2026-03-06 21:42:07 CET1344SMARAPIDTEST650A PLUS DIAGNOSTICS LAB.SAN.TIC.A.S.Turkeywww.aplustbd.comYesCommercialisedNoNoNear POC / POCAntigenNasal 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% 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 protein1833COVID-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%1232Panbio 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 antigenOther2975IVD 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 samples2374Cora 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 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 antigenNucleoprotein2578Accu-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 protein2579Accu-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 protein1669FIAflex 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 protein4054Flowflex 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%2594SARS-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 protein4045SARS-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 antigenNucleoprotein1670FIAflex 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 antigenNucleoprotein1908SARS-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 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 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 antigennucleoprotein2267SARS-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 antigenNucleoproteins2245Actim 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/YesCommercialisedNoNoManualAntigenDeep (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 protein2108AESKU.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 antigenNucleoprotein2130TestNOW® - 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 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 protein1678Instant-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 antigennucleoprotein3965SARS-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 antigenNucleoprotein1602Rapid 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 protein2936AMPER 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 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/B12032019-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%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 protein4142COVID- 19 Antigen Rapid Test Kit3179Anhui Bessie Biological Technology Co. ，Ltd.Chinawww.bessiebio.comYesCommercialisedNoNoManualAntigenNasopharyngeal 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%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 antigenNucleoprotein2089New 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 protein1451COVID-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 receptor5727AQUILAVIE ® SARS-CoV-2 Ag Diagnostic Test Kit (Colloidal Gold)3192Aquila Healthcare LimitedHong Kong S.A.Rwww.aquilavie.comYesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swabOropharyngeal swabAdenovirus 3Adenovirus 7Epstein-Barr Virus (EBV)Influenza AInfluenza BMERS-CoVMycoplasma PneumoniaeRespiratory Syncytial V (RSV) Type ARespiratory Syncytial V (RSV) Type BVaricella 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.3Thetanucleocapsid protein2022-10-25 10:05:24 CET5233OtherYesNoNoImmunochromatographyQualitativeSandwich, DoubleOtherExtraction kit, Sample Collection Device, Transport Kit15LOD1.5TCID50/ml1.5×10^2 TCID50/mL - As "Value", we can put numbers and not symbols. Therefore, we have included the complete value and correct Unit information in this box for Additional info(numbers and symbols)CalibrationNot evaluatedAnalytical Sensitivity1.5%1.5×10^2 TCID50/mL - As "Value", we can put numbers and not symbols.Furthermore,the system does not allow us to amend the "Unit"(we can only select "%").Thus,we have included the complete value and correct Unit information in this box for Additional infoAnalytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives0.88%False negatives12.97%PrecisionEvaluatedAccuracy93.7%RobustnessNot evaluatedClinical Sensitivity87.03%Clinical Specificity99.12%2079mariPOC 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 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 protein1654Asan 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 protein1761Asan 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%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 protein5803COVID-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 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 protein1579COVID-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%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%2364FASTEP 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%)2454As-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 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 protein2538SARS-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 protein2426AffiDX 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 antigenOther1972Novel 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 antigenNucleoprotein1906COVID-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 antigenOther2602SARS-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 protein1782Saligen798Bakter 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%1065BD 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 30622019-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 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 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 protein2769COVID-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 protein12832019-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 protein3622SARS-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%2807Coronavirus (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 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 protein2841Novel 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 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%2810SARS-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%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 antigennucleocapsid17902019-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 protein1331SARS-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%2733COVID-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 protein2494COVID-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 protein3033Novel 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 protein1485WANTAI 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 protein1362Novel 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 antigennucleoprotein2704SARS-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 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 protein1687biocomma®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 antigennucleoprotein2902RAPID 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 negatives8samples2247CoviGnost 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%2694BOH-180 Fluorescent Immunoassay Analyzer1037BIOHIT HealthCare (Hefei) Co. Ltd.Chinawww.biouhan.comYesCommercialisedNoNoNear POC / POCSemi-automatedAntigenAnterior 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 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 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 protein1599Biomerica 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 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 protein1242NowCheck 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%2034COVID-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 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 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 antigenNucleoprotein2380COVID19Speed-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 antigenNucleoprotein1223BIOSYNEX 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 protein2947BIOSYNEX 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 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 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%3008BHM 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 protein1605Lab-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 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 antigenNucleoprotein1989AFIAS 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 protein1449AFIAS 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 protein1990ichroma™ 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 antigenNucleoprotein1236Rapid 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 antigennucleoprotein1647AllCheck 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 protein1237COVID-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 protein1173CerTest 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 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%adeno2871Novel 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%3864CHIL 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 protein1937COVID-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 antigenOther1189Novegent 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%2437COVID-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)1387COVID-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 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)2388COVID-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%Evaluated1474SARS-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 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)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 antigennucleoprotein2632SARS-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%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-AntigenYesNoImmunoassayQualitative151919Coretests 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 antigenNucleoprotein2648Covid-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%1810CORMAY 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%1581OnSite 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 antigennucleoprotein1305Test 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 protein2457SARS-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 antigenNucleoprotein3001QuantiVirus 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 NS31195OneStep 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%2096Diagnostic 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 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 antigenNucleoprotein1792COVID-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-AntigenYesImmunoassay2242COVID-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 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 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 