibodyIgGPlasmaSerum689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaChemi-Luminescence ImmunoAssay (CLIA) for the semi-quantitative determination of IgG antibodies to SARS-CoV-2 Nucleocapsid protein (NCP) in human plasma and sera. The kit is intended for monitoring of infected patients. In addition the kit may be used when testing the population and health-care workers looking for potentially infective “pauci” or a-symptomatic individuals in the early phase of infection, in combination with SARS-COV-2 molecular tests. The device has been adapted for the use in exclusive combination with the Dia.Pro CLIA random access instrument named SARA2022-08-24 09:08:01 CET2166Immuno-AntibodyCLIAQuantitativeChemiluminescence35LOD2AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%Common autoantibodies in Autoimmune Diseases did not generate false positive resultsFalse negatives0%No false negative result was foundPrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98%Clinical Specificity99%Type of antigenOther2464DIA.CHEMILUX SARS-CoV-2 NCP IgM341DIA.PRO Diagnostic Bioprobes SrlItalywww.diapro.itYesCommercialisedNoNoFully automated (robot)IgMPlasmaSerum689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1132B.1.427Epsilon1223B.1.525Eta1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaEnsayo inmunoquimioluminiscente (CLIA) para la determinación semicuantitativa de anticuerpos IgM para la proteína de la nucleocápside (NCP) del SARS-CoV-2 en plasma y suero humanos. El equipo está destinado para el seguimiento de pacientes infectados. Además, el equipo puede utilizarse al realizar pruebas a la población y al personal sanitario en busca de individuos "pauci" potencialmente infecciosos o asintomáticos en la fase inicial de la infección, en combinación con las pruebas moleculares del SARS-COV-2.2022-08-24 09:08:01 CET2167Immuno-AntibodyCLIAChemiluminescence35LOD2AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%Common autoantibodies in Autoimmune Diseases did not generate false positive resultsFalse negatives0%No false negative result was foundPrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%Clinical Specificity98%Type of antigenOther2478DIA.CHEMILUX SARS-CoV-2 Spike/RBD Ab341DIA.PRO Diagnostic Bioprobes SrlItalywww.diapro.itYesCommercialisedNoNoFully automated (robot)IgGPlasmaSerum689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThe Antibody assay is intended for testing: (a) health-care workers at risk of COVID-19 infection to verify whether or not they might be positive for potentially neutralizing anti Spike/RBD antibodies. (b) normal population for epidemiology studies on presence of potential “protective” Antibodies to SARS-CoV-2 Spike/RBD; (c) PCR-negative infected individuals, successfully recovered from infection, to assure presence of potentially neutralizing antibodies; (d) human donors, recovered from COVID-19 infection, positive for anti-Spike/RBD antibodies for the generation of hyperimmune plasma, as a possible immunotherapeutic approach to the disease; (e) vaccinated individuals to assure a reliable positive immunization with development of anti Spike/RBD antibodies2022-08-24 09:08:01 CET2181Immuno-AntibodyCLIAQuantitativeChemiluminescence23CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%No false positive reaction was observedFalse negatives0%No false reactivity was foundPrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98%Clinical Specificity98%Type of antigenOther (Spike protein, RDB protein)2457SARS-CoV-2 Antigen341DIA.PRO Diagnostic Bioprobes SrlItalywww.diapro.itYesCommercialisedNoNoManualAntigenNasal swabNasopharyngeal swab689B.1.1.7Alpha1032B.1.351BetaImmunochromatographic Rapid Test for the qualitative detection of SARS-CoV-2 antigen in nasopharyngeal swab of individuals suspected of COVID-19 in acute phase or with symptoms typical of such disease2022-08-24 09:08:01 CET2160Immuno-AntigenYesImmunochromatographyMembrane-based15LOD800AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%NoneFalse negatives0%NonePrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96%Clinical Specificity98%Type of antigenNucleoprotein3035Quantivirus Anti-SARS-CoV-2 IgG Test1328Diacarta Inc.United Stateshttps://www.diacarta.com/YesCommercialisedNoNoAutomatedIgGPlasmaSerumWhole bloodWhole blood with anti-coagulantsspike proteinsingle drop of fingerstick blood can be quatitative for antibody down to 0.17 ug/mL. It is useful for vaccination evoluation. See our paper Du et al 2022 Emerging Microbes &Infection https://doi.org/10.1080/22221751.2021.20233282022-08-24 09:08:01 CET2741Immuno-AntibodyYesImmunoassayQuantitativeSandwich170LOD0.17µg/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.8%NPA 98.2%False negatives54%PPA 46% (0-7 days)False negatives38%62% (8-14 days)False negatives2%98% (>15 days for sample collected on)PrecisionEvaluatedAccuracy98%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.5%Clinical Specificity98.2%Type of antigenSpike protein3001QuantiVirus SARS-CoV-2 Antigen Rapid Test1328Diacarta Inc.United Stateshttps://www.diacarta.com/YesCommercialisedNoNoManualAntigenAnterior nasal swab1321B.1.617.2Delta678B.1.1.529Omicronnon-structural protein NSP1non-structural protein NSP2non-structural protein NSP3non-structural protein NSP4non-structural protein NSP5N/A2022-08-24 09:08:01 CET2707Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, Double15LOD2000TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives11.76%6 out of 51PrecisionEvaluatedAccuracy100%PPVAccuracy92% NPVReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity88.24%95% CI: 76-95%Clinical Specificity100%95% CI: 94-100%Type of antigenNonstructural protein NS31307Accudiag SCoV-2 IgG ELISA582Diagnostic Automation/Cortez Diagnostics Inc.United Stateswww.rapidtest.comYesCommercialisedNoNoAutomatedManualAntibodyIgGSerum2022-08-24 09:08:01 CET1079Immuno-AntibodyNoYesELISAQualitative150Clinical Sensitivity97.8% IgGClinical Specificity98.9% IgG1193Accudiag SCoV-2 IgM ELISA Kit582Diagnostic Automation/Cortez Diagnostics Inc.United Stateswww.rapidtest.comYesCommercialisedNoNoAutomatedManualAntibodyIgMSerum2022-08-24 09:08:01 CET975Immuno-AntibodyNoELISAQualitative150Manual or automated Accuracy98.95% IgMClinical Sensitivity92.5% IgM1078nCOV IgG/IgM Rapid Test582Diagnostic Automation/Cortez Diagnostics Inc.United Stateswww.rapidtest.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2022-08-24 09:08:01 CET858Immuno-AntibodyYesNoImmunoassayQualitative15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedReproducibilityEvaluatedClinical Sensitivity91.9%1195OneStep COVID-19 Antigen RapiCard InstaTest582Diagnostic Automation/Cortez Diagnostics Inc.United Stateswww.rapidtest.comYesCommercialisedNoNoNear POC / POCAntigenNasal swab2022-08-24 09:08:01 CET980Immuno-AntigenYesYesImmunoassay15LOD38.55AUClinical Sensitivity95.52%1375DIAQUICK COVID-19 Ag Cassette526DIALAB GmbHAustriawww.dialab.at/en/home/YesCommercialisedYesYesNear POC / POCOtherAntigenNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1519P.3Theta1320B.1.617.1Kappa1321B.1.617.2Delta2041C.37Lambda1224B.1.526Iota678B.1.1.529Omicron1518P.2Zetanucleocapsid proteinIt is a twin test of Alltest (ID 1257). The tests are identical in design and construction, but distributed under a different name.2022-08-24 09:08:01 CET2870Immuno-AntigenNoNoImmunoassayQualitativeMembrane-basedColloidal gold15LOD100TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.34%total 2023 negative samples. 7 wrong positive. 2016 correct negative.False negatives1.98%total 101 positive samples. 99 correct positive. 2 wrong negativePrecisionEvaluatedAccuracy99.6%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.4%relative sensitivityClinical Specificity99.9%relative specificityType of antigenNucleocapsid protein1055Diaquick Covid-19 IgG/IgM526DIALAB GmbHAustriawww.dialab.at/en/home/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2022-08-24 09:08:01 CET982Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry10Clinical Sensitivity87.9% IgMClinical Sensitivity97% IgGClinical Specificity100%986DIAQUICK COVID-19 IgG/IgM Cassette Rapid Test526DIALAB GmbHAustriawww.dialab.at/en/home/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole bloodnucleocapsid protein2022-08-24 09:08:01 CET767Immuno-AntibodyYesNoImmunoassayQualitative10Type of antigennucleocapsid protein1053SARS-CoV-2 IgG526DIALAB GmbHAustriawww.dialab.at/en/home/YesCommercialisedNoNoLab-basedAntibodyIgGPlasmaSerum2022-08-24 09:08:01 CET828Immuno-AntibodyYesImmunoassayQualitativeMagnetic Electrochemical70Analysis of cross reactivityNo cross reactivity observed with samples positive to RSV IgM/IgG/Antibodies and MP IgM/IgG/Antibodies.No interference with rheumatic factor up to 2000 U/mL, bilirubin 35 mg/dL or haemoglobin 0.9 g/dL observed.No cross specificity with similar pathogClinical Sensitivity100%(15/15)Clinical Specificity99.87%(3018/3022)1054SARS-CoV-2 IgM526DIALAB GmbHAustriawww.dialab.at/en/home/YesCommercialisedNoNoLab-basedAntibodyIgMPlasmaSerum2022-08-24 09:08:01 CET833Immuno-AntibodyYesImmunoassayQualitativeMagnetic Electrochemical70Analysis of cross reactivityEvaluatedClinical Sensitivity96.49%(165/171)Clinical Specificity98.15%(742/756)1050SARS-CoV-2 Total Ab526DIALAB GmbHAustriawww.dialab.at/en/home/YesCommercialisedNoNoLab-basedAntibodyPlasmaSerum2022-08-24 09:08:01 CET822Immuno-AntibodyNoYesELISAQualitativeMagnetic Electrochemical70Analysis of cross reactivityEvaluatedClinical Sensitivity100%(15/15)Clinical Specificity99.52%(2927/2941)2568SARS-CoV-2 antigen Immunofluorescence assay1171DianextItalyYesCommercialisedNoNoSemi-automatedAntigenNasal swabNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.3none2022-08-24 09:08:01 CET2273Immuno-AntigenYesImmunochromatographyQuantitativeFluorescence15LOD1000CalibrationNot evaluatedAnalysis of cross reactivityNot evaluatedFalse positives6AUFalse negatives1AUPrecisionEvaluatedAccuracy100%(antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92%Clinical Specificity99.26%Type of antigenMembrane protein2096Diagnostic Kit for SARS-CoV-2 Ag (Fluorescence Immunochromatographic Assay)906Diasia Biomedical Technology Co. Ltd.Chinawww.diasia.com.cnYesCommercialisedNoNoAntigenAnterior nasal swabNasopharyngeal swab20A.23.1nucleocapsid proteinOnly change that has been made is regarding the specimen type2022-08-24 09:08:01 CET1779Immuno-AntigenYesImmunochromatographyQuantitativeFluorescence3LOD997.5TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives2.75%141 specimens were negative by both test reagent and control reagent, and there is 4 specimen of falFalse negatives0.66%149 specimens were negative by both test reagent and control reagent, and there is 1 specimen of falPrecisionEvaluatedAccuracy98.31%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.24%Clinical Specificity99.33%Type of antigenNucleoprotein1977Diasia906Diasia Biomedical Technology Co. Ltd.Chinawww.diasia.com.cnYesCommercialisedNoNoAntigenNasal swabThe BFARM list is AT 573/21 The specimen was a nasal swab. LOD (U/ml) = 9.975 x 100 TCID50/mL2022-08-24 09:08:01 CET1653Immuno-AntigenImmunoassayColloidal gold15LOD36AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.7%140 specimens were negative by both test reagent and control reagent, and there is 1 specimen of falFalse negatives3.1%128 specimens were positive by both test reagent and control reagent, and there are 4 specimens of fPrecisionNot evaluatedAccuracy98.17%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.97%Clinical Specificity99.29%Type of antigenNucleoprotein1986SARA-CoV-2 Antigen Rapid Test Kit906Diasia Biomedical Technology Co. Ltd.Chinawww.diasia.com.cnYesCommercialisedNoNoAntigenNasal swabLOD (U/ml) ：9.975 x 102 TCID50/mL The BFARM list is 573/21 2022-08-24 09:08:01 CET1662Immuno-AntigenImmunoassay15LOD9.9751025AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.71%(140 specimens were negative by both test reagent and control reagent, and there is 1 specimen of falFalse negatives3.12%(128 specimens were positive by both test reagent and control reagent, and there are 4 specimens of fPrecisionNot evaluatedAccuracy98.17%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.97%Clinical Specificity99.29%Type of antigenNucleoprotein2203SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold)906Diasia Biomedical Technology Co. Ltd.Chinawww.diasia.com.cnYesCommercialisedNoNoAntigenAnterior nasal swab689B.1.1.7Alphanucleocapsid proteinLOD (U/ml) ：36pg/ml2022-08-24 09:08:01 CET1904Immuno-AntigenYesImmunochromatographyQualitativeColloidal gold15LOD36%CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.82%122 specimens were negative by both test reagent and control reagent, and there is 1 specimen of falFalse negatives0.76%131 specimens were negative by both test reagent and control reagent, and there is 1 specimen of falPrecisionEvaluatedAccuracy97.63%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.9%Clinical Specificity99.24%Type of antigenNucleoprotein911LIAISON SARS-CoV-2 S1/S2 IgG511DiaSorin S.p.AItalywww.diasorin.com/YesCommercialisedNoNoAutomatedAntibodyIgGPlasmaSerum2022-08-24 09:08:01 CET738Immuno-AntibodyYesImmunoassayQuantitativeChemiluminescence35Analysis of cross reactivityEvaluatedClinical Sensitivity97.4%Clinical Specificity98.9%1960LIAISON® SARS-CoV-2 Ag511DiaSorin S.p.AItalywww.diasorin.com/YesCommercialisedYesYesAutomatedLab-basedAntigenNasal swabNasopharyngeal swabThe method for quantitative determination of SARS-CoV-2 Ag in specimens collected and processed through the indicated pre-analytical procedure, is a direct two-step sandwich chemiluminescence immunoassay (CLIA). Specific rabbit polyclonal antibodies to nucleocapsid antigen are used for coating magnetic particles (solid phase) and linked to an isoluminol derivative (isoluminol-antibody conjugate). During the first incubation, SARS-CoV-2 viral antigen present in calibrators, samples or controls binds to the conjugate. During the second incubation, the solid phase reacts with the SARS-CoV-2 viral antigen already bound to the conjugate. After the second incubation, the unbound material is removed with a wash cycle. Subsequently, the starter reagents are added, and a flash chemiluminescence reaction is thus induced. The light signal, and hence the amount of isoluminol-antibody conjugate, is measured by a photomultiplier in relative light units (RLU) and is directly proportional to the SARS-CoV-2 viral antigen concentration present in calibrators, samples, or controls.2022-08-24 09:08:01 CET3478Immuno-AntigenNoYesCLIAQuantitativeSandwichChemiluminescence42LIAISON® SARS-CoV-2 Ag (311490)LOD22AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracy99%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99%Clinical Specificity98%Type of antigennucleocapside protein1900LIAISON® SARS-CoV-2 TrimericS IgG (Ref.311510)511DiaSorin S.p.AItalywww.diasorin.com/YesCommercialisedNoNoLab-basedIgGPlasmaSerumThe LIAISON® SARS-CoV-2 TrimericS IgG assay uses chemiluminescence immunoassay (CLIA) technology for the quantitative determination of anti-trimeric spike protein specific IgG antibodies to SARS-CoV-2 in human serum or plasma samples. The assay is intended as an aid in the diagnosis of CoVID-19 and to support the study of the immune status of infected patients by providing an indication of the presence of neutralizing IgG antibodies against SARS-CoV-2. Results from the LIAISON® SARS-CoV-2 TrimericS IgG assay should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform about infection status. The test has to be performed on the LIAISON® XL Analyzer only. The calibrator concentrations expressed as Binding Antibody Units (BAU)/mL are referenced to the First WHO International Standard for anti-SARS-CoV-2 Immunoglobulin (20/136). Measuring range: The LIAISON® SARS-CoV-2 TrimericS IgG assay measures between 4.81 and 2080 BAU/mL. The lowest reportable value is 4.81 BAU/mL. Values below 4.81 BAU/mL should be reported as < 4.81 BAU/mL. Specimens containing high levels of anti-trimeric spike protein specific IgG antibodies to SARS-CoV-2 above the assay measuring range (> 2080 BAU/mL) may be automatically diluted using LIAISON® TrimericS IgG Diluent Accessory ([___REF___] 311512) loaded into the ancillary reagent area. The required dilution factor is 1:20. It is the responsibility of the individual laboratory to conduct studies to determine validity of dilutions other than 1:20.2022-08-24 09:08:01 CET1576Immuno-AntibodyYesImmunoassayChemiluminescence35LOD1.85AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positivesN.A.False negativesN.A.Accuracy99% IgGReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.7% IgGClinical Specificity99.5% IgGType of antigenanti-trimeric spike protein specific IgG antibodies to SARS-CoV-21792COVID-19 Antigen Rapid Test503DIAsource ImmunoAssaysBelgiumwww.diasource-diagnostics.com/YesCommercialisedNoNoNear POC / POCAntigenNasal swabThis test is recommended by the belgian autohorities (FAMHP)2022-08-24 09:08:01 CET1749Immuno-AntigenYesImmunoassay670Diazyme DZ-LITE SARS-CoV-2 IgG390Diazyme LaboratoriesUnited Stateswww.diazyme.com/NoCommercialisedNoNoLab-basedAntibodyIgGSerum2022-08-24 09:08:01 CET538Immuno-AntibodyYesImmunoassayQualitativeChemiluminescence Other Chemiluminescence Clinical Sensitivity100%Clinical Specificity97.4%1416Diazyme DZ-LITE SARS-CoV-2 IgM CLIA kit390Diazyme LaboratoriesUnited Stateswww.diazyme.com/NoCommercialisedNoNoLab-basedAntibodyIgMPlasmaSerum PROPOSED BY BARBARA https://www.diazyme.com/images/covid19/5-EUA200922_Diazyme.DZLite.IgM.PackageInsert_08172020.pdf2022-08-24 09:08:01 CET1177Immuno-AntibodyYesCLIAQualitativeChemiluminescenceAnalysis of cross reactivity0%for tested agentsClinical Sensitivity94.4%Clinical Specificity98.3%2712CHORUS SARS-CoV-2 "NEUTRALIZING" Ab1238DIESSE Diagnostica Senese SPAItalywww.diesse.itYesCommercialisedNoNoSemi-automatedSerum689B.1.1.7Alpha1032B.1.351Beta1518P.2ZetaN.A2022-12-02 09:22:17 CET2417Immuno-AntibodyYesELISAQuantitative71LODAU/mL< 20,0 BAU/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracy99.7%total AbReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity99.6%total AbClinical Specificity99.8%total Ab2708CHORUS SARS-CoV-2 ANTIGEN1238DIESSE Diagnostica Senese SPAItalywww.diesse.itYesCommercialisedNoNoSemi-automatedAntigenNasopharyngeal swab2022-08-24 09:08:01 CET2413Immuno-AntigenYesELISASemiquantitative90CalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracy100%AntigenReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity100%AntigenClinical Specificity100%Antigen2709CHORUS SARS-CoV-2 IgA1238DIESSE Diagnostica Senese SPAItalywww.diesse.itYesCommercialisedNoNoSemi-automatedIgASerumN.A2022-08-24 09:08:01 CET2414Immuno-AntibodyYesELISAQualitative40CalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracy97.8% IgAReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity95.7% IgAClinical Specificity99.6% IgA2710CHORUS SARS-CoV-2 IgG1238DIESSE Diagnostica Senese SPAItalywww.diesse.itYesCommercialisedNoNoSemi-automatedIgGSerumN.A.2022-08-24 09:08:01 CET2415Immuno-AntibodyYesELISAQualitative40CalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracy99% IgGReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity98.2% IgGClinical Specificity99.7% IgG2711CHORUS SARS-CoV-2 IgM1238DIESSE Diagnostica Senese SPAItalywww.diesse.itYesCommercialisedNoNoSemi-automatedIgMSerumN.A2022-08-24 09:08:01 CET2416Immuno-AntibodyYesELISAQualitative40CalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracy97.8% IgMReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity93.8% IgMClinical Specificity99.4% IgM2731CHORUS SARS-CoV-2 SCREEN SERUM1238DIESSE Diagnostica Senese SPAItalywww.diesse.itYesCommercialisedNoNoSemi-automatedSerumN.A.2022-12-02 09:22:17 CET2436Immuno-AntibodyYesELISAQualitative50CalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracy99.7%total AbReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity98.8%total AbClinical Specificity100%total Ab980ENZY-WELL SARS-CoV-2 IgA543DIESSE Diagnostica Senese SPAItalywww.diesse.it/YesCommercialisedNoNoAutomatedManualAntibodyIgAPlasmaSerum2022-08-24 09:08:01 CET786Immuno-AntibodyYesImmunoassayQualitativeFluorescence135Analysis of cross reactivityEvaluatedClinical Sensitivity93.7%Clinical Specificity96.3%981ENZY-WELL SARS-CoV-2 IgG543DIESSE Diagnostica Senese SPAItalywww.diesse.it/YesCommercialisedNoNoAutomatedManualAntibodyIgGPlasmaSerum2022-08-24 09:08:01 CET787Immuno-AntibodyYesImmunoassayQualitativeFluorescence135Analysis of cross reactivityReportedClinical Sensitivity92.5%Clinical Specificity95.8%982ENZY-WELL SARS-CoV-2 IgM543DIESSE Diagnostica Senese SPAItalywww.diesse.it/YesCommercialisedNoNoAutomatedManualAntibodyIgMPlasmaSerum2022-08-24 09:08:01 CET788Immuno-AntibodyYesImmunoassayQualitativeFluorescence135Analysis of cross reactivityEvaluatedClinical Sensitivity87.7%Clinical Specificity97%2732iRAPID SARS-CoV-2 QUANT “NEUTRALIZING” Ab1238DIESSE Diagnostica Senese SPAItalywww.diesse.itYesCommercialisedNoNoManualIgGPlasmaSerumWhole blood689B.1.1.7Alpha2022-08-24 09:08:01 CET2437Immuno-AntibodyNoImmunochromatographySemiquantitativeNeutralization Antibody (NAb)10LOD125AU/mLBAU/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracy97.4% IgGReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity96.1% IgGClinical Specificity98.1% IgGType of antigenSpike protein2489Dixion Safetest SARS-CoV-2 Antigen Speichel Schnelltest1130Dixion Vertrieb medizinischer Geräte GmbH and Shenzhen Dymind Biotechnology Co. Ltd.Germanywww.dixion.deYesCommercialisedNoNoNear POC / POCAntigenSalivaPEI positive approval in Germany2022-08-24 09:08:01 CET2192Immuno-AntigenNoImmunochromatographyQualitativeSandwich15LOD150AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2.45%False negatives4.65%PrecisionEvaluatedAccuracy96.58%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.35%Clinical Specificity97.55%Type of antigenNucleocapsid protein2644Dixion Sars-CoV-2 Antigen Test Kit (Colloidal Gold)1133Dixion Vertrieb medizinischer Geräte GmbH and Shenzhen Dymind Biotechnology Co. Ltd.Chinawww.dixion.deYesCommercialisedNoNoNear POC / POCAntigenNasal swabNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1223B.1.525Eta1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31439C.36PEI approval in Germany and registered in France2022-08-24 09:08:01 CET2349Immuno-AntigenNoImmunochromatographyQualitativeSandwichColloidal gold15LOD150AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives1.59%False negatives2.65%PrecisionEvaluatedAccuracy97.9%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.58%(91.48%-99.06%)Clinical Specificity98.37%(94.25%-99.80%)Type of antigenNucleocapsid protein2492Dixion SARS-CoV-2 Neutralizing antibody test kit1133Dixion Vertrieb medizinischer Geräte GmbH and Shenzhen Dymind Biotechnology Co. Ltd.Chinawww.dixion.deYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole bloodThe kit is used to detect the neutralizing antibody to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in human serum, plasma or whole blood sample qualitatively. It is mainly used to identify individuals with acquired immune response to the SARS-CoV-2, and to evaluate the effectiveness of the vaccine clinical trials and mass vaccination. The novel coronavirus (SARS-CoV-2) belongs to the β genus. Structural proteins include spike protein (S), envelope protein (E), membrane protein (M), and nucleocapsid protein (N). The spike protein is the most important surface membrane protein of the novel coronavirus, which undertakes the function of binding the virus to the host cell membrane receptor and membrane fusion, and is an important site for host neutralizing antibodies. The SARS-CoV-2 neutralizing antibody can prevent the receptor binding domain (RBD) protein from binding to ACE2, thereby blocking the virus from contacting the host cell, and ultimately preventing the virus infection. This reagent uses the principle of colloidal gold immunochromatography to detect SARS-CoV-2 neutralizing antibodies in samples. The kit does not need to be carried out in the biosafety level 3 laboratory (BSL-3). It has the advantages of simple operation, strong specificity, high safety and low cost, and can realize rapid detection2022-08-24 09:08:01 CET2195Immuno-AntibodyNoImmunochromatographyQualitativeNeutralization Antibody (NAb)15CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives9.3%False negatives1.36%PrecisionEvaluatedAccuracy95.74%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90.7%Clinical Specificity98.63%Type of antigenOther2955COVID-19 Neutralizing Antibody Testing Cassette(GICA)/COVID-19 Antigen Testing Cassette(GICA)1303DN Laboratory Co. Ltd.ChinaYesCommercialisedNoNoLab-basedManualSemi-automatedAntibodyIgGIgMIgAAntigenNasal swabNasopharyngeal swabPlasmaSerumWhole bloodCOVID-19 Antigen Testing Cassette (GICA):The Reagent Kit can be used for a qualitative test of COVID-19 antigens in human nasopharyngeal swab and oropharyngeal swab samples in vitro, which is beneficial to the auxiliary examination of patients suffering from pneumonia caused by COVID-19 infection. COVID-19 neutralizing antibody testing cassette (GICA):The Reagent Kit can be used for a qualitative test of COVID-19 neutralizing antibodies in human serum, plasma or whole blood samples in vitro.2022-08-24 09:08:01 CET2661Immuno-AntibodyYesYesImmunochromatographySemiquantitativeSandwichColloidal gold15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positivesthe positive coincidence rate should be (+/+) 5/5False negativeshe negative coincidence rate should be (-/-) 10/10PrecisionEvaluatedAccuracy100% IgGReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100% IgGClinical Specificity100% IgG2242COVID-19 Antigen Detection Kit1042DNA DiagnosticDenmarkhttps://dna-diagnostic.com/YesCommercialisedYesYesNear POC / POCAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gammanucleocapsid proteinNo additional information2022-08-24 09:08:01 CET1943Immuno-AntigenYesNoImmunochromatographyQualitative15LOD160TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.44%1 out of 226 true negatives compared to PCRFalse negatives6.25%9 out of 144 true positives compared to PCRPrecisionEvaluatedAccuracy97.3%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity93.8%Clinical Specificity99.6%Type of antigenNucleoprotein2756SARS-CoV-2 Antigen Rapid Test1042DNA DiagnosticDenmarkhttps://dna-diagnostic.com/YesCommercialisedYesYesNear POC / POCAntigenNasal swabNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta2022-08-24 09:08:01 CET2461Immuno-AntigenYesNoImmunoassayQualitativeMembrane-based15LODTCID50/ml100 TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.16%4 out of 2318 true negatives compared to PCRFalse negatives6.55%15 out of 229 true positives compared to PCRPrecisionEvaluatedAccuracy97.6%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity93.4%Clinical Specificity99.3%Type of antigenNucleocapsid protein2814SARS-CoV-2 Antigen Rapid Test (Nasal Swab) For Self-testing1042DNA DiagnosticDenmarkhttps://dna-diagnostic.com/YesCommercialisedNoNoNear POC / POCAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2DeltaThis test is identical to RAT ID 2756, but evaluated for self-test use and packaged and sold as such.2022-08-24 09:08:01 CET2519Immuno-AntigenYesNoImmunoassayQualitativeMembrane-based15LOD100TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.6%3 out of 500 true negatives compared to PCRFalse negatives4.61%16 out of 347 true positives compared to PCRPrecisionEvaluatedAccuracy97.8%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity95.4%Clinical Specificity99.4%Type of antigenNucleocapsid protein2273Dräger Antigen Test SARS-CoV-21060Dräger Safety AG & Co. KGaAGermanywww.draeger.comYesCommercialisedYesYesManualNear POC / POCAntigenNasal swabSARS-CoV689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1132B.1.427Epsilon1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta1224B.1.526Iota678B.1.1.529Omicronnucleocapsid proteinLOD is 200 pg/Test; Osmanodja, B. et al. (2021) ‘Accuracy of a Novel SARS-CoV-2 Antigen-Detecting Rapid Diagnostic Test from Standardized Self-Collected Anterior Nasal Swabs’, Journal of Clinical Medicine, 10(10), p. 2099. doi: 10.3390/jcm10102099. Clinical Validation at Charité, Berlin, Germany2022-08-24 09:08:01 CET1974Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich15LOD200pgCalibrationNot evaluatedAnalytical Sensitivity96.8% (Ct values < 26)Analysis of cross reactivityEvaluatedFalse positives0.32%1 out of 308 samples (symptomatic and asymptomatic PCR negative)False negatives10.1%7 out of 69 samples (symptomatic PCR positive)PrecisionEvaluatedAccuracy98.9%Ct values < 26Accuracy97.1%overallReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.8%Ct values < 26Clinical Specificity99.7%Type of antigenNucleocapsid protein2647Dräger COVID-19 Home Test1209Dräger Safety AG & Co. KGaAGermanywww.draeger.comYesCommercialisedNoNoManualNear POC / POCAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1132B.1.427Epsilon1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta1224B.1.526Iota678B.1.1.529OmicronWe have updated the section on detected virus variants for ID2647. This update is based on a recent update of the corresponding technical documentation. ID2647 is the home-use version of the professional test ID2273. We have submitted an update to its section on detected virus variants, too. Thank you.2022-08-24 09:08:01 CET2352Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich15LOD200pgCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.32%1 out of 308 samples (symptomatic and asymptomatic PCR negative)False negatives10.1%7 out of 69 samples (overall, symptomatic PCR positive)PrecisionEvaluatedAccuracy98.9%Ct values < 26; 97.1% (overall)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.8%Ct values < 26Clinical Specificity99.7%Type of antigenNucleocapsid protein2551DS AntijenX1164DS Bio and Nano Technology Product Tracking Verification Corp.Turkeywww.dsbionano.comYesCommercialisedNoNoLab-basedNear POC / POCAntigenNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1321B.1.617.2DeltaNA2022-08-24 09:08:01 CET2256Immuno-AntigenYesNoImmunoassayQualitativeOther15CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives1.44%6/417False negatives0%0/417PrecisionNot evaluatedAccuracy98.79%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity98.56%Clinical Specificity99.38%Type of antigenNucleocapsid protein1717Epithod SARS-CoV-2 qAg Test Kit763DxGen Corp.South Koreawww.dxgenco.comYesCommercialisedNoNoAutomatedManualAntigenNasal swab2022-08-24 09:08:01 CET1397Immuno-AntigenYesImmunoassayQuantitative3LOD10000AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positivesA measured immunochromatic intensity is larger than cut-off value mainly due to non-specific bindingFalse negativesA measured immunochromatic intensity is lower than cut-off value mainly due to limit of sensitivityPrecisionNot evaluatedAccuracy100%(Antigen)ReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity96%(Antigen)Type of antigennucleoprotein1719Epithod® SARS-CoV-2 IgG Test Kit763DxGen Corp.South Koreawww.dxgenco.comYesCommercialisedNoNoAutomatedManualAntibodyIgGSerumWhole bloodnucleocapsid protein2022-08-24 09:08:01 CET1399Immuno-AntibodyYesYesImmunoassay3LOD10000AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positivesPositive percent agreement (PPA) was determined by testing 97 positive samples with a clinical diagnosis of COVID-19 based on a positive PCR method. Overall, 88% of the positive samples yielded an IgG positive result with 0-7 days (35/46, 76%), 8-14 daysFalse negativesNegative percent agreement (NPA) was determined by testing 100 negative samples, including 2 negative conversion samples from recovered patients. Overall, 95% of the negative samples yielded an IgG negative result. PrecisionNot evaluatedAccuracy88% IgGReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity88% IgGType of antigennucleoprotein1718Epithod®616 COVID-19 Ag Test Kit763DxGen Corp.South Koreawww.dxgenco.comYesCommercialisedNoNoAutomatedManualAntigenNasal swab2022-08-24 09:08:01 CET1398Immuno-AntigenYesImmunoassayQuantitative3LOD10000AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positivesA measured immunochromatic intensity is larger than cut-off value mainly due to non-specific bindingFalse negativesA measured immunochromatic intensity is lower than cut-off value mainly due to limit of sensitivityPrecisionNot evaluatedAccuracy100%(Antigen)ReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity96%(Antigen)Type of antigennucleoprotein1720Epithod®616 IgG Test Kit763DxGen Corp.South Koreawww.dxgenco.comYesCommercialisedNoNoAutomatedManualAntibodyIgGSerumWhole bloodnucleocapsid protein2022-08-24 09:08:01 CET1400Immuno-AntibodyYesYesImmunoassayQuantitative3LOD10000AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives24Positive percent agreement (PPA) was determined by testing 97 positive samples with a clinical diagnosis of COVID-19 based on a positive PCR method. Overall, 88% of the positive samples yielded an IgG positive result with 0-7 days (35/46, 76%), 8-14 daysFalse negatives5Negative percent agreement (NPA) was determined by testing 100 negative samples, including 2 negative conversion samples from recovered patients. Overall, 95% of the negative samples yielded an IgG negative result. PrecisionNot evaluatedAccuracy88% IgGReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity88% IgGType of antigennucleoprotein1522019 nCOV IgG/IgM Rapid Test86Dynamiker Biotechnology (Tianjin) Co. Ltd.Chinahttps://en.dynamiker.com/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2022-08-24 09:08:01 CET116Immuno-AntibodyYesNoImmunoassayQualitative10Accuracy92%8442019-nCOV IgG Antibody kit (ELISA)86Dynamiker Biotechnology (Tianjin) Co. Ltd.Chinahttps://en.dynamiker.com/YesCommercialisedNoNoAutomatedManualAntibodyIgG2022-08-24 09:08:01 CET693Immuno-AntibodyELISANot foundManual or automated Not found Not found 8452019-nCOV IgM Antibody kit (ELISA)86Dynamiker Biotechnology (Tianjin) Co. Ltd.Chinahttps://en.dynamiker.com/YesCommercialisedNoNoAutomatedManualAntibodyIgM2022-08-24 09:08:01 CET694Immuno-AntibodyELISANot found2533Dynamiker SARS-CoV-2 Ag Rapid Test1158Dynamiker Biotechnology（Tianjin) Co. Ltd.Chinahttps://en.dynamiker.com/YesCommercialisedYesYesManualAntigenNasopharyngeal swabOropharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1321B.1.617.2DeltaThe product Dynamiker SARS-CoV-2 Ag Rapid Test being listed by BfArM with AT342/21 ,and has positive results by PEI on July, 12, 2021. The version for self-test also passed the Useability study.2022-08-24 09:08:01 CET2238Immuno-AntigenNoImmunoassayQualitativeSandwich10LOD160TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.9%False negatives4.3%PrecisionEvaluatedAccuracy100%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.7%AntigenClinical Specificity99.1%AntigenType of antigenNucleocapsid protein3995Dynamiker SARS-CoV-2 Ag Rapid Test1158Dynamiker Biotechnology（Tianjin) Co. Ltd.Chinahttps://en.dynamiker.com/YesCommercialisedNoNoManualAntigenNasal swabAdenovirusAdenovirus 3Adenovirus 7Alpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Bordetella PertussisChlamydia PneumoniaeCytomegalovirus (CMV)Enterovirus A71 (EV-A71)Epstein-Barr Virus (EBV)Hemophilus InfluenzaeHepatitis A Virus (HAV)Hepatitis B Virus (HBV)Hepatitis C Virus (HCV)Human Immunodeficiency Virus (HIV)Influenza AInfluenza A H1N1Influenza A H3N2Influenza A H5N1Influenza BInfluenza B VictoriaInfluenza B YamagataMERS-CoVMumps Virus (MuV)Mycobacterium TuberculosisMycoplasma PneumoniaeRespiratory Syncytial V (RSV)RhinovirusRhinovirus ARhinovirus BSARS-CoVVaricella Zoster Virus (VZV)678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1321B.1.617.2Delta1495P.1Gammanucleocapsid protein2022-08-24 09:08:01 CET3660Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwichColloidal gold10LOD160TCID50/mlAnalytical Sensitivity98.2%Analytical Specificity100%False positives0%False negatives1.8%Accuracy100%Clinical Sensitivity98.2%Clinical Specificity100%1662CORONA-Ag529DyonMed SAGreecewww.dyonmedical.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabOtherSalivanucleocapsid protein2022-08-24 09:08:01 CET1341Immuno-AntigenYesNoImmunoassayQualitative15LOD0AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%Compared to PCR (n=60) no FP in each of saliva, and sputum.sputum, samplesFalse negatives8.3%Compared to PCR (n=60) 5 false negatives in saliva and 3 in sputumPrecisionEvaluatedAccuracy97%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95%AntigenType of antigennucleoprotein1663CovidAg529DyonMed SAGreecewww.dyonmedical.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabnucleocapsid protein2022-08-24 09:08:01 CET1342Immuno-AntigenYesNoImmunoassayQualitative15LOD0AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives9.4%Compared to PCR (n=117) 11 FPFalse negatives0.55%Compared to PCR (n=183) 1 false negativesPrecisionEvaluatedAccuracy96%(Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90.59%(Antigen)Type of antigennucleoprotein991DyonCovid19 - SARS-CoV-2 IgM/IgG Antibody Rapid Test Device.529DyonMed SAGreecewww.dyonmedical.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2022-08-24 09:08:01 CET770Immuno-AntibodyYesNoImmunoassayQualitative151651DyonCovidAg529DyonMed SAGreecewww.dyonmedical.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.2678B.1.1.529Omicron1518P.2Zetanucleocapsid proteinno other2022-08-24 09:08:01 CET1332Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD2000AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracy95.19%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.96%Clinical Specificity100%Type of antigenNucleocapsid protein1664FluCov2529DyonMed SAGreecewww.dyonmedical.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.2678B.1.1.529Omicron1518P.2Zetanucleocapsid proteinno other2022-08-24 09:08:01 CET1343Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich, Double10LOD6AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives3AUPrecisionEvaluatedAccuracy95.19%RobustnessEvaluatedClinical Sensitivity92.96%Clinical Specificity100%Type of antigenNucleocapsid protein2007SieloCovidAg529DyonMed SAGreecewww.dyonmedical.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabSalivaSputum689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.2678B.1.1.529OmicronNO OTHER2022-08-24 09:08:01 CET1685Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich, Double11LOD6AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0AUFalse negatives6AUPrecisionEvaluatedAccuracy98%(Antigen)Clinical Sensitivity95.6%(Antigen)Clinical Specificity99%(Antigen)Type of antigenNucleocapsid protein671AccuRapid SARS-CoV-2 IgM/IgG Test Kit (Lateral Flow Immunoassay)391Eachy BiopharmaceuticalsChinawww.eachybiopharma.comNoCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2022-08-24 09:08:01 CET539Immuno-AntibodyYesNoImmunoassayQualitative5Rapid diagnostic test Lateral flow 154COVID-19 IgG ELISA Assay87Eagle Biosciences Inc.United Stateseaglebio.com/NoCommercialisedNoNoAutomatedManualAntibody2022-08-24 09:08:01 CET111Immuno-AntibodyELISA153COVID-19 IgM ELISA Assay87Eagle Biosciences Inc.United Stateseaglebio.com/NoCommercialisedNoNoAutomatedManualAntibody2022-08-24 09:08:01 CET110Immuno-AntibodyELISA543CORONAVÍRUS IgG/IgM (COVID-19)334Ebram Produtos Laboratoriais Ltd.Brazilwww.ebram.com/NoCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2022-08-24 09:08:01 CET443Immuno-AntibodyYesNoImmunoassayQualitative20Analysis of cross reactivityReported Clinical Sensitivity99%Clinical Specificity98%672COVID-19 IgG/IgM ECO Teste552Eco Diagnostica Ltd.aBrazilecodiagnostica.com.br/NoCommercialisedNoNoLab-basedAntibodyIgGIgMWhole blood2022-08-24 09:08:01 CET803Immuno-AntibodyYesImmunoassayQualitative15Clinical Sensitivity98.85%Clinical Specificity95%1562019 nCoV novel coronavirus antibody detection reagent (Colloidal gold)88Edinburgh Genetics LimitedUnited Kingdomeggenetics.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2022-08-24 09:08:01 CET120Immuno-AntibodyYesNoImmunoassayQualitativeColloidal gold10Clinical Sensitivity98% IgMClinical Sensitivity99% IgG1243ActivXpress+ COVID-19 Antigen Complete Testing Kit88Edinburgh Genetics LimitedUnited Kingdomeggenetics.comYesCommercialisedYesYesNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabnucleocapsid proteinThis product was evaluated by Paul-Ehrlich-Institute in Germany..2022-08-24 09:08:01 CET1024Immuno-AntigenYesNoImmunoassayQualitative15LOD3AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positivesSpecificity 99.24%False negativesSensitivity 96.17%PrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.17%SalivaClinical Sensitivity97.27Nasopharyngeal swabClinical Sensitivity95.63Oropharyngeal swabClinical Specificity99.24%SalivaClinical Specificity99.62Nasopharyngeal swabClinical Specificity99.24Oropharyngeal swabType of antigenNucleoprotein544Edinburgh Genetics Complete Whole Blood Collection Kit88Edinburgh Genetics LimitedUnited Kingdomeggenetics.comNoCommercialisedNoNoLab-basedAntibodyWhole blood2022-08-24 09:08:01 CET460Immuno-AntibodyImmunoassay662Edinburgh Genetics COVID-19 Colloidal Gold Immunoassay Testing Kit, IgG/IgM Combined88Edinburgh Genetics LimitedUnited Kingdomeggenetics.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2022-08-24 09:08:01 CET555Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry10Clinical Sensitivity98.43%Clinical Specificity99.31%547SARS-CoV-2 (2019-nCoV) IgG/IgM Lateral Flow Assay Kit (Whole Blood/ Serum/ Plasma)335ElabscienceUnited Stateswww.elabscience.com/NoCommercialisedNoNoAutomatedManualAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET463Immuno-AntibodyYesNoImmunoassayQualitative10Clinical Sensitivity98.81%Clinical Specificity98.02%1313CovBELD647EMBIO Diagnostics Ltd.Cypruswww.embiodiagnostics.euYesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Betaspike proteinProspective study and Retrospective evaluation of 300+ samples with the new variants is currently performed on Italy2022-08-24 09:08:01 CET1083Immuno-AntigenYesYesImmunoassayQualitativeMembrane-based3LOD4000U/mlCalibrationEvaluatedAnalysis of cross reactivityNot evaluatedFalse positives2.2%3 on 136False negatives7.27%8 of 110PrecisionEvaluatedAccuracy95.52%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.73%Clinical Specificity97.8%Type of antigenSpike protein3013Speedy COVID-19 Ag Rapid Test1338Enimmune CorporationTaiwan ROCwww.enimmune.com.tw/enYesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1137B.1.429Epsilon1321B.1.617.2Delta678B.1.1.529Omicronnucleocapsid proteinNA2022-08-24 09:08:01 CET2719Immuno-AntigenNoNoImmunoassayQualitative15LOD39.1TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives7.6%PrecisionEvaluatedAccuracy98.41%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity92.31%Clinical Specificity100%Type of antigenNucleocapsid protein2032EONBT COVID-19 Antigen935EON Biotechnology LimitedUnited Kingdomeonbt.comYesCommercialisedNoNoManualAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.2678B.1.1.529Omicron1518P.2Zetanucleocapsid proteinISO13485 certified ISO 9001 certified CE marked2022-08-24 09:08:01 CET1710Immuno-AntigenYesYesNoImmunoassayQualitativeSandwich20LOD0.103ng/mLCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.76%3/170False negatives2.2%9/408PrecisionEvaluatedAccuracy98.95%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.89%Clinical Specificity99.25%Type of antigenNucleocapsid protein1044SeroFlash SARS-CoV-2 IgG/IgM ELISA Fast Kit570Epigentek Group Inc.United Stateswww.epigentek.comYesCommercialisedNoNoLab-basedAntibodyIgGIgMPlasmaSerum2022-08-24 09:08:01 CET837Immuno-AntibodyNoYesELISAQualitativeFluorescence45LOD0.002µg/mlAnalysis of cross reactivityEvaluatedPrecisionInter-assay 8%; Intra assay: 12%.1038SeroFlash SARS-CoV-2 IgM/IgG Antibody Detection Kit570Epigentek Group Inc.United Stateswww.epigentek.comNoCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood I could not find CE-IVD proof2022-08-24 09:08:01 CET962Immuno-AntibodyYesNoImmunoassayQualitativeColloidal goldAnalysis of cross reactivityReportedAccuracy92.19%Clinical Sensitivity97.8%Clinical Specificity100%157EDI Novel Coronavirus COVID-19 IgG ELISA Kit94Epitope Diagnostics Inc.United Stateswww.epitopediagnostics.com/YesCommercialisedNoNoAutomatedManualAntibodyIgGPlasmaSerum2022-08-24 09:08:01 CET121Immuno-AntibodyNoYesELISAQuantitativeFluorescence120Clinical Sensitivity100% IgGClinical Specificity100% IgG158EDI Novel Coronavirus COVID-19 IgM ELISA Kit94Epitope Diagnostics Inc.United Stateswww.epitopediagnostics.com/YesCommercialisedNoNoAutomatedManualAntibodyIgMPlasmaSerum2022-08-24 09:08:01 CET122Immuno-AntibodyNoYesELISAQuantitativeFluorescence120Clinical Sensitivity100% IgMClinical Specificity100% IgM533ErbaLisa COVID-19 IgG ELISA327Erba MannheimUnited Kingdomwww.erbamannheim.comYesCommercialisedNoNoAutomatedManualAntibodyIgGPlasmaSerum2022-08-24 09:08:01 CET436Immuno-AntibodyYesELISASemiquantitativeSandwich, Double50Analysis of cross reactivityEvaluatedPrecision6.37% IgG5.29% - 6.37%Clinical Sensitivity98.3% IgGClinical Specificity98.1% IgG534ErbaLisa COVID-19 IgM ELISA327Erba MannheimUnited Kingdomwww.erbamannheim.comNoCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET438Immuno-AntibodyYesELISAQualitativeSandwich, Double3443COVID-19 Antigen Rapid Test1414Eternal Material Co.,Ltd.Taiwan ROChttps://www.eternal-group.com/Home/EngIndexYesCommercialisedNoNoManualNear POC / POCAntigenNasal swabNasopharyngeal swabAdenovirusAlpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus OC43 (HCoV-OC43)Influenza AInfluenza BParainfluenza Virus TypeRespiratory Syncytial V (RSV)Rhinovirus678B.1.1.529Omicron689B.1.1.7Alpha1137B.1.429Epsilon1321B.1.617.2Delta1495P.1Gammanucleocapsid protein2022-08-24 09:08:01 CET3179Immuno-AntigenYesNoNoImmunochromatographyQualitativeCaptureColloidal gold10LOD1255.9TCID50/mlAnalytical Sensitivity97.73%Analytical Specificity98.67%False positives1.33%False negatives2.27%Accuracy94.78%Clinical Sensitivity81.3%Clinical Specificity99.99%3453COVID-19 Antigen Rapid Test For Self Test1414Eternal Material Co.,Ltd.Taiwan ROChttps://www.eternal-group.com/Home/EngIndexYesCommercialisedNoNoManualNear POC / POCAntigenNasal swabAdenovirusAlpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus OC43 (HCoV-OC43)Influenza AInfluenza BParainfluenza Virus TypeRespiratory Syncytial V (RSV)Rhinovirus678B.1.1.529Omicron689B.1.1.7Alpha1137B.1.429Epsilon1321B.1.617.2Delta1495P.1Gammanucleocapsid protein2022-08-24 09:08:01 CET3189Immuno-AntigenYesYesNoImmunochromatographyQualitativeCaptureColloidal gold10LOD1255.9TCID50/mlAnalytical Sensitivity97.73%Analytical Specificity98.67%False positives1.33%False negatives2.27%Accuracy94.54%Clinical Sensitivity81.05%Clinical Specificity99.99%1066COVIDual COVID-19 IgM/IgG Rapid Test573Eternal Materials Co. Ltd.Taiwan ROCwww.eternal-group.com/Home/EngIndexYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2022-08-24 09:08:01 CET844Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15CalibrationNot evaluatedAnalysis of cross reactivityNot evaluatedPrecisionEvaluatedAccuracy98.76%ReproducibilityNot evaluatedRobustnessNot evaluatedClinical Sensitivity93.94%Clinical Specificity99.311739EBS SARS-CoV-2 Ag Rapid Test294Eurobio ScientificFrancehttps://www.eurobio-scientific.com/YesCommercialisedYesYesNear POC / POCAntigenNasal swabnucleocapsid proteinEBS1020, EBS SARS-CoV-2 Ag Rapid Test2022-08-24 09:08:01 CET1417Immuno-AntigenYesYesImmunoassayQualitativeColorimetry10LOD95AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedPrecisionNot evaluatedReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity95.7%A/(A+C) x 100= 95.7% (95% CI 90.2 98.1%)Type of antigennucleoprotein1682INGEZIM Covid 19 CROM445EurofinsSpainhttps://ingenasa.eurofins-technologies.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole bloodnucleocapsid protein2022-08-24 09:08:01 CET1361Immuno-AntibodyYesNoImmunoassayQualitative15LOD0AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1%False negatives5%PrecisionEvaluatedAccuracy96%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.5%Type of antigennucleoprotein1683INGEZIM COVID 19 DR445EurofinsSpainhttps://ingenasa.eurofins-technologies.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET1362Immuno-AntibodyNoYesELISAQualitativeOther75LOD0AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1%False negatives1%PrecisionEvaluatedAccuracy97%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.3%Clinical Specificity99.2%Type of antigennucleoprotein725NovaLisa SARS-CoV-2 IgG assay445EurofinsSpainhttps://ingenasa.eurofins-technologies.comYesCommercialisedNoNoAutomatedManualAntibodyIgGSerum2022-08-24 09:08:01 CET605Immuno-AntibodyImmunoassayQualitativeFluorescenceManual or automated Fluorescence 880VIROTECH SARS-CoV-2 IgG445EurofinsSpainhttps://ingenasa.eurofins-technologies.comYesCommercialisedNoNoNear POC / POCAntibodyIgGPlasmaSerum2022-08-24 09:08:01 CET717Immuno-AntibodyNoYesImmunoassayQualitativeFluorescence1202458INGEZIM COVID 19 SPIKE CROM1121EUROFINS INGENASASpainhttps://ingenasa.eurofins-technologies.comYesCommercialisedNoNoNear POC / POCAntibodySerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2Zetadetection of antibodies specific of protein S of SARS-CoV-22022-08-24 09:08:01 CET2161Immuno-AntibodyNoImmunochromatographyQualitativeEnzyme-linked15CalibrationEvaluatedAnalysis of cross reactivityEvalautedFalse positives3.7%False negatives2.78%PrecisionEvalautedAccuracy96%ReproducibilityEvaluatedRobustnessEvalautedClinical Sensitivity97.22%(day 15 after vaccination)Clinical Specificity96.3%2552INGEZIM COVID RBD-DR1121EUROFINS INGENASASpainhttps://ingenasa.eurofins-technologies.comYesCommercialisedNoNoNear POC / POCAntibodySerumTHE PRODUCT IS UNDER CE MARKING2022-08-24 09:08:01 CET2257Immuno-AntibodyYesELISAQualitative75CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1%False negatives0.1%<0.1% Fifteen days after finishing the vaccination protocolPrecisionEvaluatedAccuracy97%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.9% Fifteen days after finishing the vaccination protocolClinical Specificity99%Type of antigenSpike protein160Anti-SARS-CoV-2 ELISA (IgA)90EUROIMMUN AGGermanywww.coronavirus-diagnostics.comYesCommercialisedNoNoAutomatedManualAntibodyIgAPlasmaSerum2022-08-24 09:08:01 CET124Immuno-AntibodyYesELISAQualitativeFluorescenceClinical Sensitivity100%Range:91.7 - 100Clinical Specificity92.4%Range:88.2- 92.4883Anti-SARS-CoV-2 ELISA (IgG)90EUROIMMUN AGGermanywww.coronavirus-diagnostics.comYesCommercialisedNoNoAutomatedManualAntibodyIgGPlasmaSerum2022-08-24 09:08:01 CET720Immuno-AntibodyYesELISAQualitativeFluorescenceClinical Sensitivity93.8% IgG(75 - 93.8)Clinical Specificity99.6% IgG2743Anti-SARS-CoV-2 QuantiVac ELISA (IgG)90EUROIMMUN AGGermanywww.coronavirus-diagnostics.comYesCommercialisedNoNoAutomatedFully automated (robot)Lab-basedManualSemi-automatedAntibodyIgGOtherPlasmaSerum689B.1.1.7Alpha1032B.1.351BetaThe EUROIMMUN Anti-SARS-CoV-2-QuantiVac-ELISA IgG (order no. EI 2606-9601-10 G) is suitable for the quantitative detection of antibodies against the S1 antigen of SARS-CoV-2 and enables the results to be given in standardized units (BAU / ml).2022-08-24 09:08:01 CET2448Immuno-AntibodyYesELISAQuantitative120CalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.2% IgG90.3-93.2Clinical Specificity99.8% IgG849Anti-SARS-CoV-2-NCP ELISA (IgG)90EUROIMMUN AGGermanywww.coronavirus-diagnostics.comYesCommercialisedNoNoAutomatedManualAntibodyIgGPlasmaSerum2022-08-24 09:08:01 CET1845Immuno-AntibodyELISA2289SARS-CoV-2 Antigen ELISA90EUROIMMUN AGGermanywww.coronavirus-diagnostics.comYesCommercialisedNoNoAutomatedFully automated (robot)Lab-basedManualSemi-automatedAntigenNasopharyngeal swabLaboratory diagnostic assay for direct pathogen detection by semiquantitative determination of the SARS-CoV-2-specific nucleocapsid protein in swab samples of the upper respiratory tract Supporting acute diagnostics, especially during COVID-19 outbreaks Established ELISA method – suitable for any diagnostic laboratory and completely automatable2022-08-24 09:08:01 CET1990Immuno-AntigenYesELISASemiquantitative195LOD0.45AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.6% (Antigen)Clinical Specificity100% (Antigen)Type of antigenNucleoprotein2751SARS-CoV-2 NeutraLISA90EUROIMMUN AGGermanywww.coronavirus-diagnostics.comYesCommercialisedNoNoAutomatedFully automated (robot)Lab-basedManualSemi-automatedAntibodyIgGIgMIgAPlasmaSerum689B.1.1.7Alpha1032B.1.351BetaThe EUROIMMUN SARS-CoV-2-NeutraLISA is a surrogate neutralisation test for the detection of neutralising antibodies, which inhibit binding if the receptor binding domain (RBD) of SARS-CoV-2 to ACE2 receptors of human cells. The SARS-CoV-2-NeutraLISA can be processed in a standardized and automated manner in every routine laboratory.2022-08-24 09:08:01 CET2456Immuno-AntibodyYesELISASemiquantitativeNeutralization Antibody (NAb)105CalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.9%Clinical Specificity99.7%2876RAPID SARS-COV-2 ANTIGEN SCREENING TEST CARD1276Excalibur Healthcare Services LimitedUnited Kingdomhttps://excaliburhealth.co.uk/YesCommercialisedNoNoManualAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2DeltaOtherN1b nucleoprotein is the analyte. This is most commonly fatal as this protein binds that RNA. The buffer does not contain Triton X-1002022-08-24 09:08:01 CET2581Immuno-AntigenNoImmunochromatographyQuantitativeSandwich, Double15LOD29ctusing RT-PCRCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positivesNone knownFalse negativesThis makes no sense. The false negative rate is dependent on the incidencePrecisionEvaluatedAccuracy98.2%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98%AntigenClinical Specificity98.3%AntigenType of antigenN1b nucleoprotein2953EXON SARS CoV-2 Rapid Antigen Test (Colloidal Gold)1301EXON BÄ°YOTEKNOLOJÄ°Turkeywww.exonbiyotek.comYesCommercialisedNoNoManualAntigenNasal swabNasopharyngeal swabSARS-CoV678B.1.1.529Omicronnucleocapsid proteinEXON SARS-CoV-2 Rapid Antigen Test is intended for the qualitative detection of SARS-CoV-2 Antigen in nasopharyngeal swab specimens in vitro.2022-08-24 09:08:01 CET2659Immuno-AntigenImmunochromatographyColloidal gold15LOD200TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives3.65%PrecisionEvaluatedAccuracy98.22%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97%Clinical Specificity100%Type of antigenNucleocapsid protein2172FAMEX Coronavirus (2019-nCoV) Antigentest1012fago medikal san. tic. Ltd. ÅŸti.Turkeyhttp://famextestkit.com/YesCommercialisedNoNoNear POC / POCAntigenAnterior nasal swabNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaAnterio Nasal Test -Vorderer Nasenabstrich2022-08-24 09:08:01 CET1873Immuno-AntigenNoImmunoassayQualitative10LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives11AUFalse negatives3AUPrecisionEvaluatedAccuracy97.7%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.32%Clinical Specificity98.32%Type of antigenNucleoprotein2173FAMEX SARS-CoV-2 AG RAPID NASOPHARTNGEAL TEST KIT1012fago medikal san. tic. Ltd. ÅŸti.Turkeyhttp://famextestkit.com/YesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swabOropharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2Zetanucleocapsid proteinNasopharygeal Nasen-Rachen-Abstrich2022-08-24 09:08:01 CET1874Immuno-AntigenYesNoImmunoassayQualitative10LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives11AUFalse negatives3AUPrecisionEvaluatedAccuracy98%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.44%Clinical Specificity99.3%Type of antigenNucleoprotein2175FAMEX SARS-CoV-2 RAPID ANTIBODY TEST1012fago medikal san. tic. Ltd. ÅŸti.Turkeyhttp://famextestkit.com/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole bloodWhole blood with anti-coagulants689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.1B.1.526.1B.1.526.21224B.1.526Iota1518P.2Zetasars-cov 2 antikörper rapid test2022-08-24 09:08:01 CET1876Immuno-AntibodyNoImmunoassayQualitative10LOD100AUCalibrationEvaluatedAnalytical Sensitivity85% IgMAnalysis of cross reactivityEvaluatedFalse positives10AUFalse negatives8AUPrecisionEvaluatedAccuracy98.6% IgGAccuracy92.8% IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100% IgGClinical Specificity98% IgGClinical Specificity96% IgMType of antigenNucleoprotein2174FAMEX SARS-CoV-2 SALIVA ANTIGEN TEST KIT1012fago medikal san. tic. Ltd. ÅŸti.Turkeyhttp://famextestkit.com/YesCommercialisedNoNoNear POC / POCAntigenSaliva689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2Zetasars-cov 2 salıva antıgen2022-08-24 09:08:01 CET1875Immuno-AntigenNoImmunoassayQualitative10LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives7AUFalse negatives4AUPrecisionEvaluatedAccuracy98%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.86%Clinical Specificity98.75%1744CORA CHECK-19777fameditec GmbHGermanyhttps://www.fameditec.de/YesCommercialisedNoNoNear POC / POCAntigenAnterior nasal swabNasal swabNasopharyngeal swabOropharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gammahttps://www.fameditec.de/2022-08-24 09:08:01 CET1422Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich, DoubleColorimetry15LOD175AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.72%False negatives3.51%PrecisionEvaluatedAccuracy98.47%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.49%Clinical Specificity98.28%Type of antigenNucleocapsid protein1781CORA-CHECK-19-comfort777fameditec GmbHGermanyhttps://www.fameditec.de/YesCommercialisedNoNoManualNear POC / POCAntigenSaliva689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2Zetanucleocapsid proteinAll study results can be provided upon request.2022-08-24 09:08:01 CET1460Immuno-AntigenYesNoImmunoassayQualitativeMembrane-basedColorimetry15LOD250AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.95% (further results can be provided upon request)False negatives3.3% (further results can be provided upon request)PrecisionEvaluatedAccuracy97.76%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.3%Clinical Specificity99.13%Type of antigenNucleoprotein164COVID-19 Antibody Test93FemtoDxUnited Statesfemtodx.com/NoIn developmentNoNoNear POC / POCAntibody2022-08-24 09:08:01 CET119Immuno-AntibodyImmunoassay2597SARS-CoV-2 Antigen Test Kit1183FENG CHUN YUAN MEDICAL EQUIPMENT(SHENZHEN) Co. Ltd.Chinawww.fcy-medical.comYesIn developmentNoNoNear POC / POCAntigenAnterior nasal swabSaliva689B.1.1.7Alpha1320B.1.617.1KappaSARS-CoV-2 Antigen Test Kit is an in vitro diagnostic rapid test for the qualitative detection of nucleocapsid protein from SARS-CoV-2 in anterior nasal (AN) swab or saliva (SA) specimens directly collected from individuals, based on the principle of latex immunochromatographic immunoassay. It is intended to be used as an aid in the diagnosis of SARS-CoV-2 infection, professional use only.2022-08-24 09:08:01 CET2302Immuno-AntigenNoImmunochromatographyQualitativeSandwich15LOD200TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2AUFalse negatives5AUPrecisionEvaluatedAccuracy95%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.24%100/105 (95% CI, 89.33%~97.95%)Clinical Specificity99.44%353/355, (95% CI, 97.97%~99.85%)Type of antigenNucleocapsid protein2598SARS-CoV-2 Neutralizing Antibody Detection Kit1183FENG CHUN YUAN MEDICAL EQUIPMENT(SHENZHEN) Co. Ltd.Chinawww.fcy-medical.comYesIn developmentNoNoNear POC / POCAntibodyPlasmaSerumWhole blood689B.1.1.7Alpha1320B.1.617.1KappaOtherThe SARS-CoV-2 Neutralizing Antibody Test Kit can be used for in-vitro semi-quantitative detection of SARS-CoV-2 neutralizing antibody in human serum, plasma or whole blood samples, which is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. The SARS-CoV-2 Neutralizing Antibody Test Kit should not be used to diagnose or exclude acute SARS-CoV-2 infection. For professional use only.2022-08-24 09:08:01 CET2303Immuno-AntibodyYesNoImmunochromatographySemiquantitativeSandwich15LOD20IU/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%0 out of 27False negatives0%0 out of 28PrecisionEvaluatedAccuracy95%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%28/28,, (95% CI 87.94%~100%)Clinical Specificity100%27/27, (95% CI 87.54%~100%)Type of antigenOther551Viral Transport Medium349Fjord Diagnostics SDNMalaysiawww.fjorddiagnostics.com/NoCommercialisedNoNoLab-basedAntibody2022-08-24 09:08:01 CET467Immuno-AntibodyImmunoassay1871SARS-CoV-2 Antigen Test Kit (Colloidal Gold)859Foregene Co. Ltd.Chinawww.foregene.comYesCommercialisedNoNoManualAntigenNasal swabNasopharyngeal swabSalivaEC Representative SUNGO Europe B.V. Address: Olympisch Stadion 24, 1076DE Amsterdam, Netherlands2022-08-24 09:08:01 CET1553Immuno-AntigenNoOtherQualitativeColorimetry15LOD150AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives100%False negatives95%PrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity100%Clinical Specificity95%Type of antigenNucleoprotein1872SARS-CoV-2 IgM/IgG Test Kit(Colloidal Gold)859Foregene Co. Ltd.Chinawww.foregene.comYesCommercialisedNoNoManualIgGIgMVenous whole bloodWhole bloodEC Representative SUNGO Europe B.V. Address: Olympisch Stadion 24, 1076DE Amsterdam, Netherlands2022-08-24 09:08:01 CET1554Immuno-AntibodyNoOtherQualitativeColorimetry10LOD200CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives91.07%False negatives95.37%PrecisionEvaluatedAccuracy92.75%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity91.07%Clinical Specificity95.37%Type of antigenNucleoprotein1208Formosa One Sure SARS-CoV-2 Ag Rapid Test Kit626Formosa Biomedical Technology Corp.Taiwan ROCwww.fbc.com.tw YesCommercialisedNoNoNear POC / POCAntigenNasal swab2022-08-24 09:08:01 CET993Immuno-AntigenYesNoImmunoassayQualitative15Clinical Sensitivity88%4055Covid-19 Antigen CARD Kit1239Fosun Diagnostics (Shanghai) Co. Ltd.Chinahttps://www.fosunpharma.com/en/product/medical-list.aspx?type=8YesCommercialisedNoNoNear POC / POCAntigenNasal swabSARS-CoV-2678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1320B.1.617.1Kappa1321B.1.617.2Delta1495P.1Gammanucleocapsid protein2022-09-20 13:49:58 CET3818Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD31.3TCID50/mlCalibrationNot evaluatedAnalytical Sensitivity96.75%Analytical Specificity98.26%Analysis of cross reactivityEvaluatedFalse positives1.7%False negatives3.3%PrecisionEvaluatedAccuracy97.91%RobustnessEvaluatedClinical Sensitivity96.75%Clinical Specificity98.26%2724Fosun Covid-19 Ag CARD1239Fosun Diagnostics (Shanghai) Co. Ltd.Chinahttps://www.fosunpharma.com/en/product/medical-list.aspx?type=8YesCommercialisedYesYesNear POC / POCAntigenNasal swabSARS-CoV678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1223B.1.525Eta1224B.1.526Iota1320B.1.617.1Kappa1321B.1.617.2Delta1323B.1.621Mu2041C.37Lambda1495P.1Gamma1518P.2Zetanucleocapsid protein2022-11-17 10:12:18 CET5325Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD31.3TCID50/mlCalibrationNot evaluatedAnalytical Sensitivity96.75%Analytical Specificity98.26%Analysis of cross reactivityEvaluatedFalse positives1.7%False negatives3.3%PrecisionEvaluatedAccuracy97.91%RobustnessEvaluatedClinical Sensitivity96.75%Clinical Specificity98.26%2730Fosun SARS-CoV-2 Neutralization Antibody Detection Kit1239Fosun Diagnostics (Shanghai) Co. Ltd.Chinahttps://www.fosunpharma.com/en/product/medical-list.aspx?type=8YesCommercialisedNoNoAntibodyNothing2022-08-24 09:08:01 CET2435Immuno-AntibodyNeutralization Antibody (NAb)2727Fosun SARS-CoV-2 Neutralization Antibody Rapid (Immunofluorescence)1239Fosun Diagnostics (Shanghai) Co. Ltd.Chinahttps://www.fosunpharma.com/en/product/medical-list.aspx?type=8YesCommercialisedNoNoAntibody2022-08-24 09:08:01 CET2432Immuno-AntibodyImmunoassayFluorescence3028COVID-19 Antigen Rapid Test Kit1346FUJIAN ERCON MEDICAL MANAGEMENT Co. Ltd.Chinawww.erconmedical.comYesCommercialisedNoNoManualAntigenNasal swabSARS-CoV678B.1.1.529Omicronnucleocapsid proteinNo additional information2022-08-24 09:08:01 CET2734Immuno-AntigenYesImmunoassay15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives2%PrecisionEvaluatedAccuracy99.56%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.26%Clinical Specificity100%Type of antigenNucleocapsid protein2428FUJIFILM COVID-19 Ag Test1110FUJIFILM CorporationJapanhttps://www.fujifilm.com/YesCommercialisedNoNoManualNear POC / POCAntigenNasopharyngeal swabnucleocapsid proteinFUJIFILM COVID-19 Ag Test is using Fujifilm’s proprietary silver amplification immunochromatographic method for signal amplification to increase the sensitivity and giving results in less than 15minutes. Yamaoka et al., Highly specific monoclonal antibodies and epitope identification against SARS-CoV-2 nucleocapsid protein for antigen detection tests, Cell Reports Medicine (2021), https://doi.org/10.1016/j.xcrm.2021.1003112022-08-24 09:08:01 CET2131Immuno-AntigenYesNoImmunochromatographyQualitativeOther11LOD110AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%- Specificity 100% (104/104)False negatives9.1%- Sensitivity 90.9% Ct-value <35, n=121PrecisionEvaluatedAccuracy100% (Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90.9% (Antigen)Clinical Specificity100% (Antigen)Type of antigenNucleoprotein2147ESPLINE SARS-CoV-2994FujirebioJapanhttps://www.fujirebio.com/enYesCommercialisedYesYesNear POC / POCAntigenNasopharyngeal swabESPLINE SARS-CoV-2 is a cassette-style assay using a simple procedure without any special instruments. SARS-CoV-2 can be detected within 30 minutes.2022-08-24 09:08:01 CET1837Immuno-AntigenNoImmunochromatographyQualitativeEnzyme-linked30LOD50PFU/mL(Viral Copy equivalent = 1.09 x 10 exp5 copies/ml)CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%Specificity = 100% (n=644, no false positives)False negatives12.2%Sensitivity = 87.8% (n=98, Ct<33)PrecisionEvaluatedAccuracy98.3%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity87.8% (n=98, Ct<33)Clinical Specificity100%Type of antigenNucleoprotein2124Lumipulse G SARS-CoV-2 Ag984Fujirebio Inc.Japanhttps://www.fujirebio.comYesCommercialisedYesYesAutomatedFully automated (robot)Lab-basedAntigenNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161321B.1.617.2Delta20A.23.1678B.1.1.529Omicronnucleocapsid proteinhttps://www.fujirebio.com/en/products-solutions/lumipulse-g-sars-cov2-ag2022-08-24 09:08:01 CET3479Immuno-AntigenNoNoYesImmunoassayQuantitativeSandwich25LOD2.95TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positivessee IFUFalse negativessee IFUPrecisionEvaluatedAccuracy97.5%Precision: ≤ 2.5% (total %CV)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.6%NPS: 95% CI: 93.3-99.2% (124/127) ; Ct-value <30Clinical Sensitivity100%NSP: 95%CI: 95.8-100.0% (87/87) ; Ct-value <25Clinical Specificity99.3%Nasopharyngeal swab: (95% CI: 97.8-99.7%) (397/400) Type of antigenNucleocapsid protein1580GA CoV-2 Antigen Rapid351GA Generic Assays GmbHGermanywww.genericassays.