antigennucleoprotein1651DyonCovidAg529DyonMed 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 protein1243ActivXpress+ 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 antigenNucleoprotein1313CovBELD647EMBIO 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 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 protein3443COVID-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%1739EBS 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 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 antigenNucleoprotein1744CORA 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 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%2428FUJIFILM 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 antigenNucleoprotein1580GA 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 antigenNucleoprotein2781SARS-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 antigennucleoprotein1244GenBody 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 protein1297GenBody 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%4081GB 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%4072RapiCov 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%3139Neisseria 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 antigennucleoprotein3127GENnow 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 protein2012SARS-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%1454COVID-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 protein2183One 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 antigennucleoprotein2695Novel 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 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%1197SARS-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 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%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 antigennucleoprotein12162019-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)1360COVID-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%1318V-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%1314V-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 protein3094SARS-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 protein3459COVID-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%1312Wondfo 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 protein1214Wondof 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 gold3005COVID-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%1256COVID-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-AntigenYesImmunoassay1947COVID-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 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 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 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 antigenNucleoprotein2390SARS-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)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%24752COVID-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%24751COVID-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%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 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%4112COVID-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%4113COVID-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%1363COVID-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 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%25664SARS-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 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 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 protein1795Novel 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 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%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%3146GENnasal 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 protein1945SARS-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)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 protein2210COVID-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 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 protein1392COVID-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 antigennucleoprotein4108SARS-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 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 swab1735Rapid 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 antigenNucleoprotein2974Healfo 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 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, Other1931Influenza 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 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 antigenOther1263Humasis 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 swab1262Humasis COVID-19/Flu Ag Combo Test1062Humasis Co. Ltd.South Koreahttp://www.humasis.com/en/YesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swab2022-08-24 09:08:01 CET1037Immuno-AntigenYesImmunoassayQualitative151575OJABIO 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 protein2555Covid-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 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 antigenNucleoprotein1791Rapid 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%1801Innova 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 protein2278Novel 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 antigenNucleoprotein1728iD 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%19942019-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 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 protein2484Rapid 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 protein1988Biozek 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 protein2217PixoTest® 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%2107Novel 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 protein1264PerfectPOC 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-AntigenYesImmunoassay1920COVID-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 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 antigenNucleoprotein2585SARS-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 protein2006SARS-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 antigenNucleoprotein3974SARS-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%2586SARS-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 antigennucleoprotein2144COVID-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 antigenNucleoprotein4099SARS-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 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%1205COVID-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 protein1777SARS-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%1764SARS-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 antigenNucleoprotein2779nCoVega 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 protein1596COVID-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 antigenNucleoprotein3936SARS-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%1667LooK 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 antigennucleoprotein1648COVID-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 protein3973SARS-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%2866COVID-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%1353Covid-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 protein678COVID-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 Antigen3678Lomina 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 protein4147Lomina 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 protein1267QuickProfile 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.ImmunoassayQualitativeFluorescence51146SARS-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)1917Severe 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 protein2125AxenTM 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 antigenNucleoprotein2161EONBT 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 antigenNucleoprotein1190mö-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 antigenNucleoprotein1784Novel 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 protein2973MediDia 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 protein1180MEDsan 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%3954MEDsan® 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%1182Rapid 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-AntigenYesNoImmunoassayQualitative202923COVIFIND 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 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 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%2792VERI-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 protein2640COVIOS 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 protein1320SARS-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 antigennucleoprotein1481Rapid 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 antigennucleoprotein2258Covid19Check-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 antigenNucleoprotein2260Covid19Check-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 antigenNucleoprotein2343CoviSelf 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 protein2320PathoCatch 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 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 antigenNucleoprotein4062NADAL® 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%3088SARS-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 protein2301StrongStep® 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 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 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%1849Severe 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 (S2200NanoRepro 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 antigenNucleoprotein1354COVID-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%2678ND 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 protein2608COVID 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 protein2241MARESKIT1041NESAPOR 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 protein1501COVID-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 protein2845COVID-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 protein1646NG-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.1.621Mu2041C.37Lambda1224B.1.526Iota678B.1.1.529Omicronnucleocapsid proteinUpdated list of variants2022-08-24 09:08:01 CET1982Immuno-AntigenYesYesNoImmunochromatographyQualitativeMembrane-based20LOD1AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.512 false positive result out of 390 negative samples confirmed by RT-PCR)False negatives2.34%3 false negative results out of 128 positive samples confirmed by RT-PCRPrecisionEvaluatedReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity98%Clinical Specificity99%Type of antigenNucleocapsid protein4049SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Method)1388NINGBO LVTANG BIOTECHNOLOGY Co. Ltd.Chinawww.lvtangbio.comYesCommercialisedYesYesManualAntigenNasal swabSARS-CoV678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1321B.1.617.2Delta1323B.1.621Mu2041C.37Lambda1495P.1Gammanon-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 protein2022-09-20 12:46:21 CET5461Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD350TCID50/mlCalibrationEvaluatedAnalytical Sensitivity97.97%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives1.3%False negatives4.5%PrecisionEvaluatedAccuracy97.8%RobustnessEvaluatedClinical Sensitivity95.5%Clinical Specificity98.7%1762SARS CoV-2 Antigen Rapid Test661NovatechTurkeywww.novadiag.comYesCommercialisedYesYesNear POC / POCAntigenNasal swabNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31518P.2Zetanucleocapsid proteinIntended Use The Novacheck SARS-CoV-2 rapid diagnostic test is an immunochromatographic per-patient test based on the sandwich principle, which contains two specific antibodies for qualitative detection of N-protein antigen in human nasal swab samples. This test kit is used to detect the SARS-CoV-2 N-protein antigen that occurs in the acute phase of an infection. An antigen is generally detectable in upper respiratory specimen during the acute phase of the infection (within the first 5 to 7 days from symptom onset). The Novacheck SARS-CoV-2 rapid diagnostic test can be used in symptomatic and asymptomatic people for lay users.2022-08-24 09:08:01 CET1441Immuno-AntigenYesNoImmunochromatographyQualitative15LOD1.7U/mlAnalytical Sensitivity97.54%Analysis of cross reactivityEvaluatedFalse positives0%(0/517 with negative PCR result There was no false positiv sample from the sample)False negatives4.09(14/342 positive PCR result 14 false negative samples did not come out of the sample) PrecisionEvaluatedAccuracy98%RobustnessEvaluatedRobustnessNot evaluatedClinical Sensitivity95%Clinical Specificity100%Type of antigenNucleoprotein2157SARS CoV-2 Antigen Rapid Test1001Novatech Tıbbi Cihaz Ãœrünleri Sanayi ve Ticaret A.Åž.Turkeywww.novadiag.comYesCommercialisedNoNoNear POC / POCAntigenAnterior nasal swabNasal swabNasopharyngeal swabOropharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31518P.2Zetanucleocapsid proteinIntended Use The Novacheck SARS-CoV-2 rapid diagnostic test is an immunochromatographic per-patient test based on the sandwich principle, which contains two specific antibodies for qualitative detection of N-protein antigen in human nasal swab samples. This test kit is used to detect the SARS-CoV-2 N-protein antigen that occurs in the acute phase of an infection. An antigen is generally detectable in upper respiratory specimen during the acute phase of the infection (within the first 5 to 7 days from symptom onset). The Novacheck SARS-CoV-2 rapid diagnostic test can be used in symptomatic and asymptomatic people for lay users.2022-08-24 09:08:01 CET1858Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich15LOD1.7AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%517 with negative PCR result There was no false positiv sample from the sample. 0/517False negatives4.09%342 positive PCR result 14 false negative samples did not come out of the sample. 14/342PrecisionEvaluatedAccuracy98.37%ReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity95.91%Clinical Specificity100%Type of antigenN-protein2868Surety1274NulifeIndianulifecare.inYesCommercialisedNoNoManualNear POC / POCAntigenNasal swabNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu1224B.1.526IotaB.1.526.1B.1.526.2678B.1.1.529Omicronnon-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 proteinspike proteinThe test has been CE approved by Global Euro Accreditation Centre. It is manufactured in India by NuLife (IS09001/2015 & CMP certified company) under contract for E.J. Bodkin + Co, Dublin, Ireland. Accuracy rates are independently assessed and verified by Indian government.2022-08-24 09:08:01 CET2573Immuno-AntigenYesYesNoImmunochromatographySandwich15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.4%98.6False negatives0%100PrecisionEvaluatedAccuracy98.6%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.6%AntigenClinical Specificity100%AntigenType of antigenNucleocapsid protein1199CAT610Oncosem Onkolojik Sistemler San. ve Tic. A.S.Turkeywww.oncosem.comYesCommercialisedYesYesNear POC / POCAntigenNasal swab https://oncosem.com/cat/2022-08-24 09:08:01 CET985Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD0.01AUFalse positives6.25%out of 32 confirmed positive people 2 of them were diagnosed as negative 30 of them succesfulFalse negatives1.96%out of 204 confirmed negative people 4 of them were diagnesed as positive 200 of them succesfulAccuracy97.46%Clinical Sensitivity93.75%Clinical Specificity98.04%1593GeneFinder™ COVID-19 Ag Dipstick702OSANG Healthcare Co. Ltd.South Koreahttp://www.osanghc.com/enYesIn developmentYesYesNear POC / POCOtherAntigenNasopharyngeal swabOropharyngeal swabOtherSARS-CoV689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1321B.1.617.2Delta678B.1.1.529Omicron1518P.2Zetanucleocapsid proteinNasal Swab -> GeneFinder™ COVID-19 Ag Dipstick Self Test: other linkages detected: BA2.0 (Stealth); antigen_epi Monoclonal anti-SARS-CoV-2 nucleoprotein antibody (detection Ab) Epitope Target : 47-173 Monoclonal anti-SARS-CoV-2 nucleoprotein antibody (capture Ab) Epitope arget : 44-1752022-08-24 09:08:01 CET3670Immuno-AntigenYesNoNoImmunoassayQualitativeCapture15Around 30 pathogens tested and confirmed no cross-reactivity, except SARS-CoV. lineages_performances 1. Positve standard material : 750 TCID50/mL 2. B.1.1.7 (Alpha) : 750 TCID50/mL 3. B.1.351 (Beta) : 750 TCID50/mL 4. B.1.617.2 (Delta) : 750 TCID50/mL 5.. P.1 (Gamma) : 750 TCID50/mL 6. B.1.1.529 (Omicron) : 750 TCID50/mLLOD750TCID50/mlCt Value (RdRP/S) 27.67CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives1.04%Predict Positive Value : 98.96%False negatives0.83%Predict Negative Value : 99.17%PrecisionEvaluatedAccuracy99.09%95% CI : 97.89 - 99.61, 545/550ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96%95% CI : 90.16 - 98.43, 96/100Clinical Specificity99.78%95% CI : 98.75 - 99.96, 449/450Type of antigenNucleocapsid protein3100GeneFinder™ COVID-19 Ag Dipstick Self Test702OSANG Healthcare Co. Ltd.South Koreahttp://www.osanghc.com/enYesCommercialisedNoNoNear POC / POCAntigenNasal swabSARS-CoV689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1321B.1.617.2Delta678B.1.1.529Omicron1518P.2Zetanucleocapsid proteinUsing Dipstick Self test, FIND is providing Osang Healthcare with a support package that following an open call for proposals to accelerate the availability of affordable SARS-CoV-2 self-tests(Nasal swab) in low- and middle-income countries (LMICs)2022-08-24 09:08:01 CET2806Immuno-AntigenYesYesNoImmunoassayQualitativeCapture15lineages_performances 1. Positve standard material : 750 TCID50/mL 2. B.1.1.7 (Alpha) : 750 TCID50/mL 3. B.1.351 (Beta) : 750 TCID50/mL 4. B.1.617.2 (Delta) : 750 TCID50/mL 5.. P.1 (Gamma) : 750 TCID50/mL 6. B.1.1.529 (Omicron) : 750 TCID50/mL; antigen_epi Monoclonal anti-SARS-CoV-2 nucleoprotein antibody (detection Ab) Epitope Target : 47-173 Monoclonal anti-SARS-CoV-2 nucleoprotein antibody (capture Ab) Epitope arget : 44-175; other lineages detected: BA2.0 (Stealth)LOD750TCID50/mlRdRP/S gene : Ct value 27.23CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%Predict Postivie Value : 100% (95% CI : 93.79 - 100.00)False negatives1.68%Predict Negative Value : 98.32% (95% CI : 94.08 - 99.54)PrecisionEvaluatedAccuracy99.32%95% CI : 96.25 - 99.88, 146/147ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.67%95% CI : 83.33 - 99.41, 29/30Clinical Specificity100%95% CI : 96.82 - 100.00, 117/117Type of antigenNucleocapsid protein2741GeneFinder™ COVID-19 Ag Plus Rapid Test702OSANG Healthcare Co. Ltd.South Koreahttp://www.osanghc.com/enYesCommercialisedYesYesNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabSARS-CoV689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1321B.1.617.2Delta678B.1.1.529Omicron1518P.2Zetanucleocapsid proteinPublished article 1 : https://www.mdpi.com/2075-4418/12/5/1126 - Title : Validation of GeneFinder COVID-19 Ag Plus Rapid Test and Its Potential Utility to Slowing Infection Waves: A Single-Center Laboratory Evaluation Study - Published article 2: - https://www.mdpi.com/2673-8112/2/3/16 - Title : BA.1 Omicron Variant of SARS-CoV-2: First Case Reported in Calabria Region, Italy * Clinical Performance 1. Direct Nasopharyngeal Swab (Prospective study) Total : 603 Samples (Positive : 151, Negative : 452) Sensitivity: 96.03% (95% CI 91.55 - 98.53) Specificity: 99.78% (95% CI: 98.77 - 99.96) 2. Direct Oropharyngeal Swab (Prospective study) Total : 544 Samples (Positive : 144, Negative : 400) Sensitivity: 90.28% (95% CI 84.34 - 94.12) Specificity: 100.00% (95% CI: 99.05 - 100.00) 3. Direct Nasal Swab (Prospective study) Total : 170 Samples (Positive : 70, Negative : 100) Sensitivity: 92.86% (95% CI 84.34 - 96.91) Specificity: 100.00% (95% CI: 96.30 - 100.00) 4. Stored swab samples in transport media (Retrospective study) Total : 500Samples (Positive : 100, Negative : 400) Sensitivity: 89.00% (95% CI 81.37 - 93.75) Specificity: 100.00% (95% CI: 99.05 - 100.00)2022-08-24 09:08:01 CET2446Immuno-AntigenYesNoNoImmunoassayQualitativeCapture151) Available to detect asymptomatic patients => 90% (63/70) sensitivity and 100% specificity (28/28) in brazil clinical study (Total 70 positive patients and 28 negative out of 98 asymptomatic participants); 2) Available to use stored freeze specimens in transport media (UTM/VTM) : Please refer to manual file. lineages_performances 1. Positve standard material : 750 TCID50/mL 2. B.1.1.7 (Alpha) : 750 TCID50/mL 3. B.1.351 (Beta) : 380 TCID50/mL 4. B.1.617.2 (Delta) : 750 TCID50/mL 5. P.1 (Gamma) : 750 TCID50/mL 6. B.1.1.529 (Omicron) : 750 TCID50/mL. antigen_epi Monoclonal anti-SARS-CoV-2 nucleoprotein antibody (detection Ab) Epitope Target : 47-173 Monoclonal anti-SARS-CoV-2 nucleoprotein antibody (capture Ab) Epitope arget : 44-175. Ohter variants detected: BA2 (Stealth)LOD750TCID50/mlRdRP/S gene : Ct value 27.67CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.68%Predict Postivie Value : 99.32% (95% CI : 96.25 - 99.88)False negatives1.1%Predict Negative Value : 98.69% (95% CI : 97.46 - 99.53)PrecisionEvaluatedAccuracy99%95% CI : 97.85 - 99.54, 597/603ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.0395% CI : 91.55% - 98.53%, 146/151Clinical Specificity99.7895% CI : 98.76% - 99.96%, 451/452Type of antigenNucleocapsid protein2806GeneFinder™ COVID-19 Ag Self Test702OSANG Healthcare Co. Ltd.South Koreahttp://www.osanghc.com/enYesCommercialisedNoNoNear POC / POCAntigenNasal swabSARS-CoV689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1321B.1.617.2Delta1518P.2Zeta678B.1.1.529Omicronnucleocapsid proteinMFDS 22-106 approved by Korea FDA A. OI-01SA-SE : CE COC (Certification No. 1434-IVDD-082-2022) B. OI-01SA-SH : FDA EUA (EUA No. 220037) C. G-Tech COVID-19 Ag Rapid Test : ANVISA (No. 0440463227)2022-08-24 09:08:01 CET2511Immuno-AntigenYesYesNoImmunoassayQualitativeCapture15antigen_epi Monoclonal anti-SARS-CoV-2 nucleoprotein antibody (detection Ab) Epitope Target : 47-173 Monoclonal anti-SARS-CoV-2 nucleoprotein antibody (capture Ab) Epitope arget : 44-17; lineages_performances 1. Positve standard material : 750 TCID50/mL 2. B.1.1.7 (Alpha) : 750 TCID50/mL 3. B.1.351 (Beta) : 380 TCID50/mL 4. B.1.617.2 (Delta) : 750 TCID50/mL 5.. P.1 (Gamma) : 750 TCID50/mL 6. B.1.1.529 (Omicron) : 750 TCID50/mL; other lineages detected: BA2.0 (Stealth)LOD750TCID50/mlCt value (RdRP/S) 27.23CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%Predict Postivie Value : 100% (95% CI : 93.79 - 100.00)False negatives1.68%Predict Negative Value : 98.32% (95% CI : 94.08 - 99.54)PrecisionEvaluatedAccuracy98.8795% CI : 95.97 - 99.69 - (175/177)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.67%95% CI: 88.64 – 99.08 - (58/60)Clinical Specificity100%95% CI: 96.82 – 100.00 - (117/117)Type of antigenNucleocapsid protein1379Vstrip Covid-19 Antigen Rapid Test658Panion & BF Biotech Inc.Taiwan ROCwww.pbf.com.tw/YesCommercialisedNoNoNear POC / POCAntigenNasal swabOthernucleocapsid protein2022-08-24 09:08:01 CET1145Immuno-AntigenYesNoImmunoassayQualitativeColloidal gold10LOD157U/mlFalse positives1.8%False negatives8.7%Accuracy96.2%Clinical Sensitivity91.3%Type of antigennucleoprotein1270Pantest Coronavirus Ag599Pantest SAPortugalwww.pantest.ptYesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swabOropharyngeal swab2022-08-24 09:08:01 CET1045Immuno-AntigenYesImmunoassayQualitative20Clinical Sensitivity96%Clinical Specificity100%2271Pantest Coronavirus Ag (Nasopharyngeal Swab)599Pantest SAPortugalwww.pantest.ptYesCommercialisedYesYesNear 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 proteinRegistered in Infarmed in Portugal2022-08-24 09:08:01 CET1972Immuno-AntigenYesNoImmunochromatographyQualitativeCapture15LOD39.51AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.92%In 326 samples evaluated, 3 tests are false positivesFalse negatives3.98%In 326 samples, 13 are false negativesPrecisionEvaluatedAccuracy97.9%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.7%Clinical Specificity99.1%Type of antigenNucleoprotein2243PCL COVID19 Ag Gold202PCL Inc.South Koreawww.pclchip.com/YesCommercialisedNoNoNear POC / POCAntigenNasal swabNasopharyngeal swabSalivaSARS-CoV-2678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid proteinCompatible with Saliva specimen, NP Swab Specimen & Nasal Specimen2022-08-24 15:42:41 CET3704Immuno-AntigenYesNoNoImmunochromatographyQualitativeMembrane-basedColloidal gold10LOD562TCID50/mlCalibrationEvaluatedAnalytical Sensitivity100%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives0%False negatives9.7%PrecisionEvaluatedAccuracy97.52%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90.83%AntigenClinical Specificity99.5%AntigenType of antigenNucleoprotein3694PCL SELF TEST - COVID19 Ag1043PCL Inc.South Koreawww.pclchip.comYesCommercialisedNoNoManualAntigenNasal swabSalivaSARS-CoV678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1137B.1.429Epsilon1223B.1.525Eta1320B.1.617.1Kappa1321B.1.617.2Delta1495P.1Gammanucleocapsid protein2022-08-24 09:08:01 CET3377Immuno-AntigenYesYesNoImmunochromatographyQualitativeMembrane-basedColloidal gold10LOD562TCID50/mlAnalytical Sensitivity100%Analytical Specificity100%False positives0.3%False negatives9.9%Accuracy97.31%Clinical Sensitivity90.1%Clinical Specificity99.68%2116SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Immunochromatographic Assay)981PerGrande BioTech Development Co. Ltd.Chinawww.pergrande.com.cnYesCommercialisedYesYesNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gammanucleocapsid proteinPlease review, thanks.2022-08-24 09:08:01 CET1806Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold20LOD20AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.89%False negatives5.72%PrecisionEvaluatedAccuracy96.41%( 95.24%-97.30%)（Antigen）ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.28%( 92.33%-95.76% )（Antigen）Clinical Specificity99.11%( 97.94%-99.62%)（Antigen）Type of antigenNucleoprotein1823RAPIDIGEN COVID19 AG IMMUNOASSAY830Pharmaline ASTurkeypharmaline.com.tr/enYesCommercialisedNoNoAutomatedAntigenNasal swabNasopharyngeal swabOropharyngeal swabThroat swab1. Product Information Product Name COVID-19 Ag Test Trade Name Rapidigen Product Code PHRPD 2020 Manufacturer Pharmaline Saglik Hizmetleri Ticaret A.S. Address Headquarter: Atatürk Caddesi, Atatürk Caddesi Konutlari, No: 43 A Blok Daire 6 Sahrayicedit-Kadiköy, 34734 Istanbul, Turkey. Factory: Bati Sitesi Mah. 2308 Cad. Gersan Sit. No.: 52, Yenimahalle, Ankara, Turkey. 2. Product Description Single-use cassette test for professional in vitro diagnostic usage. 3. Classification according to 98/79/EC In-vitro Diagnostic Medical Devices Professional Use IVD, 98/79/EC. 4. Intended Use Rapidigen COVID-19 Ag Test is used for in vitro qualitative detection of novel coronavirus antigen in human throat swabs or nasal swabs. 5. Sample Type Human throat or nasal swab. 6. Reagents This test included 2019- nCoV antibody, anti-chicken IgY polyclonal antibody, chicken IgY and colloidal gold conjugate. 7. Analysis Method Rapidigen COVID-19 Ag Test is a rapid, qualitative, immunochromatographic assay for detecting the 2019-nCoV antigen in human oropharyngeal or nasopharyngeal swabs. The sample will be under the capillary action to move forward along the test cassette when it contains a new antigen crown at a detectable level. The antigens with colloidal gold labeling are coronavirus monoclonal antigens—the complex immune fixes on the membrane. If the coronavirus monoclonal antibody forms the colored line, the visualization is positive for the coronavirus antigen; If the line does not show color, the result is negative. A colored line will always appear in the control line region, indicating that the proper specimen volume has been added and membrane wicking has occurred. 8. Performance Evaluation Rapidigen COVID-19 Ag Test has been evaluated using clinical samples. PCR methods are used to compare Rapidigen COVID- 19 Ag Test, and the following results are obtained.   8.1. Sensitivity & Specificity Rapidigen COVID - 19 Ag Test PCR Test Total Positive Negative Positive 164 3 167 Negative 12 438 450 Total 176 441 617 Analysis of coincidence rate of Rapidigen COVID-19 Ag Test and PCR Test in nasal samples: Sensitivity: 164/ (164+12) × 100% = 93.18% Specificity: 438 / (3+438) × 100% = 99.32% Accuracy: (164+438) / (164+12+3+438) × 100% = 97.57% 8.2. Interferences Samples containing Mucin, Hemoglobin, Histamine Hydrochloride, Human albumin, α- interferon, Lopinavir, Tobramycin, Ribavirin, Tramadol, Azithromycin, Meropenem, Oseltamivir, Benzocaine, Peramivir in different concentrations do not affect the test result. Test results present no interference. 8.3. Cross-Reactivity This product does not cross-react with pathogens of HKU1, OC43, NL63, 229E, MERS Coronavirus, Human Metapneumovirus, Influenza A virus H1N1, Influenza A virus H3N2, Influenza A virus H5N1, Influenza A virus H7N9, Influenza B virus, Mycoplasma pneumonia, Rhinovirus A, Rhinovirus B, Rhinovirus C, Staphylococcus aureus, Adenovirus 1, Adenovirus 2, Adenovirus 3, Adenovirus 4, Adenovirus 5, Adenovirus 7, Adenovirus 55, Enterovirus A, Enterovirus B, Enterovirus C, Enterovirus D, EB Virus, Measles virus, Human cytomegalovirus, Rotavirus, Norovirus, Mumps virus, Varicella-zoster virus, Respiratory syncytial virus, Mycoplasma pneumonia, and Escherichia Coli. 9. Packaging Consumer package includes: a) Primary package: An aluminum pouch including test cassette and silica gel. b) Secondary package: Carton box including tests in aluminum pouches, sterile swab, sample extraction tube, extraction tube tips, extraction reagent (R), workstation and instructions for use sheet. Packing instructions, labeling and symbols are prepared according to the 98/79/EC in-vitro diagnostic medical device directive, harmonized standards. c) The transportation package is a carton package covered with strong nylon film to provide extra protection for the products during transportation and storage. 10. Kit components Test cassettes, sterile swab, sample extraction tube, extraction tube tips, extraction reagent (R), workstation and instructions for use. 11. Storage & Shelf Life Store at 4 - 30°C (39 - 86°F); maximum 24 months 12. Transportation Truck or aircraft freight. Transport conditions should be between 4-30°C (39 - 86°F).2022-08-24 09:08:01 CET1501Immuno-AntigenYesNoImmunochromatographyQualitativeMagnetic Electrochemical15LOD30AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positivesSample contamination or not following the IFU protocolFalse negativesSample contamination or not following the IFU protocolPrecisionEvaluatedAccuracy98%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93%Clinical Specificity99%3014INDICAID COVID-19 Rapid Antigen Test Kit1339PHASE Scientific International LimitedHong Kong S.A.Rwww.phasescientific.