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabnucleocapsid protein in instruction manual: Limit of detection: 100 pg/ml of the recombinant protein 2022-08-24 09:08:01 CET1259Immuno-AntigenYesNoImmunoassayQualitative15LOD70AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives3.6%It was compared with results of the RT-PCR reference method and found a sensitivity 96.4%False negatives0.8%It was compared with results of the RT-PCR reference method and found a specificity 99.2%Precision99%>99%Accuracy98%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.4%Clinical Specificity99.2%Type of antigennucleoprotein1855GA CoV-2 Antigen Rapid Test351GA Generic Assays GmbHGermanywww.genericassays.comYesCommercialisedYesYesManualAntigenNasopharyngeal swabnucleocapsid proteinGA CoV-2 Antigen Rapid Test is used for the qualitative determination of SARS-Coronavirus 2 (COVID-19) Antigen in human nasopharynx specimen. The test is intended for use by trained clinical laboratory personnel.2022-08-24 09:08:01 CET1535Immuno-AntigenYesNoImmunochromatographyQualitativeMembrane-based15LOD10AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.8%4/500False negatives2.94%3/102PrecisionEvaluatedAccuracy98%ReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity97.059%Clinical Specificity99.2%Type of antigenNucleoprotein554GA CoV-2 IgG/IgM/IgG+351GA Generic Assays GmbHGermanywww.genericassays.comYesCommercialisedNoNoAutomatedManualAntibodyIgGIgMPlasmaSerum2022-08-24 09:08:01 CET469Immuno-AntibodyNoYesELISAQualitativeFluorescence105Manual or automated Fluorescence Clinical Sensitivity98%Clinical Specificity98% 2781SARS-COV-2 Antigen Test1249Gaobeidian PRISES Biotechnology Co. Ltd.Chinawww.prisesbio.comYesCommercialisedNoNoManualNear POC / POCAntigenNasopharyngeal swabnucleocapsid proteinThis product is used for in vitro qualitative detection of the antigen of novel coronavirus in human nasopharyngeal swabs. SARS-COV-2 Antigen Rapid Test is a test and provides a preliminary test result to aid in the diagnosis of infection with novel Coronavirus. Any interpretation or use of this preliminary test result must also rely on other clinical findings as well as on the professional judgment of health care providers. Alternative test method(s) should be considered to confirm the test result obtained by this test. It is valid for 24 months from date of manufacturing.2022-08-24 09:08:01 CET2486Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich, Double20CalibrationNot evaluatedAnalysis of cross reactivityNot evaluatedFalse positives0.83%2/240False negatives7.5%6/80PrecisionEvaluatedAccuracy97.7%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.5%Clinical Specificity99.2%Type of antigenNucleocapsid protein1144GENEDIA W COVID-19 Ag1400GC Medical Science Corp.South Koreahttp://www.greencrossms.com/YesCommercialisedYesYesNear POC / POCAntigenAnterior nasal swabNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta678B.1.1.529Omicron1495P.1Gamma1321B.1.617.2Deltanucleocapsid proteinClinical study has updated at VISMEDERI Pharma in Italy.2022-08-24 09:08:01 CET3680Immuno-AntigenYesNoImmunochromatographyQualitativeMembrane-based10LOD750TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%None of Total 400 negative specimens.False negatives17.9%21 of total 117 positive specimensPrecisionEvaluatedAccuracy100%RobustnessEvaluatedClinical Sensitivity82.05%Clinical Specificity100%Type of antigenNucleocapside protein3190GENEDIA W COVID-19 Ag (643K)1472GC Medical Science Corp.South KoreaYesCommercialisedYesYesNear POC / POCAntigenAnterior nasal swab678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1321B.1.617.2Delta1495P.1Gammanucleocapsid protein2022-10-05 14:00:03 CET3928Immuno-AntigenYesNoNoImmunochromatographyQualitativeMembrane-basedChemiluminescence10LOD750TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives6.25%4 of the total 64 positive specimens compared to RT-PCR Ct interval ≤ 25, in All PopulationFalse negatives0%0 of the total 400 negative specimens.compared to RT-PCR Ct interval ≤ 25, in All PopulationPrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity93.75%Clinical Specificity100%Type of antigenNucleocapside protein1585GenaBio SARS-CoV-2 Antigen Lateral Flow Test698GenaBio Diagnostics Inc.United Stateswww.genabio.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabnucleocapsid protein Issue between the data (colloidal gold and the website link provided: immunofluorescence 2022-08-24 09:08:01 CET1265Immuno-AntigenYesNoImmunoassayQualitativeColloidal gold15LOD1AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives4.93%False negatives0.26%PrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.07%(Antigen)Type of antigennucleoprotein1576SARS-CoV-2 IgM/IgG (GICA) Test698GenaBio Diagnostics Inc.United Stateswww.genabio.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole bloodnucleocapsid protein2022-08-24 09:08:01 CET1255Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry10Rapid diagnostic test cassette colloidal gold LOD1CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0False negatives1.65%PrecisionEvaluatedAccuracy100% IgGAccuracy100% IgMReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity100% IgMClinical Sensitivity100% IgGClinical Specificity99.2%combinedType of antigennucleoprotein721Maverick SARS-CoV-2 Multi-Antigen Serology Panel442GenalyteUnited Stateswww.genalyte.com/NoCommercialisedNoNoLab-basedAntigenWhole blood2022-08-24 09:08:01 CET601Immuno-AntigenYesImmunoassaySemiquantitativePhosphor technology20Serological panel, Photonic ring resonance Accuracy98%Clinical Sensitivity87%Clinical Specificity100%Type of antigenSARS-CoV-21244GenBody COVID-19 Ag97GenBody Inc.South Koreawww.genbody.co.krYesCommercialisedYesYesNear POC / POCAntigenNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1132B.1.427Epsilon1137B.1.429Epsilon1321B.1.617.2Delta1224B.1.526Iota678B.1.1.529Omicron1518P.2Zetanucleocapsid protein2022-08-24 09:08:01 CET1025Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich, Double15antigen_epi Clone #2F4 for gold dye, Clone #3C3 for capture(membrane). Based on the Epitope Mapping Results, the target epitope is presented below; (Reference: NCBI Reference Sequence ID: NC_045512.2, Domain CDS 28274 to 29533; Nucleocapsid phosphoprotein) 1) Clone #2F4 258P, 260Q, 261K, 262R, 263T, 264A. 265T, 266K, 269N, 273A, 286F, 294Q, 296T, 297D, 298Y, 302P, 305A, 306Q, 311A, 312S, 313A, 316G, 335G, 340D, 343D, 356H 2) Clone #3C3 3D, 114G, 262R, 264A, 322M, 323E, 324V, 325T, 326P, 329T, 335G, 340D, 346F, 348D, 350V, 355K, 365P -Conclusion Both #2F4 and #3C3 recognize conformational epitope as below; #2F4 : PQKRTTKNAQTDYPAQASAGGDDH #3C3 : DGRAMEVTPTGDFDVKPLOD507TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2.91%3/103False negatives0%0/301PrecisionEvaluatedAccuracy99.26%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.09%Clinical Specificity100%Type of antigenNucleocapsid protein169GenBody COVID-19 IgM/IgG97GenBody Inc.South Koreawww.genbody.co.krYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2022-08-24 09:08:01 CET127Immuno-AntibodyYesNoImmunoassayQualitative15Rapid diagnostic test cassette Analysis of cross reactivityReportedAccuracy96.5%Clinical Sensitivity91.7%Clinical Specificity97.5%1297GenBody FIA COVID-19 Ag97GenBody Inc.South Koreawww.genbody.co.krYesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swabOropharyngeal swab http://genbody.co.kr/bbs/board.php?bo_table=human01&wr_id=222022-08-24 09:08:01 CET1067Immuno-AntigenYesNoImmunoassayQualitative20LOD898TCID50/mlAccuracy92.95%Clinical Sensitivity89.47%Clinical Specificity96.43%170GenBody FIA COVID-19 IgM/IgG97GenBody Inc.South Koreawww.genbody.co.krNoCommercialisedNoNoAutomatedManualAntibodyIgGIgM2022-08-24 09:08:01 CET128Immuno-AntibodyImmunoassayManual or automated 850Genelogic COVID-19 IgM/IgG Antibody Test Kit484Genelogic Research LimitedHong Kong S.A.Rwww.genelogic.com.hk/YesCommercialisedNoNoAutomatedManualAntibodyIgGIgMWhole blood2022-08-24 09:08:01 CET671Immuno-AntibodyYesNoImmunoassayQualitative15Clinical Sensitivity94.8%Clinical Specificity91.7%Type of antigenSARS-CoV-24081GB COVID-19 Ag POCT104General Biologicals CorporationTaiwan ROCwww.gbc.com.tw/YesCommercialisedYesYesManualNear POC / POCAntigenNasopharyngeal swabSARS-CoVSARS-CoV-2678B.1.1.529Omicron1321B.1.617.2Deltanucleocapsid protein2022-09-20 14:54:12 CET20270Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwichColloidal gold15LOD100TCID50/mlCalibrationEvaluatedAnalytical Sensitivity84%Analytical Specificity98.14%Analysis of cross reactivityEvaluatedFalse positives1.8%False negatives16%PrecisionNot evaluatedAccuracy94.8%RobustnessEvaluatedClinical Sensitivity84%Clinical Specificity98.14%1586GB SARS-CoV-2 Ab ELISA104General Biologicals CorporationTaiwan ROCwww.gbc.com.tw/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET1266Immuno-AntibodyNoYesELISAQualitative120LOD0.089AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives1.92%PrecisionEvaluatedAccuracy98.75%(Total antibody)ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity100%(Total antibody)Type of antigennucleoprotein4072RapiCov Rapid Antigen Test Kit for COVID‐191460Genes2me Private LTDIndiaYesCommercialisedNoNoManualAntigenNasopharyngeal swabAdenovirusAlpha Coronavirus 229E (HCoV-229E)Influenza A H1N1Influenza A H3N2Influenza BMERS-CoVMycoplasma PneumoniaeParainfluenza Virus Type 1Parainfluenza Virus Type 2Parainfluenza Virus Type 3Parainfluenza Virus Type 4Respiratory Syncytial V (RSV)RhinovirusSARS-CoVSARS-CoV-2689B.1.1.7Alpha1032B.1.351Beta1137B.1.429Epsilon1223B.1.525Eta1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.3Other1495P.1Gamma1518P.2ZetaOther2022-09-20 14:45:47 CET3833Immuno-AntigenYesYesNoImmunoassayQualitativeN.A.Other10LOD0.4ng/mLCalibrationEvaluatedAnalytical Sensitivity98.33%Analytical Specificity98.6%Analysis of cross reactivityEvaluatedFalse positives24ng/mLFalse negatives24ng/mLPrecisionEvaluatedAccuracy100%RobustnessEvaluatedClinical Sensitivity98.33%Clinical Specificity98.6%3075Novel Coronavirus (2019-nCoV) Antigen Testing Kit (Lateral Flow Assay)1362GeneSign Biotech (Xiamen) Co. Ltd.ChinaYesCommercialisedNoNoManualNear POC / POCAntigenAnterior nasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.2678B.1.1.529Omicron1518P.2Zetanucleocapsid proteinProduct registered at CIBG (Netherlands MOH)2022-08-24 09:08:01 CET2781Immuno-AntigenNoNoImmunochromatographyQualitativeSandwich, Double15LOD20TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.719%False negatives4.25%PrecisionEvaluatedAccuracy97.85%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.74%Clinical Specificity99.28%Type of antigenNucleocapsid protein3138Chlamydia Antigen Rapid Test Cassette704Genesprint Group LimitedYesCommercialisedNoNoAntigenenvelope protein2022-08-24 09:08:01 CET2846Immuno-AntigenImmunoassay5CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2.04%False negatives2.01%PrecisionEvaluatedAccuracy100%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.95%AntigenClinical Specificity97.98%AntigenType of antigenEnvelop protein1609Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV- 2704Genesprint Group LimitedYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2022-08-24 09:08:01 CET1289Immuno-AntibodyYesNoImmunoassayQualitativeColloidal gold10LOD170CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.64%False negatives1.52%PrecisionEvaluatedAccuracy87.06% IgGAccuracy86.57% IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity87.06% IgGClinical Sensitivity86.57% IgM3139Neisseria Gonorrhoeae Antigen Rapid Test Cassette704Genesprint Group LimitedYesCommercialisedNoNoAntigenenvelope protein2022-08-24 09:08:01 CET2847Immuno-AntigenYesImmunoassay5CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.99%False negatives1.43%PrecisionEvaluatedAccuracy98.38%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.01%AntigenClinical Specificity98.57%AntigenType of antigenEnvelop protein1595SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold)704Genesprint Group LimitedYesCommercialisedNoNoNear POC / POCAntigenNasal swabnucleocapsid protein2022-08-24 09:08:01 CET1275Immuno-AntigenYesNoImmunoassayQualitativeColloidal gold5Rapid diagnostic test cassette colloidal gold LOD103AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives5%(Less than 5%)False negatives5%(Less than 5%)PrecisionEvaluatedAccuracy99%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity98.96%Type of antigennucleoprotein1276Immuno-AntigenYesNoImmunoassayQualitativeColloidal gold5Rapid diagnostic test cassette colloidal gold LOD103AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives5%(Less than 5%)False negatives5%(Less than 5%)PrecisionEvaluatedAccuracy99%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity98.96%Type of antigennucleoprotein3140Trichomonas Vaginalis Antigen Rapid Test Cassette704Genesprint Group LimitedYesCommercialisedNoNo2022-12-02 09:22:17 CET2848Immuno-AntigenImmunoassay5CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2.25%False negatives1.29%PrecisionEvaluatedAccuracy98.38%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.75%AntigenClinical Specificity98.71%AntigenType of antigenEnvelop protein557ACE2 antibody [N1N2], N-term (GTX101395)353GeneTex International CorporationUnited Stateswww.genetex.com/NoCommercialisedNoNoAutomatedManualAntibody2022-08-24 09:08:01 CET472Immuno-AntibodyImmunoassay558SARS-CoV / SARS-CoV-2 (COVID-19) nucleocapsid antibody [6H3] (GTX632269)_ELISA353GeneTex International CorporationUnited Stateswww.genetex.com/NoCommercialisedNoNoAutomatedManualAntibody2022-08-24 09:08:01 CET473Immuno-AntibodyELISA559SARS-CoV / SARS-CoV-2 (COVID-19) spike antibody [1A9] (GTX632604)353GeneTex International CorporationUnited Stateswww.genetex.com/NoCommercialisedNoNoAutomatedManualAntibody2022-08-24 09:08:01 CET474Immuno-AntibodyImmunoassay560SARS-CoV-2 (COVID-19) nucleocapsid antibody (GTX135357)_ELISA353GeneTex International CorporationUnited Stateswww.genetex.com/NoCommercialisedNoNoAutomatedManualAntibody2022-08-24 09:08:01 CET475Immuno-AntibodyELISA561SARS-CoV-2 (COVID-19) nucleocapsid protein (GTX135357-pro)353GeneTex International CorporationUnited Stateswww.genetex.com/NoCommercialisedNoNoAutomatedManualAntigen2022-08-24 09:08:01 CET476Immuno-AntigenImmunoassay562SARS-CoV-2 (COVID-19) spike antibody (GTX135360)_ELISA353GeneTex International CorporationUnited Stateswww.genetex.com/NoCommercialisedNoNoAutomatedManualAntibody2022-08-24 09:08:01 CET477Immuno-AntibodyELISA563COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)524Genitech NSAN Pharmaceutical Pvt. Ltd.Indiawww.linkedin.com/in/genitech-nsan-pharmaceutical-pvt-ltd-3739061a0/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2022-08-24 09:08:01 CET763Immuno-AntibodyYesNoImmunoassayQualitative10Rapid diagnostic test cassette Not found Accuracy92.9%3149GENnasal SARS-CoV-2 Antigen Rapid Test1384Genius Pharmaceutical AGSwitzerlandYesCommercialisedNoNoManualAntigenNasal swabSARS-CoV689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1321B.1.617.2Delta678B.1.1.529Omicronnucleocapsid proteinSensitivity, specificity and accuracy are from the newest performance evaluation - including false-positives and false-negatives. German Paul-Ehrlich-Institur (PEI) evaluated this test under the test-ID AT 1269/212022-08-24 09:08:01 CET2857Immuno-AntigenYesNoImmunochromatographyQualitativeMembrane-based10LOD400TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1%False negatives6%PrecisionEvaluatedAccuracy98.5%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.5%Clinical Specificity99.9%Type of antigenNucleocapsid protein3127GENnow SARS-CoV-2 Antigen Rapid Test Cassette1384Genius Pharmaceutical AGSwitzerlandYesCommercialisedNoNoManualAntigenNasal swabNasopharyngeal swabOropharyngeal swabSARS-CoV689B.1.1.7Alpha1032B.1.351Beta1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon678B.1.1.529Omicron1321B.1.617.2Deltanucleocapsid proteinPlease accept our correction of specimen type. Looks like that the tick marks in the electronic form were not taken over. It is definitely oropharyngeal swab, nasal swab and nasopharyngeal swab for our GENnow (3127).2022-08-24 09:08:01 CET2835Immuno-AntigenYesNoNoImmunoassayQualitativeMembrane-based15LOD50pg/ml for recombine COVID-19 proteinCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1%False negatives6%PrecisionEvaluatedAccuracy100%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.3%95% KI: 92.20%~ 98.70%Clinical Specificity99.7%95% KI: 98.20%~ 99.90%Type of antigenNucleocapsid protein2642Virusee® SARS-CoV-2 Antigen Rapid Test (Colloidal Gold)1207Genobio Pharmaceutical Co. Ltd.Chinawww.era-bio.comYesCommercialisedYesYesNear POC / POCAntigenNasopharyngeal swabOropharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1321B.1.617.2Deltanucleocapsid proteinThe product is listed by BfArM with AT1100/21 ,and has positive results by PEI.2022-08-24 09:08:01 CET2347Immuno-AntigenYesNoImmunoassayQualitativeColloidal gold15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.74%4/538False negatives2.8%9/321PrecisionEvaluatedAccuracy98.49%846/859ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.2%Clinical Specificity99.26%Type of antigenNucleocapsid protein786Novel Coronavirus (2019-nCoV) IgG/IgM Test Kit (Colloidal Gold)472Genrui Biotech Inc.Chinawww.genrui-bio.comYesCommercialisedNoNoLab-basedAntibodyIgGIgM2022-08-24 09:08:01 CET653Immuno-AntibodyImmunoassay www.genrui-bio.com/products-detail.php?ProId=572012SARS-CoV-2 Antigen Test Kit (Colloidal Gold)472Genrui Biotech Inc.Chinawww.genrui-bio.comYesCommercialisedYesYesNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swab1032B.1.351Beta1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.3nucleocapsid proteinPEI Evaluation: Positive2022-08-24 09:08:01 CET1690Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD180AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.98%False negatives8.85%PrecisionEvaluatedAccuracy94.88%Nasal SwabAccuracy97.15%NP SwabReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity91.15%Nasal SwabClinical Sensitivity95.03%NP SwabClinical Specificity99.02%Nasal SwabClinical Specificity99.02%NP SwabType of antigenNucleoprotein4159SARS-CoV-2 Antigen Test Kit (Colloidal Gold) (Self-Testing)472Genrui Biotech Inc.Chinawww.genrui-bio.comYesCommercialisedNoNoManualOtherAntigenNasal swabSARS-CoV-220A.23.170AT.1678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526IotaB.1.526.1B.1.526.23939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu1439C.362041C.37LambdaOther1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid protein2022-10-14 10:51:22 CET5192Immuno-AntigenYesYesN.A.ImmunochromatographyQualitativeSandwichColloidal gold15LOD180TCID50/mlCalibrationNot evaluatedAnalytical Sensitivity100%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives0%False negatives1.87%PrecisionEvaluatedAccuracy99.03%RobustnessEvaluatedClinical Sensitivity98.13%Clinical Specificity100%1620SARS-CoV-2 Spike S1-RBD IgG&IgM ELISA Detection Kit111GenScriptNetherlandswww.genscript.comNoCommercialisedNoNoLab-basedAntibodyIgGIgMPlasmaSerum2022-08-24 09:08:01 CET1300Immuno-AntibodyELISAFalse positives0%False negatives0%Type of antigenspike protein2860cPass™ SARS-CoV-2 Neutralization Antibody Detection Kit1270GenScript Biotech CorporationChinahttps://www.genscript.com/YesCommercialisedNoNoManualAntibodyPlasmaSerumcPass™ SARS-CoV-2 Neutralization Antibody Detection Kit is authorized with FDA EUA authorization. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/eua-authorized-serology-test-performance.2022-08-24 09:08:01 CET2565Immuno-AntibodyELISAQuantitative90CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%Compared to PRNT50 and PRNT90, out of 88 negative samples, 0 is positiveFalse negatives0%Compared to PRNT50 and PRNT90, out of 26 positive samples, 0 is negativePrecisionEvaluatedAccuracy100%Neutralizing antibodyReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%Neutralizing antibodyClinical Specificity100%Neutralizing antibodyType of antigenSpike protein1454COVID-19/Flu A/B Antigen Combo Rapid Test340GenSure Biotech Inc.Chinawww.gensbio.com/YesCommercialisedNoNoNear POC / POCAntigenNasal swabnucleocapsid protein2022-08-24 09:08:01 CET1204Immuno-AntigenYesNoImmunoassayQualitative15Accuracy: 97.5 (Influenza A); 96.9 (Influenza B). Clinical sensitivity: 91.7 (Influenza A); 86.2 (Influenza B)LOD50AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positivesThe samples collected were contaminated, do not follow the instructions manual, etc. False negativesSamples collected contained low levels of the virus, do not follow the instructions manual, etc. PrecisionEvaluatedAccuracy98.9%(COVID-19)ReproducibilityNot evaluatedRobustnessNot evaluatedClinical Sensitivity96.9%(COVID-19)Type of antigennucleoprotein1253GenSure COVID-19 Antigen Rapid Kit340GenSure Biotech Inc.Chinawww.gensbio.com/YesCommercialisedYesYesNear POC / POCAntigenNasal swabNasopharyngeal swabSARS-CoV-2678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1223B.1.525Eta1224B.1.526Iota1320B.1.617.1Kappa1321B.1.617.2Delta1323B.1.621Mu2041C.37Lambda1495P.1Gammanucleocapsid proteinGenSure COVID-19 Antigen Rapid Test Kit (REF: P2004)2022-11-28 10:30:56 CET5343Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwichNot found15LOD50TCID50/mlCalibrationNot evaluatedAnalytical Sensitivity96.86%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives%False negatives3.14%PrecisionEvaluatedAccuracy98.91%ReproducibilityEvaluatedRobustnessEvaluatedType of antigenNucleocapsid protein2853GenSure COVID-19 Antigen Rapid Test Kit340GenSure Biotech Inc.Chinawww.gensbio.com/YesCommercialisedYesYesManualAntigenNasal swabSaliva689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu2041C.37Lambda2022-08-24 09:08:01 CET2558Immuno-AntigenYesNoImmunoassayQualitative15LOD50TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positivesThere is a very small possibility of false positives.False negativesThere is a very small possibility of false negatives.PrecisionEvaluatedAccuracy98.68%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.73%Clinical Specificity100%Type of antigenNucleocapsid protein565GenSure COVID-19 IgG/IgM Rapid Test (REF: P2002)340GenSure Biotech Inc.Chinawww.gensbio.com/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2022-08-24 09:08:01 CET450Immuno-AntibodyYesNoImmunoassayQualitative15566GenSure COVID-19 IgM Rapid Test (REF: P2001)340GenSure Biotech Inc.Chinawww.gensbio.com/YesCommercialisedNoNoNear POC / POCAntibodyIgMWhole blood2022-08-24 09:08:01 CET452Immuno-AntibodyYesNoImmunoassayQualitative15Clinical Sensitivity95%Clinical Specificity95%1826GenSure COVID-19 Neutralizing Antibody Test (Fluorescence)340GenSure Biotech Inc.Chinawww.gensbio.com/YesCommercialisedNoNoManualAntibody2022-08-24 09:08:01 CET1503Immuno-AntibodyImmunoassayNeutralization Antibody (NAb)15LODEvaluatedCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedReproducibilityNot evaluatedRobustnessNot evaluated2112GenSure COVID-19 Neutralizing Antibody Test (Latex)979GenSure Biotech Inc.Chinahttp://www.gensbio.comYesCommercialisedNoNoAntibody689B.1.1.7Alpha1032B.1.351Beta2022-08-24 09:08:01 CET1802Immuno-AntibodyImmunoassayNeutralization Antibody (NAb)15LOD0AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positivesThere is a very small possibility of false positives.False negativesThere is a very small possibility of false negatives.PrecisionEvaluatedAccuracy98.1%ReproducibilityNot evaluatedRobustnessNot evaluatedClinical Sensitivity94.6%Clinical Specificity100%2593Novel Coronavirus (2019-nCoV) IgM/IgG antibody Fast Test Kit (Immunofluorescence Assay)112Getein Biotech Inc.Chinaen.bio-gp.com.cnYesCommercialisedNoNoSemi-automatedIgGIgMPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351BetaNovel Coronavirus (2019-nCoV) IgM/IgG antibody Fast Test Kit (Immunofluorescence Assay) is intended for the quantitative detection of 2019-Novel Coronavirus IgM and IgG antibody in serum, plasma or whole blood samples from patients suspected of COVID-19 infection by a healthcare provider.2022-08-24 09:08:01 CET2298Immuno-AntibodyYesImmunoassayQualitativeSandwichImmunofluorescence10CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2.73%8 of 292False negatives3.89%6 of 154PrecisionEvaluatedAccuracy96.86%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.1%Clinical Specificity97.26%Type of antigenOther2590One Step Test for SARS-CoV-2 Antigen (Colloidal Gold) (Saliva)112Getein Biotech Inc.Chinaen.bio-gp.com.cnYesCommercialisedNoNoManualAntigenSaliva689B.1.1.7Alpha1032B.1.351BetaOne Step Test for SARS-CoV-2 Antigen (Colloidal Gold) is intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in human saliva samples from patients suspected of COVID-19 infection by a healthcare provider.2022-08-24 09:08:01 CET2295Immuno-AntigenNoImmunoassayQualitativeSandwichColloidal gold10LOD200TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.38%1 of 257False negatives1.29%2 of 154PrecisionEvaluatedAccuracy99.27ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.7%Clinical Specificity99.61%Type of antigenNucleocapsid protein190One Step Test for Novel Coronavirus(2019-nCoV) IgM/IgG antibody (Colloidal Gold)112Getein Biotech Inc.Chinaen.bio-gp.com.cnYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2022-08-24 09:08:01 CET578Immuno-AntibodyYesImmunoassayQualitativeColloidal gold15Rapid diagnostic test cassette Colloidal Gold 2183One Step Test for SARS-CoV-2 Antigen (Colloidal Gold)1017Getein Biotech Inc.Chinaen.bio-gp.com.cnYesCommercialisedYesYesManualAntigenNasal swabSaliva689B.1.1.7Alpha1032B.1.351Betanucleocapsid proteinOne Step Test for SARS-CoV-2 Antigen (Colloidal Gold) is intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in human nasal swab samples or saliva samples from patients suspected of COVID-19 infection by a healthcare provider.2022-08-24 09:08:01 CET1884Immuno-AntigenYesNoImmunoassayQualitativeSandwichColloidal gold10LOD200AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2.9%(5 of 170)False negatives2.9%(5 of 170)PrecisionEvaluatedAccuracy98.13%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.06%Clinical Specificity98.71%Type of antigenNucleoprotein1820SARS-CoV-2 Antigen (Colloidal Gold)112Getein Biotech Inc.Chinaen.bio-gp.com.cnYesCommercialisedYesYesManualAntigenNasal swabSaliva689B.1.1.7Alpha1032B.1.351Betanucleocapsid proteinOne Step Test for SARS-CoV-2 Antigen (Colloidal Gold) is intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in human nasal swab samples or saliva samples from patients suspected of COVID-19 infection by a healthcare provider.2022-08-24 09:08:01 CET1498Immuno-AntigenYesNoImmunoassayQualitativeSandwichColloidal gold10The antigen test has been validated by Germany for the use. PEI report is availableLOD200AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2.9%5 of 170False negatives2.9%5 of 170PrecisionEvaluatedAccuracy98.13%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.06%Clinical Specificity98.71%Type of antigennucleoprotein2591SARS-CoV-2 Antigen Fast Test Kit (Immunofluorescence Assay)112Getein Biotech Inc.Chinaen.bio-gp.com.cnYesCommercialisedNoNoSemi-automatedAntigenNasal swab689B.1.1.7Alpha1032B.1.351BetaSARS-CoV-2 Antigen Fast Test Kit (Immunofluorescence Assay) is intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in human nasal swab samples from patients suspected of COVID-19 infection by a healthcare provider.2022-08-24 09:08:01 CET2296Immuno-AntigenYesImmunoassayQualitativeSandwichImmunofluorescence10LOD200TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.64%1 of 154False negatives1.47%1 of 68PrecisionEvaluatedAccuracy99.1%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.53%Clinical Specificity99.35%Type of antigenNucleocapsid protein2592SARS-CoV-2 Neutralizing Antibody Fast Test Kit (Immunofluorescence Assay)112Getein Biotech Inc.Chinaen.bio-gp.com.cnYesCommercialisedNoNoSemi-automatedAntibodyPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351BetaSARS-CoV-2 Neutralizing Antibody Fast Test Kit (Immunofluorescence Assay) is intended for in vitro qualitative detection of SARS-CoV-2 neutralizing antibody in serum, plasma or whole blood samples. The test is only used for professional and laboratory use, not for home testing.2022-08-24 09:08:01 CET2297Immuno-AntibodyYesImmunoassayQualitativeCaptureImmunofluorescence15LOD0.50 BAU/mLCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.38%1 of 257False negatives0.65%1 of 152PrecisionEvaluatedAccuracy99.51%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.34%Clinical Specificity99.61%Type of antigenOther2695Novel Coronavirus (2019-nCoV) Antigen Test Kit (Colloidal gold immunochromatography)1231Glallergen Co. Ltd.YesCommercialisedYesYesManualAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2Zeta678B.1.1.529OmicronThe product is listed by BfArM with AT755/21 ,and has positive results by PEI.2022-08-24 09:08:01 CET2400Immuno-AntigenYesNoImmunochromatographyQualitativeColloidal gold15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.98%False negatives5.56%PrecisionEvaluatedAccuracy96.67%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.44%Clinical Specificity99.02%Type of antigenNucleocapsid protein2800Novel Coronavirus (2019-nCoV) Antigen Test Kit (Colloidal Gold Immunochromatography) - Nasopharyngeal1237Glallergen Co. Ltd.Chinawww.glallergen.comYesCommercialisedNoNoManualAntigenNasopharyngeal swabSARS-CoV689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2Zeta678B.1.1.529Omicronnon-structural protein NS6non-structural protein NSP6The principle of the kit is based on the nucleocapsid protein of SARS- CoV-2,and the performance is not affected by mutations in SARS- Cov-2 spike glycoprotein antigens.2022-08-24 09:08:01 CET2505Immuno-AntigenYesNoYesImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD9.65TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positivesnot allowedFalse negativesImproper operation procedures, below limits detection, mutant strains, disease stagePrecisionEvaluatedAccuracy97.57%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.19%Clinical Specificity99.01%Type of antigenNonstructural protein NS62802Novel Coronavirus (2019-nCoV) Antigen Test Kit (Colloidal gold immunochromatography) - Saliva1237Glallergen Co. Ltd.Chinawww.glallergen.comYesCommercialisedNoNoManualAntigenSaliva689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThe COVID-19 Antigen Rapid Test Kit - Oral saliva specimen collection - is a lateral flow immunoassay based on the principle of the double-antibody sandwich technique. The test uses SARS-CoV-2 antibody (test line T) and goat anti-mouse IgG (control line C) immobilized on a nitrocellulose strip.2022-08-24 09:08:01 CET2507Immuno-AntigenYesImmunochromatographyQualitativeSandwich, Double15LOD9.65TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positivesnot allowedFalse negativesImproper preparation, mutant strains, virus in the samples below detection limitsPrecisionEvaluatedAccuracy96.19%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.52%Clinical Specificity99.02%Type of antigenNonstructural protein NS62777Novel Coronavirus (2019-nCov) Antigen Test Kit (Colloidal Gold immunochromatography)- Lolly Pop1237Glallergen Co. Ltd.Chinawww.glallergen.comYesCommercialisedNoNoManualAntigenSaliva689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThe COVID-19 Antigen Rapid Test Kit is intended for in vitro qualitative detection of 2019-nCoV nucleocapsid antigens in oral saliva specimen from individuals who are suspected of COVID-19.2022-08-24 09:08:01 CET2482Immuno-AntigenYesImmunochromatographyQualitativeSandwich, DoubleColloidal gold20LOD9.65TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positivesFalse positive is not allowedFalse negativesImproper operation procedures, below limits detection, mutant strains, disease stagePrecisionEvaluatedAccuracy96.67%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.59%Clinical Specificity99.02%Type of antigenNonstructural protein NS64064Novel Coronavirus (2019-nCoV) Antigen Test Kit (Latex Method)1231Glallergen Co. Ltd.YesCommercialisedYesYesManualAntigenNasal swabSARS-CoV-220A.23.170AT.1678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526IotaB.1.526.1B.1.526.23939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu1439C.362041C.37Lambda1495P.1Gamma1518P.2Zeta1519P.3Thetanon-structural protein NSP1non-structural protein NSP10non-structural protein NSP12non-structural protein NSP13non-structural protein NSP14non-structural protein NSP15non-structural protein NSP16non-structural protein NSP2non-structural protein NSP3non-structural protein NSP4non-structural protein NSP5non-structural protein NSP6non-structural protein NSP7non-structural protein NSP8non-structural protein NSP9nucleocapsid protein2022-09-29 09:07:46 CET20271Immuno-AntigenYesN.A.NoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD9.65TCID50/mlCalibrationEvaluatedAnalytical Sensitivity94.44%Analytical Specificity99.02%Analysis of cross reactivityEvaluatedFalse positives0.66%False negatives6.94%PrecisionEvaluatedAccuracy96.53%RobustnessEvaluatedClinical Sensitivity93.06%Clinical Specificity99.34%2707Novel Coronavirus (2019-nCoV) Neutralization Antibody Test Kit (Colloidal Gold Immunochromatography)1237Glallergen Co. Ltd.Chinawww.glallergen.comYesCommercialisedNoNoManualAntibodyWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2Zetanon-structural protein NSP6ORF1a polyproteinORF1ab polyproteinNovel coronavirus (2019-nCoV) neutralization antibody test kit is a solid phase immunochromatographic assay for the in vitro qualitative detection of neutralization antibodies in human serum, plasma and whole blood after vaccination against 2019-nCoV.2022-08-24 09:08:01 CET2412Immuno-AntibodyYesYesImmunochromatographyQualitativeSandwich, DoubleColloidal gold20LOD9.65TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positivesFalse positive is not allowedFalse negativesImproper operation procedures, below limits detection, mutant strains, disease stagePrecisionEvaluatedAccuracy96.67%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.44%Clinical Specificity99.02%Type of antigenNonstructural protein NS61197SARS-CoV-2 Antigen Kit (Colloidal Gold)117Goldsite Diagnostics Inc.Chinaen.goldsite.com.cn/YesCommercialisedYesYesManualNear POC / POCAntigenNasal swabNasopharyngeal swabOther689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.2678B.1.1.529Omicron1518P.2Zetanucleocapsid proteinN/A2022-08-24 09:08:01 CET983Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwichColloidal gold15LOD2.5ng/mL2.5 ng/mL of SARS-CoV-2 nucleocapsid protein antigen.CalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracy97.84%95% CI: 95.78 – 99.06%ReproducibilityEvaluatedClinical Sensitivity93.04%95% CI: 86.75 – 96.95%Clinical Specificity100%95% CI: 98.56 – 100.0%Type of antigenNucleocapsid protein192SARS-CoV-2 IgG/IgM Kit (manual)117Goldsite Diagnostics Inc.Chinaen.goldsite.com.cn/YesCommercialisedNoNoAutomatedManualAntibodyIgGIgMWhole blood2022-08-24 09:08:01 CET154Immuno-AntibodyYesNoImmunoassayQualitativeFluorescence121145GENEDIA W ONE COVID 19 IgM&IgG600Green Cross Medical Science Corp.South Koreawww.greencrossms.com/eng/main.do?lang=ENYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2022-08-24 09:08:01 CET922Immuno-AntibodyYesNoImmunoassayQualitative15Accuracy98%Clinical Sensitivity95.6%17472019-nCoV Antigen Test Kit (colloidal gold method)779Guangdong Hecin Scientific Inc.Chinahttps://www.hecin-scientific.cn/YesCommercialisedYesYesNear POC / POCAntigenNasal swabSARS-CoV678B.1.1.529Omicronnucleocapsid proteinother pathogens tested for cross-reactivity: Influenza A H7N9，Rhinovirus C, Adenovirus(type 1,2, 4, 5, 55), Measles virus, Rotavirus, Norovirus, Haemophiluspamsuis2022-08-24 09:08:01 CET3678Immuno-AntigenNoYesImmunochromatographyQualitativeSandwich, DoubleColorimetry15LOD175TCID50/mlAnalysis of cross reactivityEvaluatedFalse positives0.22%False negatives2.91%PrecisionEvaluatedAccuracy98.28%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.09%Clinical Specificity99.78%Type of antigenNucleocapsid protein40882019-nCoV Antigen Test Kit (colloidal gold method) (for self-testing)779Guangdong Hecin Scientific Inc.Chinahttps://www.hecin-scientific.cn/YesCommercialisedNoNoNear POC / POCAntigenNasal swabSARS-CoV-220A.23.170AT.1678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526IotaB.1.526.1B.1.526.23939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu1439C.362041C.37Lambda1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid protein2022-09-20 17:22:27 CET3843Immuno-AntigenYesYesYesImmunochromatographyQualitativeSandwich, DoubleImmunofluorescence15LOD175TCID50/mlCalibrationNot evaluatedAnalytical Sensitivity100%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives0.22% (1 false positive out of 263 PCR negative samples.)False negatives2.91%(9 false negative results out of 101 PCR positive samples for Ct<=30.)PrecisionEvaluatedAccuracy99.28%RobustnessEvaluatedClinical Sensitivity97.09%Clinical Specificity99.78%18072019-nCoV IgM/IgG Antibody Test Kit (colloidal gold method)779Guangdong Hecin Scientific Inc.Chinahttps://www.hecin-scientific.cn/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgM/2022-08-24 09:08:01 CET1484Immuno-AntibodyYesImmunoassayQualitativeColloidal gold15LOD1AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2AUFalse negatives3AUPrecisionEvaluatedAccuracy98.02%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.17%Clinical Specificity98.63%18112019-nCoV Neutralizing Antibody Test Kit (colloidal gold method)779Guangdong Hecin Scientific Inc.Chinahttps://www.hecin-scientific.cn/YesCommercialisedNoNoLab-basedAntibodyOther2022-08-24 09:08:01 CET1490Immuno-AntibodyYesImmunoassayQualitativeNeutralization Antibody (NAb)15LOD1AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives16AU16False negatives8AU8PrecisionEvaluatedAccuracy91.97%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity91.3%Clinical Specificity92.27%Type of antigenother18122019-nCoV Neutralizing Antibody Test Kit (Fluorescent immunochromatography)779Guangdong Hecin Scientific Inc.Chinahttps://www.hecin-scientific.cn/YesCommercialisedNoNoLab-basedAntibody2022-08-24 09:08:01 CET1491Immuno-AntibodyImmunochromatographyQualitativeNeutralization Antibody (NAb)15fluorescence detectionLOD1AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives5False negatives3PrecisionEvaluatedAccuracy97.32%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.74%Clinical Specificity97.58%18092019-nCoV/IAV/IBV Antigen Test Kit (colloidal gold method)779Guangdong Hecin Scientific Inc.Chinahttps://www.hecin-scientific.cn/YesCommercialisedNoNoNear POC / POCAntigennucleocapsid protein2022-08-24 09:08:01 CET1487Immuno-AntigenYesImmunoassayQualitativeColorimetry15LOD1AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2AUFalse negatives2AUPrecisionEvaluatedAccuracy98.51%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.23%Clinical Specificity99.07%Type of antigennucleoprotein1806COVID-19 IgG Antibody Test Kit (colloidal gold method)779Guangdong Hecin Scientific Inc.Chinahttps://www.hecin-scientific.cn/YesCommercialisedNoNoNear POC / POCIgGhttps://www.hecin-scientific.cn/productinfo/362189.html2022-08-24 09:08:01 CET1488Immuno-AntibodyImmunoassayColorimetry13422019-nCoV Ag & Influenza A/B Rapid Co-DetectionKit (Immuno-Chromatography)569Guangdong Longsee Biomedical Co. Ltd.Chinawww.longseemed.comNoCommercialisedNoNoNear POC / POCAntigenSalivanucleocapsid protein2022-08-24 09:08:01 CET1110Immuno-AntigenYesNoImmunochromatographyOther15LOD0.1AUFalse positives0AUFalse negatives1AUAccuracy95%Clinical Sensitivity99%Type of antigennucleoprotein13232019-nCoV Ag & Influenza AB Ag RapidCo-Detection Kit (Immuno-Chromatography)569Guangdong Longsee Biomedical Co. Ltd.Chinawww.longseemed.comNoCommercialisedNoNoNear POC / POCAntigenSaliva2022-08-24 09:08:01 CET1090Immuno-AntigenYesNoImmunochromatographyOtherColorimetry15LOD0.1AUFalse positives0AUFalse negatives1AUAccuracy99%Clinical Sensitivity99%12162019-nCoV Ag Rapid Detection Kit (Immuno-Chromatography)569Guangdong Longsee Biomedical Co. Ltd.Chinawww.longseemed.comYesCommercialisedYesYesNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabSARS-CoV-220A.23.1678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526IotaB.1.526.1B.1.526.23939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu2041C.37LambdaOther1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid proteinThis update is mainly for vaviants detected.2022-10-12 09:45:49 CET3966Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD600TCID50/mlOropharyngeal swabLOD600TCID50/mlNasal swabLOD600TCID50/mlNasopharyngeal swabAnalysis of cross reactivityEvaluatedFalse positives0.28%Nasopharyngeal swabFalse positives0.32%Nasal swabFalse positives0.28%Oropharyngeal swabFalse negatives4.49%Nasopharyngeal swabFalse negatives5.85%Nasal swabFalse negatives4.78%Oropharyngeal swabPrecisionEvaluatedAccuracy97.64%Nasopharyngeal swabAccuracy97.6%Nasal swabAccuracy97.5%Oropharyngeal swabReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.51%Nasopharyngeal swabClinical Sensitivity95.22%Oropharyngeal swabClinical Sensitivity94.15%Nasal swabClinical Specificity99.72%Nasopharyngeal swabClinical Specificity99.72%Oropharyngeal swabClinical Specificity99.68%Nasal swabType of antigenNucleocapsid protein25042019-nCoV Ag Rapid Detection Kit (Immuno-Chromatography) (Nasopharyngeal Swab)1141Guangdong Longsee Biomedical Co. Ltd.Chinahttp://www.longseemed.com/YesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta1320B.1.617.1Kappa1321B.1.617.2Delta1224B.1.526Iota1518P.2Zeta1. Type if Antigen: Nucleocapsid protein (N protein); 2. PEI test is positive; 3. Approved and registered in Germany, Italy, Austria, Peru and so on.2022-08-24 09:08:01 CET2208Immuno-AntigenYesImmunoassaySandwich, Double15LOD600TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1AUFalse negatives17AUPrecisionEvaluatedAccuracy97.49%(Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.22%Antigen)Clinical Specificity99.72%(Antigen)25092019-nCoV Ag Rapid Detection Kit (Immuno-Chromatography) (Oropharyngeal swab)1141Guangdong Longsee Biomedical Co. Ltd.Chinahttp://www.longseemed.com/YesCommercialisedNoNoNear POC / POCAntigenOropharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta1320B.1.617.1Kappa1321B.1.617.2Delta1224B.1.526Iota1518P.2Zetanucleocapsid protein1. Type of Antigen: Nucleocapsid protein (N protein); 2. PEI test is positive; 3. Approved and registered in Germany, Italy, Belgium, Autria, Peru, and so on.2022-08-24 09:08:01 CET2213Immuno-AntigenYesImmunoassaySandwich, Double15LOD600TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives1AUFalse negatives19AUPrecisionEvaluatedAccuracy97.21%(Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.66%(Antigen)Clinical Specificity99.72%(Antigen)Type of antigenNucleocapsid protein (N protein)1440Coronavirus COVID-19 IgM/IgG Test Kit655Guangdong Wesail Biotech Co. Ltd.Chinahttp://en.wesailbio.com/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2022-08-24 09:08:01 CET1191Immuno-AntibodyYesNoImmunoassayQualitativeColloidal gold6LOD3.125CalibrationNot evaluatedAnalysis of cross reactivityNot evaluatedPrecisionNot evaluatedAccuracy93%ReproducibilityNot evaluatedRobustnessNot evaluatedClinical Sensitivity93%1428Coronavirus COVID-19 lgM/IgG Test Kit (colloidal)655Guangdong Wesail Biotech Co. Ltd.Chinahttp://en.wesailbio.com/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood http://en.wesailbio.com/product/82.html2022-08-24 09:08:01 CET1187Immuno-AntibodyYesNoImmunoassayQualitativeColloidal gold6Accuracy97.93%Clinical Sensitivity92.86%Clinical Specificity99%2266COVID-19 Ag Saliva Test Kit1014Guangdong Wesail Biotech Co. Ltd.Chinahttp://www.wesailbio.comYesCommercialisedNoNoLab-basedManualNear POC / POCAntigenSaliva689B.1.1.7Alpha1032B.1.351Beta1495P.1Gammano2022-08-24 09:08:01 CET1967Immuno-AntigenNoImmunochromatographyQualitativeSandwich15LOD1600AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives5AUFalse negatives10AUPrecisionEvaluatedAccuracy97.5%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity90.1%Clinical Specificity99%Type of antigenNucleoprotein1360COVID-19 Ag Test Kit655Guangdong Wesail Biotech Co. Ltd.Chinahttp://en.wesailbio.com/YesCommercialisedYesYesManualNear POC / POCAntigenNasal swabNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31518P.2Zetanucleocapsid proteinN/A2022-08-24 09:08:01 CET1132Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich, DoubleColorimetry15LOD80TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.3%False negatives3.7%PrecisionEvaluatedAccuracy98.8%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.3%Clinical Specificity99.7%Type of antigenNucleocapsid protein1470Flu+COVID-19 Ag Test Kit655Guangdong Wesail Biotech Co. Ltd.Chinahttp://en.wesailbio.com/YesCommercialisedNoNoNear POC / POCAntigenNasal swab2022-08-24 09:08:01 CET1217Immuno-AntigenYesNoImmunoassayQualitativeColloidal gold15LOD560AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives10False negatives0.8PrecisionEvaluatedAccuracy95.6%ReproducibilityNot evaluatedRobustnessNot evaluatedClinical Sensitivity91.1%3021COVID-19 Antigen Rapid Test Kit（Colloidal Gold）1344Guangzhou Biokey Health Technologies Co. Ltd.Chinahttp : // biokeyhealth.comYesCommercialisedNoNoManualAntigenNasal swabAdenovirusAdenovirus 3Adenovirus 7Bordetella PertussisChlamydia PneumoniaeCoronaviruses (HCoV)Alpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)MERS-CoVHemophilus InfluenzaeInfluenza AInfluenza A H1N1Influenza A H3N2Influenza A H5N1Influenza B VictoriaInfluenza B YamagataMumps Virus (MuV)Mycoplasma PneumoniaeParainfluenza Virus Type 1Parainfluenza Virus Type 2Parainfluenza Virus Type 3Parainfluenza Virus Type 4Respiratory Syncytial V (RSV)RhinovirusVaricella Zoster Virus (VZV)689B.1.1.7Alpha1032B.1.351Beta1321B.1.617.2Delta678B.1.1.529Omicronnucleocapsid proteinNone2022-08-24 09:08:01 CET2727Immuno-AntigenNoNoImmunoassayQualitativeMembrane-basedColloidal gold15LOD2340TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives5%5%False negatives5%5%PrecisionEvaluatedAccuracy95%AntigenReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity95%AntigenClinical Specificity100%AntigenType of antigenNucleocapsid protein1962019 Novel Coronavirus (2019-nCoV) IgG Antibody Detection Kit (ELISA Method)116Guangzhou Darui Biotechnology Co. Ltd.Chinawww.daruibiotech.com/NoCommercialisedNoNoAutomatedManualAntibody2022-08-24 09:08:01 CET152Immuno-AntibodyELISA1952019 Novel Coronavirus (2019-nCoV) IgM Antibody Detection Kit (ELISA Method)116Guangzhou Darui Biotechnology Co. Ltd.Chinawww.daruibiotech.com/NoCommercialisedNoNoAutomatedManualAntibody2022-08-24 09:08:01 CET151Immuno-AntibodyELISA198Novel Coronavirus 2019-nCoV IgG Antibody Detection Kit (Colloidal Gold Method)116Guangzhou Darui Biotechnology Co. Ltd.Chinawww.daruibiotech.com/NoCommercialisedNoNoNear POC / POCAntibody2022-08-24 09:08:01 CET155Immuno-AntibodyYesImmunoassayColloidal gold197Novel Coronavirus 2019-nCoV IgM Antibody Detection Kit (Colloidal Gold Method)116Guangzhou Darui Biotechnology Co. Ltd.Chinawww.daruibiotech.com/NoCommercialisedNoNoNear POC / POCAntibodyIgM2022-08-24 09:08:01 CET153Immuno-AntibodyYesImmunoassayColloidal goldRapid diagnostic test 24682019-nCoV Rapid Antigen Test382Guangzhou Decheng Biotechnology Co. Ltd.Chinawww.dochekbio.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabSaliva1032B.1.351Beta1223B.1.525Eta1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.3the product is evaluated in Swedish lab. And popularly accepted by the end use because of the easy operation.2022-08-24 09:08:01 CET2171Immuno-AntigenImmunochromatographySandwich, Double10LOD100TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.5%False negatives3.17%PrecisionEvaluatedAccuracy98.47%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.83%Clinical Specificity99.5%Type of antigenNucleoprotein24982019-nCoV Saliva Ag EASY TEST382Guangzhou Decheng Biotechnology Co. Ltd.Chinawww.dochekbio.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabSaliva689B.1.1.7Alpha1032B.1.351Beta1223B.1.525EtaThe Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from 2019-nCoV in saliva specimens directly collected from individuals who are suspected of COVID-19. and very easy to use.2022-08-24 09:08:01 CET2201Immuno-AntigenImmunochromatography10LOD100TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.85%False negatives6.09%PrecisionEvaluatedAccuracy96.55%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.91%Clinical Specificity99.15%Type of antigenNucleocapsid protein1318V-CHEK 2019-nCoV Ag & FLU A/B Combo Rapid Test382Guangzhou Decheng Biotechnology Co. Ltd.Chinawww.dochekbio.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabnucleocapsid protein2022-08-24 09:08:01 CET1086Immuno-AntigenYesNoImmunoassayQualitative15Rapid diagnostic test Card LOD100AUClinical Sensitivity96.67%[85.42(FLU A);85.34(FLU B)]Type of antigennucleoprotein1316V-CHEK 2019-nCoV Ag Rapid Test Kit382Guangzhou Decheng Biotechnology Co. Ltd.Chinawww.dochekbio.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabnucleocapsid protein2022-08-24 09:08:01 CET527Immuno-AntigenYesYesImmunoassayQualitativeFluorescence10Rapid diagnostic test card fluorescence LOD90AUClinical Sensitivity95.06%(Antigen)Type of antigennucleoprotein5762V-Chek 2019-nCoV Ag Rapid Test Kit (Immunochromatography)382Guangzhou Decheng Biotechnology Co. Ltd.Chinawww.dochekbio.comYesCommercialisedNoNoManualAntigenNasal swabAdenovirus 3Alpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Bordetella PertussisChlamydia PneumoniaeEpstein-Barr Virus (EBV)Human Metapneumovirus (HMPV)Influenza A H1N1Influenza A H3N2Influenza A H5N1Influenza B VictoriaInfluenza B YamagataMERS-CoVMycobacterium TuberculosisMycoplasma PneumoniaeParainfluenza Virus Type 2Respiratory Syncytial V (RSV)Rhinovirus678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu1495P.1Gammanucleocapsid protein2022-11-21 09:01:32 CET5333Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD100TCID50/mlCalibrationNot evaluatedAnalytical Sensitivity%Analytical Specificity%Analysis of cross reactivityEvaluatedFalse positives0.58%False negatives3.45%PrecisionEvaluatedAccuracy98.39%RobustnessEvaluatedClinical Sensitivity96.55%Clinical Specificity99.42%5763V-Chek 2019-nCoV Ag Saliva Rapid Test Card (Immunochromatography)382Guangzhou Decheng Biotechnology Co. Ltd.Chinawww.dochekbio.comYesCommercialisedNoNoManualAntigenSalivaAdenovirus 3Alpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Bordetella PertussisChlamydia PneumoniaeEpstein-Barr Virus (EBV)Human Metapneumovirus (HMPV)Influenza A H1N1Influenza A H3N2Influenza A H5N1Influenza B VictoriaInfluenza B YamagataMERS-CoVMycobacterium TuberculosisMycoplasma PneumoniaeParainfluenza Virus Type 2Respiratory Syncytial V (RSV)Rhinovirus70AT.1678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu1495P.1Gammanucleocapsid protein2022-11-21 09:00:58 CET5332Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold10LOD100TCID50/mlCalibrationNot evaluatedAnalytical Sensitivity%Analytical Specificity%Analysis of cross reactivityEvaluatedFalse positives1.17%False negatives7.86%PrecisionEvaluatedAccuracy96.47%RobustnessEvaluatedClinical Sensitivity92.14%Clinical Specificity98.83%2909V-Chek 2019-nCoV Ag Saliva Rapid Test Card (Immunochromatography)382Guangzhou Decheng Biotechnology Co. Ltd.Chinawww.dochekbio.comYesCommercialisedNoNoManualNear POC / POCAntigenSaliva689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu2041C.37Lambda678B.1.1.529Omicronnucleocapsid proteinRapid diagnostic test Card2022-08-24 09:08:01 CET2614Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich, Double10LOD100TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives1.17%False negatives7.86%PrecisionEvaluatedAccuracy96.47%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.14%Clinical Specificity98.83%Type of antigenNucleocapsid protein2244V-Chek 2019-nCoV Ag Speichel Schnelltestkarte HGH382Guangzhou Decheng Biotechnology Co. Ltd.Chinawww.dochekbio.comYesCommercialisedNoNoManualAntigenSaliva689B.1.1.7Alpha1032B.1.351BetaNo unpleasant or painful swab of the throat or nose is required for the test. It is ideal for children, nurseries, playschools, schools and in the private sector.2022-08-24 09:08:01 CET1945Immuno-AntigenNoImmunoassayOther10LOD97.12AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2.88%95,65%False negatives1.56%98,44%PrecisionEvaluatedAccuracy97%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95%Clinical Specificity98%Type of antigenNucleoprotein1314V-CHEK SARS-CoV-2 Ag Rapid Test Kit382Guangzhou Decheng Biotechnology Co. Ltd.Chinawww.dochekbio.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabnucleocapsid protein2022-08-24 09:08:01 CET1084Immuno-AntigenYesNoImmunoassayQualitative15Clinical Sensitivity96.67%AntigenType of antigennucleoprotein1325V-CHEK, 2019-nCoV Ag & FLU A/B Combo Rapid382Guangzhou Decheng Biotechnology Co. Ltd.Chinawww.dochekbio.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabnucleocapsid protein2022-08-24 09:08:01 CET1092Immuno-AntigenYesYesImmunoassayQualitative15LOD1000Clinical Sensitivity96.67(Antigen);85.42(FLU A);85.34(FLU B)Type of antigennucleoprotein1883V-CHEK, 2019-nCoV Ag Rapid Test Card (Immunochromatography)382Guangzhou Decheng Biotechnology Co. Ltd.Chinawww.dochekbio.comYesCommercialisedNoNoNear POC / POCAntigenSalivanucleocapsid protein2019-nCoV Ag Saliva Rapid Test Card ; The Test Card is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from 2019-nCoV in saliva specimens directly collected from individuals who are suspected of COVID-19 by their healthcare provider within the first 7 days of symptom onset. This Card uses a double-antibody sandwich to detect the antigen presence of novel coronavirus (2019-nCoV) in saliva samples. During detection, the gold labeled anti-2019-nCoV monoclonal antibody in the labeling pad binds to the 2019-nCoV antigen in the sample to form a complex. The reaction complex moves along the nitrocellulose membrane under the action of chromatography. It is then captured by the anti-2019-nCoV monoclonal antibody pre-coated in the detection zone (T) on the nitrocellulose membrane, and finally a red color reaction line is formed in the T zone. If the sample does not contain 2019-nCoV antigen, a red color reaction line cannot be formed in the T zone. Regardless of whether the sample to be tested contains 2019-nCoV antigen, a red reaction line will always form in the quality control area (C).2022-08-24 09:08:01 CET1562Immuno-AntigenYesNoImmunochromatographyQualitative15LOD100%CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positivesA reaction time of less than 15 minutes may lead to a false negative resultFalse negativesA reaction time of more than 15 minutes may lead a false positive result.PrecisionEvaluatedAccuracy97.12%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.65%Clinical Specificity98.44%Type of antigenNucleoprotein1326V-CHEK, 2019-nCoV Ag Rapid Test Kit (Fluorescence Immunochromatographic Assay)382Guangzhou Decheng Biotechnology Co. Ltd.Chinawww.dochekbio.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabnucleocapsid protein2022-08-24 09:08:01 CET1095Immuno-AntigenYesYesImmunochromatographyQualitativeFluorescence10LOD90AUClinical Sensitivity95.06%Type of antigennucleoprotein1324V-CHEK, 2019-nCoV Ag Rapid Test Kit (Immunochromatography)382Guangzhou Decheng Biotechnology Co. Ltd.Chinawww.dochekbio.comYesCommercialisedYesYesManualNear POC / POCAntigenNasal swabNasopharyngeal swabAdenovirus 3Alpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Bordetella PertussisChlamydia PneumoniaeEpstein-Barr Virus (EBV)Human Metapneumovirus (HMPV)Influenza AInfluenza A H1N1Influenza A H3N2Influenza A H5N1Influenza BInfluenza B VictoriaInfluenza B YamagataMERS-CoVMycobacterium TuberculosisMycoplasma PneumoniaeParainfluenza Virus Type 2Respiratory Syncytial V (RSV)Rhinovirus678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu2041C.37Lambda1495P.1Gammanucleocapsid proteinRapid diagnostic test2022-11-17 09:59:49 CET5320Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich, DoubleColloidal goldIVD rapid test kit15LOD100TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.33%Nasopharyngeal swabFalse positives0.33%Nasal swabFalse negatives9.48%Nasopharyngeal swabFalse negatives14.49%Nasal swabPrecisionEvaluatedAccuracy95.28%Nasal swabAccuracy97.16%Nasopharyngeal swabReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90.52%Nasopharyngeal swabClinical Sensitivity85.51%Nasal swabClinical Specificity99.67%Nasopharyngeal swabClinical Specificity99.67%Nasal swabType of antigenNucleocapsid protein2475Whisting 2019-nCoV Saliva Ag EASY TEST382Guangzhou Decheng Biotechnology Co. Ltd.Chinawww.dochekbio.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabSaliva689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.2B.1.526.11518P.2Zetahe Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from 2019-nCoV in saliva specimens directly collected from individuals who are suspected of COVID-19.2022-08-24 09:08:01 CET2178Immuno-AntigenNoImmunochromatographyQualitativeSandwich, Double10LOD100TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.85%False negatives6.09%PrecisionEvaluatedAccuracy96.55%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.91%Clinical Specificity99.15%Type of antigenNucleoprotein3094SARS-CoV-2 Antigen Test (Lateral Flow Method)1373Guangzhou Dongsheng Biotech Co. Ltd.Chinawww.gdsbio.comYesCommercialisedNoNoManualAntigenNasal swabNasopharyngeal swabOropharyngeal swabSARS-CoV689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1519P.3Theta1321B.1.617.2Delta2041C.37LambdaB.1.526.1B.1.526.2678B.1.1.529Omicron1518P.2Zetanucleocapsid protein3.7 × 10^5 TCID50 / mL SARS-CoV-2 virus is tested after heat extinguishing, and there is no HOOK effect. The following substances, which are naturally present in respiratory specimens or may be artificially introduced into the nasal cavity or nasopharynx, were evaluated at the following concentrations during the SARS-CoV-2 antigen rapid test and found that they did not affect the test performance: 5 mg/mL Human blood (EDTA anticoagulated), 5 mg/mL Mucin, 5 mg/mL Oseltamivir phosphate, 5 mg/mL Ribavirin, 5 mg/mL Levofloxacin, 5 mg/mL Azithromycin, 5 mg/mL Meropenem, 5 mg/mL Tobramycin, 20% (v/v) Phenylephrine, 20% (v/v) . Oxymetazoline, 20% (v/v) 0.9% sodium chloride, 20% (v/v) A natural soothing ALKALOL, 20% (v/v) Beclomethasone, 20% (v/v) Triamcinolone, 20% (v/v) Budesonide, 20% (v/v) Mometasone, 20% (v/v) Fluticasone, 20% (v/v) Fluticasone propionate2022-08-24 09:08:01 CET2800Immuno-AntigenYesNoNoImmunoassayQualitativeMembrane-based15LOD120TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.78%False negatives0.79%PrecisionEvaluatedAccuracy99.22%AntigenReproducibilityNot evaluatedRobustnessNot evaluatedClinical Sensitivity97.67%AntigenClinical Specificity99.48%AntigenType of antigenNucleocapsid protein199Combined Detection Kit for Novel Coronavirus (2019-nCoV) IgM/IgG Antibody118Guangzhou Fenghua Bioengineering Co. Ltd.Chinawww.bio-fenghua.com/en/index.aspNoCommercialisedNoNoNear POC / POCAntibodyIgGIgM2022-08-24 09:08:01 CET156Immuno-AntibodyYesImmunoassay 3459COVID-19 Antigen Rapid Test1404Guangzhou Weimi Bio-Tech Co., Ltd.Chinahttps://www.weimibio.cn/YesCommercialisedNoNoManualAntigenAnterior nasal swabOther678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1223B.1.525EtaOthernucleocapsid protein2022-08-24 09:08:01 CET3195Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwichColloidal gold20LOD250TCID50/mlAnalytical Sensitivity100%Analytical Specificity100%False positives0%False negatives4.59%Accuracy99.02%Clinical Sensitivity95.41%Clinical Specificity100%39912019-nCoV Antigen Test (Lateral Flow Method)124Guangzhou Wondfo Biotech Co. Ltd.Chinahttps://en.wondfo.com.cn/YesCommercialisedNoNoNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabSARS-CoV678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1321B.1.617.2Deltanucleocapsid protein2022-08-24 09:08:01 CET3656Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD110TCID50/mlAnalytical Sensitivity100%Analytical Specificity100%False positives0.52%False negatives2%Accuracy98.92%Clinical Sensitivity98%Clinical Specificity99.48%39922019-nCoV Antigen Test (Lateral Flow Method) - Nasal and Saliva124Guangzhou Wondfo Biotech Co. Ltd.Chinahttps://en.wondfo.com.cn/YesCommercialisedNoNoNear POC / POCAntigenNasal swabSalivaSARS-CoV678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1321B.1.617.2Deltanucleocapsid protein2022-08-24 09:08:01 CET3657Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwichColloidal gold10LOD100TCID50/mlAnalytical Sensitivity100%Analytical Specificity100%False positives0.61%False negatives1.63%Accuracy99.05%Clinical Sensitivity98.37%Clinical Specificity99.39%206Finecare SARS-CoV-2 Antibody Test124Guangzhou Wondfo Biotech Co. Ltd.Chinahttps://en.wondfo.com.cn/YesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET163Immuno-AntibodyYesYesImmunoassayQualitativeFluorescenceRapid diagnostic test chip fluorescence 1191Finecare SARS-CoV-2 IgG Test124Guangzhou Wondfo Biotech Co. Ltd.Chinahttps://en.wondfo.com.cn/YesCommercialisedNoNoNear POC / POCAntibodyIgG2022-08-24 09:08:01 CET976Immuno-AntibodyYesYesImmunoassayFluorescenceRapid diagnostic test Fluorescence 977Immuno-AntibodyYesImmunoassayRapid diagnostic test 1211Finecare SARS-CoV-2 IgM/IgG Test124Guangzhou Wondfo Biotech Co. Ltd.Chinahttps://en.wondfo.com.cn/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgM2022-08-24 09:08:01 CET994Immuno-AntibodyYesImmunoassay2929Finecare™ 2019-nCoV Antigen Test1285Guangzhou Wondfo Biotech Co. Ltd.Chinahttps://en.wondfo.com.cn/YesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swabOropharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.2678B.1.1.529Omicron1518P.2Zetanucleocapsid proteinRefer to IFU2022-08-24 09:08:01 CET2635Immuno-AntigenNoYesImmunoassayQualitativeSandwich, Double15LOD100TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives3AUFalse negatives2AUPrecisionEvaluatedAccuracy99.07%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.37%AntigenClinical Specificity99.43%AntigenType of antigenNucleocapsid protein2925Finecare™ 2019-nCoV RBD Antibody Test1285Guangzhou Wondfo Biotech Co. Ltd.Chinahttps://en.wondfo.com.cn/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumVenous whole bloodWhole bloodnucleocapsid proteinFinecare™ 2019-nCoV RBD Antibody Test is a fluorescence immunoassay used along with Finecare™ FIA Meters (Model No.: FS-113, FS-114, FS-205) for qualitative detection of spike receptor-binding domain (RBD) antibodies of novel coronaviruses (2019-nCoV) in human fingerstick whole blood, venipuncture whole blood, serum or plasma specimen.2022-08-24 09:08:01 CET2631Immuno-AntibodyNoYesImmunoassayQualitativeNeutralization Antibody (NAb)Fluorescence15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2AUFalse negatives1AUPrecisionEvaluatedAccuracy98.99%RBD AntibodyReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.83%RBD AntibodyClinical Specificity99.57%RBD Antibody1437Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)124Guangzhou Wondfo Biotech Co. Ltd.Chinahttps://en.wondfo.com.cn/YesCommercialisedYesYesNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabSARS-CoV678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1321B.1.617.2Deltanucleocapsid protein2022-10-12 09:14:29 CET5204Immuno-AntigenN.A.NoNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD110TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.52%False negatives2%N.APrecisionEvaluatedAccuracy98.92%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98%Clinical Specificity99.48%Type of antigenNucleocapsid protein1312Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)-Nasal swab124Guangzhou Wondfo Biotech Co. Ltd.Chinahttps://en.wondfo.com.cn/YesCommercialisedNoNoNear POC / POCAntigenNasal swabSARS-CoV689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1321B.1.617.2Delta678B.1.1.529Omicronnucleocapsid proteinN.A.2022-08-24 09:08:01 CET1082Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD110TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives/False negatives/PrecisionEvaluatedAccuracy98.6%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.83%Clinical Specificity99.08%Type of antigenNucleocapsid protein3589Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)-Nasopharyngeal/Oropharyngeal/Nasal swab124Guangzhou Wondfo Biotech Co. Ltd.Chinahttps://en.wondfo.com.cn/YesCommercialisedNoNoNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabSARS-CoV678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1321B.1.617.2Deltanucleocapsid protein2022-08-24 09:08:01 CET3306Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold152908Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)-Self-test1285Guangzhou Wondfo Biotech Co. Ltd.Chinahttps://en.wondfo.com.cn/YesCommercialisedNoNoNear POC / POCAntigenNasal swabSARS-CoV689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1321B.1.617.2Delta678B.1.1.529Omicronnucleocapsid proteinN.A.2022-08-24 09:08:01 CET2613Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, Double15LOD5000TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracy97.99%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.4%Clinical Specificity99.9%Type of antigenNucleocapsid protein461Wondfo SARS-CoV-2 Antibody Test (lateral flow method)124Guangzhou Wondfo Biotech Co. Ltd.Chinahttps://en.wondfo.com.cn/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaWhole blood2022-08-24 09:08:01 CET372Immuno-AntibodyYesNoImmunoassayQualitative15Analysis of cross reactivityEvaluatedReproducibilityEvaluatedClinical Sensitivity85.8%IgM+IgG1214Wondof SARS-CoV-2 Antigen Test (Lateral Flow Method)124Guangzhou Wondfo Biotech Co. Ltd.Chinahttps://en.wondfo.com.cn/YesCommercialisedNoNoNear POC / POCAntigen2022-08-24 09:08:01 CET998Immuno-AntigenYesNoImmunoassayQualitativeColloidal gold1212Wondof SARS-CoV-2 IgG Antibody Test (Lateral Flow Method)124Guangzhou Wondfo Biotech Co. Ltd.Chinahttps://en.wondfo.com.cn/YesCommercialisedNoNoNear POC / POCAntibodyIgG2022-08-24 09:08:01 CET996Immuno-AntibodyYesImmunoassayColloidal gold1306Wondof SARS-CoV-2 IgM Antibody Test124Guangzhou Wondfo Biotech Co. Ltd.Chinahttps://en.wondfo.com.cn/YesCommercialisedNoNoNear POC / POCAntibodyIgMPlasmaSerumWhole blood2022-08-24 09:08:01 CET1078Immuno-AntibodyYesNoImmunoassayQualitativeColorimetryRapid diagnostic test lateral flow colloidal gold 1213Wondof SARS-CoV-2 IgM Antibody Test (Lateral Flow Method)124Guangzhou Wondfo Biotech Co. Ltd.Chinahttps://en.wondfo.com.cn/YesCommercialisedNoNoNear POC / POCAntibodyIgM2022-08-24 09:08:01 CET997Immuno-AntibodyYesImmunoassayQualitative2904SARS-CoV-2 Antigen Rapid Testing kit(Colloidal Gold)1283Guangzhou Yunrui Medical Technology Co. Ltd.Chinahttps://jrui.onesite.alibaba.com/YesCommercialisedNoNoManualAntigenAnterior nasal swabMid-turbinates swabNasal swabNasopharyngeal swabOropharyngeal swabThroat swabOtherThe SARS-CoV-2 Antigen Rapid Testing kit(Colloidal Gold)of Guangzhou Yunrui Medical Technology Co., Ltd is a colloidal gold immunochromatography assay, intended for the qualitative detection of SARS-CoV-2 antigen in nasopharyngeal swab (NPS), oropharyngeal swab (OPS) and saliva specimens from individuals suspended SARS-CoV-2 infection patients. It is suitable for the pathogen examination for suspected novel coronavirus- induced pneumonia (COVID-19) patients.2022-08-24 09:08:01 CET2609Immuno-AntigenYesNoELISAQualitativeMicrotiterColloidal gold15LOD0.3ng/mLCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positivesResults are for reference only and cannot be used as the sole criterion for clinical diagnosisFalse negativesDue to methodological limitations, low virus burden in a specimen may lead to false negative resulPrecisionEvaluatedAccuracy98.77%95% CI:95.61%-99.85%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.28%95%CI:90.76%-99.96%Clinical Specificity99.04%95% CI: 94.76%-99.98%673SARS-CoV-2 IgM/IgG Combo Rapid Test Kit392Guanxhow Fenghua Bioengineering Co. Ltd.Chinawww.bio-fenghua.com/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole bloodnucleocapsid proteinspike protein2022-08-24 09:08:01 CET540Immuno-AntibodyYesNoImmunoassayQualitativeType of antigenSARS-CoV-2 N-, S1- and S2-Proteine1172Anti-COVID-19 virus IgM/IgG Test Kit (lateral flow assay)616H&Z Life Science Co. Ltd.South Koreawww.hzlifescience.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMOtherSerumWhole blood2022-08-24 09:08:01 CET953Immuno-AntibodyYesImmunoassayQualitative101636Novel Coronavirus COVID-19 IgM/IgG Test Kit (colloidal gold)732H-GuardChinawww.h-guard.com.cnNoCommercialisedNoNoNear POC / POCAntibody2022-08-24 09:08:01 CET1316Immuno-AntibodyYesImmunoassayColloidal gold104158SARS-CoV-2 Rapid Antigen Test Kit (RAT-01)1234HA TECH PTY Ltd.Australiahttps://ha-tech-ltd.com/YesCommercialisedNoNoManualNear POC / POCAntibodyNasal swabSARS-CoV-2678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1321B.1.617.2Deltanucleocapsid protein2022-10-14 09:36:48 CET4012Immuno-AntibodyYesYesNoImmunochromatographyQualitativeN.A.Colorimetry15LOD130TCID50/mlCalibrationNot evaluatedAnalytical Sensitivity96.97%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives5samplesThe RAT-01 Kit correctly identified 103/108 RT-PCR positive samples False negatives1samplesThe RAT-01 Kit correctly identified 300/301 RT-PCR negative samplesPrecisionEvaluatedAccuracy98.53%RobustnessEvaluatedClinical Sensitivity95.58%Clinical Specificity99.67%4160SARS-CoV-2 Rapid Antigen Test Kit (RAT-01)1234HA TECH PTY Ltd.Australiahttps://ha-tech-ltd.com/YesCommercialisedNoNoManualNear POC / POCAntibodyNasal swabSARS-CoV-2678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1321B.1.617.2Deltanucleocapsid protein2022-10-14 10:52:17 CET5193Immuno-AntibodyYesNoNoImmunochromatographyQualitativeN.A.Colorimetry15LOD130TCID50/mlN/ACalibrationNot evaluatedAnalytical Sensitivity96.97%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives5samplesThe RAT-01 Kit correctly identified 103/108 RT-PCR positive samples False negatives1samplesThe RAT-01 Kit correctly identified 300/301 RT-PCR negative samplesPrecisionEvaluatedAccuracy98.53%RobustnessEvaluatedClinical Sensitivity95.58%Clinical Specificity99.67%3005COVID-19 Antigen Rapid Test Device1331Hangzhou Aichek Medical Technology Co. Ltd.Chinawww.aichek.comYesCommercialisedYesYesManualNear POC / POCAntigenNasopharyngeal swab678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1321B.1.617.2Delta1495P.1Gammanucleocapsid proteinAichek COVID-19 Antigen Rapid Test Device has been listed of BfArm and ANSM.2023-02-01 14:54:39 CET5456Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich, Double15LOD50TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives%0 false positives in 350 samplesFalse negatives5%5 false negatives in 100 samplesPrecisionEvaluatedAccuracy98.75%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95%AntigenClinical Specificity100%AntigenType of antigenNucleocapsid protein4107SARS-CoV-2 (COVID-19) Antigen Rapid Test (Saliva) for self testing 1467Hangzhou AllTest Biotech Co LtdChinaYesCommercialisedNoNoNear POC / POCAntigenSalivaAdenovirus 3Adenovirus 7Alpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Influenza A H1N1Influenza A H3N2Influenza BMERS-CoVParainfluenza Virus Type 2Parainfluenza Virus Type 3Respiratory Syncytial V (RSV)20A.23.170AT.1678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526IotaB.1.526.1B.1.526.23939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu1439C.362041C.37LambdaOther1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid proteinThe SARS-CoV-2 (COVID-19) Antigen Rapid Test (Saliva) is a single-use test kit intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19 in human saliva. This test is designed for home use1 with self-collected saliva samples from symptomatic individuals who are suspected of being infected with SARS-CoV-2. The SARS-CoV-2 (COVID-19) Antigen Rapid Test (Saliva) obtain a preliminary results only, the final confirmation should be based on clinical diagnosis results.2022-09-29 09:36:38 CET3892Immuno-AntigenYesYesNoImmunoassayQualitativeSandwichImmunofluorescence15LOD100AU/mLCalibrationEvaluatedAnalytical Sensitivity99%Analytical Specificity99.7%Analysis of cross reactivityEvaluatedFalse positives0.01%False negatives0.003%PrecisionEvaluatedAccuracy99.6%RobustnessEvaluatedClinical Sensitivity99%Clinical Specificity99.7%2082019-nCoV IgG/IgM Rapid Test Cassette126Hangzhou AllTest Biotech Co. Ltd.Chinawww.alltests.com.cnYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2022-08-24 09:08:01 CET165Immuno-AntibodyYesImmunoassayQualitative6742019-nCoV IgG/IgM Rapid Test Dipstick126Hangzhou AllTest Biotech Co. Ltd.Chinawww.alltests.com.cnNoCommercialisedNoNoNear POC / POCAntibody2022-08-24 09:08:01 CET567Immuno-AntibodyYesImmunoassay1256COVID-19 and Influenza A+B Antigen Combo Rapid Test126Hangzhou AllTest Biotech Co. Ltd.Chinawww.alltests.com.cnYesCommercialisedNoNoNear POC / POCAntigen2022-08-24 09:08:01 CET1032Immuno-AntigenYesImmunoassay1386COVID-19 and M.pneumoniae IgG Combo Rapid Test126Hangzhou AllTest Biotech Co. Ltd.Chinawww.alltests.com.cnYesCommercialisedNoNoNear POC / POCAntibodyIgGPlasmaSerumWhole blood http://www.alltests.com.cn/EN/Prodetail.asp?newsid=1788&cclassid=2&classid=512022-08-24 09:08:01 CET1152Immuno-AntibodyYesNoImmunoassayQualitative10CalibrationNot evaluatedFalse positives2% IgG5.4% IgG (M.pneumoniae)False negatives0%7.8% IgG (M.pneumoniae)RobustnessNot evaluatedClinical Sensitivity100% IgG+ (Mycoplasma pneumoniae= 92.2% IgG )Clinical Specificity98.6% IgG+ (Mycoplasma pneumoniae = 93.7% IgG )1385COVID-19 and M.pneumoniae IgG/IgM Combo126Hangzhou AllTest Biotech Co. Ltd.Chinawww.alltests.com.cnYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2022-08-24 09:08:01 CET1151Immuno-AntibodyYesNoImmunoassayQualitative10Rapid diagnostic test lateral flow LOD0AU0CalibrationNot evaluatedFalse positives2% IgG+ M.pneumoniae IgG: 5.4%; M.pneumoniae IgM: 5.2%False positives4% IgMFalse negatives0% IgG+ M.pneumoniae IgG: 7.8%; M.pneumoniae IgM: 8.5%False negatives15% IgMRobustnessNot evaluatedClinical Sensitivity100% IgG+92.2(Mycoplasma pneumoniae IgG); 91.5(Mycoplasma pneumoniae IgM)Clinical Sensitivity85% IgMClinical Specificity98.6% IgG+ 93.7(Mycoplasma pneumoniae IgG); 93.7(Mycoplasma pneumoniae IgM)Clinical Specificity92.9% IgM2389COVID-19 Antigen Rapid Test (Nasopharyngeal Swab)1003Hangzhou AllTest Biotech Co. Ltd.Chinawww.alltests.com.cnYesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThe COVID-19 Antigen Rapid Test (Nasopharyngeal Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 antigens in nasopharyngeal swab specimens from individuals with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2 Antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19. The COVID-19 Antigen Rapid Test is intended for use by trained clinical laboratory personnel.2022-08-24 09:08:01 CET2091Immuno-AntigenYesImmunoassayQualitativeSandwich15LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.036AUFalse negatives0.008AUPrecisionEvaluatedAccuracy98%(Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.4%(Antigen)Clinical Specificity99.2%(Antigen)Type of antigenNucleoprotein1947COVID-19 Antigen Rapid Test (Oral Fluid)126Hangzhou AllTest Biotech Co. Ltd.Chinawww.alltests.com.cnYesCommercialisedNoNoNear POC / POCAntigenSalivanucleocapsid proteinThe COVID-19 Antigen Rapid Test (Oral Fluid) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in oral fluid specimens from individuals with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2 nucleocapsid protein antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.2022-08-24 09:08:01 CET1623Immuno-AntigenYesImmunochromatographyQualitative15LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.007AUFalse negatives0.0099AUPrecisionEvaluatedAccuracy97%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90.1%Clinical Specificity99.3%Type of antigenNucleoprotein2159COVID-19 Antigen Rapid Test (Oral Fluid) SELFTESTING1003Hangzhou AllTest Biotech Co. Ltd.Chinawww.alltests.com.cnYesCommercialisedNoNoNear POC / POCAntigenSaliva689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.1B.1.526.1B.1.526.21518P.2Zetanucleocapsid proteinThe COVID-19 Antigen Rapid Test (Oral Fluid) is a single-use test kit intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19 in human oral fluid. This test is designed for home use with self-collected oral fluid samples from symptomatic individuals who are suspected of being infected with COVID-19. The COVID-19 Antigen Rapid Test (Oral Fluid) obtain a preliminary results only, the final confirmation should be based on clinical diagnostic results.2022-08-24 09:08:01 CET1860Immuno-AntigenYesNoImmunoassayQualitativeSandwich15LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.099%False negatives0.007%PrecisionEvaluatedAccuracy97%(Antigen）ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90.1%(Antigen）Clinical Specificity99.3%(Antigen）Type of antigenNucleoprotein2402COVID-19 Antigen Rapid Test (Swab)(NP)1003Hangzhou AllTest Biotech Co. Ltd.Chinawww.alltests.com.cnYesCommercialisedNoNoNear POC / POCAntigenNasal swabNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.361224B.1.526Iota70AT.1B.1.526.1B.1.526.21518P.2ZetaThe COVID-19 Antigen Rapid Test (Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 Nucleocapsid Protein antigens in swab specimens from individuals with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2 Antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.2022-08-24 09:08:01 CET2104Immuno-AntigenNoImmunoassayQualitativeSandwich15LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.036AUFalse negatives0.01AUPrecisionEvaluatedAccuracy98.2%(Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.4%(Antigen)Clinical Specificity99%(Antigen)Type of antigenNucleoprotein1254COVID-19 Antigen Test cassette (FIA)126Hangzhou AllTest Biotech Co. Ltd.Chinawww.alltests.com.cnYesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swab2022-08-24 09:08:01 CET1030Immuno-AntigenYesImmunoassayQualitativeFluorescence15FIA method2302COVID-19 Antigen Test Cassette (Nasopharyngeal Swab)1003Hangzhou AllTest Biotech Co. Ltd.Chinawww.alltests.com.cnYesCommercialisedYesYesNear POC / POCAntigenNasopharyngeal swabAdenovirus 3Adenovirus 7Alpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)MERS-CoVInfluenza A H1N1Influenza A H3N2Influenza BParainfluenza Virus Type 2Parainfluenza Virus Type 3Respiratory Syncytial V (RSV)689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2Zeta678B.1.1.529Omicronnucleocapsid proteinThe COVID-19 Antigen Test Cassette (Nasopharyngeal Swab) is based on fluorescence immunoassay for the qualitative detection of SARS-CoV-2 Nucleocapsid protein antigens in nasopharyngeal swab specimens from individuals with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2 Nucleocapsid protein antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19, and confirmed with a molecular assay, if necessary for patient management.2022-08-24 09:08:01 CET2003Immuno-AntigenYesNoYesImmunoassayQualitativeSandwichFluorescence15LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.0357AUFalse negatives0.0071AUPrecisionEvaluatedAccuracy97.53%(Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.43%(Antigen)Clinical Specificity99.29%(Antigen)Type of antigenNucleocapsid protein1383COVID-19 IgG Rapid Test (cassette)126Hangzhou AllTest Biotech Co. Ltd.Chinawww.alltests.com.cnYesCommercialisedNoNoNear POC / POCAntibodyIgGPlasmaSerumWhole blood2022-08-24 09:08:01 CET1149Immuno-AntibodyYesNoImmunoassayQualitative10Rapid diagnostic test lateral flow LOD0AUCalibrationNot evaluatedFalse positives4.7%False negatives5.7%Accuracy95% IgGRobustnessNot evaluatedClinical Sensitivity94.3% IgG1384COVID-19 IgG Rapid Test (strip)126Hangzhou AllTest Biotech Co. Ltd.Chinawww.alltests.com.cnYesCommercialisedNoNoNear POC / POCAntibodyIgGPlasmaSerumWhole blood2022-08-24 09:08:01 CET1150Immuno-AntibodyYesNoImmunoassayQualitative10LOD0CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives4.7%False negatives5.7%Accuracy96% IgGRobustnessNot evaluatedClinical Sensitivity94.3% IgG1381COVID-19 IgG/IgM Rapid Test126Hangzhou AllTest Biotech Co. Ltd.Chinawww.alltests.com.cnYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2022-08-24 09:08:01 CET1147Immuno-AntibodyYesNoImmunoassayQualitative10Rapid diagnostic test Strip LOD0False positives5%False negatives5.6%Accuracy94.9%Clinical Sensitivity94.4%1377COVID-19 IgG/IgM Rapid Test Cassette126Hangzhou AllTest Biotech Co. Ltd.Chinawww.alltests.com.cnYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood similar to 208 (name a bit different but in website : 2019-nCoV IgG/IgM Rapid Test Cassette)2022-08-24 09:08:01 CET1142Immuno-AntibodyYesNoImmunoassayQualitative10Rapid diagnostic test lateral flow LOD0CalibrationNot evaluatedFalse positives5%False negatives5.6%Accuracy94.9%Clinical Sensitivity94.4%1382COVID-19 IgG/IgM Rapid Test Dipstick126Hangzhou AllTest Biotech Co. Ltd.Chinawww.alltests.com.cnYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood similar to 674 but name a bit different (on website same as 674: 2019-nCoV IgG/IgM Rapid Test Dipstick)2022-08-24 09:08:01 CET1148Immuno-AntibodyYesNoImmunoassayQualitative10LOD0AUFalse positives2% IgGFalse positives3% IgMFalse negatives0.1% IgG<0.1% False negatives9.1% IgMAccuracy98.4% IgGAccuracy95.9% IgMClinical Sensitivity99.9% IgG>99.9Clinical Sensitivity90.9% IgM2416COVID-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma)1003Hangzhou AllTest Biotech Co. Ltd.Chinawww.alltests.com.cnYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThe COVID-19 IgG/IgM Test Cassette is a fluorescence immunoassay for the qualitative detection of IgG and IgM antibodies to SARS-CoV-2 in human whole blood, serum or plasma specimen.The COVID-19 IgG/IgM Test is an aid in the diagnosis of patients with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results from the COVID-19 IgG/IgM Test should not be used as the sole basis for diagnosis. Results are for the detection of SARS-CoV-2 antibodies. IgM antibodies to SARS-CoV- 2 are generally detectable in blood several days after initial infection, although levels over the course of infection are not well characterized. IgG antibodies to SARS-CoV-2 become detectable later following infection. Positive results for both IgG and IgM could occur after infection and can be indicative of acute or recent infection. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. IgM antibodies may not be detected in the first few days of infection; the sensitivity of the COVID-19 IgG/IgM Test early after infection is unknown. False positive results for IgM and IgG antibodies may occur due to cross-reactivity from pre-existing antibodies or other possible causes. At this time, it is unknown for how long IgM or IgG antibodies may persist following infection.2022-08-24 09:08:01 CET2118Immuno-AntibodyYesImmunoassayQualitativeSandwich15LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.033AUFalse negatives0.031AUPrecisionEvaluatedAccuracy96.9%(IgG/IgM)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.7%(IgG/IgM)Clinical Specificity96.9%(IgG/IgM)Type of antigenNucleoprotein2327COVID-19 S-RBD IgG Antibody Test Cassette (Whole Blood/Serum/Plasma)1003Hangzhou AllTest Biotech Co. Ltd.Chinawww.alltests.com.cnYesCommercialisedNoNoNear POC / POCAntibodyIgGPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1223B.1.525Eta1495P.1Gamma1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThe COVID-19 S-RBD IgG Antibody Test Cassette is a fluorescence immunoassay for the qualitative detection of IgG antibodies to SARS-CoV-2 spike(S) protein receptor binding domain(RBD) in human whole blood, serum or plasma specimen.It is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2.2022-08-24 09:08:01 CET2028Immuno-AntibodyYesImmunoassayQualitativeMembrane-based15LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.048AUFalse negatives0.011AUPrecisionEvaluatedAccuracy98.2%（Antibody）ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.2%（Antibody）Clinical Specificity98.9%（Antibody）Type of antigenNucleoprotein2319CVAG4080A – GSD NovaGen SARS-CoV-2 Ag Rapid Test (NP Swab)126Hangzhou AllTest Biotech Co. Ltd.Chinawww.alltests.com.cnYesCommercialisedYesYesNear POC / POCAntigenNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2Zetanucleocapsid proteinThe SARS-CoV-2 Antigen Rapid Test (Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 Nucleocapsid protein antigens in swab specimen from individuals with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2 Nucleocapsid protein Antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.2022-08-24 09:08:01 CET2869Immuno-AntigenNoImmunoassayQualitativeSandwich15LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.006AUFalse negatives0.001AUPrecisionEvaluatedAccuracy99.6%(Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.4%(Antigen)Clinical Specificity99.9%(Antigen）Type of antigenNucleocapsid protein2325GSD NovaGen SARS-CoV-2 Ag Rapid Test (Nasal Swab)126Hangzhou AllTest Biotech Co. Ltd.Chinawww.alltests.com.cnYesCommercialisedYesYesNear POC / POCAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.2678B.1.1.529Omicron1518P.2Zetanucleocapsid proteinAdditional pathogens tested for cross-reactivity: Human Rhinovirus 14，Human Rhinovirus 16，Human Rhinovirus 2, Measles, Mumps. The SARS-CoV-2 Antigen Rapid Test (Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 Nucleocapsid protein antigens in swab specimen from individuals with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2 Nucleocapsid protein Antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.2022-08-24 09:08:01 CET3673Immuno-AntigenYesNoNoImmunoassayQualitativeSandwich15The current VOC including Alpha, Beta, Gamma, Delta, Omicron and Omicron BA.2 which will not influence the performance of the Test.LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.026AUFalse negatives0.001AUPrecisionEvaluatedAccuracy99%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.4%AntigenClinical Specificity99%AntigenType of antigenNucleocapsid protein2690GSD NovaGen SARS-CoV-2 Ag Rapid Test (Nasal Swab) for self testing1003Hangzhou AllTest Biotech Co. Ltd.Chinawww.alltests.com.cnYesCommercialisedNoNoNear POC / POCAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2Zetanucleocapsid proteinThe SARS-CoV-2 Antigen Rapid Test (Nasal Swab) is a single-use test kit intended to detect the SARS-CoV-2 that causes COVID-19 with self-collected nasal swab specimen. The test is intended for use in symptomatic individuals meeting the case definition for COVID-19, and to test asymptomatic individuals limited to contacts of confirmed COVID-19 cases or probable cases and to at-risk health workers. Results are for the detection of SARS-CoV-2 Nucleocapsid protein Antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results are indicative of the presence of SARS-CoV-2. Individuals who test positive should self-isolate and seek additional care from their healthcare provider. Positive results do not rule out bacterial infection or co-infection with other viruses. Negative results do not preclude SARS-CoV-2 infection. Individuals who test negative and continue to experience COVID-like symptoms should seek follow up care from their healthcare provider.2022-08-24 09:08:01 CET2395Immuno-AntigenYesYesNoImmunoassayQualitativeSandwich15pathogens other: Human Rhinovirus 2 / Human Rhinovirus 14 / Human Rhinovirus 16 / Measles / MumpsLOD100%CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.046AUFalse negatives0.006AUPrecisionEvaluatedAccuracy97.8%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.4%AntigenClinical Specificity99.4%AntigenType of antigenNucleocapsid protein3003One Step SARS-CoV-2(COVID-19) Antigen Rapid Test (Oral Fluid)1003Hangzhou AllTest Biotech Co. Ltd.Chinawww.alltests.com.cnYesCommercialisedNoNoNear POC / POCAntigenSaliva689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.2678B.1.1.529Omicron1518P.2Zetanucleocapsid proteinThe One Step SARS-COV-2 (COVID-19) Antigen Test (Oral Fluid) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in oral fluid specimens from individuals with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2 nucleocapsid protein antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.2022-08-24 09:08:01 CET2709Immuno-AntigenNoNoImmunochromatographyQualitativeSandwich15LOD100%CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.01AUFalse negatives0.003AUPrecisionEvaluatedAccuracy99.6%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99%AntigenClinical Specificity99.7%AntigenType of antigenNucleocapsid protein1258SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test (Nasopharyngeal Swab)126Hangzhou AllTest Biotech Co. Ltd.Chinawww.alltests.com.cnYesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swabAdenovirus 3Adenovirus 7Alpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Influenza AInfluenza A H1N1Influenza A H3N2Influenza BMERS-CoVParainfluenza Virus Type 2Parainfluenza Virus Type 3Respiratory Syncytial V (RSV)SARS-CoV20A.23.170AT.1678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526IotaB.1.526.1B.1.526.23939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu1439C.362041C.37Lambda1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid proteinThe SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test (Nasopharyngeal Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 Nucleocapsid protein, Influenza A and Influenza B virus antigens in nasopharyngeal swab specimens from individuals with suspected SARS-CoV-2/Influenza infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2 Nucleocapsid protein and Influenza A+B Antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2/ Influenza A+B infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with SARS-CoV-2/ Influenza A+B.2022-09-20 17:19:37 CET20281Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwichImmunofluorescence15LOD100AUEvaluatedFalse positives0.003%SARS-CoV-2 TestFalse positives0.018%Influenza A+B TestFalse negatives0.024%SARS-CoV-2 TestFalse negatives0.053%Influenza A+B TestAccuracy99.1%SARS-CoV-2 TestAccuracy97.7%Influenza A+B TestClinical Sensitivity97.6%SARS-CoV-2 TestClinical Sensitivity94.7%Influenza A+B TestClinical Specificity99.7%SARS-CoV-2 TestClinical Specificity98.2%Influenza A+B Test1257SARS-CoV-2 Antigen Rapid Test (COVID-19 Antigen Rapid Test) (Swab)126Hangzhou AllTest Biotech Co. Ltd.Chinawww.alltests.com.cnYesCommercialisedYesYesNear POC / POCAntigenNasopharyngeal swabAdenovirus 3Adenovirus 7Alpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Influenza AInfluenza A H1N1Influenza A H3N2Influenza BMERS-CoVParainfluenza Virus Type 2Parainfluenza Virus Type 3Respiratory Syncytial V (RSV)20A.23.170AT.1678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526IotaB.1.526.1B.1.526.23939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu1439C.362041C.37Lambda1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid proteinThe SARS-CoV-2 Antigen Rapid Test (Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 Nucleocapsid protein antigens in swab specimen from individuals with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2 Nucleocapsid protein Antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.2022-09-20 17:20:58 CET3842Immuno-AntigenYesNoNoImmunoassayQualitativeSandwichImmunofluorescence15LOD100AUEvaluatedFalse positives0.003%Nasopharyngeal swab(Antigen)False positives0.001%Nasal swab(Antigen)False negatives0.0024%Nasopharyngeal swab(Antigen)False negatives0.026%Nasal swab(Antigen)Accuracy99%Nasopharyngeal swab(Antigen)Accuracy99.1%Nasal swab(Antigen)Clinical Sensitivity97.6%Nasopharyngeal swab(Antigen)Clinical Sensitivity97.4%Nasal swab(Antigen)Clinical Specificity99.7%Nasopharyngeal swab(Antigen)Clinical Specificity99.9%Nasal swab(Antigen)2257SARS-CoV-2 Antigen Rapid Test (Nasal Swab)1003Hangzhou AllTest Biotech Co. Ltd.Chinawww.alltests.com.cnYesCommercialisedYesYesNear POC / POCAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.2678B.1.1.529Omicron1518P.2Zetanucleocapsid proteinThe SARS-CoV-2 Antigen Rapid Test (Nasal Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in nasal swab specimen from individuals with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2 Antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-192022-08-24 09:08:01 CET1958Immuno-AntigenYesNoNoImmunoassayQualitativeSandwich15LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.026%False negatives0.001%PrecisionEvaluatedAccuracy99%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.4%Clinical Specificity99.9%Type of antigenNucleocapsid protein2529SARS-CoV-2 Antigen Rapid Test (Nasal Swab) for self testing126Hangzhou AllTest Biotech Co. Ltd.Chinawww.alltests.com.cnYesCommercialisedNoNoNear POC / POCAntigenNasal swabAdenovirus 3Adenovirus 7Alpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Influenza A H1N1Influenza A H3N2Influenza BMERS-CoVParainfluenza Virus Type 2Parainfluenza Virus Type 3Respiratory Syncytial V (RSV)20A.23.170AT.1678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526IotaB.1.526.1B.1.526.23939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu1439C.362041C.37Lambda1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid proteinThe SARS-CoV-2Antigen Rapid Test(Nasal Swab)is a single-use test kit intended to detect the SARS-CoV-2 that causes COVID-19 with self-collected nasal swab specimen from symptomatic individuals who are suspected of being infected with COVID-19. Results are for the detection of SARS-CoV-2 Nucleocapsid protein Antigens.An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive resultsare indicative of thepresence of SARS-CoV-2. ndividuals who test positive should self-isolate and seek additional care from their healthcare provider. Positive results do not rule out bacteria infection or co-infection with other viruses. Negative results do not precludeSARS-CoV-2 infection. Individuals who test negative and continue to experience COVID-like symptoms should seek follow up care from their healthcare provider.2022-10-12 09:39:01 CET3963Immuno-AntigenYesYesNoImmunoassayQualitativeSandwichImmunofluorescence15LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.028%False negatives0.005%PrecisionEvaluatedAccuracy98.6%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.2%AntigenClinical Specificity99.5%AntigenType of antigenNucleocapsid protein1946SARS-COV-2 rapid antigen test (Swab)126Hangzhou AllTest Biotech Co. Ltd.Chinawww.alltests.com.cnYesCommercialisedNoNoNear POC / POCAntigenNasal swabnucleocapsid proteinThe SARS-CoV-2 Antigen Rapid Test (Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 Nucleocapsid protein antigens in swab specimen from individuals with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2 Nucleocapsid protein Antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with SARS-CoV-2.2022-08-24 09:08:01 CET1622Immuno-AntigenYesImmunochromatographyQualitative15LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.006AUFalse negatives0.066AUPrecisionEvaluatedAccuracy97.9%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.4%Clinical Specificity99.4%Type of antigenNucleoprotein2403SARS-CoV-2 S-RBD Antibody Rapid Test (Whole Blood/Serum/Plasma)1003Hangzhou AllTest Biotech Co. Ltd.Chinawww.alltests.com.cnYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThe SARS-CoV-2 S-RBD Antibody Rapid Test (Whole Blood/Serum/ Plasma) is a rapid chromatographic immunoassay intended for the qualitative detection of antibodies to SARS-CoV-2 spike (S) protein receptor binding domain (RBD) in human serum, plasma, or whole blood. It is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2. Results are for the detection of antibodies to SARS-CoV-2 spike (S) protein receptor binding domain (RBD). Positive results indicate the presence of antibodies to SARS-CoV-2 spike (S) protein receptor binding domain (RBD).2022-08-24 09:08:01 CET2105Immuno-AntibodyNoImmunoassayQualitativeSandwich10LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.022AUFalse negatives0.015AUPrecisionEvaluatedAccuracy98.2%(Antibody)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.8%(Antibody)Clinical Specificity98.5%(Antibody)Type of antigenOther2404SARS-CoV-2 S-RBD IgG Antibody Rapid Test (Whole Blood/Serum/Plasma)1003Hangzhou AllTest Biotech Co. Ltd.Chinawww.alltests.com.cnYesCommercialisedNoNoNear POC / POCAntibodyIgGPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThe SARS-CoV-2 S-RBD IgG Antibody Rapid Test (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay intended for the qualitative detection of IgG antibodies to SARS-CoV-2 spike (S) protein receptor binding domain (RBD) in human serum, plasma, or whole blood. It is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2. Results are for the detection of SARS-CoV-2 S-RBD IgG antibodies. Positive results indicate the presence of IgG antibodies to SARS-CoV-2.2022-08-24 09:08:01 CET2106Immuno-AntibodyNoImmunoassayQualitativeSandwich10LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.022AUFalse negatives0.015AUPrecisionEvaluatedAccuracy98.2% IgGReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.8% IgGClinical Specificity98.5% IgGType of antigenOther2390SARS-CoV-2/Influenza A+B/RSV Antigen Combo Rapid Test (Nasopharyngeal Swab)126Hangzhou AllTest Biotech Co. Ltd.Chinawww.alltests.com.cnYesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swabAdenovirus 3Adenovirus 7Alpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Influenza A H1N1Influenza A H3N2Influenza BMERS-CoVMumps Virus (MuV)Parainfluenza Virus Type 2Parainfluenza Virus Type 3Respiratory Syncytial V (RSV)20A.23.170AT.1678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526IotaB.1.526.1B.1.526.23939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu1439C.362041C.37LambdaOther1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid proteinThe SARS-CoV-2/Influenza A+B/RSV Antigen Combo Rapid Test (Nasopharyngeal Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2, Influenza A, Influenza B and Respiratory Syncytial Virus(RSV) antigens in nasopharyngeal swab specimens from individuals with suspected SARS-CoV-2/Influenza/RSV infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2, Influenza A+B and RSV Antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out other bacterial/viral infection. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2/Influenza A+B/RSV infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with SARS-CoV-2, Influenza A+B and RSV. The SARS-CoV-2/Influenza A+B/RSV Antigen Combo Rapid Test is intended for use by trained clinical laboratory personnel.2023-01-09 10:04:20 CET20279Immuno-AntigenYesNoNoImmunoassayQualitativeSandwichImmunofluorescence15LOD100AUCalibrationEvaluatedAnalytical Sensitivity97%(Antigen)（SARS-CoV-2 Test）Analytical Specificity99%(Antigen)（SARS-CoV-2 Test）Analysis of cross reactivityEvaluatedFalse positives0.057AU(RSV Test)False negatives0.038AU(RSV Test)PrecisionEvaluatedAccuracy95.9%(Antigen)(RSV Test)RobustnessEvaluatedClinical Sensitivity92.9%(Antigen) (Influenza B test)Clinical Specificity96.2%(Antigen)(RSV Test)2392SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test (Nasopharyngeal Swab)126Hangzhou AllTest Biotech Co. Ltd.Chinawww.alltests.com.cnYesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swabAdenovirus 3Adenovirus 7Alpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Influenza A H1N1Influenza A H3N2Influenza BMERS-CoVMumps Virus (MuV)Parainfluenza Virus Type 2Parainfluenza Virus Type 3Respiratory Syncytial V (RSV)20A.23.170AT.1678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526IotaB.1.526.1B.1.526.23939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu1439C.362041C.37LambdaOther1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid proteinThe SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test (Nasopharyngeal Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2, Influenza A, Influenza B, Respiratory Syncytial Virus(RSV) and Adenovirus antigens in nasopharyngeal swab specimens from individuals with suspected SARS-CoV-2/ Influenza/ RSV/Adenovirus infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2, Influenza A+B, RSV and Adenovirus antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out other bacterial/viral infection. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2/ Influenza A+B/RSV/Adenovirus infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with SARS-CoV-2, Influenza A+B ,RSV and Adenovirus. The SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test is intended for use by trained clinical laboratory personnel.2023-01-09 10:05:07 CET20280Immuno-AntigenYesNoNoImmunoassayQualitativeSandwichImmunofluorescence15LOD100AUCalibrationEvaluatedAnalytical Sensitivity96.4%(Antigen) (SARS-CoV-2 Test)Analytical Specificity99%(Antigen) (SARS-CoV-2 Test)Analysis of cross reactivityEvaluatedFalse positives0.088AU(Adenovirus)False negatives0.014AU(Adenovirus)PrecisionEvaluatedAccuracy98.1%(Antigen)(Influenza B test)RobustnessEvaluatedClinical Sensitivity96.9%(Antigen)(Adenovirus Test)Clinical Specificity98.6%(Antigen)(Adenovirus Test)2396SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae Antigen Combo Rapid Test (Nasopharyngeal Swab)126Hangzhou AllTest Biotech Co. Ltd.Chinawww.alltests.com.cnYesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swabAdenovirus 3Adenovirus 7Alpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Influenza A H1N1Influenza A H3N2Influenza BMERS-CoVMumps Virus (MuV)Parainfluenza Virus Type 2Parainfluenza Virus Type 3Respiratory Syncytial V (RSV)20A.23.170AT.1678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526IotaB.1.526.1B.1.526.23939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu1439C.362041C.37LambdaOther1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid proteinThe SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae Antigen Combo Rapid Test (Nasopharyngeal Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2, Influenza A, Influenza B, Respiratory Syncytial Virus(RSV), Adenovirus and M.pneumoniae antigens in nasopharyngeal swab specimens from individuals with suspected SARS-CoV-2/Influenza/RSV/Adenovirus/M.pneumoniae infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2, Influenza A+B, RSV, Adenovirus and M.pneumoniae antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of correlative antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out other bacterial/viral infection. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2/ Influenza A+B/RSV/Adenovirus/M.pneumoniae infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with SARS-CoV-2, Influenza A+B,RSV , Adenovirus and M.pneumoniae. The SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae Antigen Combo Rapid Test is intended for use by trained clinical laboratory personnel.2023-01-09 10:05:47 CET5417Immuno-AntigenYesNoNoImmunoassayQualitativeSandwichImmunofluorescence15LOD100TCID50/mlCalibrationEvaluatedAnalytical Sensitivity96.4%(Antigen)（SARS-CoV-2 Test）Analytical Specificity99%(Antigen)（SARS-CoV-2 Test）Analysis of cross reactivityEvaluatedFalse positives0.082AU(M.pneumoniae)False negatives0.02AU(M.pneumoniae）PrecisionEvaluatedAccuracy95.9%(Antigen)(RSV Test)RobustnessEvaluatedClinical Sensitivity91.8%（Antigen）（M.pneumoniae)）Clinical Specificity98%(Antigen)(M.pneumoniae)2897Novel Coronavirus (SARS-CoV-2 ) Antigen Rapid Test(Colloidal Gold)127Hangzhou Bigfish Bio-tech Co. Ltd.Chinawww.bigfishgene.com/YesCommercialisedNoNoManualNear POC / POCAntigenAnterior nasal swabNasopharyngeal swabOropharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1321B.1.617.2Delta678B.1.1.529Omicronnucleocapsid protein1. Store at 4~30℃ out of direct sunlight, and it is valid for 24 months from Production Date. 2. Keep dry, and do not use frozen and expired devices. 3. Test cassette should be used within half 1 hour once opening the Aluminum foil pouch. 4. Store the buffer at 4~30℃, and it should be use within 3 months after opening.2022-08-24 09:08:01 CET2602Immuno-AntigenNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD30TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives99.25%False positives98.94%False positives99.64%False negatives95.08%In the clinical study, the PPA for three swabs are False negatives94.58%In the clinical study, the PPA for three swabs are 95.08%, 94.58% and 93.81%.False negatives93.81%In the clinical study, the PPA for three swabs are 95.08%, 94.58% and 93.81%.PrecisionEvaluatedAccuracy97.32%Antigen, Oropharyngeal SwabAccuracy97.55%Antigen, Nasopharyngeal SwabAccuracy97.26%Antigen, Anterior Nasal swabReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.86%Antigen, Nasopharyngeal SwabClinical Sensitivity98.13%Antigen, Oropharyngeal SwabClinical Sensitivity99.45%Antigen, Anterior Nasal swabClinical Specificity96.7%Antigen, Nasopharyngeal SwabClinical Specificity96.88%Antigen, Oropharyngeal SwabClinical Specificity95.88%Antigen, Anterior Nasal swabType of antigenNucleocapsid protein2058SARS-CoV-2 Antigen Test Kit (colloidal gold method)949Hangzhou Bioer Technology Co. Ltd.Chinahttp://www.bioer.com.cn/en/YesCommercialisedNoNoManualAntigenNasopharyngeal swabOropharyngeal swab689B.1.1.7Alphahttp://www.bioer.com.cn/en/2022-08-24 09:08:01 CET1738Immuno-AntigenNoImmunochromatographyQualitativeSandwichColloidal gold15LOD1.75AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1%False negatives4.6%PrecisionEvaluatedAccuracy98.2%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity95.4%Clinical Specificity99%Type of antigenNucleoprotein2059SARS-CoV-2 IgM/IgG Antibody Test Kit (colloidal gold method)949Hangzhou Bioer Technology Co. Ltd.Chinahttp://www.bioer.com.cn/en/YesCommercialisedNoNoManualAntibodyIgGIgMPlasmaSerum689B.1.1.7Alphahttp://www.bioer.com.cn/en/ LoD: 250U/mL2022-08-24 09:08:01 CET1739Immuno-AntibodyNoImmunochromatographyQualitativeSandwichColloidal gold15LOD250CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.3%False negatives4.9%PrecisionEvaluatedAccuracy98.3%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity95.1%Clinical Specificity99.6%Type of antigenOther1892COVID-19 + Flu A&B + RSV + Adenovirus Antigen Combo Rapid Test Cassette (Nasopharyngeal Swab)128Hangzhou Biotest Biotech Co. Ltd.Chinaen.biotests.com.cnYesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swabA rapid test for the qualitative detection of COVID-19, Flu A&B Antigen, Respiratory Syncytial Virus (RSV), Adenovirus antigen in Nasopharyngeal swab2022-08-24 09:08:01 CET1570Immuno-AntigenNoImmunoassayQualitative10LOD0AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%No false positive result is observed in 324 negative samples confirmed by RT-PCRFalse negatives5%2 false negative results are observed in 40 positive samples confirmed by RT-PCRPrecisionEvaluatedAccuracy99.5%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95%Clinical Specificity99.9%(＞99.9)4120COVID-19 + Flu A&B + RSV Antigen Combo Rapid Test Cassette（Nasal Swab）128Hangzhou Biotest Biotech Co. Ltd.Chinaen.biotests.com.cnYesCommercialisedNoNoNear POC / POCAntigenNasal swabInfluenza AInfluenza BRespiratory Syncytial V (RSV)SARS-CoV-2689B.1.1.7Alpha1032B.1.351Beta1320B.1.617.1Kappa1321B.1.617.2Deltanucleocapsid protein2022-10-31 09:32:55 CET5264Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold10LODAUCalibrationNot evaluatedAnalytical Sensitivity98.17%Analytical Specificity99.61%Analysis of cross reactivityEvaluatedFalse positives2%2 false positive result is observed in 109 negative samples confirmed by RT-PCRFalse negatives1%1 false negative results are observed in 260 positive samples confirmed by RT-PCRPrecisionEvaluatedAccuracy99.18%RobustnessEvaluatedClinical Sensitivity98.17%Clinical Specificity99.61%1891COVID-19 + Flu A&B + RSV Antigen Combo Rapid Test Cassette (Nasopharyngeal Swab)128Hangzhou Biotest Biotech Co. Ltd.Chinaen.biotests.com.cnYesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swabA rapid test for the qualitative detection of COVID-19, Flu A&B Antigen, Respiratory Syncytial Virus (RSV) in Nasopharyngeal swab2022-08-24 09:08:01 CET1569Immuno-AntigenNoImmunoassayQualitative10LOD0AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%No false positive result is observed in 324 negative samples confirmed by RT-PCRFalse negatives%2 false negative results are observed in 40 positive samples confirmed by RT-PCRPrecisionEvaluatedAccuracy99.5%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95%Clinical Specificity99%(＞99.9)Type of antigenNucleoprotein24752COVID-19 + Flu A&B +RSV Antigen Combo Rapid Test Cassette（Nasal Swab /Nasopharyngeal Swab）128Hangzhou Biotest Biotech Co. Ltd.Chinaen.biotests.com.cnYesCommercialisedNoNoNear POC / POCAntigenNasal swabNasopharyngeal swabInfluenza AInfluenza BRespiratory Syncytial V (RSV)SARS-CoV-2678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.3Other1495P.1GammaOther2023-03-14 11:19:31 CET20264Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold10LOD1000TCID50/mlCalibrationNot evaluatedAnalytical Sensitivity93.64%Analytical Specificity96.67%Analysis of cross reactivityEvaluatedFalse positives9testsTested 270 negative samples, 9 samples are false positive.False negatives7testsTested 110 positive samples, 7 samples are false negative. PrecisionEvaluatedAccuracy95.79%RobustnessEvaluatedClinical Sensitivity93.64%Clinical Specificity96.67%1877COVID-19 + Flu A&B Antigen Combo Rapid Test Cassette (Nasopharyngeal Swab)128Hangzhou Biotest Biotech Co. Ltd.Chinaen.biotests.com.cnYesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swabA rapid test for the qualitative detection of COVID-19, Flu A&B Antigen in Nasopharyngeal swab.2022-08-24 09:08:01 CET1557Immuno-AntigenNoImmunoassayQualitative10LOD0AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.83%3 false positive results are observed in 363 negative samples confirmed by RT-PCRFalse negatives5%2 false negative results are observed in 40 positive samples confirmed by RT-PCRPrecisionEvaluatedAccuracy98.8%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95%Clinical Specificity99.2%Type of antigenNucleoprotein24751COVID-19 + Flu A&B Antigen Combo Rapid Test Cassette（Nasal Swab /Nasopharyngeal Swab）128Hangzhou Biotest Biotech Co. Ltd.Chinaen.biotests.com.cnYesCommercialisedNoNoNear POC / POCAntigenNasal swabNasopharyngeal swabInfluenza AInfluenza BSARS-CoV-2678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.3Other1495P.1GammaOther2023-03-14 11:19:08 CET20263Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold10LOD1000TCID50/mlCalibrationNot evaluatedAnalytical Sensitivity93.64%Analytical Specificity96.67%Analysis of cross reactivityEvaluatedFalse positives9testsTested 270 samples, 9 samples is false positiveFalse negatives7testsTested 110 samples, 7 samples is false negative.PrecisionEvaluatedAccuracy95.79%RobustnessEvaluatedClinical Sensitivity93.64%Clinical Specificity96.67%4119COVID-19 + Flu A&B Antigen Combo Rapid Test Cassette（Nasal Swab）128Hangzhou Biotest Biotech Co. Ltd.Chinaen.biotests.com.cnYesCommercialisedNoNoNear POC / POCAntigenNasal swabInfluenza AInfluenza BSARS-CoV-2689B.1.1.7Alpha1032B.1.351Beta1320B.1.617.1Kappa1321B.1.617.2Deltanucleocapsid protein2022-10-31 09:32:33 CET5263Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold10LODAUCalibrationNot evaluatedAnalytical Sensitivity99.2%Analytical Specificity99.47%Analysis of cross reactivityEvaluatedFalse positives1%1 false positive result is observed in 125 negative samples confirmed by RT-PCRFalse negatives2%2 false negative results are observed in 380 positive samples confirmed by RT-PCRPrecisionEvaluatedAccuracy99.41%RobustnessEvaluatedClinical Sensitivity99.2%Clinical Specificity99.47%4121COVID-19 + Flu A&B+ RSV+ Adenovirus Antigen Combo Rapid Test Cassette （Nasal Swab）128Hangzhou Biotest Biotech Co. Ltd.Chinaen.biotests.com.cnYesCommercialisedNoNoNear POC / POCAntigenNasal swabAdenovirusInfluenza AInfluenza BRespiratory Syncytial V (RSV)SARS-CoV-2689B.1.1.7Alpha1032B.1.351Beta1320B.1.617.1Kappa1321B.1.617.2Deltanucleocapsid protein2022-10-31 09:33:20 CET5265Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold10LODAUCalibrationNot evaluatedAnalytical Sensitivity98.17%Analytical Specificity99.61%Analysis of cross reactivityEvaluatedFalse positives2%2 false positive result is observed in 109 negative samples confirmed by RT-PCRFalse negatives1%1 false negative results are observed in 260 positive samples confirmed by RT-PCRPrecisionEvaluatedAccuracy99.18%RobustnessEvaluatedClinical Sensitivity98.17%Clinical Specificity99.61%4110COVID-19 Antigen Rapid Test Cassette (Saliva/Nasal Swab)128Hangzhou Biotest Biotech Co. Ltd.Chinaen.biotests.com.cnYesCommercialisedNoNoNear POC / POCOtherIgGIgMNasal swabSalivaSARS-CoV-2678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1320B.1.617.1Kappa1321B.1.617.2Delta1495P.1Gammanucleocapsid protein2022-10-31 09:28:46 CET5259Immuno-AntibodyYesNoNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold10LODAUCalibrationNot evaluatedAnalytical Sensitivity93.4%Analytical Specificity99.9%Analysis of cross reactivityEvaluatedFalse positives19%19 false positive results are observed in 363 negative samples confirmed by RT-PCRFalse negatives%0 false negative results are observed in 40 positive samples confirmed by RT-PCRPrecisionEvaluatedAccuracy97%RobustnessEvaluatedClinical Sensitivity93.4%Clinical Specificity99.9%1868COVID-19 Antigen Rapid Test Cassette (Nasopharyngeal Swab)128Hangzhou Biotest Biotech Co. Ltd.Chinaen.biotests.com.cnYesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swabnucleocapsid proteinThe COVID-19 Antigen Rapid Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of COVID-19 antigen in Nasopharyngeal swab.2022-08-24 09:08:01 CET1545Immuno-AntigenYesImmunoassayQualitative10LOD1000TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.0053AUFalse negatives0.008AUPrecisionEvaluatedAccuracy99.41%AntigenRobustnessEvaluatedClinical Sensitivity99.2%AntigenClinical Specificity99.47%AntigenType of antigenNucleoprotein1890COVID-19 Antigen Rapid Test Cassette (Saliva/Nasopharyngeal Swab)128Hangzhou Biotest Biotech Co. Ltd.Chinaen.biotests.com.cnYesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swabSalivaA rapid test for the qualitative detection of COVID-19 antigen in Saliva and Nasopharyngeal Swab2022-08-24 09:08:01 CET1568Immuno-AntigenNoImmunoassayQualitative10LOD0AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%No false positive result is observed in 324 negative samples confirmed by RT-PCRFalse negatives7.3%19 false negative results are observed in 260 positive samples confirmed by RT-PCRPrecisionEvaluatedAccuracy96.7%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.7%Clinical Specificity100%Type of antigenNucleoprotein1876COVID-19 Antigen Rapid Test Cassette(Nasal Swab)128Hangzhou Biotest Biotech Co. Ltd.Chinaen.biotests.com.cnYesCommercialisedYesYesManualNear POC / POCAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta678B.1.1.529OmicronThe COVID-19 Antigen Rapid Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 antigen in Nasal swab.2022-08-24 09:08:01 CET1846Immuno-AntigenYesNoImmunochromatographyQualitative10Human Coxsackie Virus, Haemophilusparainfluenzae, Staphylococcus aureus, Neisseria meningitides, Streptococcus sp. group A, Streptococcus sp. group B, Streptococcus sp. group C, Enterovirus EV68, Candida albicans, Haemophilus influenzae, and so onLOD1000TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.008AUFalse negatives0.068AUPrecisionEvaluatedAccuracy97.5%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.2%AntigenClinical Specificity99.2%AntigenType of antigenNucleocapsid protein5742COVID-19 Antigen Rapid Test Cassette(Nasal Swab)128Hangzhou Biotest Biotech Co. Ltd.Chinaen.biotests.com.cnYesCommercialisedNoNoManualNear POC / POCAntigenNasal swabAdenovirusAlpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Bordetella PertussisHemophilus InfluenzaeInfluenza A H1N1Influenza A H3N2Influenza BMERS-CoVMumps Virus (MuV)Mycobacterium TuberculosisMycoplasma PneumoniaeParainfluenza Virus Type 1Parainfluenza Virus Type 2Parainfluenza Virus Type 3Parainfluenza Virus Type 4Respiratory Syncytial V (RSV) Type ARhinovirus20A.23.170AT.1678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526IotaB.1.526.1B.1.526.21320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu2041C.37Lambda1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid protein2022-10-31 09:27:49 CET5257Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwichColloidal gold10LOD1000TCID50/mlCalibrationNot evaluatedAnalytical Sensitivity100%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives0.8%False negatives6.8%PrecisionEvaluatedAccuracy97.5%RobustnessEvaluatedClinical Sensitivity93.2%Clinical Specificity99.2%5743COVID-19 Antigen Rapid Test Cassette(Nasal Swab)128Hangzhou Biotest Biotech Co. Ltd.Chinaen.biotests.com.cnYesCommercialisedYesYesManualNear POC / POCAntigenNasal swabAdenovirusAlpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Bordetella PertussisHemophilus InfluenzaeHuman Metapneumovirus (HMPV)Influenza A H1N1Influenza A H3N2Influenza BMERS-CoVMumps Virus (MuV)Mycobacterium TuberculosisMycoplasma PneumoniaeParainfluenza Virus Type 1Parainfluenza Virus Type 2Parainfluenza Virus Type 3Parainfluenza Virus Type 4Respiratory Syncytial V (RSV)Rhinovirus20A.23.170AT.1678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526IotaB.1.526.1B.1.526.21320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu2041C.37Lambda1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid protein2022-10-31 09:23:48 CET5459Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwichColloidal gold10LOD1000TCID50/mlCalibrationNot evaluatedAnalytical Sensitivity100%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives0.8%False negatives6.8%PrecisionEvaluatedAccuracy97.5%RobustnessEvaluatedClinical Sensitivity93.2%Clinical Specificity99.2%2882COVID-19 Antigen Rapid Test Cassette(Nasal Swab)(Self-testing)128Hangzhou Biotest Biotech Co. Ltd.Chinaen.biotests.com.cnYesCommercialisedNoNoAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta678B.1.1.529Omicronnucleocapsid proteinThe COVID-19 Antigen Rapid Test Cassette(Nasal Swab) is a rapid chromatographic immunoassay for the qualitative detection of COVID-19 antigen in Nasal Swab in symptomatic individuals.2022-08-24 09:08:01 CET2587Immuno-AntigenYesImmunoassay10CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.008%False negatives0.068%PrecisionEvaluatedAccuracy97.5%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.2%AntigenClinical Specificity99.2%AntigenType of antigenNucleocapsid protein4112COVID-19 Antigen Rapid Test Cassette(Nasal Swab/Nasopharyngeal Swab)128Hangzhou Biotest Biotech Co. Ltd.Chinaen.biotests.com.cnYesCommercialisedNoNoNear POC / POCOtherAntigenNasal swabNasopharyngeal swabSARS-CoV-2678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1320B.1.617.1Kappa1321B.1.617.2Delta1495P.1Gammanucleocapsid protein2022-10-31 09:29:53 CET5260Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold10LODAUCalibrationNot evaluatedAnalytical Sensitivity95.7%Analytical Specificity99.2%Analysis of cross reactivityEvaluatedFalse positives5%5 false positive results are observed in 117 positive samples confirmed by RT-PCRFalse negatives3%3 false negative results are observed in 363 negative samples confirmed by RT-PCRPrecisionEvaluatedAccuracy98.3%RobustnessEvaluatedClinical Sensitivity95.7%Clinical Specificity99.2%1878COVID-19 Antigen Rapid Test Cassette(Oral Fluid)128Hangzhou Biotest Biotech Co. Ltd.Chinaen.biotests.com.cnYesCommercialisedNoNoNear POC / POCAntigenSalivaA rapid test for the qualitative detection of COVID-19 antigen in oral fluid.2022-08-24 09:08:01 CET1558Immuno-AntigenNoImmunoassayQualitative10LOD0CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%324 negative samples are confirmed by RT-PCR and tested, no false positive result is observed.False negatives5%2 false negative results are observed in 40 positive samples confirmed by RT-PCRPrecisionEvaluatedAccuracy99.5%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95%Clinical Specificity100%Type of antigenNucleoprotein4113COVID-19 Antigen Rapid Test Cassette(Swab)128Hangzhou Biotest Biotech Co. Ltd.Chinaen.biotests.com.cnYesCommercialisedNoNoNear POC / POCOtherAntigenNasal swabNasopharyngeal swabSARS-CoV-2678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1320B.1.617.1Kappa1321B.1.617.2Delta1495P.1Gammanucleocapsid protein2022-10-31 09:31:50 CET5261Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold10LODAUCalibrationNot evaluatedAnalytical Sensitivity92.6%Analytical Specificity99.6%Analysis of cross reactivityEvaluatedFalse positives23%5 false positive results are observed in 312 positive samples confirmed by RT-PCRFalse negatives2%3 false negative results are observed in 549 negative samples confirmed by RT-PCRPrecisionEvaluatedAccuracy97.1%RobustnessEvaluatedClinical Sensitivity92.6%Clinical Specificity99.6%4109COVID-19 IgG Antigen Rapid Test Cassette(Whole Blood/Serum/Plasma)128Hangzhou Biotest Biotech Co. Ltd.Chinaen.biotests.com.cnYesCommercialisedNoNoNear POC / POCIgGPlasmaSerumWhole bloodSARS-CoV-2678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1320B.1.617.1Kappa1321B.1.617.2Delta1495P.1Gammanucleocapsid protein2022-10-31 09:28:10 CET5258Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich, DoubleImmunofluorescence10LODAUCalibrationNot evaluatedAnalytical Sensitivity97.95%Analytical Specificity99.57%Analysis of cross reactivityEvaluatedFalse positives14%14 false positive result is observed in 324 negative samples confirmed by RT-PCRFalse negatives12%14 false positive result is observed in 324 negative samples confirmed by RT-PCRPrecisionEvaluatedAccuracy99.25%RobustnessEvaluatedClinical Sensitivity97.95%Clinical Specificity99.57%5744COVID-19 IgG Rapid Test Cassette(Whole blood/Serum/Plasma)128Hangzhou Biotest Biotech Co. Ltd.Chinaen.biotests.com.cnYesCommercialisedNoNoNear POC / POCIgGPlasmaSerumWhole bloodSARS-CoV-2678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1320B.1.617.1Kappa1321B.1.617.2DeltaOther1495P.1GammaOther2022-10-31 09:24:17 CET5256Immuno-AntibodyYesNoNoImmunoassayQualitativeSandwich, DoubleColloidal gold10LODAUCalibrationNot evaluatedAnalytical Sensitivity97.95%Analytical Specificity99.57%Analysis of cross reactivityEvaluatedFalse positives97.95%14 false positive result is observed in 683 samples confirmed by RT-PCRFalse negatives99.57%12 false negative results are observed in 2807 positive samples confirmed by RT-PCR negativePrecisionEvaluatedAccuracy99.25%RobustnessEvaluatedClinical Sensitivity97.95%Clinical Specificity99.57%4123COVID-19 IgG/IgM Rapid Test Cassette (Protective Antibodies)128Hangzhou Biotest Biotech Co. Ltd.Chinaen.biotests.com.cnYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole bloodSARS-CoV-2689B.1.1.7Alpha1032B.1.351Beta1320B.1.617.1Kappa1321B.1.617.2DeltaOther2022-10-31 09:34:00 CET5267Immuno-AntibodyYesNoNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold10LODAUCalibrationNot evaluatedAnalytical Sensitivity83.04%Analytical Specificity98.91%Analysis of cross reactivityEvaluatedFalse positives58%False negatives4%PrecisionEvaluatedAccuracy89.45%RobustnessEvaluatedClinical Sensitivity83.04%Clinical Specificity98.91%212COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)128Hangzhou Biotest Biotech Co. Ltd.Chinaen.biotests.com.cnYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2022-08-24 09:08:01 CET168Immuno-AntibodyYesNoImmunoassayQualitative151921SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette (Whole Blood/Serum/Plasma)128Hangzhou Biotest Biotech Co. Ltd.Chinaen.biotests.com.cnYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumVenous whole bloodWhole bloodWhole blood with anti-coagulantsA rapid test for the qualitative detection of neutralizing antibodies to SARS-CoV-2 in whole blood, serum, or plasma. Indirect method.2022-08-24 09:08:01 CET1597Immuno-AntibodyNoImmunoassayQualitativeNeutralization Antibody (NAb)10LOD0AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives1.92%2 false positive results are observed in 104 negative samplesFalse negatives0%No false negative result is observed in 152 positive samplesPrecisionEvaluatedAccuracy99%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%Clinical Specificity98%Type of antigenOther4114SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette(Combo)128Hangzhou Biotest Biotech Co. Ltd.Chinaen.biotests.com.cnYesCommercialisedNoNoNear POC / POCOtherAntibodyPlasmaSerumWhole bloodSARS-CoV-2678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1320B.1.617.1Kappa1321B.1.617.2Delta1495P.1Gammanucleocapsid proteinspike protein2022-10-31 09:32:15 CET5262Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold10LODAUCalibrationNot evaluatedAnalytical Sensitivity100%Analytical Specificity99.5%Analysis of cross reactivityEvaluatedFalse positives%0 false positive results are observed in 60 positive samples confirmed by RT-PCRFalse negatives1%3 false negative results are observed in 208 negative samples confirmed by RT-PCRPrecisionEvaluatedAccuracy99.6%RobustnessEvaluatedClinical Sensitivity100%Clinical Specificity99.5%1922SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette(Whole Blood/Serum/Plasma)128Hangzhou Biotest Biotech Co. Ltd.Chinaen.biotests.com.cnYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumVenous whole bloodWhole bloodWhole blood with anti-coagulantsA rapid test for the qualitative detection of neutralizing antibodies to SARSCoV-2 in whole blood, serum, or plasma. Competition method.2022-08-24 09:08:01 CET1598Immuno-AntibodyNoImmunoassayQualitativeNeutralization Antibody (NAb)15LOD0AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%No false positive result is observed in 130 negative samplesFalse negatives1.53%2 false negative results are observed in 130 positive samplesPrecisionEvaluatedAccuracy99%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98%Clinical Specificity100%Type of antigenOther5682019-nCoV IgG/IgM Rapid Test413Hangzhou Clongene Biotech Co. Ltd.Chinahttp://en.clongene.com/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2022-08-24 09:08:01 CET778Immuno-AntibodyYesImmunoassayQualitative675Clungene COVID-19 IgM/IgG Rapid Test Cassette413Hangzhou Clongene Biotech Co. Ltd.Chinahttp://en.clongene.com/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgM Product information is being updated...2022-08-24 09:08:01 CET568Immuno-AntibodyYesImmunoassay1363COVID-19 Antigen Rapid Test413Hangzhou Clongene Biotech Co. Ltd.Chinahttp://en.clongene.com/YesCommercialisedYesYesNear POC / POCAntigenNasal swabNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.2678B.1.1.529Omicron1518P.2Zetanucleocapsid proteinA prospective clinical study conducted in Greece from Nov. 2021 to Feb. 2022, the performance of COVID-19 Antigen Rapid Test was evaluated by detection of 626 nasopharyngeal swab specimens, setting a RT-PCR detection of nasopharyngeal specimens as comparator. The test showed a sensitivity of 95.5% (n=150/157, 95%CI: 91.1%-97.8%) and a specificity of 100% (n=469/469, 95%CI: 99.2%-100%). A genotyping analysis on unselected 88 PCR-positive specimens identified 31 cases of Omicron infection, those comparator PCR Ct values ranged from 10.5 to 31.1 (7/31 at Ct >25) and all of which were positive by COVID-19 Antigen Rapid Test. Thus, the test performance is not affected by Omicron variant.2022-08-24 09:08:01 CET1122Immuno-AntigenYesNoNoImmunochromatographyQualitative15antigen_epi AA95-175LODTCID50/ml570 TCID50/mLAnalysis of cross reactivityEvaluatedFalse positives%0%False negatives%4%PrecisionEvaluatedAccuracy99.1%Nasopharyngeal swabAccuracy99.1%Nasal swabReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96%Nasopharyngeal swabClinical Sensitivity95.5%Nasal swabClinical Specificity100%Nasopharyngeal swabClinical Specificity100%Nasal swabType of antigenNucleocapsid protein3136COVID-19 Antigen Rapid Test (self test)413Hangzhou Clongene Biotech Co. Ltd.Chinahttp://en.clongene.com/YesCommercialisedNoNoNear POC / POCAntigenNasal swabSARS-CoV689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.2678B.1.1.529Omicron1518P.2Zetanucleocapsid protein2022-08-24 09:08:01 CET2844Immuno-AntigenYesNoImmunochromatographyQualitative15antigen_epi AA95-175CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives4.5%PrecisionEvaluatedAccuracy99.1%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.5%Clinical Specificity100%Type of antigenNucleocapsid protein1610COVID-19 Antigen Rapid Test Cassette (Nasal Swab)413Hangzhou Clongene Biotech Co. Ltd.Chinahttp://en.clongene.com/YesCommercialisedYesYesNear POC / POCAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.2678B.1.1.529Omicron1518P.2Zetanucleocapsid proteinN/A2022-08-24 09:08:01 CET1290Immuno-AntigenYesNoNoImmunochromatographyQualitative15LOD570TCID50/mlAnalysis of cross reactivityEvaluatedFalse positives0%False negatives4.5%PrecisionEvaluatedAccuracy99.1%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.5%Clinical Specificity100%Type of antigenNucleocapsid protein1746COVID-19 Antigen Rapid Test Cassette(Saliva)413Hangzhou Clongene Biotech Co. Ltd.Chinahttp://en.clongene.com/YesCommercialisedNoNoNear POC / POCAntigenSalivanucleocapsid protein2022-08-24 09:08:01 CET1424Immuno-AntigenYesNoImmunoassayQualitative15LOD3470U/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives3.2AUFalse negatives0.4AUPrecisionEvaluatedAccuracy99%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity96.8%Type of antigenNucleoprotein1365COVID-19/Influenza A+B Antigen Combo Rapid Test413Hangzhou Clongene Biotech Co. Ltd.Chinahttp://en.clongene.com/YesCommercialisedYesYesNear POC / POCAntigenNasopharyngeal swab2022-08-24 09:08:01 CET1125Immuno-AntigenYesNoImmunoassayQualitative15LOD2300TCID50/mlClinical Sensitivity91%95% CI: 82.8%-95.6%Clinical Specificity100%95% CI: 98.2%-100%Type of antigenSARcov2, influenza A+B viral nucleoprotein antigens1259Novel Coronavirus S Glycoprotein Detection Kit634Hangzhou Deangel Biological Engineering Co. Ltd.Chinadagbio.en.alibaba.com/company_profile.htmlYesCommercialisedNoNoNear POC / POCAntigen2022-08-24 09:08:01 CET1035Immuno-AntigenYesImmunoassay2629COVID-19 Antigen Test Cassette1200Hangzhou Dian Biotechnology Co. Ltd.ChinaYesCommercialisedYesYesManualAntigenNasal swabNasopharyngeal swab689B.1.1.7AlphaOtherCOVID-19 Antigen Test Cassette2022-08-24 09:08:01 CET2334Immuno-AntigenYesImmunoassay15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives96%False negatives96%PrecisionEvaluatedAccuracy98%ReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity97.6%Clinical Specificity98.4%Type of antigenOther25663SARS-CoV-2/RSV/Adenovirus/Influenza A+B Antigen Combo Rapid Test Kit17452Hangzhou Fanttest Biotech Co LtdChinaYesCommercialisedNoNoNear POC / POCAntigenNasal swabNasopharyngeal swabAdenovirus 3Adenovirus 7Alpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Bordetella PertussisChlamydia PneumoniaeHuman Metapneumovirus (HMPV)Influenza A H1N1Influenza A H3N2Influenza A H5N1Influenza B VictoriaInfluenza B YamagataMERS-CoVMycobacterium TuberculosisMycoplasma PneumoniaeOtherParainfluenza Virus Type 1Parainfluenza Virus Type 2Parainfluenza Virus Type 3Parainfluenza Virus Type 4Respiratory Syncytial V (RSV) Type ARespiratory Syncytial V (RSV) Type BRhinovirus ARhinovirus BSARS-CoV678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1321B.1.617.2Delta1495P.1Gammanucleocapsid protein2024-12-11 11:29:22 CET21166Immuno-AntigenYesNoNoImmunochromatographyQualitativeMembrane-basedColloidal gold15LOD100TCID50/mlCalibrationNot evaluatedAnalytical Sensitivity97.69%Analytical Specificity99.11%Analysis of cross reactivityEvaluatedFalse positives0.88%False negatives2.3%PrecisionEvaluatedAccuracy98.79%RobustnessEvaluatedClinical Sensitivity97.69%Clinical Specificity99.11%25662SARS-CoV-2/RSV/Influenza A+B Antigen Combo Rapid Test Kit17451Hangzhou Fanttest Biotech Co LtdChinaYesCommercialisedNoNoNear POC / POCAntigenNasal swabNasopharyngeal swabAdenovirus 3Adenovirus 7Alpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Bordetella PertussisChlamydia PneumoniaeHuman Metapneumovirus (HMPV)Influenza A H1N1Influenza A H3N2Influenza A H5N1Influenza B VictoriaInfluenza B YamagataMERS-CoVMycobacterium TuberculosisMycoplasma PneumoniaeOtherParainfluenza Virus Type 1Parainfluenza Virus Type 2Parainfluenza Virus Type 3Parainfluenza Virus Type 4Respiratory Syncytial V (RSV) Type ARespiratory Syncytial V (RSV) Type BRhinovirus ARhinovirus BSARS-CoV678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1321B.1.617.2Delta1495P.1Gammanucleocapsid protein2024-12-11 11:19:50 CET21165Immuno-AntigenYesNoNoImmunochromatographyQualitativeMembrane-basedColloidal gold15LOD100TCID50/mlCalibrationNot evaluatedAnalytical Sensitivity98.55%Analytical Specificity99.13%Analysis of cross reactivityEvaluatedFalse positives0.87%False negatives1.4%PrecisionEvaluatedAccuracy99%RobustnessEvaluatedClinical Sensitivity98.55%Clinical Specificity99.13%2153Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test Cassette998Hangzhou Fanttest Biotech Co. Ltd.ChinaYesCommercialisedNoNoNear POC / POCAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1GammaThe product is used for the qualitative detection of SARS-CoV-2 infection.The entire detection process takes only 15-20 minutes, and the operation is simple and sensitive. No instrument required. It can be used for the screening of early infected patients and asymptomatic patients. This method is an effective supplement for nucleic acid detection.2022-08-24 09:08:01 CET1854Immuno-AntigenNoImmunochromatographyQualitativeSandwich, Double15LOD500AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.93%False negatives1.11%PrecisionEvaluatedAccuracy98.89%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.07%Clinical Specificity99.34%Type of antigenNucleoprotein25664SARS-CoV-2/RSV/Adenovirus/M.pneumoniae/ Influenza A+B Antigen Combo Rapid Test Kit17453Hangzhou Fanttest Biotech Co.,Ltd.ChinaYesCommercialisedNoNoManualNear POC / POCAntigenNasal swabNasopharyngeal swabAdenovirusAdenovirus 3Adenovirus 7Alpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Bordetella PertussisChlamydia PneumoniaeEnterovirus A71 (EV-A71)Hemophilus InfluenzaeHuman Metapneumovirus (HMPV)Influenza A H1N1Influenza A H3N2Influenza B VictoriaInfluenza B YamagataMycobacterium TuberculosisMycoplasma PneumoniaeOtherParainfluenza Virus Type 1Parainfluenza Virus Type 2Parainfluenza Virus Type 3Parainfluenza Virus Type 4Respiratory Syncytial V (RSV) Type ARespiratory Syncytial V (RSV) Type BRhinovirus ARhinovirus B678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1321B.1.617.2Delta1495P.1Gammanucleocapsid protein2024-12-11 11:29:50 CET21167Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD100TCID50/mlCalibrationEvaluatedAnalytical Sensitivity96.27%Analytical Specificity99.11%Analysis of cross reactivityEvaluatedFalse positives0.89%False negatives3.73%PrecisionEvaluatedAccuracy98.46%RobustnessEvaluatedClinical Sensitivity96.27%Clinical Specificity99.11%2862SARS-CoV-2 Antigen Rapid Test Device1271Hangzhou Funworld Biotech Co. Ltd.Chinawww.funworldbio.comYesCommercialisedYesYesManualAntigenNasal swabNasopharyngeal swabSaliva689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.2678B.1.1.529Omicron1518P.2ZetaNone2022-08-24 09:08:01 CET2567Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich, Double10LOD150TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives6.6%False negatives2%PrecisionEvaluatedAccuracy95.2%antigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.5%antigenClinical Specificity98%antigenType of antigenNucleocapsid protein1261COVID-19 Antigen Rapid Test Device635Hangzhou Genesis Biodetection & Biocontrol Co. Ltd.Chinawww.hgb.com.cn/YesCommercialisedNoNoNear POC / POCAntigenNasal aspirationThroat swab2022-08-24 09:08:01 CET1036Immuno-AntigenYesImmunoassay152085KaiBiLi COVID-19 Antigen964Hangzhou GENESIS Biodetection and Biocontrol Co. Ltd.Chinahttps://www.genesis-ivd.comYesCommercialisedNoNoManualNear POC / POCAntigenNasal swabNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2Zetanucleocapsid proteinOur KaiBiLi COVID-19 Antigen is marketed in countries including Spain, Cyprus, Netherland, etc. It's been listed with different authorities of France, Germany, Belgium, and Czech.2022-08-24 09:08:01 CET1768Immuno-AntigenYesNoImmunochromatographyQualitativeCapture15LOD74.8AUFalse positives0%ZeroFalse negatives0.4%(clinical sensitivity 96.6)PrecisionEvaluatedAccuracy98.9%ReproducibilityEvaluatedReproducibilityEvaluatedRobustnessEvaluatedRobustnessEvaluatedClinical Sensitivity96.6%Clinical Specificity100%Type of antigenNucleoprotein2885KaiBiLi COVID-19 Antigen Pro964Hangzhou GENESIS Biodetection and Biocontrol Co. Ltd.Chinahttps://www.genesis-ivd.comYesCommercialisedYesYesManualNear POC / POCAntigenNasal swabNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.2678B.1.1.529Omicron1518P.2Zetanucleocapsid proteinThe KaiBiLi COVID-19 Antigen Pro is an in vitro diagnostic test based on the principle of immuno- chromatography for the qualitative detection of 2019 Novel Coronavirus nucleocapsid protein antigens in nasal swab or nasopharyngeal swab.2022-08-24 09:08:01 CET2875Immuno-AntigenNoImmunochromatographyQualitativeMembrane-based15LOD140TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives3.4%PrecisionEvaluatedAccuracy98.9%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.6%AntigenClinical Specificity100%AntigenType of antigenNucleocapsid protein2890KaiBiLi Flu & COVID-19 Antigen Duo964Hangzhou GENESIS Biodetection and Biocontrol Co. Ltd.Chinahttps://www.genesis-ivd.comYesCommercialisedNoNoManualNear POC / POCAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.2678B.1.1.529Omicron1518P.2Zetanucleocapsid proteinKaiBiLi Flu & COVID-19 Antigen Duo Rapid Test is intended for the simultaneous qualitative detection and differentiation of the nucleocapsid protein antigens from SARS-CoV-2, influenza A and influenza B in direct nasal specimens. The detection is based on the antibodies which were developed specifically recognizing and reacting with the nucleoprotein of virus.2022-08-24 09:08:01 CET2595Immuno-AntigenNoImmunochromatographyQualitativeMembrane-based15LOD140TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives3.4%PrecisionEvaluatedAccuracy98.9%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.6%AntigenClinical Specificity100%AntigenType of antigenNucleocapsid protein1844Immunobio SARS-CoV-2 Antigen ANTERIOR NASAL Rapid Test Kit (minimal invasive)843Hangzhou Immuno Biotech Co. Ltd.Chinawww.immuno-test.comYesCommercialisedNoNoManualAntigenNasal swabNasopharyngeal swabnucleocapsid proteinBfArM Listed, PEI evaluated2022-08-24 09:08:01 CET2887Immuno-AntigenNoImmunochromatographyQualitative10LOD6AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives5.61%94,39False negatives0%100PrecisionEvaluatedAccuracy97.67%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94%Clinical Specificity100%Type of antigenNucleoprotein2317SARS-CoV-2 Antigen Rapid Test843Hangzhou Immuno Biotech Co. Ltd.Chinawww.immuno-test.comYesCommercialisedYesYesNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swab678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1137B.1.429Epsilon1223B.1.525Eta1224B.1.526Iota1321B.1.617.2Delta1495P.1Gamma1518P.2Zetanucleocapsid protein2022-11-14 09:03:54 CET5309Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich, Double10LOD100TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.71%False negatives%PrecisionEvaluatedAccuracy99%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.29%Clinical Specificity100%Type of antigenNucleocapsid protein2979SARS-CoV-2 Ag Rapid Test Kit1317Hangzhou Jucheng Medical Products Co. Ltd.ChinaYesCommercialisedYesYesManualAntigenAnterior nasal swabSARS-CoV678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1132B.1.427Epsilon1137B.1.429Epsilon1321B.1.617.2Deltanucleocapsid protein2022-08-24 09:08:01 CET2685Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich, Double10LOD0.5pg/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy97.8%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.9%Clinical Specificity100%Type of antigenNucleocapsid protein5818COVID-19 and Influenza A/B Antigen Test Kit302Hangzhou Laihe Biotech Co. Ltd.Chinawww.lyherbio.com/YesCommercialisedNoNoManualNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabInfluenza AInfluenza A H1N1Influenza A H3N2Influenza A H5N1Influenza BInfluenza B VictoriaInfluenza B YamagataSARS-CoV-220A.23.170AT.1678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1223B.1.525Eta1224B.1.526Iota1320B.1.617.1Kappa1321B.1.617.2Delta1323B.1.621Mu2041C.37Lambda1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid protein2023-01-09 10:07:14 CET5420Immuno-AntigenYesNoNoImmunochromatographyQualitativeN.A.Colloidal gold15LOD1350PFU/mLCalibrationEvaluatedAnalytical Sensitivity100%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives%False negatives6.36%PrecisionEvaluatedAccuracy99.99%Flu BRobustnessEvaluatedClinical Sensitivity99.99%Flu BClinical Specificity99.99%Flu B1215LYHER Novel Coronavirus (COVID-19) Antigen Test Kit(Colloidal Gold)302Hangzhou Laihe Biotech Co. Ltd.Chinawww.lyherbio.com/YesCommercialisedYesYesNear POC / POCAntigenNasal swab2022-08-24 09:08:01 CET1041Immuno-AntigenYesNoImmunoassayQualitativeColloidal gold477LYHER Novel Coronavirus(2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold)302Hangzhou Laihe Biotech Co. Ltd.Chinawww.lyherbio.com/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgM2022-08-24 09:08:01 CET399Immuno-AntibodyYesImmunoassayColloidal gold2634Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold) - (saliva, sputum)1203Hangzhou Laihe Biotech Co. Ltd.Chinawww.lyherbio.comYesCommercialisedNoNoManualNear POC / POCAntigenSalivaSputum689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2Zetanucleocapsid proteinlineages performances: Omicron (B.1.1.529), Mu (B.1.621), Lambda (C.37), Delta (B.1.617.2), Alpha (B.1.1.7), Beta (B.1.351, Gamma (P.1)2022-08-24 09:08:01 CET3130Immuno-AntigenYesNoNoImmunoassayQualitativeColloidal gold15LOD0.5ng/mLCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.52Tested out 1 false positive result from 189 negative cases.False negatives4.42Tested out 5 false negative results from 113 positive cases.PrecisionEvaluatedAccuracy98.01%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.58%Clinical Specificity99.47%Type of antigenNucleocapsid protein2224Novel Coronavirus (COVID-19) Antigen Testkit (Colloidal Gold1033Hangzhou Laihe Biotech Co. Ltd.Chinawww.lyherbio.comYesCommercialisedNoNoManualNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabThroat swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1518P.2Zeta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31224B.1.526IotaB.1.526.1B.1.526.2nucleocapsid proteinIn case of questions kindly do not hesitate to contact us.2022-08-24 09:08:01 CET1925Immuno-AntigenYesNoImmunochromatographyQualitativeMembrane-basedColloidal gold15LOD135CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives10% prevalence, no more than 0,1%False negatives10% prevalence, no more than 5,0%PrecisionEvaluatedAccuracy97%(96% to 98%)ReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity95(>95%)Clinical Specificity98(>98%)Type of antigenNucleoprotein2139COVID-19 Antigen Rapid Test Device（Colloidal Gold）990HANGZHOU LYSUN BIOTECHNOLOGY Co. Ltd.Chinahttp://www.lysunbio.com/YesCommercialisedYesYesManualNear POC / POCAntigenAnterior nasal swabNasal swabNasopharyngeal swabOropharyngeal swabThroat swabAdenovirusAdenovirus 3Adenovirus 7Alpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Enterovirus A71 (EV-A71)Epstein-Barr Virus (EBV)Influenza AInfluenza A H1N1Influenza A H3N2Influenza A H5N1Influenza BInfluenza B VictoriaInfluenza B YamagataMumps Virus (MuV)RhinovirusRhinovirus ARhinovirus BSARS-CoV-2Varicella Zoster Virus (VZV)678B.1.1.529Omicron1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.3nucleocapsid protein2022-08-24 15:42:41 CET3702Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold10LOD150TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%479 of 479False negatives2.5%4 of 163PrecisionEvaluatedAccuracy99.38%95% CI: 98.41%~99.83%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.55%95%CI: 93.84%~99.33%Clinical Specificity100%95%CI: 99.38%~100%Type of antigenNucleocapsid protein2142COVID-19 Neutralizing Antibody Rapid Test Device（Colloidal Gold）990HANGZHOU LYSUN BIOTECHNOLOGY Co. Ltd.Chinahttp://www.lysunbio.com/YesIn developmentNoNoManualNear POC / POCAntibodyPlasmaSerumWhole blood689B.1.1.7AlphaOtherNone2022-08-24 09:08:01 CET1832Immuno-AntibodyYesYesImmunochromatographyQualitativeCaptureColloidal gold10LOD0AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%(0 of 413）False negatives0.42%(1 of 239）PrecisionEvaluatedAccuracy99.85%(95%CI: 99.15%~100%)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.58%(95%CI: 97.69%~99.99%)Clinical Specificity100%(95%CI: 99.28%~100%)Type of antigenOther2141nCoV-19 IgG/IgM Rapid Test Device (Whole Blood/Plasma/Serum)990HANGZHOU LYSUN BIOTECHNOLOGY Co. Ltd.Chinahttp://www.lysunbio.com/YesIn developmentNoNoManualNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood689B.1.1.7AlphaOtherNone2022-08-24 09:08:01 CET1831Immuno-AntibodyYesYesImmunochromatographyQualitativeCapture15LOD0AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0% IgM(0 of 102)False positives1.96% IgG(2 of 102)False negatives4.55% IgM(2 of 44)False negatives0% IgG (0 of 102)PrecisionEvaluatedAccuracy98.6% IgM(95%CI:96.7%~100%)Accuracy98.7% IgG(95%CI:97.0%~100%)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.5% IgM(95%CI:89.3%~100%)Clinical Sensitivity100% IgG(95%CI:99.7%~100%)Clinical Specificity100% IgM(95%CI:99.8%~100%)Clinical Specificity98% IgG(95%CI:95.4%~100%)Type of antigenOther2142019-nCov Rapid Test Kit130Hangzhou Matridx Biotechnology Co. Ltd.Chinawww.matridx.com/matridx.htmlNoCommercialisedNoNoManualAntibody2022-08-24 09:08:01 CET170Immuno-AntibodyImmunoassay5702019-nCOV IgG/LgM Rapid Test Device344Hangzhou Realy Tech Co. Ltd.Chinawww.realytech.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2022-08-24 09:08:01 CET458Immuno-AntibodyYesNoImmunoassayQualitativeRapid diagnostic test cassette 17932019-nCoV-IgG Assay Reagent Kit (CMIA)344Hangzhou Realy Tech Co. Ltd.Chinawww.realytech.comYesCommercialisedNoNoNear POC / POCAntibodyIgGSerum2022-08-24 09:08:01 CET1472Immuno-AntibodyYesImmunoassayQualitativeChemiluminescence40False positives0.48%False negatives1.11%Accuracy99%Clinical Sensitivity98.89%17942019-nCoV-IgM Assay Reagent Kit (CMIA)344Hangzhou Realy Tech Co. Ltd.Chinawww.realytech.comYesCommercialisedNoNoNear POC / POCIgMSerum2022-08-24 09:08:01 CET1473Immuno-AntibodyYesImmunoassayQualitativeChemiluminescence40False positives0.97%False negatives7.78%Accuracy98.17%Clinical Sensitivity92.22%1795Novel Coronavirus (2019-nCOV) Antigen Rapid Test Cassette (Quantum Dot-based Fluorescence Immunochromatography)344Hangzhou Realy Tech Co. Ltd.Chinawww.realytech.comYesCommercialisedNoNoNear POC / POCAntigenNasal swab2022-08-24 09:08:01 CET1474Immuno-AntigenYesNoImmunochromatographyFluorescence20LOD1250IU/mlFalse positives0%False negatives3.83%Accuracy98.79%Clinical Sensitivity96.17%1743Novel Coronavirus (SARS-Cov-2) Antigen rapid test344Hangzhou Realy Tech Co. Ltd.Chinawww.realytech.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabThis product is being used currently by Westland Health on the Irish market with its customers. All positive candidates who have tested positive with the Realy antigen test kit, have been subsequently confirmed positive by the Irish Health Service. 2022-08-24 09:08:01 CET1421Immuno-AntigenYesNoImmunoassayQualitative15LOD1250U/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positivesNot FoundFalse negativesNot FoundPrecisionEvaluatedAccuracy98.79%ReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity97.14%1220Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab)344Hangzhou Realy Tech Co. Ltd.Chinawww.realytech.comYesCommercialisedYesYesNear POC / POCAntigenNasopharyngeal swab20A.23.170AT.1689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526IotaB.1.526.1B.1.526.23939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu1439C.362041C.37Lambda1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid proteinChange Specimen type2023-07-27 10:44:46 CET21089Immuno-AntigenYesNoImmunochromatographyQualitativeMembrane-basedColorimetry15LOD1250TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives%450 samples are proven negative of 450 negative specimensFalse negatives3.83%8 samples are proven negative of 209 positive specimensPrecisionEvaluatedAccuracy98.79%ReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity96.17%Clinical Specificity99.9%>99.9%Type of antigenNucleocapsid protein2018Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (nasal swab)344Hangzhou Realy Tech Co. Ltd.Chinawww.realytech.comYesCommercialisedNoNoNear POC / POCAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2Zeta678B.1.1.529Omicronnucleocapsid proteinNo2022-08-24 09:08:01 CET1696Immuno-AntigenYesNoNoImmunochromatographyQualitativeMembrane-based10LOD625TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%450 samples are proven negative of 450 negative specimensFalse negatives3.7%5 samples are proven negative of 135 positive specimensPrecisionEvaluatedAccuracy99.15%ReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity96.3%Clinical Specificity99.9%(＞99.9%)Type of antigenNucleocapsid protein3027Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (nasal swab) (self-test)344Hangzhou Realy Tech Co. Ltd.Chinawww.realytech.comYesCommercialisedNoNoManualAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1137B.1.429Epsilon1321B.1.617.2Delta678B.1.1.529Omicronnucleocapsid proteinNo2022-08-24 09:08:01 CET2733Immuno-AntigenYesNoImmunochromatographyQualitativeMembrane-based10LOD625TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%450 samples are proven negative of 450 negative specimensFalse negatives3.7%5 samples are proven negative of 135 positive specimensPrecisionEvaluatedAccuracy99.15%AntigenReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity96.3%AntigenClinical Specificity%>99% - AntigenType of antigenNucleocapsid protein1796Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (saliva)344Hangzhou Realy Tech Co. Ltd.Chinawww.realytech.comYesCommercialisedNoNoNear POC / POCAntigenSaliva2022-08-24 09:08:01 CET1475Immuno-AntigenYesNoImmunochromatographyQualitativeColorimetry20LOD125IU/mlFalse positives0.42%False negatives7.1%Accuracy96.79%Clinical Sensitivity92.9%1802Novel Coronavirus Neutralizing Antibody Assay Reagent Kit344Hangzhou Realy Tech Co. Ltd.Chinawww.realytech.comYesCommercialisedNoNoNear POC / POCAntibody2022-08-24 09:08:01 CET1481Immuno-AntibodyNoYesImmunoassayQualitativeNeutralization Antibody (NAb)40LOD0AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.44%228 samples are proven negative of 229 negative specimens.False negatives0%120 samples are proven negative of 120 positive specimens.PrecisionEvaluatedAccuracy99.71%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.9%Clinical Specificity99.56%1896Novel coronavirus neutralizing antibody Rapid Test Device344Hangzhou Realy Tech Co. Ltd.Chinawww.realytech.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole bloodThe Novel coronavirus neutralizing antibody Rapid Test Device is a qualitative product, not applicable to LOD.2022-08-24 09:08:01 CET1573Immuno-AntibodyNoImmunoassayQualitativeColorimetry10LOD0AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%371 samples are proven negative of 371 negative specimens，so the false positive percentage is 0%.False negatives5.27%144 samples are proven negative of 152 positive specimens，so the false negative percentage is 5.26%.PrecisionEvaluatedAccuracy98.47%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.73%Clinical Specificity99.9%(>99.9)3116Novel Coronavirus（SARS-Cov-2）Antigen Rapid Test Device（saliva）（self-test）344Hangzhou Realy Tech Co. Ltd.Chinawww.realytech.comYesCommercialisedNoNoManualAntigenSalivaSARS-CoV689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1137B.1.429Epsilon1321B.1.617.2Delta678B.1.1.529Omicronnucleocapsid protein/2022-08-24 09:08:01 CET2823Immuno-AntigenYesNoImmunochromatographyQualitativeMembrane-based10LOD625TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%450 samples are proven negative of 450 negative specimens，so the false positive percentage is 0%False negatives7.24%10 samples are proven negative of 138 positive specimens，so the false negative percentage is 7.24%PrecisionEvaluatedAccuracy98.3%ReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity92.75%Clinical Specificity99.9%>99.9%Type of antigenNucleocapsid protein1789SARS-Cov-2&Influenza A&B Combo Rapid Test Cassette (swab)344Hangzhou Realy Tech Co. Ltd.Chinawww.realytech.comYesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swab2022-08-24 09:08:01 CET1468Immuno-AntigenNoImmunochromatographyQualitativeColorimetry20LOD0AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives3.83%PrecisionEvaluatedAccuracy98.79%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.17%Clinical Specificity99.9%3964SARS-Cov-2＆Influenza A/B Combo Rapid Test Cassette (swab)1416Hangzhou Realy Tech Co., Ltd.Chinawww.realytech.comYesCommercialisedNoNoManualAntigenNasal swabSARS-CoV678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1137B.1.429Epsilon1321B.1.617.2Delta1495P.1Gammanucleocapsid protein2022-08-24 09:08:01 CET3629Immuno-AntigenYesYesNoImmunochromatographyQualitativeMembrane-basedColloidal gold15LOD625TCID50/mlAnalytical Sensitivity95.45%Analytical Specificity100%False positives0%False negatives4.5%Accuracy99.11%Clinical Sensitivity95.45%Clinical Specificity100%1970COVID-19 IgG/IgM Rapid Test Cassette887Hangzhou Sejoy Electronics & Instruments Co. Ltd.Chinasejoy.com/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood with anti-coagulantsWe have evulated the relative interference substances.2022-08-24 09:08:01 CET1646Immuno-AntibodyNoImmunoassayQualitativeSandwich15LOD40AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0% IgGFalse positives2% IgMFalse negatives0AUFalse negatives9% IgMPrecisionEvaluatedAccuracy100% IgGAccuracy93.33% IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100% IgGClinical Sensitivity88.61% IgMClinical Specificity100% IgGClinical Specificity97.67% IgMType of antigenOther3146GENnasal SARS-CoV.2 Antigen Rapid Test1391Hangzhou Sejoy Electronics & Instruments Co. Ltd.ChinaYesCommercialisedNoNoManualAntigenNasal swabSARS-CoV689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1321B.1.617.2Delta678B.1.1.529Omicronnucleocapsid proteinSensitivity, specificity and accuracy are from the newest performance evaluation - including false-positives and false-negatives. German Paul-Ehrlich-Institut (PEI) evaluated this test under test-ID AT 1269/212022-08-24 09:08:01 CET2854Immuno-AntigenYesYesNoImmunochromatographyQualitativeMembrane-based10LOD400TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1%False negatives6%PrecisionEvaluatedAccuracy98.5%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.5%Clinical Specificity99.9%Type of antigenNucleocapsid protein2063SARS-CoV-2 & Influenza A+B Antigen Combo Rapid Test Cassette887Hangzhou Sejoy Electronics & Instruments Co. Ltd.Chinasejoy.com/YesCommercialisedYesYesNear POC / POCAntigenNasopharyngeal swabOropharyngeal swab1518P.2ZetaWe have also evaluated the interference substances.2022-10-05 14:06:10 CET3934Immuno-AntigenNoImmunoassayQualitativeSandwich20LOD40050AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives2AUFalse negatives3AUPrecisionEvaluatedAccuracy98.5%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.4%Clinical Specificity99.1%Type of antigenNucleoprotein1945SARS-CoV-2 Antigen Rapid Test Cassette887Hangzhou Sejoy Electronics & Instruments Co. Ltd.Chinasejoy.com/YesCommercialisedYesYesNear POC / POCAntigenNasal swabnucleocapsid proteinThe cross substances and interference substance are also evaluated.2022-08-24 09:08:01 CET1621Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich20LOD400AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2AUFalse negatives3AUPrecisionEvaluatedAccuracy98.5%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.4%Clinical Specificity99.1%Type of antigenNucleoprotein2671SARS-CoV-2 Antigen Rapid Test Cassette887Hangzhou Sejoy Electronics & Instruments Co. Ltd.Chinasejoy.com/YesCommercialisedYesYesNear POC / POCAntigenNasopharyngeal swabOropharyngeal swabSARS-CoV-2689B.1.1.7Alphanucleocapsid proteinWe have also evaluated interference substance as following:Whole Blood,Ibuprofen,Tetracycline,Mucin,Erythromycin,Tobramycin,Menthol,Afrin, Compound Benzoin Gel,Cromolyn glycate , Chloramphenicol ,Mupirocin,Oseltamivir,Naphazoline Hydrochlo-ride Nasal Drops,Fluticasone propionate spray,Deoxyepinephrine hydro-chloride2023-03-02 11:30:05 CET21058Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwichOther10LOD400TCID50/mlCalibrationNot evaluatedAnalytical Sensitivity87%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives%False negatives13%PrecisionEvaluatedAccuracy97.79%RobustnessEvaluatedClinical Sensitivity87%Clinical Specificity100%1952SARS-CoV-2 Antigen Rapid Test Cassette (nasal, nasopharyngeal, oropharyngeal, saliva)887Hangzhou Sejoy Electronics & Instruments Co. Ltd.Chinasejoy.com/YesCommercialisedYesYesNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabSalivaSARS-CoV-2689B.1.1.7Alphanucleocapsid proteinWe have also evulated the interference substance.2023-02-23 18:20:31 CET20251Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwichImmunofluorescence20LOD400AUCalibrationNot evaluatedAnalytical Sensitivity97.4%Analytical Specificity99.1%Analysis of cross reactivityEvaluatedFalse positives2tests2(Nasal swab),3(Oropharyngeal swabs),2(Nasopharyngeal swabs),3(Saliva)False negatives3tests3(Nasal swab),5(Oropharyngeal swabs),3(Nasopharyngeal swabs),5(Saliva)PrecisionEvaluatedAccuracy98.5%98.48%(Nasal swab),98.67%(Oropharyngeal swabs),98.48%(Nasopharyngeal swabs),98.46%(Saliva)RobustnessEvaluatedClinical Sensitivity97.4%97.4%(Nasal swab),95.76%(Oropharyngeal swabs),97.4%(Nasopharyngeal swabs),95.65%(Saliva)Clinical Specificity99.1%99.1%(Nasal swab),99.38%(Oropharyngeal swabs),99.1%(Nasopharyngeal swabs),99.26%(Saliva)2740SARS-CoV-2 Antigen Saliva Lolly Test952Hangzhou Sejoy Electronics & Instruments Co. Ltd.Chinahttp://www.sejoy.com.cn/YesCommercialisedNoNoNear POC / POCAntigenSalivaAbout interference,we also have evaluated.2022-08-24 09:08:01 CET2445Immuno-AntigenNoImmunochromatographyQualitativeSandwich10LOD400000TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives1AUFalse negatives7AUPrecisionEvaluatedAccuracy96.55%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.91%Clinical Specificity99.15%Type of antigenNucleocapsid protein2062SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette952Hangzhou Sejoy Electronics & Instruments Co. Ltd.Chinahttp://www.sejoy.com.cn/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood1518P.2ZetaWe have also evaluated the cross reactivity and interference substances.2022-08-24 09:08:01 CET1742Immuno-AntibodyNoImmunoassayQualitativeSandwich15neutralizing antibodyLOD5050AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives3AUFalse negatives2AUPrecisionEvaluatedAccuracy98.97%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.4%Clinical Specificity99.2%Type of antigenOther10002019-nCoV Ab Test (Colloidal Gold)1191Hangzhou Singclean Medical Products Co. Ltd.Chinawww.singclean.netYesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET907Immuno-AntibodyYesNoImmunoassayQualitativeColloidal gold15Analysis of cross reactivityReportedClinical Sensitivity87.3%Clinical Specificity100%1446COVID-19 Antigen Test Kit (Colloidal Gold)1191Hangzhou Singclean Medical Products Co. Ltd.Chinawww.singclean.netYesCommercialisedYesYesNear POC / POCAntigenNasal swabSARS-CoV678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1224B.1.526Iota1320B.1.617.1Kappa1321B.1.617.2Delta2041C.37Lambda1495P.1Gammanucleocapsid proteinThe specimen is Nasal swab2022-10-05 14:05:17 CET3933Immuno-AntigenYesNoYesImmunochromatographyQualitativeSandwichColorimetry15LOD9.75AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives1%False negatives2.78%PrecisionNot evaluatedAccuracy98.63%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.22%Clinical Specificity99%Type of antigenNucleocapsid protein995COVID-19 IgG/IgM Combined Test kit(Colloidal Gold Method)1191Hangzhou Singclean Medical Products Co. Ltd.Chinawww.singclean.netNoCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2022-08-24 09:08:01 CET903Immuno-AntibodyYesNoImmunoassayQualitativeColloidal gold151001Covid-19 IgG/IgM test kit (Colloidal Gold Method)1191Hangzhou Singclean Medical Products Co. Ltd.Chinawww.singclean.netYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2022-08-24 09:08:01 CET775Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry152210COVID-19 Test Kit (Colloidal Gold Method)1191Hangzhou Singclean Medical Products Co. Ltd.Chinawww.singclean.netYesCommercialisedNoNoManualAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1321B.1.617.2Deltanucleocapsid proteinThe specimen was Nasal swab.2023-07-27 10:45:35 CET21090Immuno-AntigenYesNoImmunochromatographyQualitativeSandwichColloidal gold15LOD9.75AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives1%False negatives2.78%PrecisionNot evaluatedAccuracy98.63%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.22%Clinical Specificity99%Type of antigenNucleocapsid protein2778COVID-19 Test Kit (Colloidal Gold Method)(for self-testing）1191Hangzhou Singclean Medical Products Co. Ltd.Chinawww.singclean.netYesCommercialisedNoNoManualNear POC / POCAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1321B.1.617.2DeltaBfarm list AT1259/21 The specimen was Nasal swab.2022-08-24 09:08:01 CET2483Immuno-AntigenYesImmunochromatographyQualitativeSandwichColloidal gold15LOD9.75AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives2.01%False negatives0.29%PrecisionEvaluatedAccuracy99.2%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.99%Clinical Specificity99.71%Type of antigenNucleocapsid protein2609COVID-19 Test Kit (Colloidal Gold Method)(Nasal Swab)1191Hangzhou Singclean Medical Products Co. Ltd.Chinawww.singclean.netYesCommercialisedNoNoAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1321B.1.617.2Deltanucleocapsid proteinBfarm list AT 1013/21 The specimen was Nasal swab.2022-08-24 09:08:01 CET2314Immuno-AntigenYesNoImmunochromatographyQualitativeSandwichColloidal gold15LOD9.75AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives1%False negatives2.78%PrecisionNot evaluatedAccuracy98.63%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.22%Clinical Specificity99%Type of antigenNucleocapsid protein1974Singclean1191Hangzhou Singclean Medical Products Co. Ltd.Chinawww.singclean.netYesCommercialisedNoNoManualAntigenNasopharyngeal swabBfarm list AT 437/212022-08-24 09:08:01 CET1650Immuno-AntibodyNoImmunochromatographyQualitativeSandwich15LOD9.975U/ml[LOD (U/ml)=9.975 x 102 TCID50/mL]CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positivesThe results of test reagent and control reagent both were 309 negative specimens, there are three spFalse negativesThe results of test reagent and control reagent both were 209 positive specimens, there are three spPrecisionNot evaluatedAccuracy98.84%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.56%Clinical Specificity99.03%Type of antigenNucleoprotein1392COVID-19 Antigen Test Cassette131Hangzhou Testsea Biotechnology Co. Ltd.Chinawww.testsealabs.com/YesCommercialisedYesYesNear POC / POCAntigenNasal swabnucleocapsid protein2022-08-24 09:08:01 CET1158Immuno-AntigenYesNoImmunoassayQualitative10LOD0.1AUCalibrationNot evaluatedFalse positives2AUFalse negatives8AUAccuracy96.5%Clinical Sensitivity92.1%Clinical Specificity98.1%Type of antigennucleoprotein1632COVID-19 IgG/IgM Antibody Test(Colloidal Gold)131Hangzhou Testsea Biotechnology Co. Ltd.Chinawww.testsealabs.com/YesCommercialisedNoNoLab-basedAntibodyIgGIgMPlasmaSerumWhole blood2022-08-24 09:08:01 CET1312Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15857COVID-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma)131Hangzhou Testsea Biotechnology Co. Ltd.Chinawww.testsealabs.com/YesCommercialisedNoNoAutomatedManualAntibodyIgGIgMWhole blood2022-08-24 09:08:01 CET831Immuno-AntibodyYesNoImmunoassayQualitativeColloidal gold5Accuracy94%Clinical Sensitivity88%676One Step SARS-nCoV2 (COVID-19) IgG/IgM test131Hangzhou Testsea Biotechnology Co. Ltd.Chinawww.testsealabs.com/NoIn developmentNoNoLab-basedAntibodyWhole blood2022-08-24 09:08:01 CET805Immuno-AntibodyNoImmunoassayQualitativeColloidal gold5Accuracy94%Clinical Sensitivity88%4108SARS-CoV-2 Antigen Test(Nasal swab)1468Hangzhou Tongzhou Biotechnology Co LtdChinaYesCommercialisedNoNoNear POC / POCAntigenNasal swabAdenovirus 3Adenovirus 7Alpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Influenza A H1N1Influenza A H3N2Influenza BMERS-CoVParainfluenza Virus Type 2Parainfluenza Virus Type 3Respiratory Syncytial V (RSV)20A.23.170AT.1678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526IotaB.1.526.1B.1.526.23939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu1439C.362041C.37LambdaOther1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid protein2022-09-29 09:37:02 CET3893Immuno-AntigenYesNoNoImmunoassayQualitativeSandwichImmunofluorescence15LOD100%CalibrationEvaluatedAnalytical Sensitivity97%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives0.03%False negatives0%PrecisionEvaluatedAccuracy99%RobustnessEvaluatedClinical Sensitivity97%Clinical Specificity100%24766SARS-CoV-2 Antigen Test（nasopharyngeal swab）17328Hangzhou Tongzhou Biotechnology Co LtdChinawww.tongzhoubio.comYesCommercialisedYesYesNear POC / POCAntigenNasopharyngeal swabAdenovirus 3Adenovirus 7Alpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Influenza AInfluenza A H1N1Influenza A H3N2Influenza A H5N1Influenza BMERS-CoVMumps Virus (MuV)Parainfluenza Virus Type 2Parainfluenza Virus Type 3Respiratory Syncytial V (RSV)20A.23.170AT.1678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526IotaB.1.526.1B.1.526.23939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu1439C.362041C.37LambdaOther1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid protein2023-07-27 10:46:07 CET21091Immuno-AntigenYesNoN.A.ImmunochromatographyQualitativeSandwichImmunofluorescence10LOD100TCID50/mlCalibrationEvaluatedAnalytical Sensitivity93.4%Analytical Specificity99.3%Analysis of cross reactivityEvaluatedFalse positives0.066AUFalse negatives0.007AUPrecisionEvaluatedAccuracy98.1%RobustnessEvaluatedClinical Sensitivity93.4%Clinical Specificity99.3%2942SARS-CoV-2 Nucleocapsid (N) Antigen Rapid Test Cassette (Swab)1298Hangzhou Zheda Dixun Biological Gene Engineering Co. Ltd.Chinahttps://www.zdbiogene.comYesCommercialisedYesYesManualNear POC / POCAntigenNasopharyngeal swabOropharyngeal swabSARS-CoV689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1224B.1.526Iota678B.1.1.529Omicron1518P.2Zetanucleocapsid proteinnone2022-08-24 09:08:01 CET2648Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich15LOD100TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives4.86%PrecisionEvaluatedAccuracy98.07%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.14%Clinical Specificity100%Type of antigenNucleocapsid protein2362CLINITEST® Rapid COVID-19 Antigen Test1092HealgenUnited Stateshealgen.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1321B.1.617.2DeltaThe RAT is already registered at https://covid-19-diagnostics.jrc.ec.europa.eu/devices/detail/1767 - however with another name. To be able of using the RAT in Switzerland as an aid for the COVID-Certificate i was told it needs to have the exact same name. As the RAT with ID 1767 doesn't have the same name, eventhough it's the same test, herbey the application. If it is possible to add the name to 1767 it will work for Switzerland as well, I guess. Otherwise it needs to be added. Thank you and best regards Kristian Palas2022-08-24 09:08:01 CET2063Immuno-AntigenNoImmunochromatographyQualitative15LOD1.15AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positivessensitivity: 98.32% specificity: 99.6%False negativessensitivity: 98.32% specificity: 99.6%PrecisionEvaluatedAccuracy98.73%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.32%Clinical Specificity99.6%Type of antigenNucleoprotein2238Clinitest Rapid Covid-19 Antigen Self Test554Healgen ScientificUnited Stateshttps://www.healgen.com/YesCommercialisedNoNoNear POC / POCAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon20A.23.11518P.2Zetan/a2022-08-24 09:08:01 CET1939Immuno-AntigenNoImmunochromatographyQualitative15LOD115CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives97.25% Sensitivity, 100% SpecificityFalse negatives97.25% Sensitivity, 100% SpecificityPrecisionNot evaluatedAccuracy98.73%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.25%Clinical Specificity100%Type of antigenNucleoprotein2737CLINITEST® Rapid COVID-19 Antigen Test554Healgen ScientificUnited Stateshttps://www.healgen.com/YesCommercialisedNoNoNear POC / POCAntigenNasal swabNasopharyngeal swabRationale: Updating already-existing listing to correct the manufacturer and antigen type2022-08-24 09:08:01 CET2442Immuno-AntigenNoImmunochromatographyQualitativeSandwich15Accuracy99.42%nasopharyngeal swabAccuracy98.73%nasal swabClinical Sensitivity98.32%nasopharyngeal swabClinical Sensitivity97.25%nasal swabClinical Specificity99.6%nasopharyngeal swabClinical Specificity100%nasal swabType of antigenNucleocapsid protein1767Coronavirus Ag Rapid Test Cassette554Healgen ScientificUnited Stateshttps://www.healgen.com/YesCommercialisedYesYesNear POC / POCAntigenNasal swabNasopharyngeal swab2022-08-24 09:08:01 CET1446Immuno-AntigenYesNoImmunochromatographyQualitative15Accuracy98.73%Nasal swabAccuracy99.42%Nasopharyngeal swabClinical Sensitivity97.25%Nasal swabClinical Sensitivity98.32%Nasopharyngeal swabClinical Specificity100%Nasal swabClinical Specificity99.6%Nasopharyngeal swab677COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)554Healgen ScientificUnited Stateshttps://www.healgen.com/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2022-08-24 09:08:01 CET806Immuno-AntibodyYesNoImmunoassayQualitative101735Rapid COVID-19 Antigen Test554Healgen ScientificUnited Stateshttps://www.healgen.com/YesCommercialisedNoNoNear POC / POCAntigenNasal swabOthernucleocapsid protein2022-08-24 09:08:01 CET1414Immuno-AntigenYesNoImmunoassayQualitativeColloidal gold15LOD115U/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.35%3 of 865False negatives0.23%2 of 865PrecisionNot evaluatedAccuracy99.42%ReproducibilityNot evaluatedRobustnessNot evaluatedClinical Sensitivity98.32%Type of antigenNucleoprotein1612Rapid COVID-19 AntigenTest554Healgen ScientificUnited Stateshttps://www.healgen.com/NoCommercialisedNoNoAntigenNasopharyngeal swab2022-08-24 09:08:01 CET1796Immuno-AntigenYesCLIAQualitative152974Healfo SARS-CoV-2 Ag Saliva Rapid Test1313Healvet Medtech GZ Ltd.Chinahttp://www.hnhealfo.com/YesCommercialisedNoNoManualAntigenOropharyngeal swabSalivaSARS-CoV689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1321B.1.617.2Delta1323B.1.621Mu2041C.37Lambda678B.1.1.529Omicron1. False negative results can occur if the saliva is not collected properly. 2. Do not eat or drink any things for 2 hours before the test.2022-08-24 09:08:01 CET2680Immuno-AntigenYesNoNoImmunochromatographyQualitative15LODFor in vitro diagnostic use.CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.85False negatives6.6PrecisionEvaluatedAccuracy97.5%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.3Clinical Specificity99.1Type of antigenNucleocapsid protein478COVID-19 IgM Antibody Rapid Test Kit303Hecin Scientific Inc.Chinawww.hecin-scientific.cn/YesCommercialisedNoNoNear POC / POCAntibodyIgM2022-08-24 09:08:01 CET400Immuno-AntibodyYesImmunoassay1637SARS-CoV-2 IgM/IgG Antibody Test Kit (Colloidal Gold Method)733Hefei Biohit HealthcareChinawww.biouhan.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole bloodAnti-Nuclear AntibodyHemophilus InfluenzaeHepatitis B Virus (HBV)Hepatitis C Virus (HCV)Influenza AInfluenza BRespiratory Syncytial V (RSV)689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1132B.1.427Epsilon1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta2041C.37Lambda678B.1.1.529Omicronnucleocapsid proteinspike proteinThe SARS-CoV-2 IgM/IgG Antibody Test Kit is a single-use rapid immunochromatographic test for the qualitative detection and differentiation of Immunoglobulin M(IgM) and Immunoglobulin G(IgG) antibodies to SARS-CoV-2 in human serum, plasma (heparin, K2-EDTA, and sodium citrate), and whole blood (heparin, K2-EDTA, sodium citrate, and no anticoagulant).2022-08-24 09:08:01 CET1317Immuno-AntibodyYesNoNoImmunochromatographyQualitativeSandwichColloidal gold14LOD10AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy99.4% IgGAccuracy99.1% IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.66% IgMClinical Sensitivity99.46% IgGClinical Specificity98.66% IgMClinical Specificity100% IgGType of antigenNucleocapsid protein2946UDXBIO1299Henan UDX Biotechnology Co. Ltd.Chinawww.udxbio.comYesCommercialisedNoNoNear POC / POCAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta678B.1.1.529Omicronnucleocapsid proteinBFArM ：AT1191/21 The product is listed on the FDA website2022-08-24 09:08:01 CET2652Immuno-AntigenNoNoImmunoassayQualitativeOther15CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%n=363False negatives7.62%n=105PrecisionEvaluatedAccuracy98.29%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.38%Clinical Specificity100%Type of antigenNucleocapsid protein1958Covid-19 Slide Test896HGH Desinfections und Cosmetique GmbHAustriawww.hgh-group.at/YesCommercialisedNoNoManualNear POC / POCAntigenSalivaDetects SARS-CoV-2 S antigen and SARS-CoV-2 N antigen2022-08-24 09:08:01 CET1634Immuno-AntigenNoImmunoassayOther15LOD1.25AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives93%(95%CI:83%-95%)False negatives100%(95%CI:93%-100%)PrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93%Clinical Specificity100%Type of antigenNucleoprotein2628SARS-CoV-2 Antigen Test Kit (Colloidal Gold) - Saliva1199Hipro Biotechnology Co. Ltd.ChinaYesCommercialisedNoNoAntigenSalivaSARS-CoV-2 Antigen Test Kit (saliva）(Colloidal Gold) can quickly detect SARS-CoV-2 antigen in saliva by forming visible lines and provide auxiliary diagnosis for Covid-19 infection2022-08-24 09:08:01 CET2333Immuno-AntigenImmunoassayQualitativeSandwich, DoubleColloidal gold10LOD130TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives1.66%10/600False negatives1.87%5/267PrecisionNot evaluatedAccuracy98.27% (95%CI: 97,46%-99,08%)ReproducibilityNot evaluatedRobustnessNot evaluatedClinical Sensitivity98.6% (95%CI: 96,04%-99,24%)Clinical Specificity97% (95%CI: 96,62%-99,84%)Type of antigenNucleocapsid protein1929Corona Virus (COVID-19) Antigen Rapid Test (Colloidal Gold)883Hoyotek Biomedical Co. Ltd.Chinahttp://hoyotek.cn/YesCommercialisedYesYesManualNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabAdenovirusAlpha Coronavirus 229E (HCoV-229E)Influenza AInfluenza A H3N2Influenza BParainfluenza Virus Type 2Parainfluenza Virus Type 3Parainfluenza Virus Type 4Rhinovirus1321B.1.617.2Delta678B.1.1.529Omicronnucleocapsid proteinOtherThe nasal swab model of the product has been evaluated by Braizil lab and Thai RAMA Hospital. For Braizil lab: Sensitivity 97.1%, For RAMA hospital Sensitivity 95%, specificity 100%2022-08-24 09:08:01 CET1605Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold13antigen_epi: 45-181aa. Other pathogens tested for cross-reactivity: MERS-coronavirus,Adenovirus 71,Human Metapneumovirus,Enterovirus,RStreptococcus pneumoniae,espiratory syncytial virus A,Rhinovirus,Haemophilus influenza,Streptococcus pneumoniaeLOD200TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives1%Nasopharyngeal swab/AntigenFalse positives2.5%Oropharyngea swab/AntigenFalse positives5.45%Nasal swabFalse negatives4%Nasopharyngeal swab/AntigenFalse negatives7%Oropharyngea swab/AntigenFalse negatives0.21%Nasal swabPrecisionEvaluatedAccuracy98.4%Nasopharyngeal swab/AntigenAccuracy98.79%Nasal swabAccuracy94.8%Oropharyngea swab/AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93%Oropharyngea swabClinical Sensitivity96%Nasopharyngeal swabClinical Sensitivity94.55%Nasal swabClinical Specificity99%Nasopharyngeal swabClinical Specificity97.5%Oropharyngea swabClinical Specificity99.79%Nasal swabType of antigenNucleocapsid protein, Other1930Corona Virus (COVID-19) Combined (IgM/IgG/Neutralizing antibody) Rapid Test (Colloidal gold)883Hoyotek Biomedical Co. Ltd.Chinahttp://hoyotek.cn/YesCommercialisedNoNoManualAntibodyIgGIgMWhole bloodThis kit consists of test card 1 and test card 2. Test card 1 adopts the principle of colloidal gold immunochromatographic sandwich method to detect the novel Corona Virus (COVID-19) IgM / IgG antibody. When a positive sample is added to the sample well，COVID-19 Antibodies (IgM/IgG) in the sample will be combined with colloidal gold labeled COVID-19 RBD recombinant protein and form into immune complexes。