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1321B.1.617.2Delta1323B.1.621Mu678B.1.1.529Omicronnucleocapsid proteinNone2022-08-24 09:08:01 CET2720Immuno-AntibodyYesNoImmunochromatographyQualitativeSandwich20Ares(2022)1534514LOD140TCID50/mlswabCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%No false positive detectedFalse negatives0%No false negative detectedPrecisionEvaluatedAccuracy100%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96%AntigenClinical Specificity100%AntigenType of antigenNucleocapsid protein1611Gmate® COVID-19 Ag715PhilosysSouth Koreahttp://www.philosys.com/YesCommercialisedNoNoNear POC / POCAntigenNasal swab2022-08-24 09:08:01 CET1291Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD5.07U/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracy96.67%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity91.11%1854Gmate® COVID-19 Ag Saliva715PhilosysSouth Koreahttp://www.philosys.com/YesCommercialisedNoNoManualAntigenSalivanucleocapsid proteinN.A2022-08-24 09:08:01 CET1534Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD5.07AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives-False negatives-PrecisionEvaluatedAccuracy98.87%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.83%Clinical Specificity99.6%Type of antigenNucleoprotein2830SoluM COVID 19-Ag1262PhilosysSouth Koreawww.philosys.comYesCommercialisedNoNoNear POC / POCAntigenNasal swab678B.1.1.529OmicronVarious variants of SARS-CoV-2 virus are emerged majorly due to the mutation of Spike protein(S) • Therefore, accuracy of PCR test, vaccine are affected as they aim at Spike protein • On the other hand, accuracy of Gmate COVID-19 Ag test kit is not affected as it aims at Nucleocapsid (N) for its test2022-08-24 09:08:01 CET2535Immuno-AntigenYesYesNoImmunoassayQualitative15LOD5.07U/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives9.09%10 out of 110False negatives9.09%100 out of 110PrecisionEvaluatedAccuracy96.67%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95%Clinical SpecificityschwalbachType of antigenSpike protein2829SoluM COVID-19 Ag Saliva1262PhilosysSouth Koreawww.philosys.comYesCommercialisedNoNoManualAntigenSaliva678B.1.1.529Omicronspike proteinVarious variants of SARS-CoV-2 virus are emerged majorly due to the mutation of Spike protein(S) • Therefore, accuracy of PCR test, vaccine are affected as they aim at Spike protein • On the other hand, accuracy of Gmate COVID-19 Ag test kit is not affected as it aims at Nucleocapsid (N) for its test2022-08-24 09:08:01 CET2534Immuno-AntigenYesYesNoImmunoassayQualitative15LOD5.07AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives9.09%10 out of 110False negatives9.09%100 out of 110PrecisionEvaluatedAccuracy96.67%Accuracy98.87%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.84%Clinical SpecificityschwalbachType of antigenNucleocapsid protein2672(SARS-CoV-2) Antigen Rapid Test COVIDENT COVID-191025Pierenkemper GmbHGermanyhttps://covident.health/YesCommercialisedYesYesNear 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.1.526.2678B.1.1.529Omicron1518P.2Zetanucleocapsid proteinTest is listed by the German Federal Institute for Drugs and Medical Devices as the SARS-CoV-2 Antigen (List of antigen rapid tests for professional use (§1 sentence 1 TestV, reimbursement) according to Test Law Regulation.2022-08-24 09:08:01 CET2377Immuno-AntigenYesNoNoImmunochromatographyQualitativeMembrane-based15LOD425TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.78%test has total sensitivity (PPA) of 99.22% with 4 different specimensFalse negatives0.11%test has total specificity (NPA) of 99.89% with 4 different specimensPrecisionEvaluatedAccuracy99.41%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.27%Clinical Specificity100%Type of antigenNucleocapsid protein2197(SARS-CoV-2) Antigen Rapid Test COVIDENT COVID-19 / Saliva1025Pierenkemper GmbHGermanyhttps://covident.health/YesCommercialisedNoNoLab-basedManualNear 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.2Zeta678B.1.1.529Omicronnucleocapsid proteinTest is listed by the German Federal Institute for Drugs and Medical Devices as the SARS-CoV-2 Antigen (List of antigen rapid tests for professional use (§1 sentence 1 TestV, reimbursement) according to Test Law Regulation.2022-08-24 09:08:01 CET1898Immuno-AntigenYesNoNoImmunochromatographyQualitativeOther10LOD250TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.78%test has total sensitivity (PPA) of 99.22% with 4 different specimensFalse negatives0.11%test has total specificity (NPA) of 99.89% with 4 different specimensPrecisionEvaluatedAccuracy99.41%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.27%Clinical Specificity100%Type of antigenNucleocapsid protein2583POLOFLUOR 21177Polonord Adeste SrlItalyYesCommercialisedNoNoAntigenNasopharyngeal swabnucleocapsid proteinPOLOFLUOR 2 is a membrane fluorescence qualitative test for the detection of SARS-Cov-2 nucleocapsid protein antigen in the human rhinopharyngeal swab sample. The COVID-19 antigen test cassette (nasopharyngeal swab) is capable of detecting SARS-COV-2 heat inactivated viral strain from 1 x 102 TCID50/ml. Other studies on performance characteristics: - Detection Level Determination - Interfering Substances - Specificity Testing with Strains - Dose Hook Study - Variability (Inter/Intra/Day to day assay) - Reading Time Flex Study - Specimen Volume Flex Study - Open Pouch Stability Study - Accelerated Stability Study2022-08-24 09:08:01 CET2288Immuno-AntigenYesImmunochromatographyQualitativeFluorescence10CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives5.4%8/148False negatives0.46%1/217PrecisionNot evaluatedAccuracy97.5%ReproducibilityNot evaluatedRobustnessNot evaluatedClinical Sensitivity96.4%Clinical Specificity99.3%Type of antigenNucleocapsid protein1271Exdia COVID-19 Ag637Precision BiosensorSouth Koreawww.precision-bio.com/en/YesCommercialisedYesYesNear POC / POCAntigenNasopharyngeal swab2022-08-24 09:08:01 CET1046Immuno-AntigenYesImmunoassayQualitative20Clinical Sensitivity93.9%Clinical Specificity98%2299SURE STATUS COVID-19 ANTIGEN CARD TEST1072PREMIER MEDICAL CORPORATION PRIVATE LIMITEDIndiawww.premiermedcorp.comYesCommercialisedNoNoManualNear POC / POCAntigenNasopharyngeal swabnucleocapsid proteinLOD: 250 pfu/ml ~ 353 TCID50/ml2022-08-24 09:08:01 CET2000Immuno-AntigenYesNoImmunochromatographyQualitative20LOD353AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives3%False negatives9%PrecisionEvaluatedAccuracy91% SENSTIVITY AND 97% SPECIFICITY In comparison with the RT-PCRReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity91%Clinical Specificity97%Type of antigenNucleoprotein12022019-nCoV Antigen Device575Prestige Diagnostics UK Ltd.United Kingdomwww.prestigediagnostics.co.ukYesCommercialisedNoNoNear POC / POCAntigenNasal swabSaliva2022-08-24 09:08:01 CET988Immuno-AntigenYesNoImmunoassayQualitative15False positives0.8%False negatives3.6%Accuracy98%Clinical Sensitivity96.4%2686COVID-19 Antigen Professional Rapid Test1228PRIMA Lab SASwitzerlandhttps://primahometest.com/YesCommercialisedNoNoNear POC / POCAntigenAnterior nasal swabNasopharyngeal swabSARS-CoV689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1321B.1.617.2Delta678B.1.1.529Omicronnucleocapsid proteinCOVID-19 Antigen Professional Rapid Test was tested with the following viral strains, no cross-reaction was observed at the following concentrations: - MERS 1.17x10^5 TCID50/mL - NL63 4.68x10^4 TCID50/mL - OC43 5.01x10^5 TCID50/mL - 229E 1.41x10^5 TCID50/mL - Adenovirus 7A (species B) 1.02x10^8 TCID50/mL - Parainfluenza Virus Type 1 9.12x10^8 TCID50/mL - Parainfluenza Virus Type 2 4.17x10^5 TCID50/mL - Parainfluenza Virus Type 3 2.57x10^8 TCID50/mL - Parainfluenza Virus Type 4 1.41x10^5 TCID50/mL - Rhinovirus 1A 1.70x10^5 TCID50/mL - Influenza A H1N1 New Caledonia/20/99 4.17x10^5 TCID50/mL - Influenza B Florida/02/06 4.68x10^4 TCID50/mL - Respiratory Syncytial Virus Type B (RSV-B) CH93-18(18) 1.55x10^4 TCID50/mL - Enterovirus Type 71 2003 Isolate (cell line LLC-mk2) 1x10^5.86 TCID50/mL - Human Metapneuomovirus 16 (hMPV-16) Type A1 IA10-2003 3.8x10^6 TCID50/mL - Recombinant Nucleocapsid SARS-CoV (2003) 1.24 mg/mL2022-08-24 09:08:01 CET2391Immuno-AntigenYesNoNoImmunochromatographyQualitative15LOD102000TCID50/ml600 pg/mL of recombinant nucleocapsid proteinAnalysis of cross reactivityEvaluatedFalse positivesN.A.False negativesN.A.PrecisionEvaluatedAccuracy95.1%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90.3%Clinical Specificity100%Type of antigenNucleocapsid protein2685COVID-19 Antigen Rapid Test1228PRIMA Lab SASwitzerlandhttps://primahometest.com/YesCommercialisedYesYesNear POC / POCAntigenNasopharyngeal swab20A.23.11518P.2Zeta689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1321B.1.617.2Deltanucleocapsid proteinCOVID-19 ANTIGEN RAPID TEST was tested with the following viral strains, no cross-reaction was observed at the following concentrations: Adenovirus type 3 3.16 x 10^4 TCID50/ml Influenza B 3.16 x 10^6 TCID50/ml Adenovirus type 7 1.58 x 10^5 TCID50/ml Human Rhinovirus 2 2.81 x 10^4 TCID50/ml Human Coronavirus OC43 1 x 10^6 TCID50/ml Human Rhinovirus 14 1.58 x 10^6 TCID50/ml Human Coronavirus 229E 5 x 10^5 TICID50/ml Human Rhinovirus 16 8.89 x 10^6 TCID50/ml Human Coronavirus NL63 1 x 10^6 TICID50/ml Masern-Virus 1.58 x 10^4 TCID50/ml Human Coronavirus HKU1 1 x 10^6 TICID50/ml Mumps-Virus 1.58 x 10^4 TCID50/ml MERS COV Florida 1.17 x 10^4 TICID50/ml Parainfluenza virus 2 1.58 x 10^7 TCID50/ml Influenza A H1N1 3.16 x 10^5 TCID50/ml Parainfluenza virus 3 1.58 x 10^8 TCID50/ml Influenza A H3N2 1 x 10^5 TCID50/ml Respiratory syncytial virus 8.89 x 10^4 TCID50/ml Hangzhou Alltest Biotech CO., Ltd is the contract OEM manufacturer of COVID-19 Antigen Rapid Test which is already on the Common list of rapid antigen tests (JRC Device ID 1257).2022-08-24 09:08:01 CET2390Immuno-AntigenYesNoImmunochromatographyQualitativeMembrane-based15LOD100TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positivesN.A.False negativesN.A.PrecisionEvaluatedAccuracy99.6%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.4%Clinical Specificity99.9%Type of antigenNucleocapsid protein321P4DETECT COVID-19 Ag1349PRIME4DIA Co. Ltd.YesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swabOropharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1137B.1.429Epsilon1321B.1.617.2Delta678B.1.1.529Omicronnucleocapsid proteinP4DETECT COVID-19 Ag is a qualitative, lateral flow immunoassay for the detection of specific antigens Coronavirus in nasopharyngeal specimens. In this test, antibody specific to the SARS-CoV-2 antigen is separately coated on the test line regions of the test device. During testing, the extracted specimen reacts with the antibody to SARS-CoV-2 that are coated onto particles. The mixture migrates up the membrane to react with the antibody to SARS-CoV-2 on the membrane and generate one colored lines in the test regions. If SARS-CoV-2 antigens are present in the specimen a colored test line would be visible in the result window. If SARS-CoV-2 antigens are not present in the specimen, then no color appears in the test line.2022-08-24 09:08:01 CET269Immuno-AntigenYesNoNoImmunochromatographyQualitativeMembrane-based20LOD800TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0AUFalse negatives3.3AUPrecisionEvaluatedAccuracy98.33%AntigenReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity96.67%AntigenClinical Specificity100%AntigenType of antigenNucleocapsid protein2782PathFlow™ COVID-19 Rapid Antigen PRO17293Primer