When reaching Test Zone, the complexes will be combined with mouse anti-human IgM monoclonal antibody and mouse anti-human IgG monoclonal antibody. M line and G line occur red color. When testing negative samples, there’s no COVID-19 IgM or IgG in the samples, no immune complexes will be formed and color only appears in the Control line. Test card 2 adopts the principle of colloidal gold immunochromatographic competition method to detect Neutralizing antibody. When testing negative samples, colloidal gold labeled ACE2 protein will be combined with COVID-19 RBD recombinant protein which coated on test line and the detection line develops color. When a positive sample is added to the sample well, COVID-19 Neutralizing antibody in the sample mix with colloidal gold labeled ACE2 protein, and does not bind to COVID-19 RBD recombinant protein. The intensity of T line color is) less than C line.2022-08-24 09:08:01 CET1606Immuno-AntibodyNoImmunoassayQualitativeCaptureColloidal gold15Neutralizing antibodyLOD0.5AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives3%False negatives1%PrecisionEvaluatedAccuracy98%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity99%Clinical Specificity97%Type of antigenOther1931Influenza A/B/Corona Virus (COVID-19) Antigen Rapid Test (Colloidal Gold)883Hoyotek Biomedical Co. Ltd.Chinahttp://hoyotek.cn/YesCommercialisedNoNoManualAntigenNasopharyngeal swabOropharyngeal swabOtherThe product is based on the principle of sandwich and colloidal gold immunochromatography, the nitrocellulose membrane Test Zone is pre-coated with mouse anti-Influenza A/B/Corona Virus (COVID-19) monoclonal antibody, the Control Zone is pre-coated with goat anti-mouse polyclonal antibody, the gold conjugation pad is pre-coated with colloidal gold labeled mouse anti-Influenza A/B/Corona Virus (COVID-19) monoclonal antibody. When testing positive samples, Influenza A/B/COVID-19 Antigen the sample will be combined with colloidal gold (Au) labeled mouse anti-Influenza A/B/Corona Virus (COVID-19) monoclonal antibody and form into immune complexes (Au-mouse anti-Influenza A/B/Corona Virus (COVID-19) monoclonal antibody-[ Influenza A/B/COVID-19- (Antigen)]), the complexes will move forward inside the nitrocellulose membrane by chromatography effect. When reaching Test Zone, the complexes will be combined with mouse anti-Influenza A/B/Corona Virus (COVID-19) monoclonal antibody, and form into “(Au-mouse anti-Influenza A/B/Corona Virus (COVID-19) monoclonal antibody-[COVID-19- (Antigen)])-[ mouse anti-Influenza A/B/Corona Virus (COVID-19) monoclonal antibody]”, thus agglutination color appears; The residual colloidal gold labeled mouse anti-Influenza A/B/Corona Virus (COVID-19) monoclonal antibody will be combined with goat anti-mouse polyclonal antibody at the Control Zone, and produce color under agglutination. When testing negative samples, there’s no Influenza A/B/COVID-19 Antigen in the samples, no immune complexes will be formed and color only appears in the Control line.2022-08-24 09:08:01 CET1607Immuno-AntigenYesNoImmunochromatographyQualitativeSandwichColloidal gold15LOD5.25AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives1%COVID-19False positives1.5%FluBFalse positives2%FluAFalse negatives4%COVID-19False negatives8%FluBFalse negatives6%FluAPrecisionEvaluatedAccuracy97.5%FluAAccuracy95.3%FluBAccuracy98.4%COVID-19ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94%FluAClinical Sensitivity92.1%FluBClinical Sensitivity96COVID-19Clinical Specificity98%FluAClinical Specificity98.5%FluBClinical Specificity99COVID-19Type of antigenOther3562Corona Virus (COVID-19) Antigen Rapid Test (Colloidal Gold) - self-testing1418Hoyotek Biomedical Co.,Ltd,Chinahttp://hoyotek.cn/YesCommercialisedNoNoManualNear POC / POCAntigenNasal swabAdenovirusAlpha Coronavirus 229E (HCoV-229E)Influenza AInfluenza A H3N2Influenza BParainfluenza Virus Type 2Parainfluenza Virus Type 3Parainfluenza Virus Type 4Rhinovirus20A.23.1678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351BetaB.1.526.1B.1.526.23939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta2041C.37Lambdanucleocapsid protein2022-08-24 09:08:01 CET3280Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold1317482019-nCoV Ag Rapid Test Kit - REF: CY-F006-AG25780Huachenyang (Shenzhen) Technology Co. Ltd.Chinahttps://www.chenyanglobal.comYesCommercialisedNoNoOtherAntigenNasal swabNasopharyngeal swabSalivanucleocapsid protein2022-08-24 09:08:01 CET1426Immuno-AntigenYesNoImmunochromatographyQualitative15LOD50U/mlAnalysis of cross reactivityEvaluatedFalse positives6.6%4 false positives out of 61 testsFalse negatives0.22%1 false negatives out of 449 testsPrecisionEvaluatedAccuracy99.02%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity96.67%Type of antigenNucleoprotein3153COVID-19 Ag Rapid Test Kit780Huachenyang (Shenzhen) Technology Co. Ltd.Chinahttps://www.chenyanglobal.comYesCommercialisedYesYesLab-basedManualNear POC / POCAntigenAnterior nasal swabnucleocapsid proteinOthervariants_detected BA.1, BA.22022-10-17 12:54:53 CET5205Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich15CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives9AUPrecisionEvaluatedAccuracy98.36%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity91%Clinical Specificity100%Type of antigenNucleocapsid protein2527COVID-19 lgM/lgG Antibody Diagnostic Kit(Colloidal Gold)780Huachenyang (Shenzhen) Technology Co. Ltd.Chinahttps://www.chenyanglobal.comYesCommercialisedNoNoManualAntibodyIgGIgMAnterior nasal swabNasal swabNasopharyngeal swabOropharyngeal swabSalivaThroat swab689B.1.1.7Alpha1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.320A.23.1for Covid-19 antibody IgG/IGM rapid test kit, in 10-15 minutes2022-08-24 09:08:01 CET2231Immuno-AntibodyNoImmunochromatographyQualitativeNeutralization Antibody (NAb)Colloidal gold10CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy97.3%ReproducibilityNot evaluatedRobustnessNot evaluatedClinical Sensitivity90%Clinical SpecificityshenzhenType of antigenEnvelop protein1759SARS-CoV-2 Antigen Test Kit786Hubei Jinjian Biology Co. Ltd.Chinaen.jinjianbio.com/YesCommercialisedYesYesAutomatedAntigenNasopharyngeal swabnucleocapsid protein2022-08-24 09:08:01 CET1437Immuno-AntigenYesYesImmunochromatographyQualitativeColorimetry15LOD115U/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives1%1 out of 100False negatives1.35%2 out of 148PrecisionEvaluatedAccuracy98.8%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.02%Type of antigenNucleoprotein2635Celltrion DiaTrust ™– Covid-19 Ag Rapid Test1062Humasis Co. Ltd.South Koreahttp://www.humasis.com/en/YesCommercialisedNoNoManualAntigenNasal swabNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31224B.1.526Iota1518P.2ZetaOtherCelltrion DiaTrustTM COVID-19 Ag Rapid Test is designed for qualitative detection of SARS-CoV-2 antigens in nasopharyngeal and nasal swab specimen of symptomatic patients suspected of COVID-19 [ MATERIAL COMPOSITION ] ● Monoclonal antibody to SARS-CoV-2 Nucleocapsid ● Monoclonal antibody specific to RBD of SARS-CoV-2 Spike Protein ● Goat anti-mouse IgG Celltrion DiaTrust COVID-19 Ag Rapid Test: Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for emergency use. EUA Number: EUA2101902022-08-24 09:08:01 CET2340Immuno-AntigenYesNoImmunochromatographyQualitativeOther15LOD32TCID50/ml5 x 100.8 TCID50/mLCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positivesUnknownFalse negativesUnknownPrecisionEvaluatedAccuracyUnknownReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity92%Clinical Specificity100%Type of antigenOther5719Celltrion DiaTrust™ COVID-19 IgG/IgM Rapid Test1062Humasis Co. Ltd.South Koreahttp://www.humasis.com/en/YesCommercialisedNoNoManualAntibodyIgGIgMPlasmaSerumWhole bloodOtherOtherOther2022-10-18 08:52:01 CET5210Immuno-AntibodyYesNoNoImmunochromatographyQualitativeCaptureColloidal gold15LOD0%CalibrationEvaluatedAnalytical Sensitivity100%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy100%RobustnessEvaluatedClinical Sensitivity96%% IgMClinical Sensitivity92% IgGClinical Specificity98.7%% IgMClinical Specificity100% IgG2276Humasis COVID-19 Ag Home Test1062Humasis Co. Ltd.South Koreahttp://www.humasis.com/en/YesCommercialisedNoNoManualAntigenNasal swab2022-08-24 09:08:01 CET1977Immuno-AntigenNoImmunochromatographyQualitativeCapture15LOD0%CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives5.6%PrecisionEvaluatedAccuracy97.4%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity95.3%Clinical Specificity100%1263Humasis COVID-19 Ag Test1062Humasis Co. Ltd.South Koreahttp://www.humasis.com/en/YesCommercialisedYesYesManualNear POC / POCAntigenNasal swabNasopharyngeal swabSARS-CoV-2678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526Iota1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31495P.1Gamma1518P.2Zetanucleocapsid proteinspike protein[Contents] ● Test devices packaged individually in aluminum pouch (25tests/box) ● Disposable test tube with extraction buffer (25ea/box) ● Filter cap (25ea/box) ● Sterilized swabs for specimen collection (25ea/box) ● Instructionsfor use (1ea) [Storage] Room temperature (2~30℃)2023-03-30 10:56:38 CET21092Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwichColloidal gold15LOD32TCID50/ml5 x 100.8 TCID50/mLCalibrationNot evaluatedAnalytical Sensitivity100%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives%False negatives%PrecisionEvaluatedAccuracy98.3%Nasal swabRobustnessNot evaluatedClinical Sensitivity91.9%Nasal swabClinical Sensitivity90.48%Nasal swabClinical Sensitivity90.2%Nasopharyngeal swabClinical Specificity99.7%Nasal swabClinical Specificity100%Nasal swabClinical Specificity100%Nasopharyngeal swab219Humasis COVID-19 IgG/IgM Test1062Humasis Co. Ltd.South Koreahttp://www.humasis.com/en/YesCommercialisedNoNoManualAntibodyIgGIgMPlasmaSerumWhole bloodNA2022-08-24 09:08:01 CET180Immuno-AntigenYesNoImmunochromatographyQualitativeCapture15LOD0%CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives4% IgMFalse positives8% IgGFalse negatives1.3% IgMFalse negatives0% IgGPrecisionEvaluatedAccuracy99ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity96% IgMClinical Sensitivity92% IgGClinical Specificity98.7% IgMClinical Specificity100% IgG1262Humasis COVID-19/Flu Ag Combo Test1062Humasis Co. Ltd.South Koreahttp://www.humasis.com/en/YesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swab2022-08-24 09:08:01 CET1037Immuno-AntigenYesImmunoassayQualitative15220COVID-19 IgG/IgM Detection Kit (Colloidal Gold)135Hunan Lituo Biotechnology Co. Ltd.Chinawww.lituo.com.cn/en/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2022-08-24 09:08:01 CET175Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15221SARS-COV-2 specific antibody test kit (Immunochromatography)136Hunan Yonghe-Sun Biotechnology Co. Ltd.Chinawww.yh-sun.com/NoCommercialisedNoNoNear POC / POCAntibody2022-08-24 09:08:01 CET176Immuno-AntibodyImmunochromatography1575OJABIO SARS-CoV-2 Antigen Detection Test Kit (Colloidal Gold Method)1348Hunan Zhongke Lanhai Biotechnology Co. Ltd.Chinawww.ojabio.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.2678B.1.1.529Omicron1518P.2Zetanucleocapsid proteinORF1ab polyproteinORF1b polyproteinNone2022-08-24 09:08:01 CET1254Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD116TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.66%11/661False negatives0.28%1/350PrecisionEvaluatedAccuracy99.1%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.29%Clinical Specificity99.54%Type of antigenNucleocapsid protein3045OJABIO SARS-CoV-2 Neutralizing Antibody Detection Kit (Colloidal Gold Method)1348Hunan Zhongke Lanhai Biotechnology Co. Ltd.Chinawww.ojabio.comYesCommercialisedNoNoManualAntibodyPlasmaSerumWhole bloodOthersend email to us2022-08-24 09:08:01 CET2751Immuno-AntibodyYesNoImmunoassayQualitativeNeutralization Antibody (NAb)Colloidal gold15LOD0.25AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives10%False negatives5.5%PrecisionEvaluatedAccuracy92%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90%Clinical Specificity94.5%3018SARS-CoV-2 Antigen Detection Test Kit (Colloidal Gold Method)1342Hunan Zhongke Lanhai Biotechnology Co. Ltd.Chinawww.zoonkr.netYesCommercialisedNoNoNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.2678B.1.1.529Omicron1518P.2ZetaORF1ab polyproteinORF1b polyproteinNone2022-08-24 09:08:01 CET2724Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD116TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.66%11/661False negatives0.28%1/350PrecisionEvaluatedAccuracy99.1%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.29%Clinical Specificity99.54%Type of antigenNucleocapsid protein3046SARS-CoV-2 Neutralizing Antibody Detection Kit (Colloidal Gold Method)1342Hunan Zhongke Lanhai Biotechnology Co. Ltd.Chinawww.zoonkr.netYesCommercialisedNoNoManualAntibodyPlasmaSerumWhole bloodOther2022-08-24 09:08:01 CET2752Immuno-AntibodyYesYesNoImmunoassayQualitativeNeutralization Antibody (NAb)Colloidal gold15LOD0.25AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives10%False negatives5.5%PrecisionEvaluatedAccuracy92%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90%Clinical Specificity94.5%2470LollyTest 2019-CoV Ag Saliva Rapid Test Card1125Hunan Zonka Biotech Co. Ltd.ChinaYesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swabSaliva689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThe Test Card is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from 2019-nCoV in saliva and nasopharyngeal (NP) specimens.2022-08-24 09:08:01 CET2173Immuno-AntigenNoImmunochromatographyQualitativeSandwich, Double15LOD100TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.5%False negatives3.17%PrecisionEvaluatedAccuracy98.47%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.83%Clinical Specificity99.5%Type of antigenNucleoprotein2473LollyTest 2019-nCoV Ag Rapid Test Kit1125Hunan Zonka Biotech Co. Ltd.ChinaYesCommercialisedNoNoNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swab1032B.1.351Beta1519P.3Theta1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.320A.23.170AT.1This kit is used for in vitro qualitative detection of 2019-nCoV antigen. It is an Immunochromatography sandwich assay, intended for the qualitative detection of the nucleocapsid protein antigen from 2019-nCoV in nasopharyngeal (NP) swab, nasal (NS) swab and oropharyngeal swab specimens.2022-08-24 09:08:01 CET2176Immuno-AntigenNoImmunochromatographyQualitativeSandwich, Double15LOD100TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.5%False negatives3.17%PrecisionEvaluatedAccuracy98.47%(NP)Accuracy95.05%(NS)Accuracy96.55%(OP)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.83%(NP)Clinical Sensitivity93.91%(OP)Clinical Sensitivity90.52%(NS)Clinical Specificity99.5%(NP)Clinical Specificity99.22%(NS)Clinical Specificity99.15%(OP)Type of antigenNucleoprotein2474LollyTest 2019-nCoV IgG&IgM Antibody Rapid Test Kit1125Hunan Zonka Biotech Co. Ltd.ChinaYesCommercialisedNoNoNear POC / POCIgGIgMPlasmaSerumVenous whole bloodWhole bloodWhole blood with anti-coagulants689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThis Kit is an in vitro diagnostic test for the qualitative detection of IgG and IgM antibodies to the 2019-nCoV in human serum, plasma, whole blood or finger stick blood.2022-08-24 09:08:01 CET2177Immuno-AntibodyNoImmunochromatographyQualitativeSandwich, Double15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.85%False negatives4.88%PrecisionEvaluatedAccuracy96.14% IgGAccuracy97.51% IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.12% IgGClinical Sensitivity95.61% IgMClinical Specificity97.03% IgGClinical Specificity99.15% IgMType of antigenOther859ID Screen SARS-CoV-2-N IgG Indirect ELISA Kit (manual, automated)41ID.vetFrancewww.id-vet.com/YesCommercialisedNoNoAutomatedManualAntibodyIgGPlasmaSerum2022-08-24 09:08:01 CET48Immuno-AntibodyYesELISASemiquantitativeFluorescence95Clinical Sensitivity99.9% IgGClinical Specificity99.9% IgG571SARS-CoV-2 IgG ELISA Kit360Ideal Tashkhis Atieh Co.Iranwww.idealdiag.com/en/YesCommercialisedNoNoAutomatedManualAntibodyIgGPlasmaSerum2022-08-24 09:08:01 CET485Immuno-AntibodyYesELISAQualitativeFluorescence75Clinical Sensitivity94.1% IgGClinical Specificity98.3% IgGType of antigennucleocapsid659SARS-CoV-2 IgM ELISA Kit360Ideal Tashkhis Atieh Co.Iranwww.idealdiag.com/en/YesCommercialisedNoNoAutomatedManualAntibodyIgMPlasmaSerum2022-08-24 09:08:01 CET552Immuno-AntibodyYesELISAQualitativeFluorescence75Clinical Sensitivity97.3% IgMClinical Specificity79.4% IgMType of antigennucleocapsid2555Covid-19 Antigen Schnelltest (Colloidales Gold)1166IEDAU INTERNATIONAL GMBHGermanyYesCommercialisedYesYesNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2Zetanucleocapsid proteinThe product is listed by BfArM with AT1204/21,and has positive results by PEI.2022-08-24 09:08:01 CET2260Immuno-AntigenYesNoImmunoassayQualitativeColloidal gold15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.8%Nasal swabFalse positives0.8%Oropharyngeal swabFalse positives0.8%Nasopharyngeal swabFalse negatives3.9%Oropharyngeal swabFalse negatives2.9% Nasopharyngeal swabFalse negatives3.9%Nasal swabPrecisionEvaluatedAccuracy98.7%Nasal swabAccuracy98.7%Oropharyngeal swabAccuracy98.8%Nasopharyngeal swabReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.1%Nasal swabClinical Sensitivity96.1%Oropharyngeal swabClinical Sensitivity97.1% Nasopharyngeal swabClinical Specificity99.2%Oropharyngeal swabClinical Specificity99.2%Nasopharyngeal swabClinical Specificity99.2%Nasal swabType of antigenNucleocapsid protein1881IDK® anti-SARS-CoV-2 IgG ELISA845Immundiagnostik AGGermanywww.immundiagnostik.comYesCommercialisedNoNoAutomatedManualIgGPlasmaSerumEberhardt KE et al 2021 medRxiv, 20212022-08-24 09:08:01 CET1560Immuno-AntibodyYesELISAQuantitativeEnzyme-linked130LOD0.4%CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.9%False negatives0%PrecisionEvaluatedAccuracy99.1%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%Clinical Specificity99.1%Type of antigenOther2815PreventID ® SARS-CoV-2-Antigen845Immundiagnostik AGGermanywww.immundiagnostik.comYesCommercialisedNoNoNear POC / POCAntigenAnterior nasal swabNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1321B.1.617.2Deltawww.immundiagnostik.com www.preventis.com2022-08-24 09:08:01 CET2520Immuno-AntigenNoImmunochromatographyQualitativeSandwich15LOD126TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.6%False negatives3.9%PrecisionEvaluatedAccuracy98.4%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.1%anterior nasal swabClinical Specificity100%Anterior nasal swabType of antigenNucleocapsid protein2265COVID-19 Ag Detection Kit (Colloidal Gold Immunochromatography)1056ImmunoDiagnostics LimitedHong Kong S.A.Rhttps://www.immunodiagnostics.com.hk/YesCommercialisedNoNoManualNear POC / POCAntigenNasopharyngeal swabOropharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gammanucleocapsid proteinThe LOD of COVID-19 Ag Detection Kit (Colloidal Gold Immunochromatography) was confirmed as 2.8x102 TCID50/ml and 75 pg/ml SARS-CoV-2 NP.2022-08-24 09:08:01 CET1966Immuno-AntigenYesNoImmunochromatographyQualitativeMembrane-basedColloidal gold15LOD280AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives2.82%False negatives7.14%PrecisionEvaluatedAccuracy95.02%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.86%Clinical Specificity97.18%Type of antigenNucleoprotein1903Rapid New Coronavirus (COVID19) IgG/IgM Combo Test806Immunospark s.r.l.Italywww.immunospark.comYesCommercialisedNoNoManualNear POC / POCIgGIgMPeripheral bloodPlasmaSerumWhole bloodMore information available in detailes report of the technicla file!2022-08-24 09:08:01 CET1579Immuno-AntibodyNoImmunochromatographyQualitativeColorimetry15LOD30AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positivesA smal amount of results did not correltaed with the reference but correlated with rapid testFalse negativesA smal amount of results did not correltaed with the reference but correlated with rapid testPrecisionEvaluatedAccuracy99%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98%Clinical Specificity98%Type of antigenOther1904Rapid New Coronavirus (COVID19) Neutralizing Antibody Test806Immunospark s.r.l.Italywww.immunospark.comYesCommercialisedNoNoManualNear POC / POCAntibodyPeripheral bloodPlasmaSerumWhole bloodcompetitive assay that provide a multiple interpretatino of the protection level2022-08-24 09:08:01 CET1580Immuno-AntibodyNoImmunochromatographyQualitativeNeutralization Antibody (NAb)10Colloidal Gold detectionLOD40AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positivesA smal amount of results did not correltaed with the reference but correlated with rapid testFalse negativesA smal amount of results did not correltaed with the reference but correlated with rapid testPrecisionEvaluatedAccuracy99%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93%Clinical Specificity99%Type of antigenOther1791Rapid SARS-Cov2 Antigen Test806Immunospark s.r.l.Italywww.immunospark.comYesCommercialisedYesYesNear POC / POCAntigenNasopharyngeal swabNo additional information2022-08-24 09:08:01 CET1470Immuno-AntigenYesNoNoImmunochromatographyQualitativeMembrane-basedChemiluminescence10LOD3.22IU/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0AUFalse negatives0AUPrecisionEvaluatedAccuracy99.72%RobustnessEvaluatedClinical Sensitivity98.5%Clinical Specificity100%1656Anti-SARS-Cov-2 ELISA IgA742Immunostep S.LSpainwww.immunostep.com/YesCommercialisedNoNoAutomatedManualAntibodyIgAPlasmaSerum2022-08-24 09:08:01 CET1335Immuno-AntibodyYesELISAQualitativeFluorescence120LOD0AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluated1657Anti-SARS-Cov-2 ELISA IgG742Immunostep S.LSpainwww.immunostep.com/YesCommercialisedNoNoAutomatedManualAntibodyIgGPlasmaSerum2022-08-24 09:08:01 CET1336Immuno-AntibodyNoYesELISAQualitativeFluorescence120Manual or automated fluorescence LOD0CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positivesSee technical Data SheetFalse negativesSee technical Data SheetPrecisionEvaluatedAccuracySee technical Data SheetReproducibilityEvaluatedRobustnessEvaluatedClinical SensitivitySee technical Data Sheet660SARS-CoV-2 Total Antibody EIA403ImmyUnited Stateswww.immy.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET553Immuno-AntibodyYesImmunoassayQualitativeFluorescence60Accuracy98%Clinical Sensitivity92%Clinical Specificity100%1421SCoV-2 Ag Detect Rapid Test139InBios InternationalUnited Statesinbios.com/NoIn developmentNoNoNear POC / POCAntigenNasal swabnucleocapsid protein2022-08-24 09:08:01 CET1181Immuno-AntigenYesImmunochromatographyQualitative30Type of antigennucleoprotein1409SCoV-2 Detect IgG ELISA139InBios InternationalUnited Statesinbios.com/YesCommercialisedNoNoLab-basedAntibodyIgGSerum https://inbios.com/scov-2-detect-igg-elisa-kit-2/2022-08-24 09:08:01 CET1172Immuno-AntibodyNoYesELISAQualitativeMagnetic Electrochemical150Analysis of cross reactivity0% IgGfor tested agentsClinical Sensitivity97.8% IgGClinical Specificity98.95% IgG1410SCoV-2 Detect IgM ELISA139InBios InternationalUnited Statesinbios.com/YesCommercialisedNoNoLab-basedAntibodyIgMSerum https://inbios.com/scov-2-detect-igm-elisa-kit/2022-08-24 09:08:01 CET1173Immuno-AntibodyYesELISAQualitativeMagnetic Electrochemical150Analysis of cross reactivity0% IgMfor tested agentsClinical Sensitivity92.5% IgMClinical Specificity98.95% IgM225COVID Serology Kit: Multiplexed Immunoassay141InDevR Inc.United Stateswww.indevr.com/NoIn developmentNoNoNear POC / POCAntibody Microarray; Throughput 1,000 microarrays in 8 hours 2022-08-24 09:08:01 CET181Immuno-AntibodyYesImmunoassay1801Innova SARS CoV-2 Antigen Rapid Qualitative Test821Innova Medical Group Inc.United Stateswww. innovamedgroup.comYesCommercialisedYesYesNear POC / POCAntigenAnterior nasal swabNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Deltanucleocapsid proteinPoint of Care version.2022-08-24 09:08:01 CET1480Immuno-AntigenYesNoImmunoassayQualitativeMembrane-basedColorimetry20LOD1600TCID50/mlAnalysis of cross reactivityEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.4%(22/5942)False negatives6%(5/84) @ viral loads > 10^6 RNA copies/mLAccuracy99.6%RobustnessNot evaluatedClinical Sensitivity94%@ viral loads > 10^6 RNA copies/mLClinical Specificity99.6%Type of antigenNucleocapsid protein2285Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (Saliva)1066Innovation Biotech(Beijing) Co. Ltd.Chinawww.invbio.comYesCommercialisedNoNoNear POC / POCAntigenSaliva689B.1.1.7Alpha1032B.1.351Beta1495P.1GammaThe novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.2022-08-24 09:08:01 CET1986Immuno-AntigenImmunoassay15LOD125AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives3.27%False negatives1.32%PrecisionEvaluatedAccuracy98.68%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.73%Clinical Specificity99%Type of antigenNucleoprotein2332Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (Saliva)1084Innovation Biotech(Beijing) Co. Ltd.Chinawww.invbio.comYesCommercialisedNoNoManualNear POC / POCAntigenSaliva689B.1.1.7Alpha1032B.1.351Beta1495P.1GammaCoronavirus (SARS-Cov-2) Antigen Rapid Test Device (Saliva) is an in vitro diagnostic test for the qualitative detection of novel coronavirus antigens in human saliva, using the rapid immunochromatographic method. The identification is based on the monoclonal antibodies specific for the novel coronvirus antigen. It will provide information for clinical doctors to prescribe correct medications.2022-08-24 09:08:01 CET2033Immuno-AntigenYesImmunochromatography15LOD1AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2.9%False negatives1%PrecisionEvaluatedAccuracy99.57%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.1%Clinical Specificity99%Type of antigenNucleoprotein2287COVID-19 Neutralizing Antibody Rapid Test Device1066Innovation Biotech(Beijing) Co. Ltd.Chinawww.invbio.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1GammaThe COVID-19 Neutralizing Antibody Rapid Test is a lateral flow chromatographic immunoassay for qualitative detection of neutralizing antibody to SARS-CoV-2 in human whole blood,serum,or plasma as an aid in the evaluation of human anti-SARS-CoV-2 neutralizing antibody titer.2022-08-24 09:08:01 CET1988Immuno-Antibody15LOD1AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives4.61%False negatives0.01%PrecisionEvaluatedAccuracy93.36%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.39%Clinical Specificity99.9%Type of antigenNucleoprotein2278Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab)1063Innovation Biotech(Beijing) Co. Ltd.Chinawww.invbio.comYesCommercialisedYesYesNear POC / POCAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gammanucleocapsid proteinThe Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) is a rapid chromatographic immunoassay for the qualitative detection of N protein antigens to SARS-CoV-2 present in nasal swab . This test is for professional used only, as an aid to early diagnosis of SARS-CoV-2 infection in patient. The result of this test should not be the sole basis for the diagnosis; confirmatory testing is required2022-08-24 09:08:01 CET1979Immuno-AntigenYesImmunochromatographySandwich, Double15LOD1AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives5.26AUFalse negatives1AUPrecisionEvaluatedAccuracy98.21%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.6%Clinical Specificity100%Type of antigenNucleoprotein2331Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab)1084Innovation Biotech(Beijing) Co. Ltd.Chinawww.invbio.comYesCommercialisedNoNoNear POC / POCAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1GammaThe Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) is a rapid chromatographic immunoassay for the qualitative detection of N protein antigens to SARS-CoV-2 present in nasal swab . This test is for professional used only, as an aid to early diagnosis of SARS-CoV-2 infection in patient. The result of this test should not be the sole basis for the diagnosis; confirmatory testing is required2022-08-24 09:08:01 CET2032Immuno-AntigenYesImmunochromatography15LOD1AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives5.26%False negatives1%PrecisionEvaluatedAccuracy98.21%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.6%Clinical Specificity100%Type of antigenNucleoprotein2286RAPID 2019-NCOV IGG/IGM COMBO TEST CARD1066Innovation Biotech(Beijing) Co. Ltd.Chinawww.invbio.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1GammaThe Coronavirus COVID-19 IgG/IgM Rapid Test Device is a rapid chromatographic immunoassay for the qualitative detection of IgG&IgM antibody of Coronavirus Disease 2019 in human whole blood,serum,or plasma as an aid in the diagnosis of COVID-19 infections.2022-08-24 09:08:01 CET1987Immuno-Antibody15LOD1AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives13.06%False negatives0.69%PrecisionEvaluatedAccuracy93.36%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity86.94%Clinical Specificity99.31%Type of antigenNucleoprotein2566InnoScreenTM COVID-19 Antigen Rapid Test Device1169Innovation Scientific Pty Ltd.Australiawww.innovationsci.com.auNoCommercialisedNoNoNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaSensitivity, specificity and accuracy may vary depending on samples cohort. 2022-08-24 09:08:01 CET2271Immuno-AntigenNoNoImmunoassayQualitative15CalibrationEvalautedAnalysis of cross reactivityEvalautedFalse positives0.1%(less than 0.1%)False negatives5%(less than 5%)PrecisionEvalautedAccuracy90%(>90%)ReproducibilityEvalautedRobustnessEvalautedClinical Sensitivity95%(>95%)Clinical Specificity99.9%(>99.9%)Type of antigenNucleocapsid protein2565InnoScreenTM COVID-19 IgG/IgM Rapid Test Device1169Innovation Scientific Pty Ltd.Australiawww.innovationsci.com.auNoCommercialisedNoNoNear POC / POCAntibodyIgGIgMPeripheral bloodPlasmaSerumWhole bloodSensitivity, Specificity and Accuracy may vary depending on samples cohort2022-08-24 09:08:01 CET2270Immuno-AntibodyImmunochromatographyQualitative15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.1%(less than 0.1%)False negatives5%(less than 5%)PrecisionEvaluatedAccuracy90%(>90%)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90%(>90%)Clinical Specificity99.9%(>99.9%)Type of antigenOther1728iD Rapid® COVID-19 Antigen766Innovative DiagnosticsFrancewww.innovative-diagnostics.com/YesCommercialisedNoNoNear POC / POCAntigenNasal swab2022-08-24 09:08:01 CET1408Immuno-AntigenYesNoImmunoassayQualitative15LOD1800AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives2.47%2 false negative on 81 samples tested positive by PCRPrecisionEvaluatedAccuracy96.9%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.7%1727ID Screen® SARS-CoV-2 Double Antigen Multi-species766Innovative DiagnosticsFrancewww.innovative-diagnostics.com/NoCommercialisedNoNoAutomatedManualAntibodyIgAPlasmaSerumWhole blood2022-08-24 09:08:01 CET1407Immuno-AntibodyYesImmunoassayQualitative95LOD0AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.9%7 false positive on 788 samples tested negative by PCRFalse negatives0%PrecisionNot evaluatedAccuracyNot evaluatedReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100Type of antigennucleoprotein1726ID Screen® SARS-CoV-2-N IgG Indirect766Innovative DiagnosticsFrancewww.innovative-diagnostics.com/YesCommercialisedNoNoAutomatedManualAntibodyIgGPlasmaSerum2022-08-24 09:08:01 CET1406Immuno-AntibodyNoYesELISAQualitative95LOD0AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.4% IgG5 false positive on 1242 samples tested negative by PCRFalse negatives4.8% IgG4 false negative on 84 samples tested positive by PCRPrecisionEvaluatedAccuracy99.6ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.2% IgGType of antigennucleoprotein2272019-nCoV Ab Test (Colloidal Gold) (IgM/IgG Whole Blood/Serum/Plasma Combo)1144INNOVITA (Tangshan) Biological Technology Co. Ltd.Chinawww.innovita.com.cnYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole bloodWe want to correct our company name. Innovita Biological Technology is wrong. The correct name is INNOVITA (Tangshan) Biological Technology Co., Ltd.2022-08-24 09:08:01 CET188Immuno-AntibodyYesImmunoassayQualitativeColorimetry1519942019-nCoV Ag Test (Latex Chromatography Assay)1144INNOVITA (Tangshan) Biological Technology Co. Ltd.Chinawww.innovita.com.cnYesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu2041C.37LambdaB.1.526.1B.1.526.2678B.1.1.529Omicron1518P.2Zetanucleocapsid proteinNone.2022-08-24 09:08:01 CET1670Immuno-AntigenYesNoNoImmunoassayQualitativeSandwich, Double15Latex chromatography assayLOD125TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives1.3%PrecisionEvaluatedAccuracy99.5%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.7%Clinical Specificity100%Type of antigenNucleocapsid protein29102019-nCoV Ag Test (Latex Chromatography Assay) (Anterior Nasal Swab)1144INNOVITA (Tangshan) Biological Technology Co. Ltd.Chinawww.innovita.com.cnYesCommercialisedNoNoNear POC / POCAntigenAnterior nasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu2041C.37LambdaB.1.526.1B.1.526.2678B.1.1.529Omicron1518P.2Zetanucleocapsid proteinNone.2022-08-24 09:08:01 CET2615Immuno-AntigenYesNoNoImmunoassayQualitativeSandwich, Double15LOD125TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives5.22%PrecisionEvaluatedAccuracy97.47%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.78%Clinical Specificity100%Type of antigenNucleocapsid protein25312019-nCoV Neutralizing Antibody Test (Quantum Dot Immunofluorescence Chromatography)1144INNOVITA (Tangshan) Biological Technology Co. Ltd.Chinawww.innovita.com.cnYesCommercialisedNoNoManualNear POC / POCAntibodyPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaNone.2022-08-24 09:08:01 CET2235Immuno-AntibodyYesImmunochromatographyQuantitative15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives3.3%False negatives8.4%PrecisionEvaluatedAccuracy94.8%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity91.6%Clinical Specificity96.7%Type of antigenSpike protein641SARS-CoV-2 antibody assay1144INNOVITA (Tangshan) Biological Technology Co. Ltd.Chinawww.innovita.com.cnNoCommercialisedNoNoNear POC / POCAntibody2022-08-24 09:08:01 CET530Immuno-AntibodyYesImmunoassay2747SERION ELISA agile SARS-COV-2 IgA1243Institut VirionSerion GmbHGermanyhttps://www.virion-serion.de/en/YesCommercialisedNoNoAutomatedManualIgAPlasmaSerum689B.1.1.7Alpha1321B.1.617.2DeltaAntigen composition: Mixture of whole spike protein and nucleocapsid protein.2022-08-24 09:08:01 CET2452Immuno-AntibodyNoYesELISAQuantitativeEnzyme-linked130LOD5AUAnalysis of cross reactivityEvaluatedFalse positives0%0/129False negatives3.7%2/54PrecisionEvaluatedAccuracy106.3AUReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.3% IgAClinical Specificity% IgA> 992745SERION ELISA agile SARS-COV-2 IgG1243Institut VirionSerion GmbHGermanyhttps://www.virion-serion.de/en/YesCommercialisedNoNoAutomatedManualIgGPlasmaSerum689B.1.1.7Alpha1321B.1.617.2Delta1518P.2ZetaTest is validated for the detection of intrathecally synthesized IgG antibodies against SARS-CoV-2.2022-08-24 09:08:01 CET2450Immuno-AntibodyNoYesELISAQuantitativeEnzyme-linked130LOD3AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.75%1/133False negatives3.63%2/55PrecisionEvaluatedAccuracy76.1% IgGReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.2% IgGClinical Specificity99.2% IgGType of antigenSpike protein2748SERION ELISA agile SARS-COV-2 IgM1243Institut VirionSerion GmbHGermanyhttps://www.virion-serion.de/en/YesCommercialisedNoNoAutomatedManualIgMPlasmaSerum689B.1.1.7Alpha1321B.1.617.2DeltaComposition of Antigen: MIxture of whole spike protein and nucleocapsid protein.2022-08-24 09:08:01 CET2453Immuno-AntibodyNoNoYesELISAQualitativeEnzyme-linked130Analysis of cross reactivityEvaluatedFalse positives0%0/139False negatives3.84%1/26PrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.2% IgMClinical Specificity99% IgM> 993098AQ+ COVID-19 Ag Rapid Test1107InTec Products Inc.Chinahttp://www.intecasi.comYesCommercialisedNoNoNear POC / POCAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta1320B.1.617.1Kappa1321B.1.617.2Delta2041C.37Lambda1224B.1.526Iota678B.1.1.529Omicron1518P.2Zetanucleocapsid proteinThe AQ+ COVID-19 Ag Rapid Test is a colloidal gold enhanced, rapid immunochromatographic assay for qualitative detection of SARS-CoV-2 antigens in the nasal specimen collected by swabs from individuals who are suspected of having COVID-19. The test is used as an aid in the diagnosis of SARS-CoV-2 infection. This test is for self-testing. The test is for self-test with self-collected anterior nasal swab samples. It is for individuals aged 18 years or older who are asymptomatic or have symptoms of COVID-19 within the first seven (7) days. Testing of individuals without symptoms should be limited to contacts of confirmed or probable cases or to other epidemiological reasons to suspect a COVID-19 infection and should be followed by additional confirmatory testing with a molecular test.2022-08-24 09:08:01 CET2804Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich, Double15Other variants detected: Delta-Plus(AY.1), Natural Wild VariantLOD160TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.91%1 in 110 casesFalse negatives0%0 in 470 casesPrecisionEvaluatedAccuracy99.83%95%CI: 99.04%-100.00%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.09%95%CI: 95.04%-99.98%Clinical Specificity100%95%CI: 99.22%-100.00%Type of antigenNucleocapsid protein3084AQ+ COVID-19 Ag Rapid Test147InTec Products Inc.Chinahttp://www.intecasi.comYesCommercialisedYesYesNear POC / POCAntigenNasal swabNasopharyngeal swabAlpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Chlamydia PneumoniaeInfluenza A H1N1Influenza A H3N2Influenza B YamagataMERS-CoVMycobacterium TuberculosisMycoplasma PneumoniaeParainfluenza Virus Type 1Respiratory Syncytial V (RSV) Type A678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526Iota1320B.1.617.1Kappa1321B.1.617.2Delta2041C.37Lambda1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid proteinOther lineages detected: Delta-Plus(AY.1). other pathogens tested for cross-reactivity: H7N9 avian influenza virus, Mycobacterium tuberculosis, Legionella, Streptococcus pneumoniae, Enterovirus A(CV-A10), Enterovirus B (Enterovirus 6), Staphylococcus aureus2023-02-01 14:56:31 CET5460Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich, Double15LOD160TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.2%1 in 494 casesFalse negatives3.14%14 in 446 casesPrecisionEvaluatedAccuracy98.4%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.86%AntigenClinical Specificity99.8%AntigenType of antigenNucleocapsid protein229Rapid SARS-CoV-2 Antibody (IgM/IgG)147InTec Products Inc.Chinahttp://www.intecasi.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgM2022-08-24 09:08:01 CET190Immuno-AntibodyYesImmunoassay228Rapid SARS-CoV-2 Antibody Test147InTec Products Inc.Chinahttp://www.intecasi.comYesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET189Immuno-AntibodyYesNoImmunoassayQualitativeRapid diagnostic test Fingertip Not found 2484Rapid SARS-CoV-2 Antigen Test147InTec Products Inc.Chinahttp://www.intecasi.comYesCommercialisedNoNoNear POC / POCAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta1320B.1.617.1Kappa1321B.1.617.2Delta2041C.37Lambda1224B.1.526Iota678B.1.1.529Omicron1518P.2Zetanucleocapsid proteinThe Rapid SARS-CoV-2 Antigen Test is a colloidal gold enhanced, rapid immunochromatographic assay for qualitative detection of SARS-CoV-2 antigens in the nasal specimen collected by swabs from individuals who are suspected of having COVID-19. The test is used as an aid in the diagnosis of SARS-CoV-2 infection. This test is for self-testing. The test is for self-test with self-collected anterior nasal swab samples. It is indicated for the use of individuals aged 18 years or older with symptoms of COVID-19 within the first seven (7) days of symptom onset. Testing of individuals without symptoms should be limited to contacts of confirmed or probable cases or to other epidemiological reasons to suspect a COVID-19 infection and should be followed by additional confirmatory testing with a molecular test.2022-08-24 09:08:01 CET2187Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, Double15Other variants detected: Delta-Plus (AY.1), Natural Wild Variant. Other pathogens tested for cross-reactivity: H7N9 avian influenza virus, Legionella, Streptococcus Pneumoniae, Enterovirus A, Enterovirus B, Staphylococcus aureusLOD425TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives6.36%7 in 110 casesFalse negatives0%0 in 470 casesPrecisionEvaluatedAccuracy98.79%95%CI: 97.53%-99.51%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.64%95%CI: 87.33%-97.40%Clinical Specificity100%95%CI: 99.22%-100.00%Type of antigenNucleocapsid protein2419Rapid SARS-CoV-2 Antigen Test (nasopharyngeal specimen)1107InTec Products Inc.Chinahttp://www.intecasi.comYesCommercialisedYesYesNear POC / POCAntigenNasopharyngeal swabPEI positive evaluated, Test-ID AT574/21.2022-08-24 09:08:01 CET2121Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich, Double15LOD425AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives6.93%7 false positives in 101 samplesFalse negatives0%0 false negatives in 299 samplesPrecisionEvaluatedAccuracy98.3%95% CI: 96.4% - 99.2%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.1%95% CI: 86.4% - 96.6%Clinical Specificity100%95% CI: 98.7% - 100%Type of antigenNucleocapsid protein1783Rapid SARS-CoV-2 Antigen Test (nasopharyngeal/nasal specimen)1107InTec Products Inc.Chinahttp://www.intecasi.comYesCommercialisedYesYesNear POC / POCAntigenNasal swabNasopharyngeal swabChlamydia PneumoniaeAlpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)MERS-CoVHuman Metapneumovirus (HMPV)Influenza A H1N1Influenza A H3N2Influenza B YamagataMycobacterium TuberculosisMycoplasma PneumoniaeParainfluenza Virus Type 1Respiratory Syncytial V (RSV) Type ASARS-CoV689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta1320B.1.617.1Kappa1321B.1.617.2Delta1323B.1.621Mu2041C.37Lambda1224B.1.526Iota678B.1.1.529Omicron1518P.2Zetanucleocapsid proteinIntended use The Rapid SARS-CoV-2 Antigen Test is a colloidal gold enhanced, rapid immunochromatographic assay for qualitative detection of SARS-CoV-2 antigens in the nasopharyngeal/nasal specimen collected by swabs from individuals who are suspected of having COVID-19. The test is used as an aid in the diagnosis of SARS-CoV-2 infection. The test is suitable for use under healthcare professional supervision. Individuals should have appropriate training in how to administer the test correctly.2022-08-24 09:08:01 CET1462Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwichColorimetry15LOD425TCID50/mlAnalysis of cross reactivityEvaluatedFalse positives0.4%2 in 1026 casesFalse negatives4.5%20 in 484 casesPrecisionEvaluatedAccuracy98.8%95%CI: 97.8%~99.0%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.5%95%CI: 93.7%~97.3%Clinical Specificity99.6%95%CI: 99.3%~99.9%Type of antigenNucleocapsid protein1018SARS-CoV-2 Antibody147InTec Products Inc.Chinahttp://www.intecasi.comYesCommercialisedNoNoNear POC / POCAntibody2022-08-24 09:08:01 CET813Immuno-AntibodyYesImmunoassay1017SARS-CoV-2 Antibody (IgM/IgG)147InTec Products Inc.Chinahttp://www.intecasi.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgM2022-08-24 09:08:01 CET812Immuno-AntibodyYesImmunoassay1882MAUVE COVID-19 Ag Test861InTelos Inc.South Koreawww.intelos.co.krYesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swabOropharyngeal swabAntigen Rapid Diagnostic Test2022-08-24 09:08:01 CET1561Immuno-AntigenNoImmunoassayQualitativeMagnetic Electrochemical15LOD5.8%CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives10%PrecisionEvaluatedAccuracy95%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90%Clinical Specificity100%Type of antigenNucleoprotein10112019-NCOV IGG/IGM555Intermedical SRLItalywww.intermedical.it/prodotti/test-rapidi/NoCommercialisedNoNoNear POC / POCAntibody2022-08-24 09:08:01 CET808Immuno-AntibodyYesImmunoassay2069LiliF GBN Covid-19 Ag Rapid kit956intron biotechnologySouth Koreawww.intronbio.comYesCommercialisedNoNoManualAntigenNasopharyngeal swab1032B.1.351BetaWe got the CE-IVD already.2022-08-24 09:08:01 CET1751Immuno-AntigenNoImmunoassayQuantitativeMembrane-based15LOD100AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives6AUFalse negatives3AUPrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity93.6%Clinical Specificity97%Type of antigenNucleoprotein1635COVID-19 IgG/IgM Ab Rapid Test731Invenio MedicalUnited Stateswww.invenio-medical.com/new-release/NoCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2022-08-24 09:08:01 CET1315Immuno-AntibodyYesNoImmunoassayQualitative15Accuracy98%1988Biozek covid-19 Antigen Rapidtest BCOV-502910Inzek International tradingNetherlandswww.biozek.comYesCommercialisedYesYesManualAntigenNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1321B.1.617.2Deltanucleocapsid proteinChanges in the IFU and additional information about variants detection. We have received the following message from the DHSC (Department of Health and social care): product progressed through phase 3A validation and has been examined at a Design Authority Review (DAR). We would like to advise you that the Biozek COVID-19 Antigen Rapid Test Cassette (Swab) was successful in the phase 3A validation and that the Biozek COVID-19 Antigen Rapid Test Cassette (Swab) showed no drop off in sensitivity when compared with the wild type with respect to the following variants - Alpha (VOC1 Kent, UK, B.1.1.7), Beta (VOC2 South Africa, B.1.351), Gamma (VOC3 Brazil, P1) and Delta (VOC4 India B.1.617.2).2022-08-24 09:08:01 CET1664Immuno-AntigenYesNoNoImmunochromatographyQualitativeMembrane-based10LOD100AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives2.65%4/151False negatives0.67%10/1484PrecisionEvaluatedAccuracy99.14%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.63%Clinical Specificity99.73%Type of antigenNucleocapsid protein1987Biozek covid-19 Antigen Rapidtest BCOV-802910Inzek International tradingNetherlandswww.biozek.comYesCommercialisedNoNoManualAntigenSalivaCheck IFU for more information. Clinical studies available. Biozek Sales organisation Mach-E BV the Netherlands2022-08-24 09:08:01 CET1663Immuno-AntigenNoImmunochromatographyQualitative10LOD100AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.28%(1 / 354)False negatives8.33%(12 / 144)PrecisionEvaluatedAccuracy97%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity91%Clinical Specificity99%Type of antigennucleocapsid protein 1639Novel Coronavirus (2019-nCoV) IgM/IgG Test Kit (Colloidal Gold Immunochromatography)735ISIAChinawww.isiabio.com/en/NoCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2022-08-24 09:08:01 CET1319Immuno-AntibodyYesYesImmunoassayQualitativeColloidal gold101640Novel Coronavirus (2019-nCoV) IgM/IgG Test Kit (Quantum Dots Immunofluorescence)735ISIAChinawww.isiabio.com/en/NoCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2022-08-24 09:08:01 CET1320Immuno-AntibodyYesYesImmunoassayQualitativeImmunofluorescence102138SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold )989ISO13485Chinahttps://www.lsybt.com/En/YesCommercialisedNoNoManualNear POC / POCAntigenAnterior nasal swabNasal swabNasopharyngeal swabOropharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.21518P.2ZetaIn vitro qualitative detection of SARS-CoV-2 nucleocapsid antigen in swab specimen within the first 5-7 days after onset of COVID-19 symptoms2022-08-24 09:08:01 CET1828Immuno-AntigenImmunochromatographyMembrane-basedColloidal gold15LOD400AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1%(≤1%)False negatives5%(≥95%)PrecisionEvaluatedAccuracy99.68%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.14%Clinical Specificity100%Type of antigenNucleoprotein2217PixoTest® POCT COVID-19 Antigen Test1031iXensorTaiwan ROChttps://www.ixensor.comYesCommercialisedNoNoNear POC / POCSemi-automatedAntigenAnterior nasal swabNasal swabNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31224B.1.526Iota1518P.2Zeta1495P.1Gammanucleocapsid proteinPixoTest POCT Antigen Testing solution is an analyzer based rapid antigen test designed for point-of-care. It provides an end-to-end fully digitalized solution from rapid antigen test, timely result with digital pass issuing and access control by cross-validating test results on the cloud through a suite of digital tools including PixoHealth Pass App, PixoHealth Pass Admin App and Web portal for enterprises to prevent potential outbreaks.2022-08-24 09:08:01 CET1918Immuno-AntigenYesYesImmunochromatographyQualitativeMembrane-based15LOD125AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2AUFalse negatives5AUPrecisionEvaluatedAccuracy97%(Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95% (Antigen)Clinical Specificity98% (Antigen) TaipeiType of antigenNucleoprotein5754SARS-COV-2 Antigen Rapid Test Kit3208Jiangsu Baozhilin Medical Co LtdChinaYesCommercialisedNoNoManualNear POC / POCAntigenNasal swabSARS-CoV-2678B.1.1.529Omicron1321B.1.617.2Deltanucleocapsid protein2022-11-07 14:09:56 CET5287Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwichColloidal gold15LOD1000TCID50/mlCalibrationNot evaluatedAnalytical Sensitivity100%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positivessamplesFalse negatives2samplesPrecisionNot evaluatedAccuracy99.61%RobustnessNot evaluatedClinical Sensitivity98.2%Clinical Specificity100%2821SARS-COV-2 Antigen Rapid Test Kit 1260Jiangsu Baozhilin Medical Technology Co. Ltd.ChinaYesCommercialisedNoNoFully automated (robot)Near POC / POCAntigenThroat secretionThroat swab1495P.1GammaNovel Coronavirus antigen rapid detection reagent is an effective early screening and diagnostic index of novel Coronavirus infection, which is an effective complement to the false positive of COVID-19 nucleic acid test. Rapid detection within 15 minutes with a nasopharyngeal test paper, the reagents can be stored at room temperature and transported, which is a great boon to the medical community.2022-08-24 09:08:01 CET2526Immuno-AntigenNoImmunochromatographyQualitative20Analytical Sensitivity91%Analytical Specificity97%2833SARS-CoV-2 IgG/IgM rapid test kits（Golloidal Gold)1260Jiangsu Baozhilin Medical Technology Co. Ltd.ChinaYesCommercialisedNoNoManualNear POC / POCAntibodyPeripheral bloodPlasmaSerumVenous whole bloodWhole bloodThis product is used for the qualitative detection of SARS-CoV-2 (COVID-19) IgM and IgG Antibodies in human serum, plasma, whole blood or fingertip blood.2022-08-24 09:08:01 CET2538Immuno-AntibodyYesImmunochromatographyQualitativeN.A.Colloidal gold153012SARS-CoV-2 Rapid Ag Test (Colloidal Gold)1337Jiangsu Besthree Biotechnology Co. Ltd.Chinawww.besthree.comYesCommercialisedNoNoAntigenSARS-CoV689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu2041C.37Lambda1224B.1.526Iota678B.1.1.529Omicron1518P.2Zetanucleocapsid proteinNo more additional information.2022-08-24 09:08:01 CET2718Immuno-AntigenImmunoassayColloidal gold15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives3.42%False negatives0.28%PrecisionEvaluatedAccuracy97.9%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.58%Clinical Specificity99.72%Type of antigenNucleocapsid protein2107Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit975Jiangsu Bioperfectus Technologies Co. Ltd.Chinahttps://www.bioperfectus.com/YesCommercialisedYesYesNear POC / POCOtherAntigenNasal swabNasopharyngeal swabOropharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu2041C.37Lambdanucleocapsid proteinN/A2022-08-24 09:08:01 CET1790Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich, Double15LODAU100CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positivesPast medical history and other diagnostic information is necessary to determine infection status.False negativesNegative results should be treated as presumptive and confirmed with other diagnostic techniques.PrecisionEvaluatedAccuracy98.79%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.06%Clinical Specificity99.15%Type of antigenNucleocapsid protein236Novel Corona Virus (SARS-CoV-2) IgM/IgG Rapid Test Kit145Jiangsu Bioperfectus Technologies Co. Ltd.Chinawww.bioperfectus.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2022-08-24 09:08:01 CET194Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry101264PerfectPOC Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit145Jiangsu Bioperfectus Technologies Co. Ltd.Chinawww.bioperfectus.comYesCommercialisedNoNoNear POC / POCAntigen2022-08-24 09:08:01 CET1039Immuno-AntigenYesImmunoassay3141SARS-CoV-2 Antigen Test Kit1389Jiangsu Claro MedTech Co. Ltd.ChinaYesCommercialisedNoNoNear POC / POCAntigenAnterior nasal swabSARS-CoV689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1321B.1.617.2Delta678B.1.1.529Omicronnucleocapsid proteinCE14342022-08-24 09:08:01 CET2849Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich, Double15LOD10TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives3.92%False negatives0%PrecisionEvaluatedAccuracy99.34%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.08%Clinical Specificity100%Type of antigenNucleocapsid protein1043Rapid test for IgM/IgG Antibody to SARS-CoV-2553Jiangsu Dabo Pharmaceutical Co. Ltd.Chinawww.dabloodpharmaceutical.com/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgM Data provided by the Manufacturer2022-08-24 09:08:01 CET804Immuno-AntibodyYesNoImmunoassayQualitative15Analysis of cross reactivityEvaluatedAccuracy98%RobustnessEvaluated1920COVID-19 Antigen Rapid Test Cassette (Colloidal Gold)877Jiangsu Diagnostics Biotechnology Co. Ltd.Chinahttp://www.diagnostics-bio.comYesCommercialisedYesYesNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabThroat swabnucleocapsid proteinNo2022-08-24 09:08:01 CET1596Immuno-AntigenYesNoNoImmunoassayQualitativeCaptureColloidal gold15LOD500TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives7AUFalse negatives0%PrecisionEvaluatedAccuracy98.87%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.31%Clinical Specificity100%Type of antigenNucleocapsid protein2893COVID-19 Antigen Rapid Test Cassette (Saliva)877Jiangsu Diagnostics Biotechnology Co. Ltd.Chinahttp://www.diagnostics-bio.comYesCommercialisedNoNoNear POC / POCAntigenSalivanucleocapsid protein2022-08-24 09:08:01 CET2598Immuno-AntigenNoImmunochromatographyQualitativeCapture15LODTCID50/ml5 × 102.67 TCID50 / mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives4AUFalse negatives0%PrecisionEvaluatedAccuracy98.57%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.26%Clinical Specificity100%Type of antigenNucleocapsid protein2892COVID-19 Antigen Rapid Test Cassette(Nasopharyngeal/Oropharyngeal /Nasal)877Jiangsu Diagnostics Biotechnology Co. Ltd.Chinahttp://www.diagnostics-bio.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabnucleocapsid proteinNO2022-08-24 09:08:01 CET2597Immuno-AntigenYesNoImmunochromatographyQualitativeCapture15LODTCID50/ml5 × 102.67 TCID50 / mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2%Nasopharyngeal swabFalse positives2%oropharyngel swabsFalse positives3%nasal swabsFalse negatives0%PrecisionEvaluatedAccuracy99.32%oropharyngel swabsAccuracy99.28%Nasopharyngeal swabAccuracy99.04%nasal swabsReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.86%Nasopharyngeal swabClinical Sensitivity98.81%oropharyngeal swabsClinical Sensitivity98.45%nasal swabsClinical Specificity100%Type of antigenNucleocapsid protein5842COVID-19/Influenza A+B /RSV Antigen Combo Rapid Test Cassette（Colloidal Gold ）877Jiangsu Diagnostics Biotechnology Co. Ltd.Chinahttp://www.diagnostics-bio.comYesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swabOropharyngeal swabOther20A.23.170AT.1678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526IotaB.1.526.1B.1.526.23939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu1439C.362041C.37Lambda1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid protein2023-01-31 15:17:36 CET5451Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD160TCID50/mlSARS-CoV-2CalibrationEvaluatedAnalytical Sensitivity100%NP swab InF AAnalytical Specificity100%NP swab InF AAnalysis of cross reactivityEvaluatedFalse positives%NP swab InF AFalse negatives0.21%NP swab InF APrecisionEvaluatedAccuracy98.62%NP swab RSVAccuracy99.31%NP swab SARS-CoV-2Accuracy98.62%NP swab InF BAccuracy98.97%NP swab InF ARobustnessEvaluatedClinical Sensitivity98.17%NP swab InF BClinical Sensitivity98.86%NP swab SARS-CoV-2Clinical Sensitivity98.04%NP InF AClinical Sensitivity98.19%NP swab RSVClinical Specificity99.21%NP swab InF BClinical Specificity100%NP swab InF AClinical Specificity100%NP swab SARS-CoV-2Clinical Specificity99.19%NP swab RSV1899COVID-19 Antigen Rapid Test Kit (Colloidal Gold)867Jiangsu Konsung Bio-Medical Science And Technology Co. Ltd.Chinawww.konsung.comYesCommercialisedYesYesManualAntigenNasal swabNasopharyngeal swabOropharyngeal swabnucleocapsid proteinNone2022-08-24 09:08:01 CET1575Immuno-AntigenYesImmunochromatographyQualitativeColorimetry15LOD50AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives8AUFalse negatives5AUPrecisionEvaluatedAccuracy99.06%ReproducibilityNot evaluatedRobustnessNot evaluatedClinical Sensitivity97.14%Clinical Specificity99.34%Type of antigenNucleoprotein3076COVID-19 Antigen Rapid Test Kit (Colloidal Gold) -for self-testing867Jiangsu Konsung Bio-Medical Science And Technology Co. Ltd.Chinawww.konsung.comYesCommercialisedNoNoManualNear POC / POCAntigenNasal swab678B.1.1.529Omicronnucleocapsid proteinother pathogens tested: Adenovirus type 5, Enterovirus 68, Dengue Virus Type-12022-08-24 09:08:01 CET2782Immuno-AntigenYesImmunochromatographyQualitative15LOD50pg/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives3AUFalse negatives16AUPrecisionEvaluatedAccuracy97.254%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.103%AntigenClinical Specificity99.348%AntigenType of antigenNucleocapsid protein2962COVID-19 Antigen Rapid Test Kit (ColloidalGold)867Jiangsu Konsung Bio-Medical Science And Technology Co. Ltd.Chinawww.konsung.comYesCommercialisedNoNoManualNear POC / POCAntigenOropharyngeal swabBordetella PertussisAlpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)MERS-CoVSARS-CoVEnterovirus A71 (EV-A71)Hemophilus InfluenzaeHuman Metapneumovirus (HMPV)Influenza A H1N1Influenza B VictoriaParainfluenza Virus Type 1Parainfluenza Virus Type 2Parainfluenza Virus Type 3Parainfluenza Virus Type 4Respiratory Syncytial V (RSV)Rhinovirus1321B.1.617.2Delta678B.1.1.529Omicronnucleocapsid proteinN/A2022-08-24 09:08:01 CET2668Immuno-AntigenNoImmunochromatographyQualitative15LOD50pg/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives3False negatives4PrecisionEvaluatedAccuracy99.06%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96%Clinical Specificity99.53%Type of antigenNucleocapsid protein1924COVID-19 Salivary Antigen Rapid Test Kit（Colloidal Gold）867Jiangsu Konsung Bio-Medical Science And Technology Co. Ltd.Chinawww.konsung.comYesCommercialisedNoNoManualAntigenSalivaN/A2022-08-24 09:08:01 CET1600Immuno-AntigenYesImmunochromatographyQualitativeColorimetry15LOD50AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives8AUFalse negatives5AUPrecisionEvaluatedAccuracy99.03%ReproducibilityNot evaluatedRobustnessNot evaluatedClinical Sensitivity96.3%Clinical Specificity99.34%Type of antigenNucleoprotein2889SARS-CoV-2 Neutralizing Antibody Detection Kit (Colloidal gold method)1179Jiangsu Macro & Micro-Test Med-Tech Co. Ltd.Chinahttps://www.hongweitest.com/YesCommercialisedNoNoLab-basedManualNear POC / POCAntibodyPeripheral bloodPlasmaSerumVenous whole bloodWhole bloodWhole blood with anti-coagulants689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.3678B.1.1.529Omicronnucleocapsid proteinOur SARS-CoV-2 Neutralizing Antibody Detection Kit (Colloidal gold method) have passed CE certification.2022-08-24 09:08:01 CET2594Immuno-AntibodyImmunoassayColloidal gold15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.7%False negatives0.8%PrecisionEvaluatedAccuracy99.3%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.2%Clinical Specificity99.3%Type of antigenNucleocapsid protein2585SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method)1179Jiangsu Macro & Micro-Test Med-Tech Co. Ltd.Chinahttps://www.hongweitest.com/YesCommercialisedNoNoManualNear POC / POCAntigenNasal swabSARS-CoV-2678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1320B.1.617.1Kappa1321B.1.617.2Delta1495P.1Gammanucleocapsid proteinOur SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method) has been posted on the antigen list of German BfArM and French.2022-08-24 15:42:41 CET3706Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD50000copies/mlCalibrationEvaluatedAnalytical Sensitivity100%Analytical Sensitivity100%Analysis of cross reactivityEvaluatedFalse positives1%False negatives13%PrecisionEvaluatedAccuracy97.73%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95%Clinical Specificity99.82%Type of antigenNucleocapsid protein3920SARS-CoV-2 Virus Antigen Detection Kit (Colloidal gold method)1179Jiangsu Macro & Micro-Test Med-Tech Co. Ltd.Chinahttps://www.hongweitest.com/YesCommercialisedNoNoManualNear POC / POCAntigenNasal swabSARS-CoV678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1320B.1.617.1Kappa1321B.1.617.2Deltanucleocapsid protein2022-08-24 09:08:01 CET3587Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold152907SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method)-Nasal1179Jiangsu Macro & Micro-Test Med-Tech Co. Ltd.Chinahttps://www.hongweitest.com/YesCommercialisedNoNoManualNear POC / POCAntigenNasal swabSARS-CoV-2678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1320B.1.617.1Kappa1321B.1.617.2Delta1495P.1Gammanucleocapsid proteinOur product has completed clinical trials in Poland.2022-08-24 15:42:41 CET3714Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD50000copies/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1%False negatives13%PrecisionEvaluatedAccuracy99.1%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.19%Clinical Specificity99.78%Type of antigenNucleocapsid protein2658SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method)-Nasal (self-test)1179Jiangsu Macro & Micro-Test Med-Tech Co. Ltd.Chinahttps://www.hongweitest.com/YesCommercialisedNoNoAutomatedNear POC / POCAntigenAnterior nasal swabVaricella Zoster Virus (VZV)689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.3678B.1.1.529Omicronnucleocapsid proteinOur product "SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method)-Nasal " has obtained the EC Notified Body Certificate (CE1434) with EC Certificate No. 1434-IVDD-016/2022, comply with requirements of Annex III(Section 6) to Directive 98/79/EC.2022-08-24 09:08:01 CET2363Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD50000copies/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.22%A total 450 negative samples are tested, and 1 subject is tested false positive by the kit.False negatives3.8%A total 105 positive samples are tested, and 4 subjects are tested false negative by the kit.PrecisionEvaluatedAccuracy99.1%97.91% to 99.61%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.19%90.61% to 98.51%Clinical Specificity99.78%98.75% to 99.96%Type of antigenNucleocapsid protein2887SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method)-Nasopharyngeal1179Jiangsu Macro & Micro-Test Med-Tech Co. Ltd.Chinahttps://www.hongweitest.com/YesCommercialisedNoNoManualNear POC / POCAntigenNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.3678B.1.1.529Omicronnucleocapsid proteinOur SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method) has been posted on the antigen list of French.2022-08-24 09:08:01 CET2592Immuno-AntigenYesImmunoassaySandwich, DoubleColloidal gold15LOD200TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.17%False negatives4.66%PrecisionEvaluatedAccuracy98%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.34%Clinical Specificity99.83%Type of antigenNucleocapsid protein2888SARS-CoV-2-Virus-Antigen-Testkit (Kolloidales Gold)1179Jiangsu Macro & Micro-Test Med-Tech Co. Ltd.Chinahttps://www.hongweitest.com/YesCommercialisedNoNoManualNear POC / POCAntigenOropharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.3678B.1.1.529Omicronnucleocapsid proteinOur SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method) has been posted on the antigen list of German BfArM.2022-08-24 09:08:01 CET2593Immuno-AntigenYesImmunoassaySandwich, DoubleColloidal gold15LOD200TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives1.79%PrecisionEvaluatedAccuracy99.32%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.21%Clinical Specificity100%Type of antigenNucleocapsid protein500SARS-CoV-2 rapid combined IgM/IgG antibody test kit317Jiangsu Medomics Medical TechnologiesChinawww.cn-hos.com/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2022-08-24 09:08:01 CET419Immuno-AntibodyYesNoImmunoassayQualitative15Clinical Sensitivity88.66%Clinical Specificity90.63%2006SARS-CoV-2 antigen Test Kit (LFIA)903Jiangsu Medomics medical technology Co. Ltd.Chinahttps://www.medomics-dx.net/YesCommercialisedYesYesNear POC / POCAntigenAnterior nasal swabNasopharyngeal swabThroat swabSARS-CoV-2678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1224B.1.526Iota1320B.1.617.1Kappa1321B.1.617.2Delta1495P.1Gammanucleocapsid proteinMedomics SARS-CoV-2 antigen Test Kit(LFIA) is used to qualitatively detect SARS-CoV-2 in human samples in vitro. Medomics SARS-CoV-2 antigen Test Kit(LFIA) detects the SARS-CoV-2 nucleocapsid antigens with colloidal gold immunochromatography using a double antibody sandwich assay.2022-10-12 17:48:07 CET3969Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwichColloidal gold15LOD10TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives9.64%PrecisionEvaluatedAccuracy98.9%ReproducibilityNot evaluatedRobustnessNot evaluatedClinical Sensitivity90.36%Clinical Specificity100%Type of antigenNucleoprotein2982SARS-CoV-2 Antigen Test Kit (LFIA) Self-testing903Jiangsu Medomics medical technology Co. Ltd.Chinahttps://www.medomics-dx.net/YesCommercialisedNoNoNear POC / POCAntigenNasal swabAdenovirusBordetella PertussisAlpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)MERS-CoVSARS-CoVHemophilus InfluenzaeInfluenza A H1N1Influenza A H3N2Influenza A H5N1Influenza B VictoriaInfluenza B YamagataMycobacterium TuberculosisMycoplasma PneumoniaeParainfluenza Virus Type 1Respiratory Syncytial V (RSV)689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1132B.1.427Epsilon1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta1224B.1.526Iota678B.1.1.529Omicronnucleocapsid proteinSARS-CoV-2 Antigen Test Kit (LFIA) is a colloidal gold immunochromatography for the rapid qualitative detection of SARS-CoV-2 nucleocapsid antigens present in human anterior nasal samples in vitro. The test kit is designed for use as self-testing. This test kit is intended use for individuals by 18 or older with clinical symptoms of SARS-CoV-2 infection or who are suspected of COVID-19. If the suspected individual exhibits respiratory symptoms or suspected to be infected, it is recommended to combine PCR test, clinical symptoms, prevalence and further clinical data to confirm the diagnosis.2022-08-24 09:08:01 CET2688Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich, Double15LOD10TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives8.18%False negatives0%PrecisionEvaluatedAccuracy98.41%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity91.82%AntigenClinical Specificity100AntigenType of antigenNucleocapsid protein3974SARS-CoV-2 & Influenza A/B Antigen Combo Rapid Test Kit (LFIA) 1446Jiangsu Medomics Medical Technology Co., LtdChinawww.medomics-dx.comYesCommercialisedNoNoManualAntigenAnterior nasal swabInfluenza AInfluenza A H1N1Influenza A H3N2Influenza BInfluenza B VictoriaInfluenza B YamagataOther678B.1.1.529Omicron689B.1.1.7Alpha1132B.1.427Epsilon1137B.1.429Epsilon1224B.1.526Iota1320B.1.617.1Kappa1321B.1.617.2Delta1495P.1Gammanucleocapsid protein2022-08-24 09:08:01 CET3639Immuno-AntigenYesYesNoImmunochromatographyQualitativeMembrane-basedColloidal gold15LOD10TCID50/mlAnalytical Sensitivity86.46%Analytical Specificity100%False positives0%False negatives13.54%Accuracy97.8%Clinical Sensitivity86.46%Clinical Specificity100%1680A Rapid IgM-IgG Combined Antibody Test Kit for SARS-Cov-2 (ICA)753Jiangsu Mole Bioscience Co. Ltd.Chinaen.molechina.com/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2022-08-24 09:08:01 CET1359Immuno-AntibodyYesNoImmunoassayQualitative15LOD5AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2.1%False negatives1.6%PrecisionEvaluatedAccuracy98% IgGAccuracy98% IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.96% IgGClinical Sensitivity97.98% IgM1645A Rapid IgM-IgG Combined Antibody Test Kit for SARS-Cov-2-(ICA)753Jiangsu Mole Bioscience Co. Ltd.Chinaen.molechina.com/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2022-08-24 09:08:01 CET1326Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15LOD0.1AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2.1%False negatives1.6%PrecisionEvaluatedAccuracy98% IgGAccuracy98% IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.96% IgGClinical Sensitivity97.98% IgM2340Flu A/B + COVID-19 Antigen Combo Test Cassette Kit1083Jiangsu Mole Bioscience Co. Ltd.Chinahttp://en.molechina.com/YesCommercialisedNoNoManualNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabSalivaSputumThroat swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.2B.1.526.11518P.2ZetaThe test is intended for use in the simultaneous rapid in vitro detection and differentiation of influenza A virus, influenza B virus, and COVID-19 virus nucleocapsid protein antigen, but does not differentiate, between SARS-CoV and COVID-19 viruses and is not intended to detect influenza C antigens. Performance characteristics may vary against other emerging influenza viruses.2022-08-24 09:08:01 CET2041Immuno-AntigenNoImmunochromatographyQualitativeMembrane-based15LOD0.1AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%(FluA) False positives0(FluB)False positives4.8(Covid-19 Antigen)False negatives1.9%PrecisionEvaluatedAccuracy99%(FluA&FluB)Accuracy98%(COVID-19)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%(FluA )Clinical Sensitivity95.2%(COVID-19）Clinical Sensitivity100%(FluB)Clinical Specificity99.4(FluA)Clinical Specificity99.4(FluB)Clinical Specificity98.1COVID-19Type of antigenNucleoprotein2586SARS-CoV-2 Antigen Test Cassette1083Jiangsu Mole Bioscience Co. Ltd.Chinahttp://en.molechina.com/YesCommercialisedYesYesManualNear POC / POCAntigenNasal swabNasopharyngeal swabSARS-CoV689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu2041C.37Lambda1224B.1.526Iota678B.1.1.529Omicron1518P.2Zetanucleocapsid proteinNo more additional information.2022-08-24 09:08:01 CET2291Immuno-AntigenYesNoImmunochromatographyQualitativeMembrane-based15LOD100pg/ml NP-proteinCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.69%False negatives0.83%PrecisionEvaluatedAccuracy98.7%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.31%Clinical Specificity99.17%Type of antigenNucleocapsid protein1644SARS-CoV-2 Antigen Test Cassette (Nasal Swab Specimen)753Jiangsu Mole Bioscience Co. Ltd.Chinaen.molechina.com/YesCommercialisedNoNoNear POC / POCAntigenNasal swabnucleocapsid protein2022-08-24 09:08:01 CET1324Immuno-AntigenYesNoImmunoassayQualitativeColloidal gold15LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.08%False negatives0.6%PrecisionEvaluatedAccuracy99%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%Type of antigennucleoprotein2329SARS-CoV-2 IgM-IgG-IgA Combined Antibody Rapid Test Kit1083Jiangsu Mole Bioscience Co. Ltd.Chinahttp://en.molechina.com/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMIgAPlasmaSerumWhole bloodWhole blood with anti-coagulantsOtherSARS-CoV-2 IgM-IgG-IgA Combined Antibody Rapid Test Kit is a lateral flow chromatographic immunoassay for the qualitative detection of IgG, IgM and IgA antibodies to SARS-CoV-2 in human whole blood, serum or plasma specimen.2022-08-24 09:08:01 CET2030Immuno-AntibodyYesNoImmunochromatographyQualitativeMembrane-based15LOD5AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2.88% IgAFalse positives2.02% IgMFalse positives2.04% IgGFalse negatives3.96% IgAFalse negatives8.41% IgGFalse negatives7.55% IgMPrecisionEvaluatedAccuracy98% IgGAccuracy98% IgMAccuracy97% IgAReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.12% IgAClinical Sensitivity97.98% IgMClinical Sensitivity97.96% IgGClinical Specificity91.58% IgGClinical Specificity92.45% IgMClinical Specificity96.04% IgAType of antigenOther2341SARS-CoV-2 Neutralization Antibody Rapid Test Kit1083Jiangsu Mole Bioscience Co. Ltd.Chinahttp://en.molechina.com/YesCommercialisedNoNoManualNear POC / POCAntibodyPlasmaSerumWhole bloodWhole blood with anti-coagulantsThe SARS-CoV-2 Neutralization Antibody Rapid Test Kit is a lateral flow chromatographic immunoassay for the qualitative detection of neutralization antibody to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in human whole blood, serum or plasma specimen. The test is intended for detection of neutralization antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in whole blood, serum or plasma specimen from the population vaccinated with SARS-CoV-2 vaccine.2022-08-24 09:08:01 CET2042Immuno-AntibodyNoImmunochromatographyQualitativeNeutralization Antibody (NAb)15LOD1AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.69%False negatives0.87%PrecisionEvaluatedAccuracy98%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.31%Clinical Specificity99.13%Type of antigenOther2338SARS-CoV-2 Neutralization Antibody Test Kit (ELISA)1083Jiangsu Mole Bioscience Co. Ltd.Chinahttp://en.molechina.com/YesCommercialisedNoNoManualSemi-automatedAntibodyPlasmaSerumSARS-CoV-2 Neutralization Antibody Test Kit (ELISA) is an Enzyme-Linked Immunosorbent Assay (ELISA) intended for the qualitative detection of neutralization antibodies to SARS-CoV-2 in human serum or plasma specimen (dipotassium EDTA, lithium heparin and sodium citrate).2022-08-24 09:08:01 CET2039Immuno-AntibodyYesELISAQualitativeEnzyme-linked120LOD5AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.47%False negatives2.39%PrecisionEvaluatedAccuracy98.39%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.53%Clinical Specificity97.61%Type of antigenOther2339SARS-CoV-2 Total Antibody Rapid Test Kit1083Jiangsu Mole Bioscience Co. Ltd.Chinahttp://en.molechina.com/YesCommercialisedNoNoManualNear POC / POCAntibodyPlasmaSerumWhole bloodWhole blood with anti-coagulantsSARS-CoV-2 Total Antibody Rapid Test Kit is a lateral flow chromatographic immunoassay for the qualitative detection of total antibodies to SARS-CoV-2 in human whole blood, serum or plasma specimen.2022-08-24 09:08:01 CET2040Immuno-AntibodyNoImmunochromatographyQualitativeMembrane-based15LOD10AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives6.31%False negatives1.06%PrecisionEvaluatedAccuracy94%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.69%Clinical Specificity98.94%Type of antigenOther2337SARS-CoV-2 Total Antibody Test Kit (ELISA)1083Jiangsu Mole Bioscience Co. Ltd.Chinahttp://en.molechina.com/YesCommercialisedNoNoManualSemi-automatedAntibodyPlasmaSerumSARS-CoV-2 Total Antibody Test Kit (ELISA) is an Enzyme-Linked Immunosorbent Assay (ELISA) intended for the qualitative detection of IgG, IgM and IgA antibodies to SARS-CoV-2 in human serum or plasma specimen (dipotassium EDTA, lithium heparin and sodium citrate).2022-08-24 09:08:01 CET2038Immuno-AntibodyYesELISAQualitativeEnzyme-linked120LOD5AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2.6%False negatives1.21%PrecisionEvaluatedAccuracy99.21%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.4%Clinical Specificity98.79%Type of antigenOther240Fast SARS-CoV-2 lgM/lgG Antibody Detection Kit (Colloidal Gold)152Jiangsu Superbio Biomedical Technology (Nanjing) Co. Ltd.Chinawww.superbio.cn/NoCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET198Immuno-AntibodyYesNoImmunoassayQualitativeColloidal gold2144COVID-19 Ag Rapid Test Device992Jiangsu Well Biotech Co. Ltd.ChinaYesCommercialisedYesYesNear POC / POCAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gammanucleocapsid proteinCOVID-19 Ag Rapid Test Device is a rapid chromatographic immunoassay for the qualitative detection of N antigen to SARS-CoV- 2 present in human nasal swabs. This test is for professional used only, as an aid to early diagnosis of SARS-CoV-2 infection in patient. The result of this test should not be the sole basis for the diagnosis; confirmatory testing is required.2022-08-24 09:08:01 CET1834Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich, Double15LOD1AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives5.26%False negatives1%PrecisionEvaluatedAccuracy97.9%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.74%Clinical Specificity99%Type of antigenNucleoprotein2500Orawell COVID-19 Ag Rapid Saliva Test Device (CO-03)1139Jiangsu Well Biotech Co. Ltd.Chinawww.wellbioscience.comYesCommercialisedNoNoNear POC / POCAntigenSaliva689B.1.1.7Alpha1032B.1.351Beta2022-08-24 09:08:01 CET2204Immuno-AntigenNoImmunochromatographyQualitativeSandwich, Double10LOD60TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse negatives4.4%PrecisionEvaluatedAccuracy98.21%(Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.6%(Antigen)Clinical Specificity100%(Antigen)Type of antigenNucleocapsid protein2517Orawell COVID-19 Ag Rapid Saliva Test Device (CO-07)1139Jiangsu Well Biotech Co. Ltd.Chinawww.wellbioscience.comYesCommercialisedNoNoNear POC / POCAntigenSaliva689B.1.1.7Alpha1032B.1.351BetaNA2022-08-24 09:08:01 CET2221Immuno-AntigenNoImmunochromatographyQualitativeSandwich, Double10LOD60TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse negatives3.8%PrecisionEvaluatedAccuracy98.48%(Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.15%(Antigen)Clinical Specificity100%(Antigen)Type of antigenNucleocapsid protein2495OraWell COVID-19 Ag.Rapid Saliva test DEVICE, CO-07(One Step)1131Jiangsu Well Biotech Co. Ltd.Chinahttps://www.wellbioscience.com/YesCommercialisedNoNoManualNear POC / POCOtherSemi-automatedAntigenOtherSalivaSputum689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaPrinciple The COVID-19 Ag Rapid Saliva Test Device uses double antibody sandwich immunoassay. The NC membrane pre-immobilized with monoclonal antibodies against SARS-CoV-2 antigen and anti-mouse polyclonal antibodies, and the colloidal-gold conjugated with monoclonal antibodies specific to SARS-CoV-2 antigen. If SARS-CoV-2 antigen present in the sample, a complex formed between the anti-SARS-CoV-2 conjugate and the antigen will be caught by the specific anti- SARS-CoV-2 monoclonal coated on the T region. Results appear in 10 to 20 minutes in the form of a red line that develops on the strip. Whether the sample contains the SARS-CoV-2 antigen or not, the solution continues to migrate to encounter another reagent (an anti-mouse IgG antibody) that binds the remaining conjugates, thereby producing a red line on the region C. Kit Content 1) Test device (individually packed in a foil pouch with desiccant). 2) Instruction for use. Materials required but not provided Timer Precautions • For in vitro diagnostic use only. • Do not re-use the test device. • Do not use after the expiration date. • Do not use the test kit if the pouch is damaged or the seal is broken. • Perform test at room temperature 15 to 30°C. •Wear gloves when hanging the samples, avoid touching the reagent membrane and sample window. • All samples and used accessories should be treated as infectious and discarded according to local regulations. • Avoid using blood samples.2022-08-24 09:08:01 CET2198Immuno-AntigenNoImmunochromatographyQualitativeSandwich10LOD25TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives4.65%6 on 129False negatives0%0 on 200PrecisionEvaluatedAccuracy98.21%98,21 %ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.6%Clinical Specificity99%Type of antigenNucleocapsid protein2496OraWell COVID-19 NEUTRALIZING ANTIBODY Rapid Test Device - CO_04 (Check vaccination coverage)1131Jiangsu Well Biotech Co. Ltd.Chinahttps://www.wellbioscience.com/YesCommercialisedNoNoManualNear POC / POCOtherSemi-automatedAntibodyIgGPeripheral bloodPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1132B.1.427Epsilon3939B.1.6161320B.1.617.1Kappa20A.23.1COVID-19 neutralizing antibody Test is a chromatographic immunoassay for the detection of neutralizing antibodies to COVID-19 in human whole blood, serum and plasma. The test device contains: 1) Colloidal gold-labeled recombinant SARS-CoV-2 RBD antigen; 2) Detection line (T line) immobilized with SARS-CoV-2 RBD antigen for detecting COVID-19 neutralizing antibody and Control line(C line) immobilized with quality contro! antibody on nitrocellulose membrane. Ifthe sample contains COVID-19 neutralizing antibody, it will bind to antigens coated on colloidal gold, and a pink colored band will develop in the test region (T) on the membrane.If there is no COVID-19 neutralizing antibody in the sample, the pink colored band in the test region (T) will not appears and that suggests a negative result.2022-08-24 09:08:01 CET2199Immuno-AntibodyNoImmunochromatographyQualitativeNeutralization Antibody (NAb)15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives4.6%7 on 152False negatives0%0 on 371PrecisionEvaluatedAccuracy97.65%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.39%Clinical Specificity99.9%Type of antigenOther2490Saliva Orawell Covid_19 Ag1131Jiangsu Well Biotech Co. Ltd.Chinahttps://www.wellbioscience.com/YesCommercialisedNoNoManualNear POC / POCSemi-automatedAntigenOtherSaliva689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaIl test è costruito a ciclo chiuso antiadulterante del prelievo, con flacone reagente predisposto all'inserimento del tamponcino_prelievo e utilizzabile come contagocce( senza trasferimento o travasi del prelievo)2022-08-24 09:08:01 CET2193Immuno-AntigenNoImmunochromatographyQualitativeOther15Rapid test Device- CO-03 . registrato come DM n. 2015988/r al Portale DM del Ministero della SaluteLOD25TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2.85%1 su 35False negatives0%0 su 200PrecisionEvaluatedAccuracy99.57%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.1%Clinical Specificity99%Type of antigenNucleocapsid protein4099SARS-CoV-2 Antigen Rapid Test (Self-Testing) (Nasal)1466JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO. LTD.ChinaYesCommercialisedNoNoManualAntigenAnterior nasal swabSARS-CoVSARS-CoV-2678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1321B.1.617.2Deltanucleocapsid protein2022-09-29 09:02:26 CET3887Immuno-AntigenYesYesYesImmunochromatographyQuantitativeMembrane-basedColloidal gold10LOD500TCID50/mlCalibrationEvaluatedAnalytical Sensitivity93.55%Analytical Specificity99.9%Analysis of cross reactivityEvaluatedFalse positives0stripsFalse negatives8stripsPrecisionEvaluatedAccuracy98.61%RobustnessEvaluatedClinical Sensitivity93.55%Clinical Specificity99.9%2963DREHA Novel Coronavirus (SARS-CoV-2) Antigen Rapid Detection Kit3182Jiangxi Province JinHuan Medical Instrument Co. Ltd.Chinahttp://www.jinhuan123.com/YesCommercialisedYesYesNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabSalivaSARS-CoV-2678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1223B.1.525Eta1224B.1.526Iota1321B.1.617.2Delta2041C.37Lambda1495P.1Gamma1518P.2Zetanucleocapsid proteinThe device is commercialised in Germany and listed at the BfArM under the test-ID "AT770/21". The device and current submission have been updated to include nasopharyngeal, oropharyngeal and saliva swab in addition to the nasal swab, the update has been approved by BfArM under the same national test-ID AT770/21 (March 2022).2022-10-20 10:13:42 CET5221Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD1ng/mLCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.34%Nasal swabFalse negatives4%Nasal swabPrecisionEvaluatedAccuracy96.56%SalivaAccuracy99.07%Naso-/oropharyngeal swab (pooled)Accuracy98.7%Nasal swabReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96%Nasal swabClinical Sensitivity97.62%Naso-/oropharyngeal swab (pooled)Clinical Sensitivity92.16%SalivaClinical Specificity99.7%Nasal swabClinical Specificity99.64%Naso-/oropharyngeal swab (pooled)Clinical Specificity98.62%SalivaType of antigenNucleocapsid protein3004MEDSYS Novel Coronavirus (SARS-CoV-2) Antigen Rapid Detection Kit3227Jiangxi Province JinHuan Medical Instrument Co. Ltd.Chinahttp://www.jinhuan123.com/YesCommercialisedYesYesNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabSalivaSARS-CoV-2678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1223B.1.525Eta1224B.1.526Iota1321B.1.617.2Delta2041C.37Lambda1518P.2Zetanucleocapsid proteinTwin product to "DREHA Novel Coronavirus (SARS-CoV-2) Antigen Rapid Detection Kit" (EU-ID: 2963), packaged under MEDSYS label. The device is commercialised in Germany and listed at the BfArM under the test-ID "AT770/21". The device and current submission have been updated to include nasopharyngeal, oropharyngeal and saliva swab in addition to the nasal swab, the update has been approved by BfArM under the same national test-ID AT770/21 (March 2022).2022-12-12 16:50:20 CET5377Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD1ng/mLCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.34%Nasal swabFalse negatives4%Nasal swabPrecisionEvaluatedAccuracy96.56%SalivaAccuracy99.07%Naso-/oropharyngeal swab (pooled)Accuracy98.74%Nasal swabReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96%Nasal swabClinical Sensitivity97.62%Naso-/oropharyngeal swab (pooled)Clinical Sensitivity92.16%SalivaClinical Specificity99.66%Nasal swabClinical Specificity99.64%Naso-/oropharyngeal swab (pooled)Clinical Specificity98.62%SalivaType of antigenNucleocapsid protein3085Novel Coronavirus (SARS-CoV-2) Antigen Rapid Detection Kit1308Jiangxi Province JinHuan Medical Instrument Co. Ltd. ChinaChinahttp://www.jinhuan123.com/YesCommercialisedNoNoNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabSalivaSARS-CoV689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1321B.1.617.2Delta2041C.37Lambda1224B.1.526Iota678B.1.1.529Omicron1518P.2Zetanucleocapsid proteinThe device is commercialised in Germany and listed at the BfArM under the test-ID "AT770/21". The device and current submission have been updated to include nasopharyngeal, oropharyngeal and saliva swab in addition to the nasal swab, the update has been approved by BfArM under the same national test-ID AT770/21 (March 2022). The analytical components of the test are same as the EU device 2963 (https://covid-19-diagnostics.jrc.ec.europa.eu/devices/detail/2963). However, it has new instructions of use along with new specimen collection methods and respective clinical data.2022-08-24 09:08:01 CET2791Immuno-AntigenNoNoImmunochromatographyQualitativeSandwich, Double15Clone1 binding site: INTNSSP(74-80) Clone2 binding site: GTRNPANN(147-154)LOD1ng/mLCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.34%False positive occurs 1 in 297 casesFalse negatives4%False negative occurs 4 in 100 casesPrecisionEvaluatedAccuracy98.7%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96%AntigenClinical Specificity99.7%AntigenType of antigenNucleocapsid protein2528ABtex AG1153JIAXING WISETEST BIO-TECH Co. Ltd.Chinahttp://www.biotech-crm.com/YesCommercialisedNoNoManualAntibodySalivaThe company would like to work with us to sell their products in Switzerland. One requirement from Switzerland is to be listed on your list. More information about the Product: At present, the main detection method for the new coronavirus virus is nucleic acid detection, which has strict requirements on detection equipment and personnel. Therefore, the establishment of a detection method with faster detection time, easier operation, and lower cost is of great significance to the control of the epidemic. The saliva novel coronavirus antigen detection kit independently developed by JIAXING WISETEST BIO-TECH CO., LTD. is used for people who have symptoms in the early stage of infection (window period). Highly sensitive, convenient saliva collection, 15 minutes on-site results. The tested person can operate and interpret by himself, which is convenient and quick. There is no need for sample collection, storage, transportation and testing equipment.2022-08-24 09:08:01 CET2232Immuno-AntigenYesNoImmunoassayQualitativeSandwich15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0noneFalse negatives11AUPrecisionEvaluatedAccuracy95%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99%Highly sensitivClinical Specificity95%2151SARS-CoV-2 Antigen Rapid Detection Kit (Colloidal Gold Method)996JINAN BABIO BIOTECHNOLOGY Co. Ltd.Chinazhou@jnbaibo.comYesCommercialisedNoNoNear POC / POCAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gammanucleocapsid proteinSARS-CoV-2 Antigen Rapid Detection Kit (Colloidal Gold Method) is a lateral flow immunoassay intended for the qualitative detection of nucleoprotein from SARS-CoV-2 nasal swab. It is used by professionals as a test and provides a preliminary test result to aid in the diagnosis of infection with individuals suspected of COVID-19.2022-08-24 09:08:01 CET2890Immuno-AntigenNoImmunoassayQualitativeMembrane-basedColloidal gold15LOD0AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives3.33%False negatives0%PrecisionEvaluatedAccuracy96.83%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.67%AntigenClinical Specificity100%Type of antigenNucleocapsid protein4046SARS-CoV-2 Antigen Rapid Detection Kit (Colloidal Gold Method)996JINAN BABIO BIOTECHNOLOGY Co. Ltd.Chinazhou@jnbaibo.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabOropharyngeal swabSalivaAdenovirusAlpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus OC43 (HCoV-OC43)Influenza A H1N1Influenza BMERS-CoVRespiratory Syncytial V (RSV)689B.1.1.7Alpha1032B.1.351Beta1495P.1Gammanucleocapsid proteinSARS-CoV-2 Antigen Rapid Detection Kit (Colloidal Gold Method) is a lateral flow immunoassay intended for the qualitative detection of nucleoprotein from SARS-CoV-2 nasal swabs and pharyngeal swabs. It is used by professionals as a test and provides a preliminary test result to aid in the diagnosis of infection with individuals suspected of COVID-19. Results from antigen testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status. The diagnosis should be confirmed in combination with clinical symptoms or other conventional testing methods.2022-09-20 14:32:24 CET3828Immuno-AntigenYesNoNoImmunoassayQualitativeN.A.N.A.15LOD0%CalibrationEvaluatedAnalytical Sensitivity96.67%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives3.33%False negatives0%PrecisionEvaluatedAccuracy99.4%RobustnessEvaluatedClinical Sensitivity96.67%Clinical Specificity100%575(COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold)545JinHuan Medical Instrument Co. Ltd.Chinawww.jinhuan123.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2022-08-24 09:08:01 CET791Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry152875/COVID-19 Antigen Rapid Test (Colloidal Gold) anterior nasal - self testing device44Joinstar Biomedical Technology Co. Ltd.Chinawww.joinstar.cnYesCommercialisedNoNoManualAntigenAnterior nasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta678B.1.1.529Omicronnucleocapsid proteinNo.2022-08-24 09:08:01 CET2580Immuno-AntigenYesNoImmunoassayQualitativeMembrane-basedColloidal gold15LOD100pg/mLCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.84 false positives in 500 negativesFalse negatives3.924 false negatives in 102 positivesPrecisionEvaluatedAccuracy98.7%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.1%AntigenClinical Specificity99.2%AntigenType of antigenNucleocapsid protein1205COVID-19 Antigen Rapid Test (Latex)44Joinstar Biomedical Technology Co. Ltd.Chinawww.joinstar.cnYesCommercialisedNoNoNear POC / POCAntigenSalivaSputumStool689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1132B.1.427Epsilon1137B.1.429Epsilonspike proteinDIAGNOSTIC PERFORMANCE OF JOINSTAR COVID-19 ANTIGEN RAPID TEST (LATEX)- HELLENIC INSTITUTE FOR THE STUDY OF SEPSIS. Athens, April 12th 2021. Test report G20202531 issued from HANGZHOU CENTER OF MEDICAL DEVICE SUPERVISION AND TESTING, October 19th 20202022-08-24 09:08:01 CET990Immuno-AntigenYesNoImmunoassayQualitative15LOD5ng/mL SARS-COV-2 Glicoprotein SCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0% Compared to PCR (n=60)False negatives2%(Compared to PCR (n=100)PrecisionEvaluatedAccuracy93.33%Clinical Sensitivity90%Clinical Specificity100%Type of antigenSpike protein1333COVID-19 Rapid Antigen Test (Colloidal Gold)44Joinstar Biomedical Technology Co. Ltd.Chinawww.joinstar.cnYesCommercialisedYesYesNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.320A.23.1nucleocapsid proteinEvaluation performed by Paul-Ehrlich Institut on 4th December 20202022-08-24 09:08:01 CET1105Immuno-AntigenYesNoImmunoassayQualitativeMembrane-basedColorimetry15LOD100pg/mLAnalysis of cross reactivityEvaluatedFalse positives1.86%(From 215 samples tested there were 4 false positives)False negatives1.39%(From 215 samples tested there were 3 false negatives)PrecisionEvaluatedAccuracy97.6%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.1%Clinical Specificity98.1%Type of antigenNucleocapsid protein1204SARS-CoV-2 IgM/IgG Antibody Test (Colloidal Gold)44Joinstar Biomedical Technology Co. Ltd.Chinawww.joinstar.cnYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2022-08-24 09:08:01 CET51Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry10LOD0AUFalse positives0%No false positives in 112 samples vs PCR False negatives8.93%10 False negatives in 112 samples vs PCRAccuracy91.07%IgG+IgMClinical Sensitivity89%90 samples which were PCR positive1776SARS-CoV-2 Neutralizing Antibody Rapid Test (Colloidal Gold) 44Joinstar Biomedical Technology Co. Ltd.Chinawww.joinstar.cnYesCommercialisedNoNoManualIgGPlasmaSerumWhole blood2022-08-24 09:08:01 CET1455Immuno-AntibodyYesYesImmunoassayColorimetry15LOD0U/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%0/39False negatives5.04%7/139PrecisionEvaluatedAccuracy98.5%ReproducibilityEvaluatedClinical Sensitivity94.7%1777SARS-COV-2/Influenza A&B Rapid Antigen Test44Joinstar Biomedical Technology Co. Ltd.Chinawww.joinstar.cnYesCommercialisedNoNoManualAntigenNasal swab2022-08-24 09:08:01 CET1456Immuno-AntigenYesNoImmunochromatographyQualitativeColorimetry15LOD0U/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives3%False negatives1%PrecisionEvaluatedAccuracy98.9%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.1%933COVID-9 IgG/IgM Rapid Test Kit (Colloidal Gold)516JOYSBIO (Tianjin) Biotechnology Co. Ltd.Chinaen.joysbio.com/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgM2022-08-24 09:08:01 CET753Immuno-AntibodyYesImmunoassayColorimetry1764SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold)516JOYSBIO (Tianjin) Biotechnology Co. Ltd.Chinaen.joysbio.com/YesCommercialisedYesYesNear POC / POCAntigenNasal swab2022-08-24 09:08:01 CET1442Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD160AUAnalytical Sensitivity98.13%Analysis of cross reactivity0AUFalse positives3AUFalse negatives2AUAccuracy98.98%1766SARS-CoV-2 Antigen Rapid Test Kit - Saliva (Colloidal Gold)516JOYSBIO (Tianjin) Biotechnology Co. Ltd.Chinaen.joysbio.com/YesCommercialisedNoNoNear POC / POCAntigenSalivanucleocapsid protein2022-08-24 09:08:01 CET1445Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD320U/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%0 out of 260 RT-PCR negative specimensFalse negatives4.9%5 out of 102 RT-PCR positive specimensPrecisionEvaluatedAccuracy98.62%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.1%Type of antigenNucleoprotein2813SARS-CoV-2 Antigen Rapid Test Kit-PRO (Colloidal Gold)1258JOYSBIO (Tianjin) Biotechnology Co. Ltd.Chinahttps://en.joysbio.com/YesCommercialisedNoNoNear POC / POCAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2Zetathis test is evaluated by PEI in Germany and marked as passed evaluation. It is listed as "Joysbio SARS-CoV-2 Antigen rapid test kit - PRO (Colloidal Gold)" in the PEI evaluation list. 2022-08-24 09:08:01 CET2518Immuno-AntigenNoImmunochromatographyQualitativeMembrane-basedColloidal gold15LOD120TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.44%1 out of 224 RT-PCR negative specimensFalse negatives1.81%2 out of 110 RT-PCR positive specimensPrecisionEvaluatedAccuracy99.1%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.18%Clinical Specificity99.55%Type of antigenNucleocapsid protein2779nCoVega Saliva-Based Rapid Antigen COVID19 Test1247Kaya17 Inc.United Stateswww.kaya17.comYesCommercialisedNoNoManualNear POC / POCAntigenSaliva689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2Zetaspike proteinover 600 subjects in 4 external clinical trials2022-08-24 09:08:01 CET2484Immuno-AntigenYesYesImmunoassayQualitativeOther15LOD20AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positivesNo food or drink 30 min prior to giving sample to avoid false positivesFalse negativesAssay has high sensitivity and no Hook Effect so avoids false negativesPrecisionEvaluatedAccuracy98%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99%Clinical Specificity99%Type of antigenSpike protein244KDx COVID-19 Antigen Detection Rapid Test149Kephera DiagnosticsUnited Stateswww.kephera.com/NoIn developmentNoNoNear POC / POCAntigen2022-08-24 09:08:01 CET195Immuno-AntigenYesImmunoassay243KDx COVID-19 IgG and IgM ELISA (manual)149Kephera DiagnosticsUnited Stateswww.kephera.com/NoIn developmentNoNoLab-basedAntibody2022-08-24 09:08:01 CET193Immuno-AntibodyELISA242KDx COVID-19 IgG/IgM Rapid Detection Test Kit149Kephera DiagnosticsUnited Stateswww.kephera.com/NoIn developmentNoNoNear POC / POCAntibody2022-08-24 09:08:01 CET192Immuno-AntibodyYesImmunoassay1596COVID-19 Antigen Rapid Test705KitL&H Biotech LimitedChinawww.lhbiotech.com.cn/YesCommercialisedNoNoNear POC / POCAntigen2022-08-24 09:08:01 CET1277Immuno-AntigenYesImmunoassayQualitative2038COVID-19 Antigen Rapid Test Kit939Koch Biotechnology (Beijing) Co. Ltd.Chinawww.kochbiotech.netYesCommercialisedYesYesNear POC / POCAntigenNasopharyngeal swabOropharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1518P.2ZetaThe KOCH Biotechnology COVID-19 Antigen Rapid Test Kit is an in-vitro diagnostic rapid test for the qualitative detection of SARS-CoV-2 antigen (Ag) in human nasopharyngeal- (Nasopharynx) or oropharyngeal- (throat) swab specimens from individuals who meet COVID-19 clinical and / or epidemiological criteria. The KOCH COVID-19 Antigen Rapid Test Kit is for professional use only and is intended to be used as an aid in the diagnosis of SARS-CoV-2 infection. The product may be used in any laboratory and non-laboratory environment that meets the requirements specified in the Instructions for Use and local regulation. The test provides preliminary test results. Negative results don’t preclude SARS-CoV-2 infection and they cannot be used as the sole basis for treatment or other management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information. The test is not intended to be used as a blood donor screening test for SARS-CoV-2. The KOCH Biotechnology COVID-19 Antigen Rapid Test Kit is based on colloidal gold immunochromatography to detect nucleocapsid (N) of the SARS-CoV-2 virus in respiratory secretions. When the specimen is added into the solution buffer inside the virus preservation tube and the test stripe has been added, the specimen is absorbed by the test stripe by capillary action, mixes with the gold-labelled antibody and flows across the pre-coated membrane. The antigen in the sample is captured by the gold-labelled antibody N1a and then bound to the antibody N1 immobilized in the test region (T) of the membrane. This creates a coloured line and indicates a positive test result. If there is no COVID-19 antigen in the specimen or the concentration is lower than the detection limit of the test, there is not a visible coloured line in the Test Region (T) of the device. This indicates a negative result. To serve as a procedure control, a coloured line will appear at the Control Region (C), if the test has been performed properly2022-08-24 09:08:01 CET3674Immuno-AntigenYesNoImmunochromatographyQualitative15LOD115CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives1%False negatives0.7%PrecisionEvaluatedAccuracy99%(95%CI*: 98,30-99,70%)ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity98.5%(95%CI*: 97,20-99,80%)Clinical Specificity99.3%(95%CI*: 98,50-100%)Type of antigenNucleoprotein2786Laboquick COVID 19 Ag Rapid Test Kit1251Koroglu Medikal Tibbi Malzemeleri Kozmetik Ithalat Ihracat San. Ve Tic Ltd. Sti.Turkeyhttp://www.koroglugroup.comYesNoNoManualAntigenNasal swabThroat swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaLaboquick COVID 19 Rapid Test Kit Koroglu Medical Devices - English Koroglu Medikal Tıbbi Malzemeleri Kozmetik Ithalat Ihracat San. Ve Tic. Ltd. Sti. - Turkish 1776/23 Sok. No:4/A Mevlana Mah. Bornova - Izmir 35050 - Turkey Tel:+90 232 388 73 74 Fax:+90 232 388 40 43 e-mail: info@koroglugroup.com2022-08-24 09:08:01 CET2491Immuno-AntigenNoImmunochromatographyQualitativeSandwich, Double15LOD250TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy99.6%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.8%Clinical Specificity99.8%Type of antigenNucleocapsid protein248Human Anti-SARS-CoV-2 (Covid-19) IgG/IgM Rapid Test153KRISHGEN BioSystemsUnited Stateswww.krishgen.com/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2022-08-24 09:08:01 CET200Immuno-AntibodyYesNoImmunoassayQualitative15247Human Anti-SARS-CoV-2 (Covid-19) IgM Rapid Test153KRISHGEN BioSystemsUnited Stateswww.krishgen.com/NoCommercialisedNoNoNear POC / POCAntibody2022-08-24 09:08:01 CET199Immuno-AntibodyYesImmunoassay249Human Anti-SARS-CoV-2 (Covid-19) Nucleocapsid Protein IgG ELISA (manual)153KRISHGEN BioSystemsUnited Stateswww.krishgen.com/NoCommercialisedNoNoAutomatedManualAntibody2022-08-24 09:08:01 CET201Immuno-AntibodyELISA251Human Anti-SARS-CoV-2 (Covid-19) Spike Protein IgG ELISA (manual)153KRISHGEN BioSystemsUnited Stateswww.krishgen.com/NoCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET203Immuno-AntibodyYesELISAQualitativeSandwich120LODEvaluatedPrecisionEvaluated253Human SARS-CoV-2 (Covid-19) Qualitative ELISA (manual)153KRISHGEN BioSystemsUnited Stateswww.krishgen.com/NoCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET204Immuno-AntibodyYesELISAQualitativeSandwich120LODEvaluatedPrecisionEvaluated254SARS-CoV-2 Antibody IgM/IgG Testing Kit159Kurabo Industries Ltd.Japanwww.kurabo.co.jp/english/NoIn developmentNoNoNear POC / POCAntibodyIgGIgM2022-08-24 09:08:01 CET210Immuno-AntibodyYesImmunoassay15577COVID-19 (SARS-CoV-2) IgM/IgG Antibody Test Kit346Labnovation Technologies Inc.Chinawww.labnovation.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerum2022-08-24 09:08:01 CET464Immuno-AntibodyYesNoImmunoassayQualitative203936SARS-CoV-2 Antigen Influenza A B Rapid Test Kit(Immunochromatography)1441Labnovation Technologies Inc.Chinawww.labnovation.comYesCommercialisedNoNoLab-basedAntigenNasopharyngeal swabAdenovirusAdenovirus 3Adenovirus 7Adenovirus Subtype BAdenovirus Subtype CAlpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Anti-Nuclear AntibodyBeta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Bordetella PertussisChlamydia PneumoniaeCoronaviruses (HCoV)Cytomegalovirus (CMV)Enterovirus A71 (EV-A71)Epstein-Barr Virus (EBV)Hemophilus InfluenzaeHepatitis A Virus (HAV)Hepatitis B Virus (HBV)Hepatitis C Virus (HCV)Herpes Simplex (HSV)Human Immunodeficiency Virus (HIV)Human Metapneumovirus (HMPV)Influenza AInfluenza A H1N1Influenza A H3N2Influenza A H5N1Influenza BInfluenza B VictoriaInfluenza B YamagataMERS-CoVMumps Virus (MuV)Mycobacterium TuberculosisMycoplasma PneumoniaeParainfluenza Virus TypeParainfluenza Virus Type 1Parainfluenza Virus Type 2Parainfluenza Virus Type 3Parainfluenza Virus Type 4Respiratory Syncytial V (RSV)Respiratory Syncytial V (RSV) Type ARespiratory Syncytial V (RSV) Type BRhinovirusRhinovirus ARhinovirus BSARS-CoVVaricella Zoster Virus (VZV)20A.23.170AT.1678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526IotaB.1.526.1B.1.526.23939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu1439C.362041C.37Lambda1495P.1Gamma1518P.2Zeta1519P.3Thetaangiotensin-converting enzyme 2envelope proteinmembrane proteinnon-structural protein NS10non-structural protein NS3anon-structural protein NS3bnon-structural protein NS6non-structural protein NS7anon-structural protein NS9anon-structural protein Ns9bnon-structural protein NSP1non-structural protein NSP10non-structural protein NSP12non-structural protein NSP13non-structural protein NSP14non-structural protein NSP15non-structural protein NSP16non-structural protein NSP2non-structural protein NSP3non-structural protein NSP4non-structural protein NSP5non-structural protein NSP6non-structural protein NSP7non-structural protein NSP8non-structural protein NSP9Nonstructural protein NS7bnucleocapsid proteinORF1a polyproteinORF1ab polyproteinORF1b polyproteinspike protein2022-08-24 09:08:01 CET3602Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD30TCID50/mlAnalytical Sensitivity95.15%Analytical Specificity100%False positives0testsFalse negatives8testsAccuracy98.7%Clinical Sensitivity95.15%Clinical Specificity100%1266SARS-CoV-2 Antigen Rapid Test Kit (Immunochromatography)346Labnovation Technologies Inc.Chinawww.labnovation.comYesCommercialisedYesYesNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabSARS-CoV-220A.23.170AT.1678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526IotaB.1.526.1B.1.526.23939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu1439C.362041C.37Lambda1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid proteinWe need to update the commercial name of the device reported in the common list to make sure it's same with our CE certificate. The correct commercial name of the device is SARS-CoV-2 Antigen Rapid Test Kit (Immunochromatography).2022-12-05 09:30:59 CET5356Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives8AUFalse negatives%PrecisionEvaluatedAccuracy99.17%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.45%Clinical Specificity100%Type of antigenNucleocapsid protein3967Précisio TEST COVID-19 ANTIGENE1431LABORATOIRE SALEM AlgeriaWWW.labosalem.comYesCommercialisedNoNoManualAntigenNasopharyngeal swabOropharyngeal swabSARS-CoV20A.23.170AT.1678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526IotaB.1.526.1B.1.526.23939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu1439C.362041C.37Lambda1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid protein2022-08-24 09:08:01 CET3632Immuno-AntigenYesNoYesImmunochromatographyQualitativeSandwichColloidal gold15LOD850TCID50/mlAnalytical Sensitivity80%Analytical Specificity100%False positives0%False negatives3%Accuracy100%Clinical Sensitivity80%Clinical Specificity100%3010Pekit Covid-19 Rapid (Hızlı) Antigen Test1335Labormed Tıbbi Ãœrünler San Ve Tic Ltd. ÅžTÄ°Turkeywww.labormed.bizNoCommercialisedNoNoNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabThroat swabCoronaviruses (HCoV)Alpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)SARS-CoVnucleocapsid proteinwww.labormed.biz2022-08-24 09:08:01 CET2716Immuno-AntigenYesImmunochromatographyQualitativeMultiple15LOD580TCID50/mlPositive control1.66%100xTP/(TP+FP)=100x238/242=98.34%Negative control1.49%100xTN/(FN+TN)=100x530/538=98.51%Analytical Sensitivity93.76%Analytical Specificity97.5%Clinical Sensitivity96.89%Clinical Specificity99.1%578ANTI COVID-19 IGG/IGM RAPID TEST348Labtest DiagnosticaBrazillabtest.com.br/en/NoCommercialisedNoNoNear POC / POCAntibodyPlasmaSerum2022-08-24 09:08:01 CET466Immuno-AntibodyYesNoImmunoassayQualitativeFalse positivesEvaluatedFalse negativesEvaluatedClinical Sensitivity85% IgMClinical Sensitivity100% IgGClinical Specificity96% IgMClinical Specificity98% IgG1667LooK SPOT746Laipac Technology Inc.Canadawww.laipac.comYesCommercialisedNoNoAutomatedAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1223B.1.525Eta1495P.1Gamma1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2Zetanucleocapsid proteinLow-cost LooK SPOT to read over thousands of tests. Look SPOT access AI Cloud for the diagnosis of the images and it provides consistent test results including low positive cases. Under SPEED mode, it can provide test results within 30 seconds.2022-08-24 09:08:01 CET1346Immuno-AntigenYesYesImmunoassayQualitativeOtherColorimetry1LOD129000TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2%Limited to less than 2%False negatives2%Limited to less than 2%PrecisionEvaluatedAccuracy95%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.4%Clinical Specificity98.3%Type of antigennucleoprotein2368LooK SPOT 2746Laipac Technology Inc.Canadawww.laipac.comYesCommercialisedNoNoAutomatedOtherAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaLooK SPOT 2 can screen 500+ people in one hour by using SPEED mode. LooK SPOT 2 uses AI Cloud to validate the test result and provide traceability in real time. Patients can receive test certificates on their phones in real time.2022-08-24 09:08:01 CET2070Immuno-AntigenYesImmunoassayQualitative1LOD129000AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2%Limited to less than 2%False negatives2%Limited to less than 2%PrecisionEvaluatedAccuracy95%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.4%Clinical Specificity98.3%Type of antigenNucleoprotein3092COVID-19 Antigen Test Kit (Colloidal gold immunochromatographic assay)1372Langfang Xinruikang Biotechnology Co. Ltd.ChinaYesCommercialisedNoNoManualAntigenNasopharyngeal swabOropharyngeal swabSARS-CoV689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1321B.1.617.2Delta678B.1.1.529Omicronnucleocapsid proteinperformances Alpha(98;96);Beta(97;94);Gamma(98;95);Delta(98;96);Omicr on(97;96)2022-08-24 09:08:01 CET2798Immuno-AntigenNoNoImmunochromatographyQualitativeColloidal gold15LOD25pg/mLCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positivesAll diagnostic tests may be subject to false positive results, especially in low prevalence settingsFalse negativesImproper sample collection, transport and handling, and low virus concentrations in samples can lePrecisionEvaluatedAccuracy95%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity89%AntigenClinical Specificity97%AntigenType of antigenNucleocapsid protein1649(COVID-19) IgM/IgG Test Kit (Dry Fluorescence Immunoassay)739Lansion Biotechnology Co. Ltd.Chinaen.lansionbio.comYesCommercialisedNoNoAutomatedLab-basedNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2022-08-24 09:08:01 CET1330Immuno-AntibodyYesYesImmunoassayQuantitativeFluorescenceFluorescence15LOD1AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives5%False negatives3%PrecisionEvaluatedAccuracy96%(IgM, IgG)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.14%(IgM, IgG)2869COVID-19 Antigen Test Kit (Dry Color Latex Immunoassay)739Lansion Biotechnology Co. Ltd.Chinaen.lansionbio.comYesCommercialisedNoNoManualNear POC / POCAntigenSaliva1321B.1.617.2Delta678B.1.1.529Omicronspike proteinThe product is intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in saliva from individuals suspected of COVID-19 by their healthcare provider or personage within the first seven days of the onset of symptoms. Antigens are generally detectable in nasopharyngeal specimens during the acute phase of infection. COVID-19 is an acute respiratory infectious disease that is highly susceptible to human infection. Currently, the patients infected by the novel coronavirus are the main source of infection, asymptomatic infected people can also bean infectious source. Based on the current epidemiological investigation, the incubation period for COVID-19 ranges from 1 to 14 days, with most cases ranging from 3 to 7days, the main manifestations include fever, fatigue, and dry cough. Nasal congestion, runny nose,sore throat, myalgia, and diarrhea are found in a few cases.2022-08-24 09:08:01 CET2574Immuno-AntigenYesNoImmunoassayQualitativeSandwichColorimetry15LOD2.5µg/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2AUFalse negatives0AUPrecisionEvaluatedAccuracy99.29%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%Clinical Specificity96.37%Type of antigenSpike protein3123COVID-19 Antigen Test Kit (Dry Color Latex Immunoassay) for self-testing use739Lansion Biotechnology Co. Ltd.Chinaen.lansionbio.comYesCommercialisedNoNoManualAntigenAnterior nasal swabSARS-CoV689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1132B.1.427Epsilon1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta1224B.1.526Iotanucleocapsid proteinThe sample to be tested moves forward due to capillary action. The N protein in the sample binds to the gold-labeled SARS-CoV-2 N protein mouse anti human monoclonal antibody 1 pre-coated on the binding pad, and the conjugate moves upward under capillary action. If the sample contains the novel coronavirus antigens and concentration of antigens is higher than the limit of detection, the antigen will bind to the N proteinmouseanti human monoclonal antibody.2022-08-24 09:08:01 CET2831Immuno-AntigenYesYesImmunoassayQualitativeOther15COVID-19 Antigen Test Kit (Dry Color Latex Immunoassay) detects the SARS-CoV-2 with the principle of antigen-antibody reaction. The test strip contains (1) coated with red latex microspheres labeled SARS-CoV-2 N protein mouse anti human monoclonal antibody 1 and blue latex microspheres labeled chicken IgY fixed on a binding pad, (2) test line (T red) Coated paired SARS-CoV-2 N protein mouse anti human monoclonal antibody 2, quality control line (C blue) coated goat anti chicken IgY antibody fixed on a nitrocellulose membrane. T is fixed with anti-SARS-CoV-2 antibody for detecting the novel coronavirus. The quality control antibody is fixed on the C line. The immune complex will be captured by the anti-SARS-CoV-2 antibody immobilized on the membrane, forming a red T line and indicating a positive result for the novel coronavirus. The higher the N protein content in the sample, the more conjugates will be captured and the darker the color of the test line (T red). Additionally, the test Strip also contains a quality control line (C blue). Regardless of whether there is a virus in the sample, a blue band will appear in the control line (C blue). What appears in the Control Line (C blue) is the standard for judging whether there are enough samples and whether the chromatographic process is normal. If the C line does not appear it indicates that the test result is invalid and the sample is required to retest.LOD2.5µg/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.54%After comparison of clinical test, there were7 false positives for 454 positive samples.False negatives5.45%After comparison of clinical test, there were 6 false negatives for 110 positive samples.PrecisionEvaluatedAccuracy97.7%AntigenReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity94.54%AntigenClinical Specificity98.46%AntigenType of antigenOther1648COVID-19 Antigen Test Kit (Dry Fluorescence Immunoassay)739Lansion Biotechnology Co. Ltd.Chinaen.lansionbio.