Design LimitedUnited Kingdomhttps://novacyt.com/product/pathflow-covid-19-rapid-antigen-test-pro/YesCommercialisedNoNoLab-basedManualAntigenNasal swabNasopharyngeal swabSARS-CoV-2689B.1.1.7Alpha1032B.1.351Beta1223B.1.525Eta1495P.1Gammanucleocapsid proteinNone2023-03-30 10:57:26 CET21026Immuno-AntigenYesNoNoImmunochromatographyQualitativeEnzyme-linkedAbsorbance15LOD100TCID50/mlCalibrationNot evaluatedAnalytical Sensitivity97.6%Nasopharyngeal swabAnalytical Specificity99.7%Nasopharyngeal swabAnalytical Specificity99.9%Nasal swabAnalysis of cross reactivityEvaluatedFalse positives2AUNasal swabFalse negatives8AUNasal swabPrecisionEvaluatedAccuracy99%>99%RobustnessEvaluatedClinical Sensitivity93.5%Nasal swabClinical Specificity99.3%Nasal swab25543PathFlow™ COVID-19 Rapid Antigen PRO17298Primer Design LimitedUnited Kingdomhttps://novacyt.com/product/pathflow-covid-19-rapid-antigen-test-pro/YesCommercialisedNoNoLab-basedManualAntigenNasal swabNasopharyngeal swabSARS-CoV-2689B.1.1.7Alpha1032B.1.351Beta1223B.1.525Eta1495P.1Gammanucleocapsid proteinNone2023-04-03 10:08:14 CET21047Immuno-AntigenYesNoNoImmunochromatographyQualitativeEnzyme-linkedAbsorbance15LOD100TCID50/mlCalibrationNot evaluatedAnalytical Sensitivity97.6%Nasopharyngeal swabAnalytical Specificity99.7%Nasopharyngeal swabAnalytical Specificity99.9%Nasal swabAnalysis of cross reactivityEvaluatedFalse positives2AUNasal swabFalse negatives8AUNasal swabPrecisionEvaluatedAccuracy99%>99%RobustnessEvaluatedClinical Sensitivity93.5%Nasal swabClinical Specificity99.3%Nasal swab2482COVID-19 Antigen Rapid Detection Kit (Colloidal Gold)1127Pro-med (Beijing) Technology Co. Ltd.Chinawww.pmdt.com.cnYesCommercialisedNoNoManualAntigenNasal swabOropharyngeal swab689B.1.1.7Alphanucleocapsid proteinNone2022-08-24 09:08:01 CET2185Immuno-AntigenYesNoImmunochromatographyQualitativeOtherColloidal gold15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.56%Nasal swabFalse positives0.56%Oropharyngeal swabFalse negatives6.02%Nasal swabFalse negatives5.26%Oropharyngeal swabPrecisionEvaluatedAccuracy97.12%Nasal swabAccuracy97.44%Oropharyngeal swabReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.98%Nasal swabClinical Sensitivity94.74%Oropharyngeal swabClinical Specificity99.44%Nasal swabClinical Specificity99.44%Oropharyngeal swabType of antigenNucleocapsid protein2636COVID-19 Antigen Rapid Detection Kit (Colloidal Gold)1205Pro-med (Beijing) Technology Co. Ltd.Chinawww.pmdt.com.cnYesCommercialisedNoNoManualAntigenNasal swab689B.1.1.7Alpha1321B.1.617.2Delta678B.1.1.529Omicronnucleocapsid protein-2022-08-24 09:08:01 CET2341Immuno-AntigenYesImmunochromatographyQualitativeOtherColloidal gold15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.56%False negatives6.02%PrecisionEvaluatedAccuracy97.12%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.98%Clinical Specificity99.44%Type of antigenNucleocapsid protein1495Rapid Test Ag 2019-nCov688Prognosis BiotechGreecehttps://www.prognosis-biotech.comYesCommercialisedYesYesNear 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 proteinAdditional information provided upon request2022-08-24 09:08:01 CET1245Immuno-AntigenYesNoNoImmunoassayQualitativeSandwich15LOD358.75TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.26%1/385 - Nasal specimen False positives0.42%2/478 - Nasopharyngeal specimenFalse negatives1.41%2/142 - Nasal specimen False negatives4.44%6/135 - Nasopharyngeal specimenPrecisionEvaluatedAccuracy99.43%Nasal specimenAccuracy98.7%Nasopharyngeal specimenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.59%Nasal specimenClinical Sensitivity95.56%Nasopharyngeal specimenClinical Specificity99.74Nasal specimenClinical Specificity99.58%Nasopharyngeal specimenType of antigenNucleocapsid protein1733DROP-TECH768Promoitalia Group SpAItalywww.webpromoitalia.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabSalivanucleocapsid protein2022-08-24 09:08:01 CET1412Immuno-AntigenYesNoImmunoassayQualitative15LOD320AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positivesBased on the accuracy confirmed by studies, fales positives are not likely to occur.False negativesBased on the accuracy confirmed by studies, fales negatives are not likely to occur.PrecisionEvaluatedAccuracy98%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.59%Type of antigennucleoprotein1341SARS-CoV-2 Antigen Rapid Test286Qingdao Hightop Biotech Co. Ltd.Chinawww.hightopbio.comYesCommercialisedYesYesManualNear POC / POCAntigenAnterior nasal swabNasal swabNasopharyngeal 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 proteinHIGHTOP SARS-COV-2 ANTIGEN RAPID TEST, CAN BE USED FOR SELF-TESTING AND FOR PROFESSIONAL TESTING, CONTACT FOR ORDERS ALLEN@HIGHTOPBIO.COM2022-11-17 09:51:03 CET5319Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, DoubleColorimetry15LOD8TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives%False negatives1.96%PrecisionEvaluatedAccuracy99.5%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.04%Clinical Specificity100%Type of antigenNucleocapsid protein2191SARS-CoV-2 Antigen Rapid Test (Immunochromatography)286Qingdao Hightop Biotech Co. Ltd.Chinawww.hightopbio.comYesCommercialisedNoNoManualAntigenNasal 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 CET1892Immuno-AntigenYesImmunochromatography15LOD2000AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives5AUFalse negatives0.98%1/102PrecisionEvaluatedAccuracy98%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95%Clinical Specificity99%Type of antigenNucleoprotein2754SARS-CoV-2/Flu A+B/RSV Antigen Rapid Test286Qingdao Hightop Biotech Co. Ltd.Chinawww.hightopbio.comYesCommercialisedYesYesNear 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 proteinNone2022-08-24 09:08:01 CET2459Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich, Double15LOD10000TCID50/mlRSV Type ALOD525000TCID50/mlFlu BLOD12200TCID50/mlFlu ALOD160TCID50/mlSARS-CoV-2LOD10000TCID50/mlRSV Type BCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.25SARS-CoV-2False positives2.13%RSVFalse positives2.16%Influenza BFalse positives2.74%Influenza AFalse negatives5.88%RSVFalse negatives6.38%Influenza BFalse negatives6.98%Influenza AFalse negatives5SARS-CoV-2PrecisionEvaluatedAccuracy96.88%RSVAccuracy96.77%Influenza BAccuracy96.3%Influenza AAccuracy98.8%SARS-CoV-2ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%SARS-CoV-2 at Ct lower or equal to 25Clinical Sensitivity93.02%Influenza AClinical Sensitivity93.62%Influenza BClinical Sensitivity94.12%RSVClinical Specificity99.75%SARS-CoV-2Clinical Specificity97.26%Influenza AClinical Specificity97.84%Influenza BClinical Specificity97.84%RSVType of antigenNucleocapsid protein2269QuickVue SARS Antigen FIA216Quidel CoorporationUnited Stateswww.quidel.comYesCommercialisedNoNoManualNear POC / POCAntigenNasal swab689B.1.1.7Alpha1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.3nucleocapsid proteinAccuracy (98,8%) as overall percent agreement with PCR; UK B1.1.7 (D3L+S235F+R230K+S235F+G240R+S235F+S194L) / SA 501Y.V2 (T205I) / UK+SA B.1.1.7/501Y.V2 (D3L+T205I+S235F) / Bra P1 501Y.V3 (I292I+R 203K+G204R+A119S+M234)/ India I/A3I (P13L)/ Delta B.1617.2 (G478K.V1)/ Delta plus AY1 (D63G+D377Y+G215+R230M)2022-08-24 09:08:01 CET1970Immuno-AntigenYesNoImmunochromatographyQualitativeSandwichFluorescence10LOD7570TCID50/mlAnalysis of cross reactivityEvaluatedFalse positives0.7%False negatives3.4%Accuracy98.45%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.7%Clinical Specificity99.3%Type of antigenNucleocapsid protein2682Sofia Flu + SARS Antigen FIA1226Quidel CoorporationUnited Stateswww.quidel.comYesCommercialisedNoNoAutomatedLab-basedNear POC / POCOtherAntigenAnterior nasal swabNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.3nucleocapsid proteinFurther information on detection of SARS CoV-2 variants available from the manufacturer / There were no Influenza PCR-positive specimens at time of clinical evaluation. Thus, sensitivity of the Influenza target could not be calculated / Detection via Immune-Fluorescence2022-08-24 09:08:01 CET2387Immuno-AntigenYesYesImmunoassayQualitativeSandwichFluorescence15LOD91.7TCID50/mlSARS CoV-2LOD50TCID50/mlFlu ALOD1.9TCID50/mlFlu BCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%SARS CoV-2 Target False positives0%Flu B-TargetFalse positives0%Flu A-TargetFalse negatives4.8%SARS CoV-2 Target False negatives0%Flu B-Target: no PCR positives at time of clinical studyFalse negatives0%Flu A-Target: no PCR positives at time of clinical studyPrecisionNot evaluatedAccuracy100%Flu BAccuracy100%Flu AAccuracy98.8%SARS CoV-2ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.2%SARS CoV-2Clinical Specificity100%Flu AClinical Specificity100%Flu BClinical Specificity100%SARS CoV-2Type of antigenNucleocapsid protein1097Sofia SARS Antigen FIA216Quidel CoorporationUnited Stateswww.quidel.comYesCommercialisedYesYesNear POC / POCAntigenNasal swabNasopharyngeal swabnucleocapsid protein2022-08-24 09:08:01 CET878Immuno-AntigenYesYesImmunoassayQualitativeFluorescence15LOD113TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives3.3%Accuracy99.5%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.7%Clinical Specificity100%Type of antigenNucleoprotein1846RIDA®@QUICK SARS-CoV-2 Antigen217R-Biopharm AGGermanywww.r-biopharm.comYesCommercialisedNoNoManualNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabThroat swabnucleocapsid proteinN/A2022-08-24 09:08:01 CET1522Immuno-AntigenYesNoImmunochromatographyQualitativeColorimetry20LOD237AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positivesN/AFalse negativesN/APrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.7%ct<30 Clinical Specificity97.4%Type of antigenNucleoprotein2214RIDA®QUICK SARS-CoV-2 Antigen217R-Biopharm AGGermanywww.r-biopharm.comYesCommercialisedNoNoManualAntigenNasal swabNasopharyngeal swabnucleocapsid proteinDer verwendete polyklonale Antikörper ist gegen das Nukleocapsidprotein gerichtet und insofern von den meisten Mutationen, die im Spikeprotein statfinden, nicht beeinflusst.2022-08-24 09:08:01 CET1915Immuno-AntigenYesNoImmunochromatographyQualitativeMembrane-based30LOD237AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positivesbei hohen Konzentrationen an S.aureus (> 5 Mio Keime/ml)False negativesbei Antigenkonzentrationen unterhalb 237 TCID50/mlPrecisionEvaluatedAccuracy95%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93%Clinical Specificity97%Type of antigenNucleoprotein5812SARS-CoV-2 Antigen Rapid Test (Nasal Swab)1375Rapid Labs Ltd.United Kingdomwww.rapidlabs.co.ukYesCommercialisedYesYesNear 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-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 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-19.2023-01-09 10:03:34 CET20273Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwichImmunofluorescence15LOD100AUCalibrationEvaluatedAnalytical Sensitivity95.3%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives0.047AUFalse negativesAUPrecisionEvaluatedAccuracy97.7%RobustnessEvaluatedClinical Sensitivity95.3%Clinical Specificity100%1962BIOCREDIT COVID-19 Ag220RapiGEN Inc.South Koreawww.rapigen-inc.com/engYesCommercialisedYesYesNear POC / POCAntigenNasopharyngeal swabSARS-CoV678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1321B.1.617.2Delta1323B.1.621Mu1495P.1Gamma1518P.2Zetanucleocapsid proteinBIOCREDIT COVID-19 Ag is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 antigen in human nasopharynx. This test is for in-vitro professional diagnostic use and intended as an aid to early diagnosis of SARS-CoV-2 infection in patient with clinical symptoms. It provides only an initial screening test result and more specific alternative diagnosis methods should be performed in order to confirm COVID-19 infection. BIOCREDIT COVID-19 Ag has been evaluated with clinical nasopharyngeal specimens which were identified with the RT-PCR test in Korea and Romania.2022-10-05 14:00:56 CET3931Immuno-AntigenYesNoNoImmunochromatographyQuantitativeMembrane-based10LOD562PFU/mL1963BIOCREDIT COVID-19 Ag Test Nasal220RapiGEN Inc.South Koreawww.rapigen-inc.com/engYesCommercialisedYesYesNear POC / POCAntigenNasal swabSARS-CoV678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1321B.1.617.2Delta1323B.1.621Mu1495P.1Gamma1518P.2Zetanucleocapsid proteinBIOCREDIT COVID-19 Ag Test Nasal is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 antigen in human nasal specimen. This test is for in-vitro professional diagnostic use and intended as an aid to early diagnosis of SARS-CoV-2 infection in patient with clinical symptoms. It provides only an initial screening test result and more specific alternative diagnosis methods should be performed in order to confirm COVID-19 infection. BIOCREDIT COVID-19 Ag Test Nasal has been evaluated with clinical nasal specimens which were identified with teh RT-PCR test in Korea.2022-10-17 12:59:05 CET5207Immuno-AntigenYesNoNoImmunochromatographyQualitativeMembrane-based15LOD276000TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%0 of 400False negatives7.8%10 of 128PrecisionEvaluatedAccuracy98.1%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.2%Clinical Specificity100%Type of antigenNucleocapsid protein1238COVID-19 Antigen test631RDSM nvBelgiumwww.rdsm.eu/YesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swabOropharyngeal swab https://www.rdsm.eu/covid19-Antigen-test.html2022-08-24 09:08:01 CET1021Immuno-AntigenYesNoImmunoassay15Clinical Sensitivity99.9%Clinical Specificity80.2%Clinical Specificity97.6%(CT < 30)40862019-nCoV Ag & FLU A/B ComboRapid Test1302Reach Diagnostic (Wuhan) Biotech Co. Ltd.Chinahttp://www.reachdiagnostic.com.cnYesCommercialisedNoNoNear POC / POCAntigenNasal swabInfluenza AInfluenza BSARS-CoV-2678B.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 protein2022-09-29 09:38:17 CET3895Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold10LOD50TCID50/mlCalibrationEvaluatedAnalytical Sensitivity98.8%Analytical Specificity99.4%Analysis of cross reactivityEvaluatedFalse positives0.6%False negatives1.2%PrecisionEvaluatedAccuracy99.2%RobustnessEvaluatedClinical Sensitivity98.8%Clinical Specificity99.4%2954SARS-COV-2 Ag Rapid Test1302Reach Diagnostic (Wuhan) Biotech Co. Ltd.Chinahttp://www.reachdiagnostic.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.1.526.2678B.1.1.529Omicron1518P.2Zetanucleocapsid proteinSARS-COV-2 Ag Rapid Test Cassette is already listed by BfArM2022-08-24 09:08:01 CET2660Immuno-AntigenYesNoNoImmunoassayQualitativeSandwich, Double10CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.6%False negatives1.2%PrecisionEvaluatedAccuracy99.2%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.8%AntigenClinical Specificity99.4%AntigenType of antigenNucleocapsid protein3154SARS-COV-2 Ag Rapid Test Cassette1302Reach Diagnostic (Wuhan) Biotech Co. Ltd.Chinahttp://www.reachdiagnostic.com.cnYesCommercialisedNoNoNear 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.1.617.2Delta1323B.1.621Mu2041C.37Lambda1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid proteinSARS-COV-2 Ag Rapid Test Cassette is listed by BfArM2022-09-29 09:37:55 CET3894Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold10LOD50TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.6%False negatives1.2%PrecisionEvaluatedAccuracy99.2%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.8%AntigenClinical Specificity99.4%AntigenType of antigenNucleocapsid protein3972Red Cell COVID-19 Self Test1445Red Cell Biyoteknoloji A.Ş.Turkeywww.redcell.com.trYesCommercialisedNoNoManualNear POC / POCAntigenAnterior nasal swabMid-turbinates swabNasal 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 protein2022-08-24 09:08:01 CET3637Immuno-AntigenYesYesNoImmunochromatographyQualitativeMembrane-basedOther15LOD33PFU/mLAnalytical Sensitivity100%Analytical Specificity100%False positives0N.A.False negatives0.025ng/mLAccuracy97.9%Clinical Sensitivity96.3%Clinical Specificity99.5%1715COVID-19 Antigen Test762Redcell BiyoteknolojiTurkeyen.redcell.com.tr/YesCommercialisedNoNoNear POC / POCAntigenNasal swabnucleocapsid protein2022-08-24 09:08:01 CET1395Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD50000AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives1.15%Out of 261 samples 3 of them were false positivesFalse negatives4.92%Out of 122 samples 6 of them were false negativesPrecisionEvaluatedAccuracy99.2%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.08%Type of antigennucleoprotein2095RAMP COVID-19 Antigen Test971Response Biomedical Corp.Canadawww.responsebio.comYesCommercialisedNoNoManualAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429EpsilonLOD = 100 pfu/mL2022-08-24 09:08:01 CET1778Immuno-AntigenYesYesImmunoassayQualitativeOther15LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positivesTBD 2.5% in a study against SOFIA with subjects suspected of COVID-19.False negativesTBD 11% in a study against SOFIA with subjects suspected of COVID-19.PrecisionEvaluatedAccuracy95.6%TBD 95.6% in a study against SOFIA with subjects suspected of COVID-19.ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity89%TBD 89% in a study against SOFIA with subjects suspected of COVID-19.Clinical Specificity97.5%TBD 97.5% in a study against SOFIA with subjects suspected of COVID-19.Type of antigenNucleoprotein2576Reszon COVID-19 Rapid Antigen Test1174Reszon Diagnostics International Sdn. Bhd.Malaysiahttps://reszonics.com/YesCommercialisedNoNoManualAntigenNasopharyngeal swabnucleocapsid proteinReszon COVID 19 Rapid Antigen Test is an immunochromatographic assay designed for the qualitative detection of specific SARS-CoV-2 antigen in human nasopharyngeal swab specimen .The results obtained should not be the sole determinant for clinical decision.2022-08-24 09:08:01 CET2281Immuno-AntigenYesNoImmunochromatographyQualitativeMembrane-based15LOD150TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%0 out of 110 negative samplesFalse negatives8.8%11 out of 125 positive samplesPrecisionEvaluatedAccuracy95.09% (Antigen)ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity91.2% (Antigen)Clinical Specificity100% (Antigen)Type of antigenNucleocapsid protein2938Reszon COVID-19 Rapid Antigen Test (Nasal Swab)1174Reszon Diagnostics International Sdn. Bhd.Malaysiahttps://reszonics.com/YesCommercialisedNoNoManualNear POC / POCAntigenAnterior nasal swab689B.1.1.7Alphanucleocapsid proteinReszon COVID-19 Rapid Antigen Test (Nasal Swab) is an immunochromatographic assay designed for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in human anterior nasal swab specimen. It is intended to be used for the detection of SARS-CoV-2 virus infection. The results obtained should not be the sole determinant for clinical decision. The Reszon COVID-19 Rapid Antigen Test (Nasal Swab) is intended for use by clinical laboratories or healthcare workers for point-of-care testing and home self-testing.2022-08-24 09:08:01 CET2644Immuno-AntigenYesYesNoImmunochromatographyQualitativeMembrane-based15LOD150TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%0 out of 140 negative samplesFalse negatives2.8%3 out of 107 positive samplesPrecisionEvaluatedAccuracy98.8%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.27%AntigenClinical Specificity100%AntigenType of antigenNucleocapsid protein25547SARS-CoV-2 & Flu A/B Rapid Antigen Test854Roche (SD BIOSENSOR)Switzerlandhttps://diagnostics.roche.com/YesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swabInfluenza AInfluenza A H1N1Influenza A H3N2Influenza BInfluenza B VictoriaInfluenza B YamagataSARS-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 protein2023-03-31 17:44:04 CET21050Immuno-AntigenYesNoNoImmunochromatographyQualitativeMembrane-basedColloidal gold15LOD8.29TCID50/mlCalibrationNot evaluatedAnalytical Sensitivity100%refer to the LoD and analytical studiesAnalytical Specificity100%refer to the analytical studiesAnalysis of cross reactivityEvaluatedFalse positives2tests2 out of 310False negatives20tests20 out of 105PrecisionEvaluatedAccuracy100%not applicable for rapid testsRobustnessEvaluatedClinical Sensitivity95.24%For ct ≤ 30Clinical Specificity99.35%1604SARS-CoV-2 Rapid Antigen Test854Roche (SD BIOSENSOR)Switzerlandhttps://diagnostics.roche.com/YesCommercialisedYesYesNear POC / POCAntigenNasopharyngeal swabnucleocapsid protein2022-08-24 09:08:01 CET1285Immuno-AntigenYesNoImmunoassayQualitative15Clinical Sensitivity96.52%Clinical Specificity99.2%Type of antigennucleocapside protein25546SARS-CoV-2 Rapid Antigen Test 2.0 854Roche (SD BIOSENSOR)Switzerlandhttps://diagnostics.roche.com/YesCommercialisedYesYesNear POC / POCAntigenNasopharyngeal 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 protein2023-03-31 17:45:26 CET21059Immuno-AntigenYesNoNoImmunochromatographyQualitativeMembrane-basedColloidal gold15LOD14.6TCID50/mlCalibrationNot evaluatedAnalytical Sensitivity100%Refers to the LoD and analytical studiesAnalytical Specificity100%Refers to the analytical studiesAnalysis of cross reactivityEvaluatedFalse positives1tests1 out of 402False negatives1tests1 out of 100PrecisionEvaluatedAccuracy100%Not applicable for rapid testsRobustnessEvaluatedClinical Sensitivity99%Overall Ct valuesClinical Specificity99.75%Overall Ct values5839SARS-CoV-2 Rapid Antigen Test 2.0 Nasal854Roche (SD BIOSENSOR)Switzerlandhttps://diagnostics.roche.com/YesCommercialisedNoNoNear POC / POCAntigenNasal 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 proteinIn addition to the validation studies listed in the Instructions for Use (IFU), this product was evaluated independently in a study conducted by investigators at the Technical University of Munich and the Institute of Virology at Helmholtz Munich. This study prospectively enrolled 428 healthcare workers from the University Hospital Munich Rechts der Isar of the Technical University of Munich who either reported recent onset of COVID-19 associated symptoms or completed routine diagnostic testing between 24th of May and 22nd of September 2022. Rapid test performance was compared to the standard-of-care RT-PCR results at the hospital, which was also calibrated to report viral load in genomic copies (GE) / ml. All samples with a viral load above 9.5x104 GE/ml were sequenced, and results revealed a majority of infections with BA.5 followed by BA.2 and BA.4. In the entire cohort, the SARS-CoV-2 Rapid Antigen Test 2.0 Nasal demonstrated a sensitivity of 89.4% and a specificity of 99.4%. 