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabnucleocapsid protein2022-08-24 09:08:01 CET1329Immuno-AntigenYesYesImmunoassayQuantitativeFluorescence15LOD0AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives3%False negatives2%PrecisionEvaluatedAccuracy98%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95%Type of antigennucleoprotein2818COVID-19 Antigen Test Kit (DryColorLatex Immunoassay)739Lansion Biotechnology Co. Ltd.Chinaen.lansionbio.comYesCommercialisedNoNoManualNear POC / POCAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1321B.1.617.2Delta20A.23.1The product is intended for the qualitative detection of nucleocapsid protein antigen from SARS- CoV-2 in direct nasal swabs from individuals suspected of COVID-19 by their healthcare provider within the first seven days of the onset of symptoms.Antigens are generally detectable in nasopharyngeal specimens during the acute phase of infection.COVID-19 is an acute respiratory infectious disease that is highly susceptible to human infection.Currently, the patients infected by the novel coronavirus are the main source of infection,asymptomatic infected people can also bean infectious source.Based on the current epidemiological investigation, the incubation period for COVID-19 ranges from 1 to 14 days,with most cases ranging from 3 to 7days,the main manifestations include fever,fatigue,and dry cough.Nasal congestion,runny nose,sore throat,myalgia, and diarrhea are2022-08-24 09:08:01 CET2523Immuno-AntigenYesNoImmunoassayQuantitativeColorimetry15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1AUFalse negatives2AUPrecisionEvaluatedAccuracy95%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96%Clinical Specificity99.9%Type of antigenSpike protein257Leadgene SARS/SARS-CoV-2 Antigen Rapid Test Kit157Leadgene Biomedical Inc.Taiwan ROCwww.leadgenebio.com/NoIn developmentNoNoNear POC / POCAntigenNasal swab2022-08-24 09:08:01 CET208Immuno-AntigenYesImmunoassayQualitative15258Leadgene SARS/SARS-CoV-2 IgG/IgM Rapid Test Kit157Leadgene Biomedical Inc.Taiwan ROCwww.leadgenebio.com/NoIn developmentNoNoNear POC / POCAntibodyIgGIgMWhole blood2022-08-24 09:08:01 CET214Immuno-AntibodyYesNoImmunoassayQualitative153973SARS-COV-2 Nucleocapsid (N) Antigen Rapid Test Cassette1442LiClear Biotech (Hangzhou) Co., LtdChinawww.accleargenlabs.comYesCommercialisedNoNoManualNear POC / POCAntigenNasal swabSARS-CoV678B.1.1.529Omicron1321B.1.617.2Deltanucleocapsid protein2022-08-24 09:08:01 CET3638Immuno-AntigenYesNoNoImmunoassayQualitativeSandwichColloidal gold15LOD2000TCID50/mlAnalytical Sensitivity90%Analytical Specificity100%False positives0%False negatives10%Accuracy97.32%Clinical Sensitivity90%Clinical Specificity100%3151LEPZI Qualitative COVID-19 Test162Lifeassay Diagnostics Pty Ltd.United Stateslifesadx.com/YesCommercialisedNoNoManualNear POC / POCAntigenAnterior nasal swabNasal swabOropharyngeal swabSARS-CoV1032B.1.351Beta1321B.1.617.2Delta678B.1.1.529Omicronnucleocapsid proteinThe LEPZI™ COVID-19 Antigen Detection Kit (or Test) is a lateral flow immunoassay for qualitative detection of nucleocapsid protein antigens from SARS-CoV-2 in nasal swab and throat swab specimens. This test is intended for individuals who are suspected of COVID-19 infection by their healthcare provider during the first five days from onset of symptoms.2022-08-24 09:08:01 CET2859Immuno-AntigenNoNoImmunochromatographyQualitativeSandwichColloidal gold10antigen_epi In the presence of SARS-CoV-2, nucleocapsid protein antigens from the virus bind to antibodies conjugated to colloidal gold particles. The antigen-conjugate complexes migrate by capillary action along the lateral flow strip inside the test cassette and bind to a capture antibody.LOD250PFU/mLCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives51/20False negatives00/20PrecisionEvaluatedAccuracy95%Higher than 95% - AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90%Higher than 90% - AntigenClinical Specificity100%AntigenType of antigenNucleocapsid protein259Test-it COVID-19 IgM/IgG Lateral Flow Assay162Lifeassay Diagnostics Pty Ltd.United Stateslifesadx.com/NoIn developmentNoNoNear POC / POCAntibody2022-08-24 09:08:01 CET215Immuno-AntibodyYesImmunoassay2866COVID-19 Antigen Test Cassette1273Lifecosm Biotech LimitedChinaLifecosm Biotech Limited, ChinaYesCommercialisedYesYesManualNear POC / POCAntigenNasopharyngeal swabOropharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon678B.1.1.529Omicron1321B.1.617.2Deltanucleocapsid proteinSensitivity, specificity and accuracy are from the newest performance evaluation - including false-positives and false-negatives. German Paul-Ehrlich-Institut (PEI) evaluated this test under the test-id AT 1054/21. Old performance evaluation: Sensitivity 92,20%, specificity 98,10%, accuracy 96,20%.2022-08-24 09:08:01 CET2571Immuno-AntigenYesNoNoImmunochromatographyQualitativeMembrane-based15LOD50pg/ml for recombine COVID-19 proteinLOD50TCID50/mlfor virusCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1%NoneFalse negatives6%NonePrecisionEvaluatedAccuracy98%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96%Clinical Specificity99%Type of antigenNucleocapsid protein1592Antigen Rapid Test Ag SARS-CoV-2703Lifotronic Technology Co. Ltd.Chinaen.lifotronic.com/YesCommercialisedYesYesNear POC / POCAntigen2022-08-24 09:08:01 CET3672Immuno-AntigenYesImmunoassayQualitative10Clinical Sensitivity91%Clinical Specificity98%263COVID-19 Antigen Rapid Test Device160Liming Bio-Products Co. Ltd.Chinawww.limingbio.com/YesCommercialisedNoNoNear POC / POCAntigenNasal swabOropharyngeal swab2022-08-24 09:08:01 CET212Immuno-AntigenYesNoImmunoassayQualitative15LODEvaluatedAnalysis of cross reactivityEvaluatedClinical Sensitivity93.1%Clinical Specificity100%264COVID-19 IgG/IgM Combo Rapid Test Device160Liming Bio-Products Co. Ltd.Chinawww.limingbio.com/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2022-08-24 09:08:01 CET219Immuno-AntibodyYesNoImmunoassayQualitative15Clinical Sensitivity82.2% IgGClinical Sensitivity64.7% IgMClinical Specificity100% IgGClinical Specificity100% IgM1824Rapid Test Antigen SARS- CoV-2160Liming Bio-Products Co. Ltd.Chinawww.limingbio.com/YesCommercialisedNoNoManualAntigenNasopharyngeal swabOropharyngeal swab20 Test per confezione - Due filale di diluizione - 20 tubi di estrazione - 20 confezioni tamponi - 1 postazione lavoro2022-08-24 09:08:01 CET1508Immuno-AntigenImmunoassay1867Cromatest COVID-19 Antigen Cassette857LINEAR CHEMICALS S.L.U.Spainwww.linear.esYesCommercialisedNoNoMicroplateNear POC / POCAntigenNasal swabNasopharyngeal swabN/A2022-08-24 09:08:01 CET1544Immuno-AntigenNoImmunochromatographyQualitativeColorimetry20LOD280AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives7.7%PrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.3%Clinical Specificity100%Type of antigenNucleoprotein1353Covid-19 Antigen Test Kit (Colloidal Gold)1296Linkcare Health Services (Diagnos BT)SpainYesCommercialisedYesYesNear POC / POCAntigenNasal swabNasopharyngeal swabnucleocapsid protein-2022-08-24 09:08:01 CET1127Immuno-AntigenYesNoImmunoassayQualitativeColloidal gold15LOD0.05AUAnalysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracy96%AntigenClinical Sensitivity92.59%AntigenType of antigenNucleocapsid protein1633Diagnostic kit for antibody IgM/IgG of Novel Coronavirus COVID-19729LionrunChinawww.liangrunbio.com/en/Productdetail/76NoCommercialisedNoNoLab-basedAntibody2022-08-24 09:08:01 CET1313Immuno-AntibodyImmunoassayQualitative678COVID-19 Antigen Rapid Test Device; SARS-CoV-2 (N)protein Antigen rapid test (Fluorescence Immunochromatics assay)166LOMINA AGSwitzerlandwww.lomina.ch/YesCommercialisedNoNoNear POC / POCAntigenOropharyngeal swabnucleocapsid protein2022-08-24 09:08:01 CET807Immuno-AntigenYesYesImmunochromatographyQualitativeFluorescence15LOD100ng/mLCalibrationEvaluatedAccuracy96.63%Clinical Sensitivity94.55%Clinical Specificity99.9%Type of antigenSARS-CoV-2 Nucleocapsid Protein Antigen265SARS-CoV-2(COVID19)IgM/IgG Antibody Fast Detection Kit166LOMINA AGSwitzerlandwww.lomina.ch/YesCommercialisedNoNoAutomatedManualAntibodyIgGIgMWhole blood2022-08-24 09:08:01 CET220Immuno-AntibodyNoImmunoassayQualitativeColorimetry53678Lomina SARS-CoV-2 Antigen LTX Selftest1430Lomina Sperbio a.s.Czechialomina.chYesCommercialisedNoNoNear POC / POCAntigenNasal swabSARS-CoV678B.1.1.529Omicron1321B.1.617.2Delta1495P.1Gammanucleocapsid protein2022-08-24 09:08:01 CET3365Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwichOther15False positives0.47%False negatives1.26%4070Lomina SARS-CoV-2 Antigen LTX Selftest1002Lomina Superbio a.s.Czechiawww.lomina.chYesCommercialisedNoNoNear POC / POCAntigenNasal swabSARS-CoV-2678B.1.1.529Omicron1032B.1.351Beta1321B.1.617.2Delta1495P.1GammaORF1a polyprotein2022-09-20 14:42:38 CET3832Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwichImmunofluorescence15LOD300000TCID50/ml3x10^5CalibrationEvaluatedAnalytical Sensitivity100%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives0.47%False negatives1.26%PrecisionEvaluatedAccuracy98.97%RobustnessEvaluatedClinical Sensitivity97.04%Clinical Specificity99.8%2560Lomina SARS-CoV-2 Antigen LTX test1002Lomina Superbio a.s.Czechiawww.lomina.chYesCommercialisedYesYesNear POC / POCAntigenNasal swabSARS-CoV-2678B.1.1.529Omicron689B.1.1.7Alpha1224B.1.526IotaB.1.526.11320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31495P.1Gamma1518P.2Zetanucleocapsid proteinThe kit is used for the qualitative detection of new coronavirus nucleocapsid (N) antigen in human nasal swab samples in vitro. It is used as a supplementary detection indicator for suspected cases of new coronavirus.2022-12-07 08:49:13 CET20272Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwichImmunofluorescence15LOD30000TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives%Of the 320 negativve samples, 0 were false positiveFalse negatives2.3%Of the 130 positive samples, 3 were false negativePrecisionEvaluatedAccuracy99.33%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.7%Clinical Specificity99.9%>99.9%Type of antigenNucleocapsid protein2765Lomina SARS-CoV-2 Antigen LTX test (saliva)1002Lomina Superbio a.s.Czechiawww.lomina.chYesCommercialisedNoNoNear POC / POCAntigenSaliva689B.1.1.7Alpha1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31224B.1.526IotaB.1.526.11518P.2ZetaThe kit is used for the qualitative detection of new coronavirus nucleocapsid (N) antigen in human saliva samples in vitro. It is used as a supplementary detection indicator for suspected cases of new coronavirus. It cannot be used as the only basis for the diagnosis and exclusion of pneumonitis infected by new coronavirus.2022-08-24 09:08:01 CET2470Immuno-AntigenNoImmunochromatographyQualitativeSandwich15LOD230TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%Of the 103 positive samples, 0 were false positiveFalse negatives204%Of the 250 negative samples, 6 were false negativePrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.17%Clinical Specificity100%Type of antigenNucleocapsid protein2158LOMINA SARS-CoV-2 N-Protein Antigen Rapid Test1002Lomina Superbio a.s.Czechiawww.lomina.chYesCommercialisedNoNoNear POC / POCSemi-automatedAntigenOropharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu2041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThe test kit is intended for the qualitative detection of the new Nucleocapsid (N) antigen of the coronavirus SARS-CoV-2 in human oropharyngeal swab samples in vitro. It is used as an additional early detection indicator for suspected cases of nucleic acid detection, or is used in conjunction with the detection of nucleic acid in the diagnosis of suspected cases of COVID19. It cannot be used as a main test to diagnose and rule out pneumonitis caused by a new coronavirus. Limit of detection (LOD): 20 TCID 50ml/(CT>38)2022-08-24 09:08:01 CET1859Immuno-AntigenNoImmunochromatographyQualitativeMembrane-based15LOD20AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2%False negatives2%PrecisionEvaluatedAccuracy95%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90%Clinical Specificity97%Type of antigenNucleoprotein4147Lomina SARS-CoV-2+ Influenza A/B Antigen LTX Test1002Lomina Superbio a.s.Czechiawww.lomina.chYesCommercialisedNoNoNear POC / POCAntigenNasal swabSARS-CoV-2678B.1.1.529Omicron1032B.1.351Beta1321B.1.617.2Delta1495P.1GammaORF1a polyprotein2022-10-12 09:21:18 CET3962Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwichImmunofluorescence15LOD30000TCID50/mlCalibrationEvaluatedAnalytical Sensitivity100%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives0.47%False negatives1.26%PrecisionEvaluatedAccuracy98.97%RobustnessEvaluatedClinical Sensitivity97.04%Clinical Specificity99.8%2094COVID19AgLTFLOW970LT Biotech JSCLithuaniawww.ltbiotech.ltYesCommercialisedNoNoManualAntigenNasopharyngeal swabOropharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1321B.1.617.2Deltanucleocapsid proteinAdditional validation is performed in third party laboratory in 2021-12-032022-08-24 09:08:01 CET1777Immuno-AntigenYesNoImmunochromatographyQualitativeEnzyme-linked15LOD50µgCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2AUFalse negatives20AUPrecisionEvaluatedAccuracy98.12%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.01%Clinical Specificity99.52%Type of antigenNucleocapsid protein2654LUCA NK COVID-19 Ag LLB1214LUCA AICELL Inc.South Koreahttp://lucaaicell.com/YesCommercialisedNoNoNear POC / POCAntigenNasal swabNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Betanucleocapsid proteinRegarding your question on the swabs, there is no distinction between nasal and nasopharyngeal. Our swabs can be used for both nasal and nasopharyngeal. Therefore, we have included only 25 swabs. Does this clarify your question?2022-08-24 09:08:01 CET2359Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich10LOD2ng/mLNucleocapsid protein recombinant antigenCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives3%PrecisionEvaluatedAccuracy98%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity95%AntigenClinical Specificity100%AntigenType of antigenNucleocapsid protein2668LUCA NK COVID-19 Ag Nasal LLB1214LUCA AICELL Inc.South Koreahttp://lucaaicell.com/YesCommercialisedNoNoNear POC / POCAntigenNasal swab689B.1.1.7Alpha1032B.1.351Betanucleocapsid proteinRegistration Number (at the German CA/DIMDI)DE/CA70/40838 : 1663472022-08-24 09:08:01 CET2373Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich10LOD2ng/mL(Nucleocapcid protein recombinant antigenCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives3%PrecisionEvaluatedAccuracy98%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity95%AntigenClinical Specificity100%AntigenType of antigenNucleocapsid protein2670LUCA NK COVID-19 Ag NP LLB1214LUCA AICELL Inc.South Koreahttp://lucaaicell.com/YesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Betanucleocapsid proteinRegistration Number(at the German CA/DIMDI)DE/CA70/40838 : 1663472022-08-24 09:08:01 CET2375Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich10LOD2ng/mLNucleocapcid protein recombinant antigenCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives3%PrecisionEvaluatedAccuracy98%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity95%AntigenClinical Specificity100%AntigenType of antigenNucleocapsid protein2669LUCA NK COVID-19 Ag Saliva LLB1214LUCA AICELL Inc.South Koreahttp://lucaaicell.com/YesCommercialisedNoNoNear POC / POCAntigenSaliva689B.1.1.7Alpha1032B.1.351Betanucleocapsid proteinRegistration Number(at the German CA/DIMDI)DE/CA70/40838 : 1663472022-08-24 09:08:01 CET2374Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich10LOD2ng/mLNucleocapcid protein recombinant antigenCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives3%PrecisionEvaluatedAccuracy98%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity95%AntigenClinical Specificity100%AntigenType of antigenNucleocapsid protein2128PocRoc®SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold)986Lumigenex (Suzhou) Co. Ltd.Chinahttp://www.lumigenex.com/YesCommercialisedYesYesManualNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma3939B.1.61620A.23.12041C.37LambdaThe product PocRoc SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) was registered in Spain on 1st, Nov, 2020. We have sold millions of this product on the German market. Until now, there is no negative feedback from the market. After being listed by BfArM with AT455/20, the PocRoc SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) has positive results by PEI on Mar. 15,2021.2022-08-24 09:08:01 CET1818Immuno-AntigenNoImmunochromatographyQualitativeMembrane-basedColloidal gold20LOD121AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.84%False negatives6.67%PrecisionEvaluatedAccuracy97.38%(Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.33%(Antigen)Clinical Specificity99.16%(Antigen)Type of antigenNucleoprotein267CLIP-COVID19 (smartphone-read out high sensivity antigen detection test)163Luminostics Inc.United Statesluminostics.com/NoIn developmentNoNoNear POC / POCAntigen2022-08-24 09:08:01 CET216Immuno-AntigenYesImmunoassay268QuickProfile 2019-nCoV IgG/IgM Combo Test Card167LumiQuick Diagnostics Inc.United Stateslumiquick.co/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgM2022-08-24 09:08:01 CET223Immuno-AntibodyYesImmunoassayQualitative15Type of antigenSpike and Nucleocapsid1267QuickProfile COVID-19 Antigen Test167LumiQuick Diagnostics Inc.United Stateslumiquick.co/YesCommercialisedYesYesNear POC / POCAntigen2022-08-24 09:08:01 CET1042Immuno-AntigenYesImmunoassayQualitative15LOD380TCID50/ml1268LumiraDx SARS-CoV-2 Ag Test252LumiraDx UK Ltd.United Kingdomwww.lumiradx.comYesCommercialisedYesYesNear POC / POCAntigenNasal swabnucleocapsid proteinReader required updated to yes2022-08-24 09:08:01 CET1043Immuno-AntigenYesYesImmunoassayQualitativeOther12LOD32TCID50/mlClinical Sensitivity97.6%Clinical Specificity96.6%Type of antigennucleocapsid3836LumiraDx SARS-CoV-2 Ag Ultra1087LumiraDx UK Ltd.United Kingdomwww.lumiradx.comYesCommercialisedNoNoNear POC / POCAntigenAnterior nasal swabSARS-CoV678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1321B.1.617.2Delta1323B.1.621Mu2041C.37Lambda1495P.1Gamma1519P.3Thetanucleocapsid protein2022-08-24 09:08:01 CET3513Immuno-AntigenYesNoN.A.ImmunoassayQualitativeFluorescence52342LumiraDx SARS-COV-2 Antigen Pool Test1087LumiraDx UK Ltd.United Kingdomwww.lumiradx.comYesCommercialisedNoNoNear POC / POCOtherAntigenNasal swabNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1137B.1.429Epsilon1132B.1.427Epsilon1321B.1.617.2DeltaAll the entered information is for NP swabs. For nasal swabs we have the following information; PPA 93,8% NPA 98,8%2022-08-24 09:08:01 CET2043Immuno-AntigenYesImmunoassayQualitative12LOD32AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.9%In 100 samples we detected 1,9 false positive. (NPA 98,1%)False negatives7.3%In 100 samples we detected 7,3 false negatives. (PPA 92,7%)PrecisionEvaluatedAccuracy97.2%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.7%Clinical Specificity98.1%Type of antigenNucleoprotein1147SARS-CoV-2 Antibody Test252LumiraDx UK Ltd.United Kingdomwww.lumiradx.comYesCommercialisedNoNoNear POC / POCAntibodyIgAPlasmaSerumWhole blood https://www.lumiradx.com/uk-en/what-we-do/diagnostics/test-technology/antibody-test; https://www.lumiradx.com/assets/pdfs/covid-19-antibody-test/s-com-art-00532_r2_sars_cov-2_ab_test_strip_product_insert_ce.pdf2022-08-24 09:08:01 CET338Immuno-AntibodyYesYesImmunoassayQualitativeImmunofluorescence11Analysis of cross reactivity not cross reactivity with samples positive for antibody to Influenza A, Influenza B, Hepatitis C Virus, Hepatitis B Virus (Genotype D) Hemophilus influenzae, human coronaviruses (HKU1, NL63, OC43 and 229E), Anti-Nuclear Antibody, Respiratory Syncytial VClinical Sensitivity97.2%Clinical Specificity100%1146SARS-CoV-2 Antigen Test252LumiraDx UK Ltd.United Kingdomwww.lumiradx.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabnucleocapsid proteinhttps://www.lumiradx.com/uk-en/what-we-do/diagnostics/test-technology/Antigen-test2022-08-24 09:08:01 CET315Immuno-AntigenYesYesImmunoassayQualitativeImmunofluorescence12LOD32TCID50/mlAnalysis of cross reactivityno crossreactivity with Human coronavirus 229E; Human coronavirus OC43; Human coronavirus NL63; MERS coronavirus; Adenovirus (e.g. C1 Ad. 71); Human Metapneumovirus (hMPV); Parainfluenza virus Type 1; Parainfluenza virus Type 2; Parainfluenza virus Type Accuracy96.9%Clinical Sensitivity97.6%Clinical Specificity96.6Type of antigennucleocapsid protein (N-protein)2928RAPICHECK COVID-19 Ag1290M.I.Tech Co. Ltd.South Koreawww.mitech.co.krYesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swabnucleocapsid proteinExpiration date : 18 months2022-08-24 09:08:01 CET2634Immuno-AntigenNoNoImmunochromatographyQuantitative15LOD15.6PFU/mLCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives4AUFalse negatives1AUPrecisionNot evaluatedAccuracy98%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96%Clinical Specificity99%Type of antigenNucleocapsid protein1034Maccura SARS-CoV-2 IgG168Maccura Biotechnology Co. Ltd.Chinawww.maccura.com/enYesCommercialisedNoNoNear POC / POCAntibodyIgGPlasmaSerum2022-08-24 09:08:01 CET792Immuno-AntibodyYesImmunoassayQualitativeChemiluminescence20Clinical Sensitivity98.13%Clinical Specificity97.15%1033Maccura SARS-CoV-2 IgM168Maccura Biotechnology Co. Ltd.Chinawww.maccura.com/enYesCommercialisedNoNoNear POC / POCAntibodyIgMPlasmaSerum2022-08-24 09:08:01 CET789Immuno-AntibodyYesYesImmunoassayQualitativeChemiluminescence20Clinical Sensitivity86.99%Clinical Specificity100%989SARS-CoV-2 IgG (CLIA)168Maccura Biotechnology Co. Ltd.Chinawww.maccura.com/enYesCommercialisedNoNoNear POC / POCAntibodyIgGPlasmaSerum2022-08-24 09:08:01 CET888Immuno-AntibodyYesYesImmunoassayQualitativeChemiluminescence20Clinical Sensitivity96.24%Clinical Specificity98.13%988SARS-CoV-2 IgM (CLIA)168Maccura Biotechnology Co. Ltd.Chinawww.maccura.com/enYesCommercialisedNoNoNear POC / POCAntibodyIgMPlasmaSerum2022-08-24 09:08:01 CET876Immuno-AntibodyYesYesImmunoassayQualitativeChemiluminescence20Clinical Sensitivity86.99%Clinical Specificity100%1953SARS-CoV-2 Neutralizing Antibody Kit (CLIA)168Maccura Biotechnology Co. Ltd.Chinawww.maccura.com/enYesCommercialisedNoNoAutomatedAntibodyPlasmaSerummembrane proteinFor in vitro detection of neutralizing antibodies against SARS-CoV-2 in human serum or plasma.2022-08-24 09:08:01 CET1629Immuno-AntibodyImmunoassayNeutralization Antibody (NAb)20LOD2AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2.7AUFalse negatives2.2AUPrecisionEvaluatedAccuracy97.8%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.3%Clinical Specificity98.2%Type of antigenOther1917Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV-2) Antigen Assay Kit by Colloidal Gold Method168Maccura Biotechnology Co. Ltd.Chinawww.maccura.com/enYesCommercialisedNoNoNear POC / POCAntigenNasal swabnucleocapsid protein2022-08-24 09:08:01 CET1793Immuno-AntigenYesImmunoassayColloidal goldType of antigenNucleocapsid protein1918Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV-2) IgM/IgG Antibody Assay Kit by Colloidal Gold Method168Maccura Biotechnology Co. Ltd.Chinawww.maccura.com/enYesCommercialisedNoNoManualNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood/2022-08-24 09:08:01 CET1594Immuno-AntibodyNoImmunochromatographyQualitativeColorimetry10LOD0AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positivesNoneFalse negativesNonePrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.39%Clinical Specificity97.01%Type of antigenOther2125AxenTM COVID-19 Ag RAPID985MacrogenSouth Koreawww.macrogen.comYesCommercialisedNoNoNear POC / POCAntigenAnterior nasal swabNasopharyngeal swabAR Qarad BV Pas 257 2440 Geel, Belgium Tel: + 32 14 49 04 222022-08-24 09:08:01 CET1815Immuno-AntigenYesNoImmunoassayQualitative15Analysis of cross reactivityEvaluatedPrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.9%Clinical Specificity97.3%Type of antigenNucleoprotein2126AxenTM COVID-19 IgM/IgG RAPID985MacrogenSouth Koreawww.macrogen.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumAR Qarad BV Pas 257 2440 Geel, Belgium Tel: + 32 14 49 04 222022-08-24 09:08:01 CET1816Immuno-AntibodyNoImmunoassayQualitative15ReproducibilityEvaluatedClinical Sensitivity97.7%Clinical Specificity97.3%2161EONBT COVID-19 ANTIGEN-SALIVA1004Manufactured by Eon Biotechnology LimitedUnited Kingdomwww.eonbt.comYesCommercialisedNoNoManualNear POC / POCAntigenSaliva689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2Zetanucleocapsid proteinHOW ARE EON BIOTECHNOLOGY’S PRODUCTS BETTER? Eon Biotechnology controls biotechnology assets which include clones for SARS-CoV2 antigens & antibodies, vaccine platforms, ScFv libraries for SARS-CoV-2 antibodies and the derived immunodiagnostic & therapeutic products with a specific purpose of translation & commercialization across the world. This platform technology is leveraged for COVID-19 currently and eventually to other emerging infectious diseases and lifestyle disease conditions. Eon operates a compliant biotherapeutic infrastructure with governing structure for ‘Genetic Engineering Approval Committee’, Animal Ethics Committee, and Institutional Ethics committee and product approvals from an R&D perspective. CE certificate in Europe, EN ISO 13485, ISO 9001, WHO – GMP and other requisite infrastructure compliances form the quality support system behind products of Eon Biotechnology. Eon Biotechnology’s offerings are backed by: 1. Technology refined by experience in deep research. 2. Physical infrastructure - associated hospitals that attend to COVID-19 positive subjects every day & therefore a constant real time opportunity to monitor & test improved versions of the test. 3. Physical manufacturing infrastructure capable of producing large volumes of tests. 4. EONbtTM COVID-19 Rapid Antigen test is a quality driven product backed by comprehensive real time know-how and infrastructure. Background of SARS-COV-2: SARS-CoV-2 is a novel, zoonotic coronavirus that emerged in late 2019 in patients with pneumonia of unknown cause. The virus was named SARS-CoV-2 because of its similarity to the coronavirus responsible for severe acute respiratory syndrome (SARS-CoV, a lineage B betacoronavirus). SARS-CoV-2 is an enveloped, positive sense, single stranded RNA virus sharing more than 70% of its sequence with SARS-CoV, and ~50% with the coronavirus responsible for Middle Eastern respiratory syndrome (MERS-CoV).The SARS-CoV-2 spike glycoprotein (S), which is a main target for neutralizing antibody, binds to its receptor human angiotensin converting enzyme 2 (hACE2) to initiate infection.SARS-CoV-2 is the cause of COVID-19, an infectious disease with respiratory and systemic manifestations. Disease symptoms vary, with many persons presenting with asymptomatic or mild disease and some progressing to severe respiratory tract disease including pneumonia and acute respiratory distress syndrome (ARDS), leading to multi organ failure and death. Corona virus can be extracted through respiratory secretions or transmitted through oral fluid, sneezing, physical contact, and other air droplets. There are 2 main proteins involved and necessary for the infection of humans by coronavirus. These are: 1. Spike protein (which is a trimeric protein containing 3 different sub-units, among three subunits subunit S2 is highly conserved and subunit S1 is essential to make an entry into the host cell). 2. Nucleocapsid protein which is essential for viral assembly. 3. These 2 proteins play an important role in the infection and viral life cycle in human beings. They are the potential target molecules in the development of rapid tests for detection of coronavirus infection in humans. EXECUTIVE SUMMARY: EONbtTM COVID-19 ANTIGEN-SALIVA is marketed by EON BIOTECHNOLOGY LTD., U.K and manufactured by Angstrom Biotech Private Limited is intended for Point of Care (POC) diagnosis of coronavirus infection. The product is CE approved in Europe. COVID-19 ANTIGEN-SALIVA is a lateral flow immunoassay intended for in vitro qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in saliva specimens from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of symptom onset. This test is designed for Point of Care use, as an aid to early diagnosis of SARS-CoV-2 infection in patients with clinical symptoms with SARS-CoV-2 infection. It provides only an initial screening test result. The administration of the test and the interpretation of the results should be done by a trained health professional. The result of this test should not be the sole basis for the diagnosis; confirmatory testing is required. EONbtTM COVID-19 ANTIGEN-SALIVA is an antigen-capture immunochromatographic assay, detecting presence of COVID-19 viral nucleoprotein antigen in saliva samples. The detection kit uses the principle of immunochromatography: separation of components in a mixture through a medium using capillary force and the specific and rapid binding of an antibody to its antigen. Why Saliva? Infrastructure Benefits: Nasopharyngeal and oropharyngeal swabs are inconvenient to collect and pose a transmission risk to healthcare workers due to coughing induced during the collection process. The Saliva sampling method will allow for broader population screening than the current method of nose and throat swabs. It allows people of any ability to be tested for SARS-COV-2. The impact of using Saliva samples is significant. It means health care professionals are not at risk of contracting the COVID-19 infection by administering Saliva tests when compared with performing nasopharyngeal or oropharyngeal collections. The saliva sample method preserves precious personal protective equipment (PPE) for use in vital patient care in hospitals instead of testing. The number of people tested every day can be significantly increased as sampling of saliva is quicker and more scalable than swab collections. All of this combined will have an immediate impact on testing capability across the United States.2022-08-24 09:08:01 CET1862Immuno-AntigenYesNoImmunochromatographyQualitativeMembrane-based20LOD4AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.7% (In trial of 428 negative samples compared with RTqPCR test ,3 False Positives were detected)False negatives8.05% (In trial of 149 positive samples compared with RTqPCR test, 12 False negatives were detected)PrecisionEvaluatedAccuracy99.04%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity91.95%Clinical Specificity99.27%Type of antigenNucleoprotein997mö-screen 2019-NCOV Corona Virus Test532möLabGermanywww.moelab.de/startseite.htmlYesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET774Immuno-AntibodyYesNoImmunoassayQualitative10Analysis of cross reactivityEvaluatedAccuracy99.4% IgGAccuracy97.6% IgMClinical Sensitivity99.9% IgGClinical Sensitivity91.8% IgMClinical Specificity99.5% IgGClinical Specificity99.2% IgM1190mö-screen Corona Antigen Test532möLabGermanywww.moelab.de/startseite.htmlYesCommercialisedYesYesManualNear POC / POCAntigenNasal swabNasopharyngeal swabThroat swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1320B.1.617.1Kappa1321B.1.617.2Delta1323B.1.621Mu2041C.37Lambda678B.1.1.529Omicronnucleocapsid proteinOmicron will be detected2022-08-24 09:08:01 CET974Immuno-AntigenYesNoNoImmunochromatographyQualitative15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%PrecisionEvaluatedAccuracy99.42%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.32%Clinical Specificity99.99%Type of antigenNucleocapsid protein2162Wellion SARS-CoV-2 PLUS ANTIGEN Rapid Test1005MED TRUST Handelsges.m.b.H.Austriawww.wellion.atYesCommercialisedNoNoNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.3nucleocapsid proteinClinical evaluation study from Germany is available and uploaded to the database.2022-08-24 09:08:01 CET1863Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich15LOD75.5AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%(431 negative samples were tested and 0 of them were false positive)False negatives3%(135 positive samples were tested and 5 of them were false negative)PrecisionEvaluatedAccuracy99% (Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.3% (Antigen)Clinical Specificity99.9% (Antigen)Type of antigenNucleoprotein1785Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold)801Medakit Ltd.Hong Kong S.A.Rwww.medakit.comYesCommercialisedNoNoNear POC / POCIgGIgMPlasmaSerumWhole bloodEvaluated by Institut Pasteur in France, the Medakit antibody tests is regulated by the ANSM . Medakit tests are published on the official website of the French Ministry of Health, on their approved covid test list2022-08-24 09:08:01 CET1464Immuno-AntibodyNoImmunoassayQualitativeColorimetry10LOD0.5AUFalse positives3AUFalse negatives10AUAccuracy98.12%Clinical Sensitivity96.98%1784Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold)801Medakit Ltd.Hong Kong S.A.Rwww.medakit.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabhttps://www.aphp.fr/contenu/evaluation-de-la-performance-diagnostique-de-neuf-tests-rapides-antigeniques-covid-192022-08-24 09:08:01 CET1463Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD0.5AUFalse positives0AUFalse negatives1AUAccuracy98.12%Clinical Sensitivity95.07%1713Flu A/Flu B/SARS-CoV-2 Antigen (GICA)761MEDCAPTAIN MEDICAL TECHNOLOGY Co. Ltd.Chinawww.medcaptain.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabnucleocapsid protein2022-08-24 09:08:01 CET1393Immuno-AntigenYesNoImmunoassayQualitativeColloidal gold15LOD1250AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives1.9%False negatives2.8%PrecisionEvaluatedAccuracy98%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.2%(Antigen)Type of antigennucleoprotein1711SARS-CoV-2 Antigen (GICA)761MEDCAPTAIN MEDICAL TECHNOLOGY Co. Ltd.Chinawww.medcaptain.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabNasopharyngeal swabnucleocapsid proteinN/A2022-08-24 09:08:01 CET1391Immuno-AntigenYesNoImmunochromatographyQualitativeColorimetry15LOD100TCID50/mlAnalysis of cross reactivityEvaluatedFalse positives1%False negatives1.35%PrecisionEvaluatedAccuracy94.7%AntigenAccuracy98.87%Accuracy98.85%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.65%AntigenClinical Specificity99%Type of antigenNucleocapsid protein1709SARS-CoV-2 IgG (CLIA)761MEDCAPTAIN MEDICAL TECHNOLOGY Co. Ltd.Chinawww.medcaptain.comYesCommercialisedNoNoAutomatedManualAntibodyIgGPlasmaSerum2022-08-24 09:08:01 CET1389Immuno-AntibodyYesCLIAQualitativeChemiluminescence25Manual or automated cassette chemiluminiscence LOD2AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives3.7% IgGFalse negatives3.1% IgGPrecisionEvaluatedAccuracy96.5% IgGReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.9% IgG1712SARS-CoV-2 IgG/IgM (GICA)761MEDCAPTAIN MEDICAL TECHNOLOGY Co. Ltd.Chinawww.medcaptain.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaWhole blood2022-08-24 09:08:01 CET1392Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15LOD0AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives3.7%False negatives0%PrecisionEvaluatedAccuracy96.3%(IgG, IgM)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%(IgG, IgM)1710SARS-CoV-2 IgM (CLIA)761MEDCAPTAIN MEDICAL TECHNOLOGY Co. Ltd.Chinawww.medcaptain.comYesCommercialisedNoNoAutomatedManualAntibodyIgMPlasmaSerum2022-08-24 09:08:01 CET1390Immuno-AntibodyYesCLIAQualitativeChemiluminescence25LOD0AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.2% IgMFalse negatives6.2% IgMPrecisionEvaluatedAccuracy97.4% IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.8% IgM1708SARS-CoV-2 NAbs (CLIA)761MEDCAPTAIN MEDICAL TECHNOLOGY Co. Ltd.Chinawww.medcaptain.comYesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET1388Immuno-AntibodyYesCLIAQuantitativeChemiluminescence25LOD3AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2.9%False negatives0%PrecisionEvaluatedAccuracy97.9%(Neutralizing Antibodies)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%(Neutralizing Antibodies)1626Anti-SARS-CoV-2 IgA ELISA723MediagnostGermanymediagnost.deNoCommercialisedNoNoManualAntibodyIgAPlasmaSerum2022-08-24 09:08:01 CET1306Immuno-AntibodyELISAAccuracy95%Clinical Sensitivity77.8%CI range 77.8-100%Clinical Specificity98%Type of antigenRBD1625Anti-SARS-CoV-2 IgG ELISA723MediagnostGermanymediagnost.deYesCommercialisedNoNoLab-basedAntibodyIgGPlasmaSerum2022-08-24 09:08:01 CET1552Immuno-AntibodyELISAAnalytical Specificity98.6Analysis of cross reactivityBeta Corona HKU1, SARS-CoV, VZV, HCV, HAV, HBV, EBV, CMV, HSVAccuracy96.99Clinical Sensitivity95.3(69.4-95.3)%1627Anti-SARS-CoV-2 IgM ELISA723MediagnostGermanymediagnost.deNoCommercialisedNoNoLab-basedAntibodyIgMPlasmaSerum2022-08-24 09:08:01 CET1307Immuno-AntibodyELISAAccuracy85%Clinical Sensitivity66.7%CI range: 66.7-75%Clinical Specificity98%Type of antigenRBD2050Coronavirus Disease 2019 Antibody (IgM/IgG) Combined Test Kit944MedicalSystem Biotechnology Co. Ltd.Chinahttps://en.nbmedicalsystem.com/en/YesCommercialisedNoNoLab-basedAntibodyIgGIgMOther biological fluidsPeripheral bloodPlasmaSalivaSerumSputumStoolThroat secretionThroat swabTissue homogenatesWhole bloodWhole blood with anti-coagulants689B.1.1.7Alpha20A.23.1N.A.2022-08-24 09:08:01 CET1728Immuno-AntibodyNoImmunochromatographyQualitativeOther10LOD180AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives8.23%False negatives2.1%PrecisionEvaluatedAccuracy90% IgGAccuracy90% IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.9% IgGClinical Sensitivity97.9% IgMClinical Specificity91.77% IgGClinical Specificity91.77% IgMType of antigenNucleoprotein735Coronavirus Disease 2019 Antibody (IgM/IgG) Combined Test Kit449MedicalSystem Biotechnology Co. Ltd.Chinaen.nbmedicalsystem.com/en/NoCommercialisedNoNoLab-basedAntibody2022-08-24 09:08:01 CET611Immuno-AntibodyImmunoassay2049COVID-19 Ag Rapid Test Cassette944MedicalSystem Biotechnology Co. Ltd.Chinahttps://en.nbmedicalsystem.com/en/NoCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swabOropharyngeal swabSalivaThroat swab20A.23.1N.A.2022-08-24 09:08:01 CET1727Immuno-AntigenNoImmunochromatographyQualitativeOther15LOD150AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.33%False negatives7.33%PrecisionEvaluatedAccuracy90%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.67%Clinical Specificity98.67%Type of antigenNucleoprotein276COVID-19 IgM/IgG Rapid Test Cassette449MedicalSystem Biotechnology Co. Ltd.Chinaen.nbmedicalsystem.com/en/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2022-08-24 09:08:01 CET647Immuno-AntibodyYesNoImmunoassayQualitative102526Medicovid-AG SARS-CoV-2 Antigen Schnelltest-Nase1080MEDICE Arzneimittel Pütter GmbH & Co. KGGermanywww.medice.deYesCommercialisedNoNoNear POC / POCAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1519P.3Theta1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.32041C.37Lambda1224B.1.526Iota1518P.2ZetaThe test is an immunochromatography based one step in vitro test. It is designed for the rapid qualitative determination of SARS-CoV-2 virus antigen in anterior nasal swabs from individuals suspected of COVID-19 within the first seven days of symptom onset.2022-08-24 09:08:01 CET2230Immuno-AntigenNoImmunochromatographyQualitativeSandwich, Double15LOD130AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1%False negatives4%PrecisionEvaluatedAccuracy98.73%ReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity96.19%Clinical Specificity99.2%Type of antigenNucleocapsid protein2318Medicovid-AG SARS-CoV-2 Antigen Selbsttest-Nase1080MEDICE Arzneimittel Pütter GmbH & Co. KGGermanywww.medice.deYesCommercialisedNoNoNear POC / POCAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1519P.3Theta1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.32041C.37Lambda1224B.1.526Iota1518P.2ZetaIf you need any further information, please do not hesitate to contact me.2022-08-24 09:08:01 CET2019Immuno-AntigenNoQualitativeSandwich, Double15LODAU130CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1AUFalse negatives4AUPrecisionEvaluatedAccuracy98.73%ReproducibilityNot evaluatedRobustnessNot evaluatedClinical Sensitivity96.19%Clinical Specificity99.2%277@sight COVID-19 IgG/IgM Rapid Test Kit172Mediclone Biotech Pvt Ltd.Indiamediclonebiotech.com/NoUnknownNoNoNear POC / POCAntibody2022-08-24 09:08:01 CET228Immuno-AntibodyYesImmunoassay2973MediDia COVID-19 Ag1312Medifood Hungary Innovation Kft.Hungarymedidia.huYesCommercialisedYesYesNear POC / POCAntigenNasopharyngeal swabSARS-CoVSARS-CoV-2678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1321B.1.617.2Delta2041C.37Lambda1495P.1Gammanucleocapsid proteinMediDia COVID-19 Ag is a rapid antigen test based on the license of the P4DETECT COVID-19 Ag rapid antigen test, manufactured by PRIME4DIA Co., Ltd. (South Korea). MediDia COVID-19 Ag is manufactured according to the same quality standards, using the same raw materials and production technology as those used in the production of P4DETECT COVID-19 Ag. MediDia COVID-19 Ag is identical to P4DETECT COVID-19 Ag. There have been successful clinical studies carried out in multiple countries using P4DETECT COVID-19 Ag or STANDARD Q COVID-19 Ag, another rapid antigen test identical to P4DETECT COVID-19 Ag.2022-09-20 10:58:53 CET5306Immuno-AntigenYesNoNoImmunochromatographyQuantitativeMembrane-basedColloidal gold20LOD800TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives%0 out of 334False negatives2.63%3 out of 114PrecisionEvaluatedAccuracy99.33%ReproducibilityEvaluatedClinical Sensitivity97.37%AntigenClinical Specificity100%Type of antigenNucleocapsid protein796MediKit Covid-19 Antibody Test (IgM/IgG Lateral flow Immunoassay)463MedikitIndiawww.medikitglobal.com/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood the kit's name is slighlty different 2022-08-24 09:08:01 CET640Immuno-AntibodyYesNoImmunoassayQualitative15Clinical Sensitivity88.66%Clinical Specificity90.63%2383REVEALCOVID-19(TM) Total Antibody Test1103MedMira Laboratories Inc.Canadawww.medmira.comYesCommercialisedNoNoManualNear POC / POCAntibodyIgGIgMIgAOtherPlasmaSerumWhole bloodINTENDED USE: REVEALCOVID-19TM Total Antibody Test is an in vitro diagnostic test for the qualitative detection of total antibodies to the specific SARS-CoV-2 antigens in human serum, plasma and whole blood samples collected in certified laboratories and/or by the healthcare workers at the point-of-care. DEVICE DESCRIPTION: REVEALCOVID-19TM Total Antibody Test is a manually performed, visually interpreted Rapid Vertical Flow® (RVF) immunoassay that detects total antibodies to SARS-CoV-2, the causative agent of COVID-19 disease, in human serum, plasma and venipuncture whole blood. REVEALCOVID-19TM Total Antibody Test consists of a Test Cartridge, an InstantGold Cap, and two (2) vials of pre-aliquoted universal buffer solutions. Test Cartridge consists of two plastic casings (top and bottom) that snap together to securely hold the reactive nitrocellulose membrane overlaid on top of the absorbent pad. The Test Zone of the membrane is coated with a combination of synthetic proteins that correspond to the conserved regions of the SARS-CoV-2 nucleocapsid protein (N), thus, allowing the capture of SARS-CoV-2 antibodies. As a procedural/reagent control, Protein A is immobilized in a designated area (Control Zone) on the nitrocellulose membrane to allow a non-specific capture of Ig antibodies. InstantGold cap, which contains proprietary Protein A/L colloidal gold conjugates, enables the visualization of the aforementioned antigen – antibody immunocomplexes formed on the reactive membrane. Universal buffer solutions are proprietary formulations of ionic and non-ionic detergents in Tris-buffered saline that serve four main functions: a) lysis of blood cells in whole blood specimens; b) optimization of the interactions between capture antigens on the test membrane and antibodies present in the specimen; c) reduction of non-specific binding to the membrane; d) reconstitution of the colorimetric detection agent in the InstantGold Cap.2022-08-24 09:08:01 CET2085Immuno-AntibodyNoImmunoassayQualitativeCapture3LOD20AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives3.22%Plasma: 1/37 (PPA = 97.1%)False positives0%Serum: 0/31 (PPA = 100%)False positives3.22%Whole Blood: 1/37 (PPA = 97.1%)False negatives1.61%Plasma: 2/124 (NPA = 98.1)False negatives0.91%Serum: 1/110 (NPA = 99.0%), False negatives0%Whole Blood: 0/37 (NPA = 100%)PrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.5%Clinical Specificity98.7%Type of antigenOther1068MEDsan COVID-19 IgM/IgG Rapid Test Hybrid617MEDsan GmbHhttps://www.medsan.eu/en/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood https://www.medsan.eu/en/detection/2022-08-24 09:08:01 CET995Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry101180MEDsan SARS-CoV-2 Antigen Rapid Test617MEDsan GmbHhttps://www.medsan.eu/en/YesCommercialisedYesYesNear POC / POCAntigenNasopharyngeal swabOropharyngeal swab2022-08-24 09:08:01 CET961Immuno-AntigenYesNoImmunoassayQualitative15LOD14.4TCID50/mlAccuracy98.4%Clinical Sensitivity92.5%Clinical Specificity99.8%3111MEDsan® SARS-CoV-2 Ag Duo617MEDsan GmbHhttps://www.medsan.eu/en/YesCommercialisedNoNoNear POC / POCAntigenNasal swabSalivaSARS-CoV689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1321B.1.617.2Delta678B.1.1.529Omicronnucleocapsid proteinhttps://www.medsan.eu/en/medsan-sars-cov-2-ag-duo/2022-08-24 09:08:01 CET2818Immuno-AntigenNoNoImmunoassayQualitative15LOD14.4TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0AUFalse negatives4AUPrecisionEvaluatedAccuracy99.4%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.7%AntigenClinical Specificity100%AntigenType of antigenNucleocapsid protein3954MEDsan® SARS-CoV-2 Ag Duo1434MEDsan® GmbHGermanyhttps://www.medsan.eu/en/medsan-sars-cov-2-ag-duo/YesCommercialisedNoNoManualAntigenAnterior nasal swabMid-turbinates swabNasal swabOropharyngeal swabSalivaThroat swabSARS-CoV678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1320B.1.617.1Kappa1321B.1.617.2Delta1495P.1Gammanucleocapsid protein2022-08-24 09:08:01 CET3620Immuno-AntigenYesNoN.A.ImmunochromatographyQualitativeMembrane-basedColloidal gold15LOD14.4TCID50/mlAnalytical Sensitivity98.4%Analytical Specificity100%False positives0%False negatives3.3%Accuracy98.4%Clinical Sensitivity96.7%Clinical Specificity100%583COVID 19 IgG IgM Rapid Test366Medsource Ozone BiomedicalsIndiawww.ozonebio.com/NoCommercialisedNoNoNear POC / POCAntibody2022-08-24 09:08:01 CET493Immuno-AntibodyYesImmunoassay2905MeduFlow1284Medusa19 Life SciencesUnited KingdomYesCommercialisedNoNoAntigenAnterior nasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1321B.1.617.2Delta678B.1.1.529Omicronspike proteinThe product is the first uk test to achieve home use approval.2022-08-24 09:08:01 CET2610Immuno-AntigenYesNoImmunoassayQualitative20CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1AUFalse negatives4AUPrecisionEvaluatedAccuracy98.6%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.9%Clinical Specificity99.5%Type of antigenSpike protein1182Rapid COVID-19 Antigen Qualitative Test Kit77Megna Health Inc.United Stateswww.megnahealth.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabOtherSalivaMegna Health requests the addition of this IVD Test Kit to the CE approved listing. The device is manufactured by Megna Health - and the EU Authorized Representative is MDSS (Germany). Notification of this COVID IVD has been made to the Competent Authority in Germany2022-08-24 09:08:01 CET964Immuno-AntigenYesNoImmunoassayQualitative201063Rapid COVID-19 IgM/IgG Combo Test Kit (Antibody)77Megna Health Inc.United Stateswww.megnahealth.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMACD plasmaSerumThe Megna Rapid COVID-19 IgM/IgG Combo Test Kit has been exhaustively tested - by Megna Health and by independent testing conducted by National Institute of Health and National Cancer Society - as required by FDA prior to issuing an Emergency Use Authorization letter on July 17, 2020.; https://www.megnahealth.com/wp-content/uploads/2020/07/MegnaHealth-Test-Kit_-IFU.pdf2022-08-24 09:08:01 CET97Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedRobustnessEvaluatedClinical Sensitivity100%Clinical Sensitivity83.3% IgMClinical Sensitivity100% IgGClinical Specificity95%Clinical Specificity97.5% IgMClinical Specificity97.5% IgM1894COVID-19 Antigen Detection Test461Meril Diagnostics Pvt Ltd.Indiawww.merillife.comYesCommercialisedNoNoAutomatedManualAntigenNasopharyngeal swabCOVID-19 Antigen Detection Test is a rapid immunochromatographic assay kit for the qualitative detection of SARS-CoV-2 antigen in nasopharyngeal swab from human. For professional use.2022-08-24 09:08:01 CET1571Immuno-AntigenNoImmunochromatographyQualitative20LOD250AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.6%Clinical Specificity100%Type of antigenOther2923COVIFIND COVID-19 Antigen Self Test461Meril Diagnostics Pvt Ltd.Indiawww.merillife.comYesCommercialisedNoNoManualAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.32041C.37Lambda1224B.1.526Iota678B.1.1.529Omicron1518P.2Zetanucleocapsid proteinProduct is CE certified by the notifying body PCBC 14342022-08-24 09:08:01 CET2628Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich15LODLOD of COVIFIND Covid-19 antigen Self Test is ≥ 933 TCID50/ml.CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%The product is having zero False positive, specificity is 100%False negatives1.75%The product is having sensitivity of 98.25%, Gives 1.75% false negative resultsPrecisionEvaluatedAccuracy98.25%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.25%Clinical Specificity100%Type of antigenNucleocapsid protein2924COVIFIND COVID-19 Antigen Test461Meril Diagnostics Pvt Ltd.Indiawww.merillife.comYesCommercialisedNoNoNear POC / POCAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.32041C.37Lambda1224B.1.526Iota678B.1.1.529Omicron1518P.2Zetanucleocapsid proteinProduct is Self CE certified, notified with Obelis, the EU Rep2022-08-24 09:08:01 CET2629Immuno-AntigenNoNoImmunochromatographyQualitativeSandwich15LODLOD of COVIFIND Covid-19 antigen Self Test is ≥ 933 TCID50/ml.CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%The product is having zero False positive, specificity is 100%False negatives1.75%The product is having sensitivity of 98.25%, Gives 1.75% false negative resultsPrecisionEvaluatedAccuracy98.25%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.25%Clinical Specificity100%Type of antigenNucleocapsid protein2582MERISCREEN COVID-19 Antigen Detection Test461Meril Diagnostics Pvt Ltd.Indiawww.merillife.comYesCommercialisedNoNoLab-basedNear POC / POCAntigenNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.32041C.37Lambda1224B.1.526Iota1518P.2ZetaThe product is clinically tested, validated and approved by Indian council of medical research (ICMR). Notified with European Union with the EU Representative Obelis SA from Belgium having EAR certificate.2022-08-24 09:08:01 CET2287Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich20LODMERISCREEN COVID-19 Antigen Detection Test is ≥ 933 TCID50/ml.CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%The product is having zero False positive, specificity is 100%False negatives2.88%The product is having sensitivity of 97.12%, Gives 2.88% false negative resultsPrecisionEvaluatedAccuracy97.12%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.12%Clinical Specificity100%Type of antigenNucleocapsid protein2029SARS-CoV-2 Antigen Rapid Test Cassette933Merlin Biomedical (Xiamen) Co. Ltd.Chinahttp://www.merlinbio.com.cn/en/YesCommercialisedYesYesNear POC / POCAntigenNasal swabNasopharyngeal swabnucleocapsid proteinBfArM Vorgangsnummer: AT214/20 Certificate TÜV Süd No. Q5 106286 0001 Rev. 00 CE number: BE-CA01/1-16963-00006-IVD2022-08-24 09:08:01 CET1707Immuno-AntigenYesNoImmunochromatographyQualitative15LOD160AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives5AUFalse negatives1AUPrecisionEvaluatedAccuracy97%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.05%Clinical Specificity98.99%Type of antigenNucleoprotein2596SARS-CoV-2 Antigen Rapid Test Cassette1182Merlin Biomedical (Xiamen) Co. Ltd.Chinahttp://www.merlinbio.com.cn/en/YesCommercialisedNoNoManualAntibodySaliva689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2Zetanucleocapsid proteinThis cassette belongs to in vitro diagnostic reagents, and is suitable for the qualitative cietection cf SARS-CoV-2's Nucleocapsid protein in human saliva specimen. It cannot be served as the basis of the confirmation or exclusion for coronavirus pneumonia. This product is used only far medicai institutions. The positive test result requires further confirmation. A negative test cannot rule out the possibility of infection. The test results of this cassette are only for clinica! reference. It is recommended to conduct a comprehensive analysis of the patient's condition in combination with clinical manifestations and other laboratory tests. A total of 443 clinical samples were tested in this clinical study. The clear diagnosis and exclusion criteria of the "SARS-CoV-2 diagnosis and treatment protocol" were taken as a reference. Clinical trials were conducted at Fujian's Fuzhou Lung Hospital and Zhangzliou Hospital. The positive coincidence rate of the SARS-CoV-2 Antigen Rapid Test Cassette, developed by Merlin was 95.5% and the negative coincidence rate of the cassette was 99.7%, the total coincidence rate of the cassette was 98 , 4% compared to the reference method (RT-PCR) which indicates a high consistency.2022-08-24 09:08:01 CET2301Immuno-AntigenYesImmunochromatography15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives4.5%Positive coincidence rate = 127/ (127+6) x100%=95.5%, (95% Cl: 90.5%-98.0%)False negatives0.3%Negative coincidence rate = 299/ (299+1) x100%=99.7%, (95% Cl: 98.1%-99.9%);PrecisionEvaluatedAccuracy98% (Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95% (Antigen)Clinical Specificity99% (Antigen)Type of antigenNucleocapsid protein2030SARS-CoV-2 Antigen Rapid Test Cassette (saliva)933Merlin Biomedical (Xiamen) Co. Ltd.Chinahttp://www.merlinbio.com.cn/en/YesCommercialisedNoNoNear POC / POCAntigenSalivaBfArM-Vorgangsnummer: AT790/21 ISO 13485:2016 Certificate TÜV Süd No. Q5 106286 0001 Rev. 00 CE number: BE-CA01/1-16963-00006-IVD2022-08-24 09:08:01 CET1708Immuno-AntigenNoImmunochromatographyQualitative15LOD320AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives6AUFalse negatives1AUPrecisionEvaluatedAccuracy98.4%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.5%Clinical Specificity99.7%Type of antigenNucleoprotein1928ImmTek COVID-19 Antigen Rapid Test882Metas Biomedical Inc.Taiwan ROCwww.metasbiomedical.comYesCommercialisedNoNoNear POC / POCAntigenAnterior nasal swabNasal swabNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1132B.1.427Epsilon1224B.1.526Iota1321B.1.617.2Delta2041C.37Lambda678B.1.1.529Omicronnucleocapsid proteinPrefilled buffer can inactivate coronavirus to avoid cross contamination.2022-08-24 09:08:01 CET1604Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich10LOD313TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.46AUFalse negatives4.72AUPrecisionEvaluatedAccuracy98.14%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.28%Clinical Specificity99.54%Type of antigenNucleocapsid protein1775MEXACARE COVID-19 Antigen Rapid Test794MEXACARE GmbHGermanywww.mexacare.comYesCommercialisedYesYesNear POC / POCAntigenNasal swabnucleocapsid protein2022-08-24 09:08:01 CET1454Immuno-AntigenYesNoChromatographyQualitative20LOD130TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives4.35%5 of 115False negatives0.62%2 of 321PrecisionEvaluatedAccuracy98.39%ReproducibilityEvaluatedRobustnessEvaluatedClinical SensitivityEvaluatedClinical Sensitivity96.17%Type of antigenNucleoprotein4148Vibamat3225Michael Bubolz GmbHGermanywww.vibamat.deYesCommercialisedNoNoSemi-automatedAntigenOtherSARS-CoV-220A.23.170AT.1678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526IotaB.1.526.1B.1.526.23939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu1439C.362041C.37Lambda1495P.1Gamma1518P.2Zeta1519P.3Thetaspike proteinMany thanks for the implementation of the indicated changes! 2022-12-07 08:48:05 CET5363Immuno-AntibodyYesNoYesImmunoassayQuantitativeNeutralization Antibody (NAb)Immunofluorescence1LOD100%CalibrationEvaluatedAnalytical Sensitivity99%Analytical Specificity99%Analysis of cross reactivityEvaluatedFalse positives1% IgGFalse negatives1% IgGPrecisionEvaluatedAccuracy99%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99%Clinical Specificity99%2793COVID-19 Biokit IgG/IgM174MiCo Biomed Co. Ltd.South Koreawww.micobiomed.com/YesCommercialisedNoNoManualAntibodyIgGIgMPlasmaSerumWhole bloodThe COVID-19 Biokit IgG/IgM is a single use lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 present in human capillary whole boold from patients suspected of COVID-19 infection. The COVID-19 Biokit IgG/IgM is suitable for professional use. The COVID-19 Biokit IgG/IgM is for in vitro diagnosis use only. The COVID-19 Biokit IgG/IgM is an aid in the diagnosis of patients with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results from the COVID-19 Biokit IgG/IgM should not be used as the sole basis for diagnosis. This assay only provides a preliminary result. A positive result does not necessarily mean a current infection but represents a different stage of the disease after infection. IgM positive or IgG/IgM both positive suggest recent exposure, while IgG positive suggests previous infection, or latent infection. Current infection should be confirmed by Real-Time Reverse Transcriptase (RT-PCR) or viral gene sequencing.2022-08-24 09:08:01 CET2498Immuno-AntibodyYesNoImmunochromatographyQualitativeSandwich20LODPRNT50: 20CalibrationNot evaluatedAnalysis of cross reactivityNot evaluatedFalse positives9.91%False negatives0.25%PrecisionEvaluatedAccuracy97.74%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity90.09%95% CI, 85.33% - 93.43%Clinical Specificity99.75%95% CI, 99.1% - 99.93%Type of antigenSpike protein2827MiCo BioMed Co., Ltd.1254MiCo Biomed Co. Ltd.South Koreawww.micobiomed.com/YesCommercialisedNoNoManualAntibodyIgGIgMPlasmaSerumWhole bloodThe COVID-19 Biokit IgG/IgM is a single use lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 present in human capillary whole boold from patients suspected of COVID-19 infection. The COVID-19 Biokit IgG/IgM is suitable for professional use. The COVID-19 Biokit IgG/IgM is for in vitro diagnosis use only. The COVID-19 Biokit IgG/IgM is an aid in the diagnosis of patients with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results from the COVID-19 Biokit IgG/IgM should not be used as the sole basis for diagnosis. This assay only provides a preliminary result. A positive result does not necessarily mean a current infection but represents a different stage of the disease after infection. IgM positive or IgG/IgM both positive suggest recent exposure, while IgG positive suggests previous infection, or latent infection. Current infection should be confirmed by Real-Time Reverse Transcriptase (RT-PCR) or viral gene sequencing.2022-08-24 09:08:01 CET2532Immuno-AntibodyNoImmunochromatographyQualitativeSandwich20LODPRNT50: 20CalibrationNot evaluatedAnalysis of cross reactivityNot evaluatedFalse positives9.91%False negatives0.25%PrecisionEvaluatedAccuracy97.74%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity90.09%95% CI, 85.33% - 93.43%Clinical Specificity99.75%95% CI, 99.1% - 99.93%Type of antigenSpike protein2792VERI-Q COVID-19 Ag Rapid Test174MiCo Biomed Co. Ltd.South Koreawww.micobiomed.com/YesCommercialisedNoNoManualAntigenNasopharyngeal swabnucleocapsid proteinThe VERI-Q COVID-19 Ag Rapid Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in nasal swab and nasopharyngeal swab from individuals suspected of COVID-19 by their healthcare provider. Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in sterilized swabs during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19. The VERI-Q COVID-19 Ag Rapid Test is intended for use by medical professionals who are proficient in performing rapid lateral flowtests.2022-08-24 09:08:01 CET2497Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich20LOD1000TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives12.5%False negatives0%PrecisionEvaluatedAccuracy96.85%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity96%95% CI: 86.3 % ~ 99.9 %Clinical Specificity100%95% CI: 97.7 % - 100 %Type of antigenNucleocapsid protein2789Veri-Q COVID-19 IgG ELISA Kit174MiCo Biomed Co. Ltd.South Koreawww.micobiomed.com/YesCommercialisedNoNoLab-basedIgGPlasmaSerumThe VERI-Q COVID-19 IgG ELISA Kit is a microplate based enzyme-linked immunosorbent assay for the qualitative detection of IgG antibodies to SARS-CoV-2 present in human plasma or serum from patients suspected of COVID-19 infection. The VERI-Q COVID-19 IgG ELISA Kit is intended for use by the clinical laboratory personnel specifically trained in the techniques of in vitro diagnostic procedures, and proper infection control procedures The VERI-Q COVID-19 IgG ELISA Kit is an aid in the diagnosis of patients with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of oth er laboratory tests.2022-08-24 09:08:01 CET2494Immuno-AntibodyYesELISAQualitativeEnzyme-linked100CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.7 < O.D. < 1.1False negatives0.7 < O.D. < 1.1PrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity93.4%Clinical Specificity100%2790Veri-Q COVID-19 SARS-CoV-2 Neutralizing Antibody Detection ELISA Kit174MiCo Biomed Co. Ltd.South Koreawww.micobiomed.com/YesCommercialisedNoNoLab-basedAntibodyPlasmaSerumThe VERI-Q SARS-CoV-2 Neutralizing Antibody Detection ELISA Kit is in vitro diagnostic test intended for the qualitative detection of neutralization antibody to SARS-CoV-2 in human serum or plasma (EDTA, heparin, citrate). The VERI-Q SARS-CoV-2 Neutralizing Antibody Detection ELISA Kit is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The VERI-Q SARS-CoV-2 Neutralizing Antibody Detection ELISA Kit should not be used to diagnose acute SARS-CoV-2 infection.2022-08-24 09:08:01 CET2495Immuno-AntibodyYesELISAQualitativeNeutralization Antibody (NAb)70CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positivesO.D. > 0.1False negativesO.D < 1.0PrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity94.4%Clinical Specificity100%2791Veri-Q SARS-CoV-2 Neutralizing Antibody Rapid Test Kit174MiCo Biomed Co. Ltd.South Koreawww.micobiomed.com/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole bloodThe Veri-Q SARS-CoV-2 Neutralizing Antibody Detection Rapid Test is a lateral flow immunoassay intended for the qualitative detection of neutralizing antibodies to SARS-CoV-2 in human plasma from anticoagulated blood, serum, finger-stick whole blood or venous whole blood samples. The Veri-Q SARS-CoV-2 Neutralizing Antibody Detection Rapid Test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. The Veri-Q SARS-CoV-2 Neutralizing Antibody Detection Rapid Test should not be used to diagnose or exclude acute SARS-CoV-2 infection.2022-08-24 09:08:01 CET2496Immuno-AntibodyImmunochromatographyNeutralization Antibody (NAb)20CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedReproducibilityEvaluatedRobustnessNot evaluatedClinical Specificity95.6%2179ASAPath COVID-19 Antigen Rapid Test1015Microgenics CorporationUnited Stateswww.thermofisher.comYesCommercialisedNoNoManualNear POC / POCAntigenAnterior nasal swabNasal swab689B.1.1.7Alpha1032B.1.351BetaSubclass: Enzyme-linked and Sandwich. Limit of detection (LOD): 2237 TCID50/mL (heat-inactivated virus).2022-08-24 09:08:01 CET1880Immuno-AntigenNoImmunochromatographyQualitativeEnzyme-linked30LOD2237AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%Zero false positives.False negatives6AUSix false negativesPrecisionEvaluatedAccuracy95.1% (Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity80.6% (Antigen)Clinical Specificity100% (Antigen)Type of antigenNucleoprotein2123SARS-CoV-2 Antigen Rapid Test983MICROTRACE DIAGNOSTICIItalywww.microtrace.itYesCommercialisedNoNoNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swab689B.1.1.7AlphaThe SARS-CoV-2 Antigen Rapid Test (Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 Nucleocapsid protein antigens in swab specimen from individuals with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2 Nucleocapsid protein Antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with SARS-CoV-2.2022-08-24 09:08:01 CET1813Immuno-AntigenNoImmunochromatographyQualitativeMembrane-based15LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positivesSee IFUFalse negativesSee IFUPrecisionEvaluatedAccuracy96.2% (95%CI*: 91.3%~98.7%)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.9% (95%CI*: 84.1%~97.6%)Clinical Specificity99.9%＞99.9% (95%CI*: 94.0%~100%)Type of antigenNucleoprotein10202019 NCOV IGG/IGM TEST559Microtrace Diagnostici SRLItalywww.microtrace.it/laboratori/NoCommercialisedNoNoLab-basedAntibody2022-08-24 09:08:01 CET815Immuno-AntibodyImmunoassay1629recomWell SARS-CoV-2 IgG725Mikrogen DiagnostikGermanywww.mikrogen.deYesCommercialisedNoNoLab-basedAntibodyIgGIgA2022-08-24 09:08:01 CET1309Immuno-AntibodyImmunoassay390Analysis of cross reactivitySeasonal coronaviruses (HCoV), Influenza A virus, Influenza B virus, Respiratory syncytial virus (RSV), Adenoviruses, Mycoplasma pneumoniae, Chlamydia pneumoniae, Epstein-Barr virus (EBV), Cytomegalovirus (CMV), Autoantibodies positive, Pregnant women, RClinical Sensitivity98% IgGClinical Sensitivity73% IgAClinical Specificity98.7% IgGClinical Specificity99.3% IgA284nCoVSENSe: IgM/ IgG test for spike and N-protein of SARS-CoV 2 (manual)178Module Innovations Private Ltd.Indiamoduleinnovations.com/NoIn developmentNoNoAutomatedManualAntibody2022-08-24 09:08:01 CET235Immuno-AntibodyImmunoassay285SARS-CoV-2 IgM & IgG Quantum Dot Immunoassay477Mokobio Biotechnology R&D CenterUnited Stateswww.mokobious.com/YesCommercialisedNoNoAutomatedManualAntibodyIgGIgMPlasmaSerum2022-08-24 09:08:01 CET660Immuno-AntibodyYesImmunoassayQualitativeFluorescence60Clinical Sensitivity89.52%Clinical Specificity99.36%2640COVIOS Ag COVID-19 Antigen Rapid Diagnostic Test180Mologic Ltd.United Kingdommologic.co.uk/YesCommercialisedYesYesNear POC / POCAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1320B.1.617.1Kappa1518P.2Zetanucleocapsid protein2022-08-24 09:08:01 CET2345Immuno-AntigenYes10CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%0/173False negatives3.78%18/476PrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90.6%AntigenClinical Specificity100%AntigenType of antigenNucleocapsid protein287Mologic COVID-19 Rapid Test180Mologic Ltd.United Kingdommologic.co.uk/NoIn developmentNoNoNear POC / POCAntibody2022-08-24 09:08:01 CET237Immuno-AntibodyYesImmunoassay1961SARS-CoV-2 MONLABTEST897MONLAB SLSpainwww.monlab.comYesCommercialisedNoNoManualAntigenNasopharyngeal swabLoD: Detection limit value (typical) of SARS-CoV-2 is 1.00 ng/mL of SARS-CoV-2 recombinant protein or 1x103 TCID50/mL of 2019nCoV/USA-WA1/20202022-08-24 09:08:01 CET1637Immuno-AntigenNoImmunoassayQualitativeMembrane-based10LOD1ng/mLCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.4%False negatives7.1%PrecisionEvaluatedAccuracy98%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.9%Clinical Specificity99.6%Type of antigenNucleoprotein1329COVID-19 IgA ELISA410Monocent Inc.United Stateswww.monocent.comYesCommercialisedNoNoAutomatedManualAntibodyIgA2022-08-24 09:08:01 CET1098Immuno-AntibodyYesELISAQualitative85Manual or automated Accuracy99.59% IgAClinical Sensitivity98.7% IgAType of antigennucleoprotein1327COVID-19 IgG ELISA410Monocent Inc.United Stateswww.monocent.comYesCommercialisedNoNoAutomatedManualAntibodyIgGPlasmaSerum2022-08-24 09:08:01 CET1096Immuno-AntibodyYesELISAQualitative70Manual or automated Accuracy97% IgGClinical Sensitivity95% IgGType of antigennucleoprotein1321COVID-19 IgG/IgM Rapid Test410Monocent Inc.United Stateswww.monocent.comYesCommercialisedNoNoAutomatedManualAntibodyIgGIgMPlasmaSerumWhole blood2022-08-24 09:08:01 CET1087Immuno-AntibodyNoImmunoassayQualitative15False positives0AUFalse negatives0AUAccuracy100%Clinical Sensitivity100%1328COVID-19 IgM ELISA410Monocent Inc.United Stateswww.monocent.comYesCommercialisedNoNoAutomatedManualAntibodyIgMPlasmaSerum2022-08-24 09:08:01 CET1097Immuno-AntibodyYesELISAQualitative85Accuracy99.44% IgMClinical Sensitivity96% IgMType of antigennucleoprotein1320SARS-CoV2 Antigen Rapid Test410Monocent Inc.United Stateswww.monocent.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabnucleocapsid protein2022-08-24 09:08:01 CET564Immuno-AntigenYesNoImmunoassayQualitativeColorimetry20LODAU1False positivesAU0False negatives%1Accuracy99.25Clinical Sensitivity98.25%Type of antigennucleoprotein738COVID-19 ELISA IgG Antibody Test450Mount Sinai LabsUnited Stateswww.msmc.com/clinical-services-2/laboratory/NoCommercialisedNoNoAutomatedManualAntibodySerum2022-08-24 09:08:01 CET614Immuno-AntibodyYesELISAQualitativeFluorescence937ASSURE SARS-CoV-2 IgG/IgM Rapid Test367MP BiomedicalsGermanyhttps://www.mpbio.com/eu/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood with anti-coagulants2022-08-24 09:08:01 CET737Immuno-AntibodyYesNoImmunoassayQualitative15Analysis of cross reactivityEvaluatedAccuracy99.43%Clinical Sensitivity100%Clinical Specificity99.41%1123COVID-19 nucleoprotein ELISA Kit367MP BiomedicalsGermanyhttps://www.mpbio.com/eu/YesCommercialisedNoNoAutomatedManualAntigenOtherPlasmaTissue homogenates https://www.mpbio.com/us/covid-19-nucleoprotein-elisa-kit2022-08-24 09:08:01 CET914Immuno-AntigenYesELISAQualitativeMagnetic ElectrochemicalAnalysis of cross reactivityreported1125Human anti-SARS-CoV-2 IgG ELISA Kit367MP BiomedicalsGermanyhttps://www.mpbio.com/eu/YesCommercialisedNoNoAutomatedManualAntibodyIgGOther biological fluidsPlasmaTissue homogenateshttps://www.mpbio.com/us/human-anti-sars-cov-2-igg-elisa-kit2022-08-24 09:08:01 CET908Immuno-AntibodyYesELISAQuantitativeClinical Sensitivity2.34ng/mL1124Human anti-SARS-CoV-2 IgM ELISA367MP BiomedicalsGermanyhttps://www.mpbio.com/eu/YesCommercialisedNoNoAutomatedManualAntibodyIgMOther biological fluidsPlasmaTissue homogenates https://www.mpbio.com/us/human-anti-sars-cov-2-igm-elisa-kit2022-08-24 09:08:01 CET906Immuno-AntibodyYesELISAQuantitative584MP Rapid 2019-nCoV IgG/IgM367MP BiomedicalsGermanyhttps://www.mpbio.com/eu/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgM2022-08-24 09:08:01 CET494Immuno-AntibodyYesImmunoassay1126Rapid 2019-nCoV IgG/IgM Combo Test367MP BiomedicalsGermanyhttps://www.mpbio.com/eu/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood with anti-coagulants https://www.mpbio.com/eu/2019-ncov-igg-igm-combo-test2022-08-24 09:08:01 CET909Immuno-AntibodyYesNoImmunoassayQualitative10Analysis of cross reactivitynone for tested diseases; (HBsAb, TP antibody, HCV antibody, HIV antibody,Influenza Avirus antibody, Influenza Bvirus antibody, Respiratory syncytial virus antibody,Mycoplasmapneumoniae antibody, Chlamydia pneumonia antibody, Respiratory adenovirus antibPrecision100%Accuracy95.87%Clinical Sensitivity94.74%Clinical Sensitivity70.59% IgMClinical Sensitivity90.4% IgGClinical Specificity97.06%Clinical Specificity99.67% IgMClinical Specificity97.39% IgG1481Rapid SARS-CoV-2 Antigen Test Card367MP BiomedicalsGermanyhttps://www.mpbio.com/eu/YesCommercialisedYesYesNear POC / POCAntigenAnterior nasal swabNasal swabNasopharyngeal swabOropharyngeal swabnucleocapsid proteinWe would like it to beupdated that the company is MP Biomedicals Germany GmbH and also refer to the EU website that is in this update. What is currently online directs people to the USA company.2022-08-24 09:08:01 CET1232Immuno-AntigenYesNoImmunochromatographyQualitative15LOD1AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracy98.25%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.17%Clinical Specificity99.16%Type of antigennucleoprotein1051MEDsan COVID-19 IgM/IgG Rapid Test621MPC International S.A.Germanywww.medsan.eu/en/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole bloodnucleocapsid protein2022-08-24 09:08:01 CET973Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry10Analysis of cross reactivityEvaluatedType of antigenNucleoprotein1021Novel Coronavirus(COVID-19) Test607MR HealthcareHong Kong S.A.Rwww.mr-healthcare.com/YesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET933Immuno-AntibodyYesNoImmunoassayQualitative152532MSP SARS-CoV-2 Antigen Schnelltest1157MSP bodmann GmbHGermanywww.mspbodmann.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1GammaMSP SARS-CoV-2 Antigen Schnelltest is for the rapid, qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in human nasal swab, oropharyngeal swab or nasopharyngeal swab specimen.2022-08-24 09:08:01 CET2237Immuno-AntigenNoImmunochromatographyQualitative15LOD1.51TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.52%OropharyngealFalse positives0.33%NasopharyngealFalse positives0.52%NasalFalse negatives1.32%OropharyngealFalse negatives1.22%NasopharyngealFalse negatives1.32%NasalPrecisionEvaluatedAccuracy98.78%NasopharyngealAccuracy98.68%OropharyngealAccuracy98.68%NasalReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.33%NasopharyngealClinical Sensitivity96.69%OropharyngealClinical Sensitivity96.69%NasalClinical Specificity99.48%OropharyngealClinical Specificity99.67%NasopharyngealClinical Specificity99.48%NasalType of antigenNucleocapsid protein2258Covid19Check-GEN1052Multi-G bvbaBelgiumwww.covid19check-mg.comYesCommercialisedNoNoManualAntigenNasopharyngeal swabOropharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2Zetanucleocapsid proteinAll additional data is available on demand. This test is validated by the Belgian Health agency : https://www.famhp.be/en/human_use/health_products/medical_devices_accessories/covid_19/tests2022-08-24 09:08:01 CET1959Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich, Double15LOD30AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.7%(NPA 99.3%)False negatives6.8% (PPA 93.18%, 100% for Ct values ≤33)PrecisionEvaluatedAccuracy97.57%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.18% (100% for Ct values ≤33)Clinical Specificity99.3%Type of antigenNucleoprotein2262Covid19Check-MG1052Multi-G bvbaBelgiumwww.covid19check-mg.comYesCommercialisedNoNoManualAntibodyIgGIgMPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaAll additional data is available on demand. This test is validated by the French Health agency : https://covid-19.sante.gouv.fr/tests#e786994f-fc19-4c68-a3f5-74ce44fc3bb72022-08-24 09:08:01 CET1963Immuno-AntibodyNoImmunochromatographyQualitativeCapture15LOD22.5AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives3%(NPA 97%)False negatives7%(PPA 93%)PrecisionEvaluatedAccuracy96.5%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93%Clinical Specificity97%Type of antigenOther2260Covid19Check-NAS1052Multi-G bvbaBelgiumwww.covid19check-mg.comYesCommercialisedYesYesManualAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda70AT.11439C.361224B.1.526IotaB.1.526.1B.1.526.21518P.2Zetanucleocapsid proteinAll additional data is available on demand. This test is validated by the Belgian Health agency : https://www.famhp.be/en/human_use/health_products/medical_devices_accessories/covid_19/tests2022-08-24 09:08:01 CET1961Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich, Double15LOD1600AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.5% (NPA 99.5%)False negatives3% (PPA 97%, 99.35% for Ct values ≤25)PrecisionEvaluatedAccuracy98.97%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97% (99.35% for Ct values ≤25)Clinical Specificity99.5%Type of antigenNucleoprotein2261Covid19Check-SAL1052Multi-G bvbaBelgiumwww.covid19check-mg.comYesCommercialisedNoNoManualAntigenSaliva689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2Zetanucleocapsid proteinAll additional data is available on demand. This test is validated by the Belgian Health agency : https://www.famhp.be/en/human_use/health_products/medical_devices_accessories/covid_19/tests2022-08-24 09:08:01 CET1962Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich, Double15LOD22.5AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.9% (NPA 99.1%)False negatives2.4% (PPA 97.6%, 99.35% for Ct values ≤25)PrecisionEvaluatedAccuracy98.7%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.6%Clinical Specificity99.1%Type of antigenNucleoprotein2534SARS-CoV-2 Antigen Rapid Qualitative Test1159Multibrands Trading(Suzhou) Co. Ltd.Chinawww.multibrands.eu.comYesCommercialisedNoNoManualAntigenNasal swabNasopharyngeal swabOropharyngeal swab1321B.1.617.2Deltan/a2022-08-24 09:08:01 CET2239Immuno-AntigenYesImmunochromatographyN.A.Sandwich15LOD70cfu/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.97%3 samples found false positive in total 309 samplesFalse negatives1.44%3 samples found flase negative in total 209 samplesPrecisionEvaluatedAccuracy98.84%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.56%AntigenClinical Specificity99.03%Antigen2343CoviSelf COVID-19 Antigen Lateral Flow Test Device OTC Home Test1081Mylab Discovery Solutions Pvt. Ltd.Indiahttps://mylabdiscoverysolutions.com/YesCommercialisedNoNoManualAntigenAnterior nasal swabMid-turbinates swabNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2Zeta678B.1.1.529Omicronnucleocapsid protein2022-08-24 09:08:01 CET2044Immuno-AntigenYesYesNoImmunoassayQualitativeCapture15Ares(2022)4013819LOD85TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.81%6/736False negatives1.49%11/736PrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.18 (Antigen)Clinical Specificity98.9(Antigen)Type of antigenNucleocapsid protein2423MyBox Flurescence Immunoassay Analyzer1081Mylab Discovery Solutions Pvt. Ltd.Indiahttps://mylabdiscoverysolutions.com/YesCommercialisedNoNoAutomatedAntigenMid-turbinates swabNasal aspirationNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaN/A2022-08-24 09:08:01 CET2125Immuno-AntigenNoImmunoassayQualitativeFluorescence20LOD32AUCalibrationEvaluatedAnalysis of cross reactivityNot evaluatedFalse positives0%False negatives5%PrecisionEvaluatedAccuracy100 (Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100% (Antigen)Clinical Specificity100% (Antigen)Type of antigenNucleoprotein2320PathoCatch COVID-19 Ag Lateral Flow Test Device1081Mylab Discovery Solutions Pvt. Ltd.Indiahttps://mylabdiscoverysolutions.com/YesCommercialisedNoNoManualNear POC / POCAntigenMid-turbinates swabNasal swabNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2Zetanucleocapsid proteinN/A2022-08-24 09:08:01 CET2021Immuno-AntigenYesNoImmunoassayQualitativeCapture15LOD21.25AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0.05AUPrecisionEvaluatedAccuracy100%(Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95%(Antigen)Clinical Specificity100%(Antigen)Type of antigenNucleocapsid protein2422PathoCatch COVID-19 Antigen Fluorescence Immunoassay Kit1081Mylab Discovery Solutions Pvt. Ltd.Indiahttps://mylabdiscoverysolutions.com/YesCommercialisedNoNoNear POC / POCSemi-automatedAntigenMid-turbinates swabNasal swabNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2Zeta2022-08-24 09:08:01 CET2124Immuno-AntigenYesImmunoassayQualitativeCaptureFluorescence15LOD32AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives5%PrecisionEvaluatedAccuracy100% (Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97% (Antigen)Clinical Specificity100% (Antigen)Type of antigenNucleoprotein2408PathoCatch COVID-19 Antigen Lateral Flow Test Device1081Mylab Discovery Solutions Pvt. Ltd.Indiahttps://mylabdiscoverysolutions.com/YesCommercialisedNoNoManualNear POC / POCAntigenMid-turbinates swabNasal swabNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaN/A2022-08-24 09:08:01 CET2110Immuno-AntigenNoImmunoassayQualitativeCapture15LOD21.25AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracy100% (Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100% (Antigen)Clinical Specificity100% (Antigen)Type of antigenNucleoprotein2424PathoCatch COVID-19 Neutralizing Antibody ELISA Kit1081Mylab Discovery Solutions Pvt. Ltd.Indiahttps://mylabdiscoverysolutions.com/YesCommercialisedNoNoLab-basedSemi-automatedAntibodyPlasmaSerum689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2Zeta2022-08-24 09:08:01 CET2126Immuno-AntibodyYesELISAQualitativeNeutralization Antibody (NAb)120LOD21AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives5%PrecisionEvaluatedAccuracy95%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95%Clinical Specificity93%Type of antigenNucleoprotein2425PathoCatch COVID-19 Neutralizing Antibody Lateral Flow Test Kit1081Mylab Discovery Solutions Pvt. Ltd.Indiahttps://mylabdiscoverysolutions.com/YesCommercialisedNoNoLab-basedManualNear POC / POCAntibodyPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaN/A2022-08-24 09:08:01 CET2127Immuno-AntibodyImmunoassayQualitativeNeutralization Antibody (NAb)20LOD21AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives5%PrecisionEvaluatedAccuracy95%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97%Clinical Specificity100%Type of antigenOther2128Unknown2914dedicio® COVID-19 Ag plus Test182Nal von minden GmbHGermanyhttps://www.nal-vonminden.com/YesCommercialisedNoNoManualNear POC / POCAntigenAnterior nasal swabNasopharyngeal swabOropharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1132B.1.427Epsilon1137B.1.429Epsilon1321B.1.617.2Delta1323B.1.621Mu2041C.37Lambda678B.1.1.529Omicronnucleocapsid proteinThe dedicio® COVID-19 Ag plus Test is a lateral flow chromatographic immunoassay for the qualitative detection of SARS-CoV-2 viral nucleoprotein antigens in human nasal, nasopharyngeal or oropharyngeal specimens. This test is intended for use as an aid in the diagnosis of infections with SARS-CoV-2.2022-08-24 09:08:01 CET2619Immuno-AntigenNoNoImmunochromatographyQualitativeMembrane-based15LOD75.5 TCID50/mLCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives<0.01%, 0 out of 431False negatives2.9%, 5 out of 172PrecisionEvaluatedAccuracy99.17%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.09%Clinical Specificity>99.99%Type of antigenNucleocapsid protein2373dedicio® COVID-19 Ag pro Test182Nal von minden GmbHGermanyhttps://www.nal-vonminden.com/YesCommercialisedNoNoManualNear POC / POCAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1323B.1.621Mu20A.23.170AT.1nucleocapsid protein.2022-08-24 09:08:01 CET2075Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich15LOD75.5AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.01%<0,01 % (0 out of 213)False negatives2.91% (5 out of 167)PrecisionEvaluatedAccuracy99.17%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.09%Clinical Specificity99.9%>99,9 %Type of antigenNucleoprotein2104NADAL COVID-19 Ag + Influenza A/B Test182Nal von minden GmbHGermanyhttps://www.nal-vonminden.com/YesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta1320B.1.617.1Kappa1321B.1.617.2Delta1323B.1.621Mu2041C.37Lambda1224B.1.526Iota678B.1.1.529Omicron2022-08-24 09:08:01 CET2891Immuno-AntigenNoImmunochromatographyQualitativeSandwich15LOD0.4AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives2.43%COVID: 3 out of 123, Influenza A: 13 out of 78, Influenza B: 15 out of 85False negatives0%COVID: 0 out of 161, Influenza A: 9 out of 112, Influenza B: 6 out of 105PrecisionEvaluatedAccuracy99%(over 99 %)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97%(COVID); 83,3 %(Influenza A); 82,4 % (Influenza B)Clinical Specificity98%(COVID); 92 %(Influenza A); 94,3 % (Influenza B)Type of antigenNucleoprotein1162NADAL COVID-19 Ag Test182Nal von minden GmbHGermanyhttps://www.nal-vonminden.com/YesCommercialisedYesYesManualNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabSARS-CoV678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1224B.1.526Iota1320B.1.617.1Kappa1321B.1.617.2Delta1323B.1.621Mu2041C.37Lambda1495P.1Gamma1519P.3Thetanucleocapsid protein2022-10-17 12:56:32 CET5206Immuno-AntigenNoNoImmunochromatographyQualitativeMembrane-based15LOD502.4TCID50/ml(2x10^2.4 TCID50/mL)CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.1%<0.1%, 0 out of 726False negatives2.4%3 out of 123 (Ct 20-30)PrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.56%Ct-value: 20-30Clinical Specificity99.9%>99.9%Type of antigenNucleocapsid protein289NADAL COVID-19 IgG/IgM Test (243003N-25 and 243001N-10)182Nal von minden GmbHGermanyhttps://www.nal-vonminden.com/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2022-08-24 09:08:01 CET239Immuno-AntibodyYesNoImmunoassayQualitative10CalibrationNot evaluatedAnalysis of cross reactivityReported as possiblePrecisionNot evaluatedRobustnessNot evaluatedClinical Sensitivity94.1%Clinical Specificity98.2%2848NADAL® COVID-19 Ag Test (self-testing)182Nal von minden GmbHGermanyhttps://www.nal-vonminden.com/YesCommercialisedNoNoManualNear POC / POCAntigenAnterior nasal swabThe NADAL® COVID-19 Ag Test detects components (viral nucleocapsid protein) of the COVID-19 pathogen SARS-CoV-2, and is intended for use in the qualitative detection of the virus. Samples are comprised of nasal secretions taken from the lower nasal passage (anterior nasal swab), which are collected with the help of the swab provided. The test can be used anywhere and is suitable for self-use outside a laboratory environment. A positive result provides a first indication that an infection is present and that there is therefore a risk of transmission to others.2022-08-24 09:08:01 CET2553Immuno-AntigenNoImmunochromatographyQualitativeMembrane-based15LOD0.4ng/mLCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives5.9%6 out of 102 clinical samples with Ct<30PrecisionEvaluatedAccuracy97.5%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.1%Ct<30Clinical Specificity99.9%>99.9 %Type of antigenNucleocapsid protein4062NADAL® GX COVID-19 Ag Test182Nal von minden GmbHGermanyhttps://www.nal-vonminden.com/YesCommercialisedNoNoManualNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabSARS-CoVSARS-CoV-2678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1224B.1.526Iota1320B.1.617.1Kappa1321B.1.617.2Delta1323B.1.621Mu2041C.37Lambda1495P.1Gamma1519P.3Thetanucleocapsid protein2022-09-20 14:26:19 CET3825Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwichOtherLateral flow rapid test17LOD75.5TCID50/mlCalibrationNot evaluatedAnalytical Sensitivity100%Above the limit of detection (75.5 TCID50/ml)Analytical Specificity100%For all tested potentially cross reacting organisms except SARS-CoVAnalysis of cross reactivityEvaluatedFalse positives0%False negatives2.58%PrecisionEvaluatedAccuracy99.32%RobustnessNot evaluatedClinical Sensitivity97.42%Clinical Specificity99.99%290BioPoint SARS-CoV-2 dIgA/total antibody rapid test183Nanjing BioPoint DiagnosticsChinaen.njbiopoint.com/index.htmlNoIn developmentNoNoNear POC / POCAntibody2022-08-24 09:08:01 CET240Immuno-AntibodyYesImmunoassay3088SARS-CoV-2 Antigen Rapid Detection Kit (Latex Chromatography)1369Nanjing Bioworld Biotech Co. Ltd.ChinaYesCommercialisedNoNoLab-basedAntigenNasopharyngeal swabSARS-CoV1321B.1.617.2Delta678B.1.1.529Omicronnucleocapsid proteinSARS-CoV-2 Antigen Rapid Detection Kit (Latex Chromatography)2022-08-24 09:08:01 CET2794Immuno-AntigenYesChromatography15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.01AUFalse negatives0.01AUPrecisionEvaluatedAccuracy98.4%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.9%AntigenClinical Specificity98.11%AntigenType of antigenNucleocapsid protein3090SARS-CoV-2 Saliva Antigen Rapid Detection Kit (Latex Chromatography )-Lollipop style1371Nanjing Bioworld Biotech Co. Ltd.ChinaYesCommercialisedNoNoAntigenSalivaSARS-CoV1321B.1.617.2Delta678B.1.1.529Omicronnucleocapsid proteinSARS-CoV-2 Saliva Antigen Rapid Detection Kit (Latex Chromatography )-Lollipop style2022-08-24 09:08:01 CET2796Immuno-AntigenChromatography15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.01%False negatives0.01%PrecisionEvaluatedAccuracy98.04%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.39%AntigenClinical Specificity98.54%AntigenType of antigenNucleocapsid protein3089SARS-CoV-2 Saliva Antigen Rapid Detection Kit (Latex Chromatography)1370Nanjing Bioworld Biotech Co. Ltd.ChinaYesCommercialisedNoNoAntigenSalivaSARS-CoV1321B.1.617.2Delta678B.1.1.529Omicronnucleocapsid proteinSARS-CoV-2 Saliva Antigen Rapid Detection Kit (Latex Chromatography )2022-08-24 09:08:01 CET2795Immuno-AntigenChromatography15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.01%False negatives0.01%PrecisionEvaluatedAccuracy97.26%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.23%AntigenClinical Specificity97.94%AntigenType of antigenNucleocapsid protein681COVID-19 Antigen Rapid Test Device417Nanjing Liming BioProducts Co. Ltd.Chinawww.limingbio.comNoUnknownNoNoNear POC / POCAntigenNasal swabSaliva2022-08-24 09:08:01 CET809Immuno-AntigenYesNoImmunoassayQualitative15680SARS-CoV-2 IgM/IgG Antibody Rapid Test Kit417Nanjing Liming BioProducts Co. Ltd.Chinawww.limingbio.comNoCommercialisedNoNoNear POC / POCAntibody2022-08-24 09:08:01 CET572Immuno-AntibodyYesImmunoassayType of antigenantigen colloidal gold of SARS-CoV-22301StrongStep® SARS-CoV-2 Antigen Rapid Test1073Nanjing Liming BioProducts Co. Ltd.Chinawww.limingbio.comYesCommercialisedYesYesNear POC / POCAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2Zeta678B.1.1.529Omicronnucleocapsid proteinLiverpool School of Tropical Medicine has evaluated this test which demonstrates sensitivity remains with different SARS-CoV-2 lineage. Two monoclonal antibodies were used in this assay. The first antibody corresponds to an antigen labeled from 40th to 54th amino acid; The other antibody corresponds to an antigen labeled from amino acid 100th to amino acid 130th.2022-08-24 09:08:01 CET2002Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich, Double15LOD250AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.74%False negatives3.81%PrecisionEvaluatedAccuracy98.63%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.19%Clinical Specificity99.26%Type of antigenNucleocapsid protein2506Novel Coronavirus (2019-nCoV) Antigen Testing Kit (Colloidal Gold)1143Nanjing Norman Biological Technology Co. Ltd.Chinahttps://www.normanbio.comYesCommercialisedYesYesNear POC / POCAntigenAnterior nasal swabNasopharyngeal swabOropharyngeal swabSalivanucleocapsid proteinThe Antigen Test cassette is used for the rapid, qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in human Oropharyngeal swabs, Anterior Nasal swabs, or Nasopharyngeal swab in vitro.2022-08-24 09:08:01 CET2210Immuno-AntigenYesNoImmunochromatographyQualitativeColloidal gold20https://www.normanbio.com/novel-coronavirus-2019-ncov-antigen-testing-kit-colloidal-gold_p8.htmlLOD121TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.71%Nasopharyngeal swabFalse positives0.77%Anterior Nasal swabFalse negatives6.79%Nasopharyngeal swabFalse negatives6.98%Anterior Nasal swabPrecisionEvaluatedAccuracy97.61%Nasopharyngeal swabAccuracy96.76%Anterior Nasal swabReproducibilityNot evaluatedRobustnessNot evaluatedClinical Sensitivity91.13%（Saliva）Clinical Sensitivity93.02%Anterior Nasal swabClinical Sensitivity93.21%Nasopharyngeal swabClinical Specificity93.02%Anterior Nasal swabClinical Specificity99.23%Anterior Nasal swabClinical Specificity99.29%Nasopharyngeal swabType of antigenNucleocapsid protein3178Novel Coronavirus (2019-nCoV) Antigen Testing Kit (Immunochromatography)1143Nanjing Norman Biological Technology Co. Ltd.Chinahttps://www.normanbio.comYesCommercialisedNoNoNear POC / POCAntigenAnterior nasal swabSARS-CoV678B.1.1.529Omicron1321B.1.617.2Deltanucleocapsid protein2022-08-24 09:08:01 CET3128Immuno-AntigenYesImmunochromatographyQualitative20LOD121TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.95%False negatives0%PrecisionEvaluatedAccuracy99.82%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.05%Clinical Specificity100%Type of antigenNucleocapsid protein2515Novel Coronavirus (2019-nCoV) IgG / IgM Antibody Testing Kit (Colloidal Gold)1143Nanjing Norman Biological Technology Co. Ltd.Chinahttps://www.normanbio.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood/2022-08-24 09:08:01 CET2219Immuno-AntibodyNoImmunoassayQualitativeColloidal gold15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0% IgG(whole blood)False positives0% IgM(whole blood)False negatives14.13% IgG(whole blood)False negatives4.35% IgM(whole blood)PrecisionEvaluatedAccuracy95.55% IgGAccuracy98.63% IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity85.87% IgGClinical Sensitivity95.65% IgMClinical Specificity100% IgGClinical Specificity100% IgMType of antigenOther2514Novel Coronavirus (COVID-19) Neutralizing Antibody Testing Kit (Colloidal Gold)1143Nanjing Norman Biological Technology Co. Ltd.Chinahttps://www.normanbio.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET2218Immuno-AntibodyNoImmunoassayQualitativeNeutralization Antibody (NAb)Colloidal gold15LODAU0CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives1.69%(serum)False negatives4.96%(serum)PrecisionEvaluatedAccuracy97.2%(serum)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.04%(serum)Clinical Specificity98.31%(serum)Type of antigenOther2823COVID-19 IgM/IgG Antibody Rapid Detection Kit(colloidal gold method)1007Nanjing Synthgene Medical Technology Co. Ltd.Chinahttp://www.syngenemed.com/YesCommercialisedNoNoManualNear POC / POCIgGIgMPlasmaSerumVenous whole bloodWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThe novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases. The common diagnostic methods of COVID-19 pneumonia are CT and PCR. This product is an immunoassay. This product does not require any instruments. It is used for the qualitative detection of COVID-19 IgM / IgG antibodies in humans.2022-08-24 09:08:01 CET2528Immuno-AntibodyNoImmunoassayQualitativeSandwich, DoubleColloidal gold10LOD100TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2.5%False negatives0.5%PrecisionEvaluatedAccuracy97%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.5%Clinical Specificity99.5%Type of antigenSpike protein2164SARS-COV-2 Nucleocapsid (N) Antigen Rapid Detection Kit (Colloidal gold method)1007Nanjing Synthgene Medical Technology Co. Ltd.Chinahttp://www.syngenemed.com/YesCommercialisedYesYesManualNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2Zetanucleocapsid proteinThe product is used for the qualitative detection of SARS-COV-2 infection. No instrument required. It can be used for the screening of early infected patients and asymptomatic patients. The test can be performed at the patient’s medical facility (POC – point of care-conditions). The negative result cannot rule out novel coronavirus infection, and it can not be used alone as a basis for treatment and disease management decisions.The positive result of the antigen test can be used for early triage and rapid management of suspected infected people, but the positive result only indicates the presence of the novel coronavirus N-Protein (Nucleocapsid) in the sample, and cannot be used as the basis for the diagnosis and exclusion of pneumonia caused by the novel coronavirus. It should be combined with nucleic acid testing, imaging and other diagnostic information, medical history, and contact history to determine the status of infection. Coronavirus belongs to the order Nidoviridae, and the coronavirus family is divided into three genera of α ,β, and γ. α and β are only pathogenic to mammals, and γ mainly causes bird infections. COV is mainly transmitted through direct contact with secretions or through aerosols and droplets. There is also evidence that it can be transmitted through fecal or oral routes.2022-08-24 09:08:01 CET1865Immuno-AntigenYesYesImmunoassayQualitativeSandwich, DoubleColloidal gold10LOD100TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.67%False negatives0.5%PrecisionEvaluatedAccuracy99.45%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.33%Clinical Specificity99.5%Type of antigenNucleocapsid protein2822SARS-CoV-2 Virus Neutralization Test Kit (Colloidal gold method)1007Nanjing Synthgene Medical Technology Co. Ltd.Chinahttp://www.syngenemed.com/YesCommercialisedNoNoManualNear POC / POCAntibodyPlasmaSerumWhole bloodWhole blood with anti-coagulants689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThis product does not require any equipment, and is used to qualitatively detect the neutralizing antibody of the new coronavirus (SARS-CoV-2) in the human body. The entire detection process only takes 10-15 minutes. It is easy to operate and has high sensitivity. It is convenient for the screening of people vaccinated with the new coronavirus vaccine and the judgment of the effect after vaccination2022-08-24 09:08:01 CET2527Immuno-AntibodyYesYesImmunoassayQualitativeNeutralization Antibody (NAb)Colloidal gold10LOD100TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.67%False negatives0.5%PrecisionEvaluatedAccuracy99.45%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.33%Clinical Specificity99.5%Type of antigenSpike protein4067SARS-CoV-2 Nucleocapsid (N) Antigen Rapid Detection Kit (Colloidal gold method)1459Nanjing Synthgene Medical Technology Co.， Ltd.Chinawww.syngenemed.comYesCommercialisedNoNoManualAntigenAnterior nasal swabDeep (cough) sputumMid-turbinates swabNasal swabNasopharyngeal swabOropharyngeal swabSalivaSputumThroat swabAdenovirusAdenovirus 3Adenovirus 7Adenovirus Subtype BAdenovirus Subtype CAlpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Anti-Nuclear AntibodyBeta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Bordetella PertussisChlamydia PneumoniaeCoronaviruses (HCoV)Cytomegalovirus (CMV)Enterovirus A71 (EV-A71)Epstein-Barr Virus (EBV)Hemophilus InfluenzaeHepatitis A Virus (HAV)Hepatitis B Virus (HBV)Hepatitis C Virus (HCV)Herpes Simplex (HSV)Human Immunodeficiency Virus (HIV)Human Metapneumovirus (HMPV)Influenza AInfluenza A H1N1Influenza A H3N2Influenza A H5N1Influenza BInfluenza B VictoriaInfluenza B YamagataMERS-CoVMumps Virus (MuV)Mycobacterium TuberculosisMycoplasma PneumoniaeParainfluenza Virus TypeParainfluenza Virus Type 1Parainfluenza Virus Type 2Parainfluenza Virus Type 3Parainfluenza Virus Type 4Respiratory Syncytial V (RSV)Respiratory Syncytial V (RSV) Type ARespiratory Syncytial V (RSV) Type BRhinovirusRhinovirus ARhinovirus BSARS-CoVSARS-CoV-2Varicella Zoster Virus (VZV)20A.23.170AT.1678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526IotaB.1.526.1B.1.526.23939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu1439C.362041C.37LambdaOther1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid protein2022-09-20 14:33:39 CET3829Immuno-AntigenYesYesYesImmunoassayQualitativeSandwich, DoubleColloidal gold10LOD100TCID50/mlCalibrationEvaluatedAnalytical Sensitivity99.45%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives0%False negatives0.55%PrecisionEvaluatedAccuracy99.75%RobustnessEvaluatedClinical Sensitivity99.45%Clinical Specificity100%1864Anti-SARS-CoV-2 Neutralizing Antibody ELISA Kit184Nanjing Vazyme Medical Technology Co. Ltd.Chinawww.vazyme.comYesCommercialisedNoNoLatexManualAntibodyPlasmaSerumhttp://www.vazymebiotech.com/COVID.html2022-08-24 09:08:01 CET1541Immuno-AntibodyYesELISAQualitativeEnzyme-linked120LOD92.5AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives1%PrecisionEvaluatedAccuracy99.27%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.5%Clinical Specificity99.3%Type of antigenOther1849Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Detection Kit (Colloidal Gold-Based)184Nanjing Vazyme Medical Technology Co. Ltd.Chinawww.vazyme.comYesCommercialisedYesYesManualNear POC / POCAntigenNasal swabNasopharyngeal swabSARS-CoV-2678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526Iota1320B.1.617.1Kappa1321B.1.617.2Delta2041C.37Lambda1495P.1Gammanucleocapsid proteinspike proteinVazyme has established independent process to ensure that variants are monitored in time. Each variant listed as “variant of concern” and “variant of interest” by World Health Organization (WHO) will be studied since the date of listing. And the study procedure is as follows: Step one: In-silico analysis Note: In in-silico analysis, the overlap of mutation site of new variant and the epitope of antibodies used in the test will be analyzed to identify potential impact on the performance of test kit. Step two: Validation of Limit of Detection (LOD) in form of TCID50/mL, if necessary Step three:Clinical performance validation of Positive Percent Agreement (PPA), if necessary2022-09-21 08:27:37 CET5378Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich, DoubleColloidal goldDetection Kit10LOD10000TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives%0.00% (Nasal Swab) 0.22% (Nasopharyngeal Swab)False negatives6%6.00% (Nasal Swab) 5.50% (Nasopharyngeal Swab)PrecisionEvaluatedAccuracy98.15%98.15% (Nasal Swab) 98.15% (Nasopharyngeal Swab)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94%94.00% (Nasal Swab) 94.50% (Nasopharyngeal Swab)Clinical Specificity100%100.00% (Nasal Swab) 99.78% (Nasopharyngeal Swab)Type of antigenNucleocapsid protein; Spike protein3107Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Detection Kit (Colloidal Gold-Based) - Nasal swab184Nanjing Vazyme Medical Technology Co. Ltd.Chinawww.vazyme.comYesCommercialisedYesYesManualNear POC / POCAntigenNasal swabSARS-CoV678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526Iota1320B.1.617.1Kappa1321B.1.617.2Delta2041C.37Lambda1495P.1Gammanucleocapsid proteinspike proteinThe product has entered the recommended list of antigen kit in German, Switzerland, French, Belgium. and have been registered in Russia, Ukraine, Indonesia, India, the Philippines, Columbia, Peru. The product has also obtained the CE 1434 certificate issued by the notified body, and has entered the recommended list of self-test antigen kit in French , Switzerland ,Belgium,Spain.2022-12-05 09:31:40 CET5374Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich, DoubleColloidal goldDetection Kit10LOD10000TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives%False negatives6%PrecisionEvaluatedAccuracy98.15%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94%Clinical Specificity100%Type of antigenNucleocapsid protein2983Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Detection Kit (Colloidal Gold-Based) - self-testing184Nanjing Vazyme Medical Technology Co. Ltd.Chinawww.vazyme.comYesCommercialisedNoNoManualNear POC / POCAntigenNasal swabSARS-CoV-2678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526Iota1320B.1.617.1Kappa1321B.1.617.2Delta2041C.37Lambda1495P.1Gammanucleocapsid proteinspike proteinVazyme has established independent process to ensure that variants are monitored in time. Each variant listed as “variant of concern” and “variant of interest” by World Health Organization (WHO) will be studied since the date of listing. And the study procedure is as follows: Step one: In-silico analysis Note: In in-silico analysis, the overlap of mutation site of new variant and the epitope of antibodies used in the test will be analyzed to identify potential impact on the performance of test kit. Step two: Validation of Limit of Detection (LOD) in form of TCID50/mL, if necessary. Step three:Clinical performance validation of Positive Percent Agreement (PPA), if necessary.2022-11-03 08:47:43 CET5277Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, DoubleColloidal goldDetection Kit10LOD50TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives%False negatives6%PrecisionEvaluatedAccuracy98.15%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94%AntigenClinical Specificity100%AntigenType of antigenNucleocapsid protein (N) Spike protein (S938Nano-Check COVID-9 IgG/IgM Antibody Test583Nano-Ditech CorporationUnited Stateswww.nanoditech.com/YesCommercialisedNoNoAutomatedManualAntibodyIgGIgMWhole blood2022-08-24 09:08:01 CET859Immuno-AntibodyNoImmunoassayQualitativeChemiluminescence10Analysis of cross reactivityEvaluated1420FREND COVID-19 Ag354NanoEntekSouth Koreawww.nanoentek.comYesCommercialisedYesYesAutomatedAntigenNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1518P.2Zetanucleocapsid protein-2022-12-12 16:52:17 CET5379Immuno-AntigenYesImmunoassayQuantitative3LOD147AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives%False negatives5.9%PrecisionEvaluatedAccuracy97.06% (antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.12%Clinical Sensitivity94.12%Clinical Specificity100%Clinical Specificity100%Type of antigenNucleoprotein585FREND COVID-19 IgG/IgM Duo354NanoEntekSouth Koreawww.nanoentek.comYesCommercialisedNoNoAutomatedManualAntibodyIgGIgMPlasmaSerum2022-08-24 09:08:01 CET478Immuno-AntibodyYesImmunoassayQuantitativeFluorescence3Analysis of cross reactivityEvaluatedFalse positivesEvaluatedFalse negativesEvaluatedClinical Sensitivity93%Clinical Specificity97%1411FREND COVID-19 SP354NanoEntekSouth Koreawww.nanoentek.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumspike protein http://www.nanoentek.com/theme/nanont2_en/shop/02/product01_view.php?it_id=15996404982022-08-24 09:08:01 CET1174Immuno-AntibodyYesImmunoassayQualitativeFluorescence3Analysis of cross reactivity0%for tested agentsClinical Sensitivity97.06%Clinical Specificity96.3%Type of antigenspike protein1418FREND COVID-19 total Ab354NanoEntekSouth Koreawww.nanoentek.comNoCommercialisedNoNoNear POC / POCAntibodyPlasmanucleocapsid protein http://www.nanoentek.com/theme/nanont2_en/shop/02/product01_view.php?it_id=16020498012022-08-24 09:08:01 CET1179Immuno-AntibodyYesYesImmunoassayQualitativeFluorescence3Analysis of cross reactivity0% for tested agentsClinical Sensitivity96.7%IgG, IGM combinedClinical Specificity98.8%IgG, IgM combinedType of antigenSARS-CoV-2Nucleocapsid2200NanoRepro SARS-CoV-2 Antigen Rapid Test1027NanoRepro AGGermanyhttps://www.nanorepro.com/YesCommercialisedYesYesNear POC / POCAntigenAnterior nasal swabNasopharyngeal swabOropharyngeal swabDear Sir/Madam, We, NanoRepro AG, are manufacturer of SARS-CoV-2 Antigen Rapid Test in Germany and would like to request you to add our product in your European Commision Common List of Rapid Antigen Tests. Our NanoRepro SARS-CoV-2 Antigen Rapid Test carries CE marking, have sensitivity ≥ 90% and specificity ≥ 97% and has been successfully validated in Germany according to the criteria of Paul Ehrlich Institute (PEI) by Biomex GmbH . This validation ,which was performed by Biomex GmbH , Heidelberg, has been accepted by Bundesinstitute für Arzneimittel und Medizinprodukte and Paul Ehrlich Institute. We look forward to receiving a positive response. Best Regards Ramila Sedai Regulatory Affairs Manager NanoRepro AG2022-08-24 09:08:01 CET1901Immuno-AntigenYesYesImmunochromatographyQualitativeSandwich, Double15LOD30AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.63%Among 550 specimens, 9 test results were false positives.False negatives2.8%Among 250 specimens, 7 test results were false regatives.PrecisionEvaluatedAccuracy98%(Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.2% (Antigen)Clinical Specificity98.4% (Antigen)Type of antigenNucleoprotein683NanoMedicina SARS-CoV-2 IgM/IgG Antibody Rapid Test419NanoResearchUnited Stateswww.nanoresearchinc.comNoCommercialisedNoNoNear POC / POCAntibody2022-08-24 09:08:01 CET574Immuno-AntibodyYesImmunoassay1355(2019-nCoV) New coronavirus Antibody Test (Colloidal Gold)851Nantong Diagnos Biotechnology Co. Ltd.Spainlinkcarebio.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2022-08-24 09:08:01 CET1115Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15LOD0AUAnalytical Sensitivity87.04% IgGAccuracy93.33% IgMAccuracy92.38% IgGClinical Sensitivity88.89% IgM1354COVID-19 & Influenza A+B Antigen Combo Test Kit (Colloidal Gold)851Nantong Diagnos Biotechnology Co. Ltd.Spainlinkcarebio.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabNasopharyngeal swabThroat swabnucleocapsid protein2022-08-24 09:08:01 CET1128Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15Accuracy: 97.60% Influenza. Clinical sensitivity 96.67% InfluenzaLOD0.05%Accuracy96%Clinical Sensitivity92.59%Type of antigennucleoprotein1617COVID-19 Antigen Saliva Test Kit (Colloidal Gold)851Nantong Diagnos Biotechnology Co. Ltd.Spainlinkcarebio.comYesCommercialisedNoNoManualNear POC / POCAntigenDeep (cough) sputumOropharyngeal swabOther biological fluidsSaliva689B.1.1.7Alpha1032B.1.351Beta1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.11224B.1.526IotaB.1.526.1B.1.526.2nucleocapsid proteinPlease use following Email to respond: B.Grunberg@acura-kliniken.com Thank you.2022-08-24 09:08:01 CET1297Immuno-AntigenYesNoImmunochromatographyQualitativeMembrane-basedColorimetry15LOD115AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy98.82%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.1%AntigenClinical Specificity99,33%Type of antigenNucleoprotein1301Influenza A+B Antigen Test Kit (Colloidal Gold)851Nantong Diagnos Biotechnology Co. Ltd.Spainlinkcarebio.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabnucleocapsid protein2022-08-24 09:08:01 CET1071Immuno-AntigenYesYesImmunoassayQualitative15LOD0.05AUAccuracy97.6%Clinical Sensitivity96.67%Type of antigenNucleoprotein1573COVID-19 Antigen Rapid Test Kit691Nantong Egens Biotechnology Co. Ltd.Chinawww.egens-bio.comYesCommercialisedYesYesNear POC / POCAntigenNasal swab2022-08-24 09:08:01 CET1252Immuno-AntigenYesNoImmunoassayQualitativeColloidal gold15LOD38.5AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.2%False negatives4.2%PrecisionEvaluatedAccuracy98.5%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.8%1019(COVID-19) IgG/IgM Rapid Test558NatejahSaudi Arabianatejah.com/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgM2022-08-24 09:08:01 CET814Immuno-AntibodyYesImmunoassay2348KIT REVOLUTION COVID-19 ANTIGENIC TEST FOR SARS-COV-21088NATRIX S.R.L.Italyhttps://www.natrixlab.it/YesCommercialisedNoNoManualNear POC / POCAntigenNasal swabKIT REVOLUTION COVID-19 ANTIGENIC TEST FOR SARS-COV-2 cat 10400001 Italian Ministry of Health registration number 2091165 LOD is 7,05 x 10 2 TCID 50/mL2022-08-24 09:08:01 CET2049Immuno-AntigenNoImmunochromatographyQualitativeSandwich20LOD0AUCalibrationNot evaluatedAnalysis of cross reactivityNot evaluatedFalse positives0%False negatives5.7%PrecisionEvaluatedAccuracy97%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94%Clinical Specificity100%Type of antigenNucleoprotein2349KIT REVOLUTION COVID-19 RAPID SALIVARY TEST FOR SARS-COV-21088NATRIX S.R.L.Italyhttps://www.natrixlab.it/YesCommercialisedNoNoManualNear POC / POCAntigenSalivaKIT REVOLUTION COVID-19 RAPID SALIVARY TEST FOR SARS-COV-2 cat 10400000 Italian Ministry of Health registration number 2002448 LOD is 7.05×102 TCID50/mL2022-08-24 09:08:01 CET2050Immuno-AntigenNoImmunochromatographyQualitativeSandwich25LOD0AUCalibrationNot evaluatedAnalysis of cross reactivityNot evaluatedFalse positives0%False negatives8%PrecisionEvaluatedAccuracy97%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92%Clinical Specificity100%Type of antigenNucleoprotein484Viralert COVID-19 IgG/IgM Antibody Rapid Test Kit306Naturitious LLCUnited Stateswww.virconnect.com/NoCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET405Immuno-AntibodyYesImmunoassay201303Chexel COVID-19 IgM/IgG645NB POSTECHSouth Koreawww.nbpostech.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2022-08-24 09:08:01 CET1074Immuno-AntibodyYesNoImmunoassayQualitative15Clinical Sensitivity75% IgGClinical Sensitivity96.8% IgM2678ND COVID-19 Ag Test1224NDFOS Co. Ltd.South Koreawww.ndfos.comYesCommercialisedYesYesNear POC / POCAntigenNasopharyngeal swab20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2Zeta689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Munucleocapsid proteinPOC based Immunochromatography2022-08-24 09:08:01 CET3675Immuno-AntigenYesImmunochromatography15LODTCID50/ml1.25x1,584.893CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives5.9%PrecisionEvaluatedAccuracy98.2%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.37%Clinical Specificity100%Type of antigenNucleocapsid protein3155NEMI COVID-19 RAPID ANTIGEN TEST KIT1396NEMHESIS LAB. SÄ°S. MED. PLAS. ENJEK. Ä°ML. Ä°TH. Ä°HR. SAN. TÄ°C. Ltd. ÅžTÄ°.Turkeyhttps://nemhesis.com.trNoIn developmentNoNoManualNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gammanucleocapsid proteinThis kit is used for the in vitro qualitative detection of the SARS-CoV-2 antigen.2022-08-24 09:08:01 CET2863Immuno-AntigenNoNoImmunochromatographyQualitativeSandwich15LOD100TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2%False negatives2%PrecisionEvaluatedAccuracy99.01%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.04%Clinical Specificity99.01%Type of antigenNucleocapsid protein10222019-nCoV(COVID-19) IgG&IgM Rapid Test Kit539Neo Nostics (Suzhou) Bioingeneering Co. Ltd.Chinawww.neo-nostics.com/en/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2022-08-24 09:08:01 CET782Immuno-AntibodyYesNoImmunoassayQualitative2608COVID 19 Antigen Test Kit (Colloidal Gold Method)1190Neo Nostics (Suzhou) Bioingeneering Co. Ltd.ChinaYesCommercialisedYesYesAntigenNasal swabNasopharyngeal swabOropharyngeal swabnucleocapsid proteinThis reagent is used for in vitro qualitative test of COVID 19 antigen N protein in human nasal samples. Synthetic spinous protein and genetic variants of UK cannot be detected. It is only used as a supplementary test indicator for suspected cases with negative result of COVID 19 test or combined with the 2019-nCov IgG / IgM antibody test kit for the auxiliary diagnosis of suspected cases. It cannot be used as a basis for confirmation or diagnosis of pneumonia caused by COVID 19 infection. A positive test result needs further confirmation, and a negative test result cannot exclude the possibility of infection. The test kit is recommended to be used by individuals above 18 years old. For the individuals under the age of 18 years old or older than 65 years old, the test should be done under the supervision or assistance of another adult. The 2019 novel coronavirus is also known as COVID 19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the COVID 19 are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.2022-08-24 09:08:01 CET2313Immuno-AntigenYesImmunoassayQualitativeColloidal gold15LOD0.1ng/mLCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.8%(1/123)False negatives4.1%(5/123)PrecisionEvaluatedAccuracy97.56%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.93%Clinical Specificity99.19%Type of antigenNucleocapsid protein1134NAISSA SARS-COV-2 IgA585Neomedica d.o.o.Serbiawww.neomedica.rsYesCommercialisedNoNoAutomatedAntibodyIgAPlasmaSerum https://neomedica.rs/products/immunodiagnostics/monotest-immunoanalyzer-naissa/naissa-new/2022-08-24 09:08:01 CET916Immuno-AntibodyYesImmunoassayQualitativeSandwich, Double150CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1AUFalse negatives0AUPrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity93.4%1087NAISSA SARS-COV-2 IgG585Neomedica d.o.o.Serbiawww.neomedica.rsYesCommercialisedNoNoAutomatedAntibodyIgGPlasmaSerum https://neomedica.rs/products/immunodiagnostics/monotest-immunoanalyzer-naissa/naissa-new/2022-08-24 09:08:01 CET870Immuno-AntibodyYesImmunoassayQualitativeSandwich, Double150CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1AUFalse negatives0AUPrecisionEvaluatedAccuracy99%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity97.5%1133NAISSA SARS-COV-2 IgM585Neomedica d.o.o.Serbiawww.neomedica.rsYesCommercialisedNoNoAutomatedAntibodyIgMPlasmaSerum https://neomedica.rs/products/immunodiagnostics/monotest-immunoanalyzer-naissa/naissa-new/2022-08-24 09:08:01 CET915Immuno-AntibodyYesImmunoassayQualitativeSandwich, Double150CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1AUFalse negatives0AUPrecisionEvaluatedAccuracy98%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity92.6%2377NAISSA SARS-COV-2 S1/S2/RBD Neutralizing antibodies585Neomedica d.o.o.Serbiawww.neomedica.rsYesCommercialisedNoNoAutomatedAntibodyIgGPlasmaSerumEnzyme-linked immunosorbent assay for quantitative determination of neutralizing IgG antibodies to S1/S2/RBD antigens of SARS-CoV-2 virus2022-08-24 09:08:01 CET2079Immuno-AntibodyYesELISAQuantitativeEnzyme-linked105LOD0AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%There are no false positivesFalse negatives0%There are no false negativesPrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.4%Clinical Specificity100%Type of antigenOther2236SARS-COV-2 Ag NeoMedica585Neomedica d.o.o.Serbiawww.neomedica.rsYesCommercialisedNoNoManualNear POC / POCAntigenNasal swabNasopharyngeal swab689B.1.1.7AlphaThe test is intended for qualitative detection of SARS-CoV-2 antigen in a nasopharyngeal swab sample in patients during the early phase of infection, as well as in asymptomatic patients.2022-08-24 09:08:01 CET1937Immuno-AntigenNoImmunochromatographyQualitativeMembrane-based15LOD6.31AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positivesThere are no false positivesFalse negativesThere are no false negativesPrecisionEvaluatedAccuracy98.6%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.7%Clinical Specificity99%2234SARS-COV-2 Ag NeoMedica (R2703Ag)585Neomedica d.o.o.Serbiawww.neomedica.rsYesCommercialisedNoNoManualNear POC / POCAntigenDeep (cough) sputumOtherSaliva689B.1.1.7AlphaThe test is intended for qualitative detection of SARS-CoV-2 antigen in saliva/sputum specimens in patients in the acute (early) phase of SARS-CoV-2 infection, as well as in asymptomatic patients.2022-08-24 09:08:01 CET1935Immuno-AntigenNoImmunochromatographyQualitativeMembrane-based15Ares(2021)3832559LOD6.31AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positivesThere are no false positivesFalse negativesThere are no false negativesPrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.8%Clinical Specificity99%Type of antigenNucleoprotein2241MARESKIT1041NESAPOR EUROPA SLSpainwww.mareskit.catYesCommercialisedYesYesManualAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1321B.1.617.2Deltanucleocapsid proteinNA2022-08-24 09:08:01 CET1942Immuno-AntigenYesNoImmunoassayQualitative15LOD100pg/mLCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%Positive Predictive Value 100.00%False negatives1.18%Negative Predictive Value 98.82%PrecisionEvaluatedAccuracy99.05%95% CI: 96.21% to 99.92%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.24%95% CI: 83.84% to 99.42%Clinical Specificity100%95% CI: 97.22% to 100.00%Type of antigenNucleocapsid protein2306COVID-19 Antibody Detection Kit1074New Gene (Hangzhou) Bioengineering Co. Ltd.Chinawww.new-gene.net/YesCommercialisedNoNoManualNear POC / POCAntibodyIgGIgMACD plasmaPeripheral bloodPlasmaSerum689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1132B.1.427Epsilon1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.3This product is intended for the qualitative detection of COVID-19 antibodies (IgM and IgG). It provides an aid in the diagnosis of infection with novel coronavirus.2022-08-24 09:08:01 CET2007Immuno-AntibodyNoImmunoassayQuantitativeSandwich20LOD1CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.95% IgM1 out of 105False positives0.95%1 out of 105False negatives2.04%2 out of 98 False negatives5.1% IgM5 out of 98PrecisionEvaluatedAccuracy97% IgMAccuracy98.5% IgGReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.9% IgGClinical Sensitivity94.9% IgMClinical Specificity99% IgGClinical Specificity99% IgMType of antigenOther1501COVID-19 Antigen Detection Kit1074New Gene (Hangzhou) Bioengineering Co. Ltd.Chinawww.new-gene.net/YesCommercialisedYesYesLab-basedManualNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31495P.1Gamma1223B.1.525Eta1519P.3Theta3939B.1.6161323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.2678B.1.1.529Omicron1518P.2Zetanucleocapsid proteinThe COVID-19 Antigen Detection Kit by New Gene (Hangzhou) Bioengineering Co., Ltd. has been widely used in practice in many EU member countries. Please visit the following links, and search search “New Gene” in their whitelists for more information. (Germany) https://antigentest.bfarm.de/ords/f?p=110:100:17097377707548 (France) https://covid-19.sante.gouv.fr/tests (Belgium)https://www.famhp.be/en/human_use/health_products/medical_devices_accessories/covid_19/tests ( Italy) https://www.salute.gov.it/interrogazioneDispositivi/RicercaDispositiviServlet?action=ACTION_MASCHERA (Portugal) https://www.infarmed.pt/web/Infarmed/pesquisa-dispositivos2022-08-24 09:08:01 CET1251Immuno-AntigenYesYesNoImmunoassayQualitativeSandwich, Double30LOD0.05ng/mLCalibrationEvaluatedCalibrationEvaluatedAnalysis of cross reactivityEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.87%1 out of 114False negatives2.02%5 out of 247PrecisionEvaluatedAccuracy98.3%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98%AntigenClinical Specificity99.1%AntigenType of antigenNucleocapsid protein2303COVID-19 Antigen Detection Kit - Nasal Swab (for Self-Test use)1074New Gene (Hangzhou) Bioengineering Co. Ltd.Chinawww.new-gene.net/YesCommercialisedNoNoLab-basedManualNear POC / POCAntigenAnterior nasal swabNasal swabSARS-CoV-220A.23.170AT.1678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526IotaB.1.526.1B.1.526.23939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu1439C.362041C.37Lambda1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid proteinThe COVID-19 Antigen Detection Kit - Nasal Swab by New Gene (Hangzhou) Bioengineering Co., Ltd. has got NBCE certificate (EC Certificate No. 1434-IVDD-476/2021) for SELF-TEST use by laypeople.2022-12-07 08:45:18 CET5362Immuno-AntigenYesYesNoImmunoassayQualitativeSandwich, DoubleColloidal gold30LOD0.05ng/mLCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.5%1/201False negatives3.2%7/220PrecisionEvaluatedAccuracy98.1%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.8%AntigenClinical Specificity99.1%AntigenType of antigenNucleocapsid protein2305COVID-19 Neutralizing Antibody Detection Kit1074New Gene (Hangzhou) Bioengineering Co. Ltd.Chinawww.new-gene.net/YesCommercialisedNoNoManualNear POC / POCAntibodyACD plasmaPeripheral bloodPlasmaSerum689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1132B.1.427Epsilon1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.3This product is intended for the qualitative detection of neutralizing antibodies for SARS-CoV-2 spike glycoproteins. The test results can help to identify individuals with an adaptive immune response to SARS-CoV-2, which is acquired from recent or prior infection or vaccination. The COVID-19 Neutralization Antibody Detection Kit should not be used to diagnose acute SARS-CoV-2 infection.2022-08-24 09:08:01 CET2006Immuno-AntibodyNoImmunoassayQuantitativeNeutralization Antibody (NAb)20LOD1AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.84%1 out of 118False negatives1.63%2 out of 122PrecisionEvaluatedAccuracy98.8% (Antibody)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.4% (Antibody)Clinical Specificity99.2% (Antibody)Type of antigenOther2330COVID-19/Influenza A/Influenza B Detection Kit1074New Gene (Hangzhou) Bioengineering Co. Ltd.Chinawww.new-gene.net/YesCommercialisedNoNoManualNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1132B.1.427Epsilon1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.3This product is suitable for people with symptoms similar to COVID-19, like cough, fever, fatigue and etc., to assist the early diagnosis of SARS-CoV-2 infection, Influenza A virus infection, and Influenza B virus infection. It can also be used to test people without COVID-19 symptoms to regularly monitor their health status.2022-08-24 09:08:01 CET2031Immuno-AntigenNoImmunoassayQualitativeSandwich30LOD1CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.87%1 out of 114 (COVID-19); False positives0.81%1 out of 123 (IFB)False positives0.81%1 out of 123 (IFA)False negatives2.02%5 out of 247 (COVID-19); False negatives2.67%3 out of 112 (IFB)False negatives3.41%4 out of 117 (IFA)PrecisionEvaluatedAccuracy98.3%(Antigen COVID-19); Accuracy98.3% (Antigen IFB)Accuracy97.9% (Antigen IFA)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98% (Antigen COVID-19); Clinical Sensitivity96.6% (Antigen IFA);Clinical Sensitivity97.3% (Antigen IFB)Clinical Specificity99.2%(Antigen IFA);Clinical Specificity99.2%(Antigen IFB)Clinical Specificity99.1% (Antigen COVID-19); Type of antigenNucleoprotein1029COVID-19 Coronavirus Rapid Test Kit613Newbury Pharmaceuticals S.ASwedenwww.newburypharma.ch/YesCommercialisedNoNoNear POC / POCAntibodyWhole bloodhttps://www.newburypharma.ch/pages/covid-19-instant-antibody-test-kit-15-min2022-08-24 09:08:01 CET947Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry2845COVID-19 and Influenza A+B Rapid Antigen Combo Test1267NewScen Coast Bio-Pharmaceutical Co. Ltd. (NewScen)Chinahttps://newscenbiotech.com/YesCommercialisedNoNoManualNear POC / POCAntigenThroat swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.2678B.1.1.529Omicron1518P.2Zeta2022-08-24 09:08:01 CET2550Immuno-AntigenYesYesYesImmunoassayQualitativeSandwich, Double15LOD250TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy99.6%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.8%Clinical Specificity99.8%Type of antigenNucleocapsid protein2844COVID-19 Antigen Cassetle Rapid Test (Pharyngeal swab)1267NewScen Coast Bio-Pharmaceutical Co. Ltd. (NewScen)Chinahttps://newscenbiotech.com/YesCommercialisedNoNoManualNear POC / POCAntigenNasal swabThroat swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.2678B.1.1.529Omicron1518P.2Zeta2022-08-24 09:08:01 CET2549Immuno-AntigenNoImmunoassayQuantitativeSandwich15LOD250TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy99.6%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.8%Clinical Specificity99.8%Type of antigenNucleocapsid protein2820COVID-19 Antigen Mircrofluidic Chip1259NewScen Coast Bio-Pharmaceutical Co. Ltd. (NewScen)Chinawww.newscen.comYesCommercialisedNoNoSemi-automatedAntigenNasal swabSalivaThroat swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaFor more information , please contact with us via our email address : anna.int@newscen.com2022-08-24 09:08:01 CET2525Immuno-AntigenImmunoassay4LOD2.5TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0AUFalse negatives0AUPrecisionEvaluatedAccuracy99.8%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.8%Clinical Specificity99.8%Type of antigenNucleocapsid protein2847COVID-19 Antigen Rapid Test Cassetle1267NewScen Coast Bio-Pharmaceutical Co. Ltd. (NewScen)Chinahttps://newscenbiotech.com/YesCommercialisedNoNoManualNear POC / POCAntigenNasal swabThroat swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.2678B.1.1.529Omicron1518P.2Zeta2022-08-24 09:08:01 CET2552Immuno-AntigenYesImmunoassayQualitativeSandwich, Double15LOD250TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy99.6%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.8%Clinical Specificity99.8%Type of antigenNucleocapsid protein2846Influenza Antigen A/B Rapid Test1267NewScen Coast Bio-Pharmaceutical Co. Ltd. (NewScen)Chinahttps://newscenbiotech.com/YesCommercialisedNoNoManualNear POC / POCAntigenNasal swabNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.2678B.1.1.529Omicron1518P.2Zeta2022-08-24 09:08:01 CET2551Immuno-AntigenYesYesImmunoassayQuantitativeSandwich, Double15LOD250TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy99.6%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.8%Clinical Specificity99.8%Type of antigenNucleocapsid protein865NG-Test IgG-IgM COVID-19572NG BiotechFrancehttps://ngbiotech.com/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2022-08-24 09:08:01 CET841Immuno-AntibodyYesNoImmunoassayQualitative151646NG-Test SARS-CoV-2 Ag572NG BiotechFrancehttps://ngbiotech.com/YesCommercialisedYesYesNear POC / POCAntigenNasopharyngeal swabSARS-CoV678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526Iota1320B.1.617.1Kappa1321B.1.617.2Delta1323B.1.621Mu2041C.37LambdaOther1495P.1Gammanucleocapsid proteinUpdate of performances with additional data2022-10-05 13:56:28 CET3927Immuno-AntigenYesNoNoImmunochromatographyQualitativeMembrane-basedColloidal gold15LOD1TCID50/mlCalibrationNot evaluatedAnalytical Sensitivity100%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives0.33%1 false positive out of 305 negative samples confirmed by RT-PCRFalse negatives24%29 false negative results out of 121 positive samples confirmed by RT-PCRPrecisionEvaluatedAccuracy95.3%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity92%for Ct <30Clinical Sensitivity97.5%for CT < 25Clinical Specificity99%Type of antigenNucleocapsid protein1880Ninonasal572NG BiotechFrancehttps://ngbiotech.com/YesCommercialisedYesYesNear POC / POCAntigenNasal swabNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta1323B.1.621Mu2041C.37Lambda1224B.1.526Iota678B.1.1.529Omicronnucleocapsid proteinupdated list of variants2022-08-24 09:08:01 CET1559Immuno-AntigenYesNoNoImmunochromatographyQualitativeMembrane-basedColorimetry20LOD1AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.51%2 false positive result out of 390 negative samples confirmed by RT-PCRFalse negatives2.34%3 false negative results out of 128 positive samples confirmed by RT-PCRPrecisionEvaluatedReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity98%Clinical Specificity99%Type of antigenNucleocapsid protein2281Ninonasal-Autotest572NG BiotechFrancehttps://ngbiotech.com/YesCommercialisedNoNoNear POC / POCAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta1323B.1.621