2023-01-24 10:04:16 CET5447Immuno-AntigenYesNoNoImmunochromatographyQualitativeMembrane-basedColloidal gold15LOD13TCID50/mlCalibrationNot evaluatedAnalytical Sensitivity100%With reference to the LoD and analytical studiesAnalytical Specificity100%With reference to the analytical studiesAnalysis of cross reactivityEvaluatedFalse positivestests0/487False negatives6tests6/143PrecisionEvaluatedAccuracy99%RobustnessEvaluatedClinical Sensitivity99.15%For ct≤30Clinical Specificity100%2228SARS-CoV-2 Rapid Antigen Test Nasal854Roche (SD BIOSENSOR)Switzerlandhttps://diagnostics.roche.com/YesCommercialisedYesYesNear POC / POCAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1132B.1.427Epsilon1320B.1.617.1Kappa1323B.1.621Munucleocapsid proteinThe SARS-CoV-2 Rapid Antigen Test Nasal is technically identical to the nasopharyngeal test launched in 2020 (SARS-CoV-2 Rapid Antigen Test), which is already included in the EU common list of COVID-19 rapid antigen tests.2022-08-24 09:08:01 CET1929Immuno-AntigenYesNoImmunochromatographyQualitative15LOD146.6AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.91%5 false positives out of 546 PCR negative samples.False negatives10.68%14 false negative results out of 131 PCR-positive samples for Ct ≤ 30PrecisionEvaluatedAccuracy95.5% (95% CI: 93.7 % - 97.0 %)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity89.6% (Ct ≤ 30) and 93.1 % (for Ct below LOD 27)Clinical Specificity99.1%Type of antigenNucleoprotein1489COVID-19 Antigen Rapid Test Kit (Swab)546Safecare Biotech (Hangzhou) Co. Ltd.Chinawww.safecare.com.cnYesCommercialisedYesYesNear POC / POCAntigenNasal swabnucleocapsid protein2022-08-24 09:08:01 CET1234Immuno-AntigenYesNoImmunoassayQualitativeColorimetry10LOD0.5AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives2.96%False negatives0.56%PrecisionEvaluatedAccuracy98.41%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.04%Type of antigennucleoprotein1819COVID-19 Antigen Rapid Test Kit(Saliva)546Safecare Biotech (Hangzhou) Co. Ltd.Chinawww.safecare.com.cnYesCommercialisedNoNoNear POC / POCAntigenSalivaLOD: 0.25ng/ml, Ct <=302022-08-24 09:08:01 CET1497Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich15LOD0.25AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.55%False negatives1.5%PrecisionEvaluatedAccuracy99.05%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.5%Clinical Specificity99.45%1490Multi-Respiratory Virus Antigen Test Kit(Swab) (Influenza A+B/ COVID-19)546Safecare Biotech (Hangzhou) Co. Ltd.Chinawww.safecare.com.cnYesCommercialisedYesYesNear POC / POCAntigenNasal swabnucleocapsid protein2022-08-24 09:08:01 CET1235Immuno-AntigenYesNoImmunoassayQualitativeColorimetry10FP: FluA:0, FluB:0. FN: FluA:0.56%, FluB: 0. Accuracy: FluA:99.54%, FluB:100%. Clinical Sensitivity: FluA:100%, FluB:100%.LOD1.5AU1.5CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2.96%COVID-19False positives0%FluBFalse positives0%FluAFalse negatives0.56%COVID-19False negatives0%FluBFalse negatives0.56%FluAPrecisionEvaluatedAccuracy100%FluBAccuracy99.54%FluAAccuracy98.41%COVID-19:ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%FluAClinical Sensitivity100%FluBClinical Sensitivity97.04%COVID-19Type of antigennucleoprotein2129Salocor SARS-CoV-2 Antigen Rapid Test Cassette567Salofa OyFinlandhttps://www.salofa.comYesCommercialisedNoNoManualNear 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.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2Zetanucleocapsid proteinThe SARS-CoV-2 Antigen Rapid Test Cassette is a rapid chromatographic immunoassay for the for qualitative detection of SARS-CoV-2 nucleocapsid protein in human nasopharyngeal swab samples. It is intended to aid in the rapid diagnosis of COVID-19 infections.2022-08-24 09:08:01 CET1819Immuno-AntigenYesNoImmunoassayQualitativeSandwich10LOD1250TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.1%5 of 445False negatives4.1%6 of 146PrecisionEvaluatedAccuracy98.1%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.9%Clinical Specificity98.9%Type of antigenNucleocapsid protein2240Salocor SARS-CoV-2 Antigen Rapid Test Kit567Salofa OyFinlandhttps://www.salofa.comYesCommercialisedNoNoManualNear POC / POCAntigenNasopharyngeal swabOropharyngeal swabSerum689B.1.1.7Alpha1032B.1.351Betanucleocapsid proteinThe SARS-CoV-2 Antigen Rapid Test Kit is a rapid chromatographic immunoassay for the for qualitative detection of SARS-CoV-2 nucleocapsid protein in human serum and nasopharyngeal swab and/or oropharyngeal swab samples. It is intended to aid in the rapid diagnosis of COVID-19 infections. This rapid kit uses a fluorescence immunochromatography method to detect SARS-CoV-2 N antigen.2022-08-24 09:08:01 CET1941Immuno-AntigenYesImmunoassayQualitativeSandwich10LOD40AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.4% 249/250 (Nasopharyngeal swab negative specimens) False positives1%(186/188 serum negative specimens)False negatives2.88%(135/139 Nasopharyngeal swab positive specimens) False negatives3.9%(97/101 serum positive specimens)PrecisionEvaluatedAccuracy97.9%(serum)Accuracy99.5%(Nasopharyngeal swab) ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.04% (serum)Clinical Sensitivity97.12% (Nasopharyngeal swab) Clinical Specificity98.9% (serum)Clinical Specificity99.6% (Nasopharyngeal swab) Type of antigenNucleoprotein2127Sienna COVID-19 Antigen Rapid Test Cassette567Salofa OyFinlandhttps://www.salofa.comYesCommercialisedNoNoManualNear 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.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2Zetanucleocapsid proteinThe Sienna COVID-19 Antigen Rapid Test Cassette is a rapid chromatographic immunoassay for the for qualitative detection of SARS-CoV-2 nucleocapsid protein in human nasopharyngeal swab samples. It is intended to aid in the rapid diagnosis of COVID-19 infections.2022-08-24 09:08:01 CET1817Immuno-AntigenYesNoImmunoassayQualitativeSandwich10LOD1250TCID50/ml1.25×10^3 TCID50/mLCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.1%5 of 445False negatives4.1%6 of 146PrecisionEvaluatedAccuracy98.1%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.9%Clinical Specificity98.9%Type of antigenNucleocapsid protein2097SARS-CoV-2 Rapid Antigen Test (Colloidal Gold Method)972Sansure Biotech Inc.Chinawww.sansure.com.cnYesCommercialisedYesYesNear POC / POCAntigenNasal swabNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gammanucleocapsid proteinThe SARS-CoV-2 Rapid Antigen Test (Colloidal Gold Method) is intended for the qualitative detection of the SARS-CoV-2 nucleocapsid protein in human nasopharyngeal or nasal swab sampled from individuals suspected of COVID- 19.2022-08-24 09:08:01 CET1780Immuno-AntigenYesNoImmunochromatographyQualitativeMembrane-basedColloidal gold15LOD800TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.6%False negatives1.9%PrecisionEvaluatedAccuracy98.2%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.4%Clinical Specificity98.1%Type of antigenNucleocapsid protein2366SARS-CoV-2 Rapid Antigen Test (Immunochromatography Assay)972Sansure Biotech Inc.Chinawww.sansure.com.cnYesCommercialisedNoNoNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gammanucleocapsid proteinThe SARS-CoV-2 Rapid Antigen Test (Immunochromatography Assay) is intended for the qualitative detection of the SARS-CoV-2 nucleocapsid protein in human nasal, nasopharyngeal or oropharyngeal swab.2022-08-24 09:08:01 CET2067Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich, Double15LOD80TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.83%False negatives0%PrecisionEvaluatedAccuracy98.89%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.17%Clinical Specificity100%Type of antigenNucleocapsid protein2683Savvycheck SARS-CoV-2 Ag1227Savyon Diagnostics Ltd.Israelwww.savyondx.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabThe SavvycheckTM SARS-CoV-2 Ag is an immunoassay in which SARS-CoV-2 nucleocapsid protein antigens extracted from nasal swabs of individuals suspected of COVID-19, interact during flow along the test strip with anti-SARS- CoV-2 nucleocapsid protein specific antibodies conjugated to a red latex particles used as a detector. The resulting complex flows along the strip and interacts with immobilized anti-SARS-CoV-2 nucleocapsid-specific antibodies in the detection zone(“T”), forming an observable red-colored line. The presence of a red line at the test line position indicates a positive result. The conjugated latex particles interact downstream the test line with other specific antibodies to create the control line. The presence of a green line at the control line position indicates proper function of the test.2022-08-24 09:08:01 CET2388Immuno-AntigenYesNoOtherQualitative10CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives3%False negatives1%PrecisionEvaluatedAccuracy98%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.2%Clinical Specificity98.8%1201ScheBo SARS CoV-2 Quick Antigen359ScheBo BiotechGermanywww.schebo.de/YesCommercialisedYesYesNear POC / POCAntigenNasopharyngeal swabOropharyngeal swabSerumnucleocapsid protein2022-08-24 09:08:01 CET987Immuno-AntigenYesNoImmunochromatographyQualitativeFluorescence15LOD3.5U/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.12%6/534False negatives3.44%4/116PrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.77%Clinical Sensitivity96.6%Ct 30Type of antigenNucleoprotein1681SCREEN TEST COVID-19 AG - COVID-19 ANTIGEN RAPID TEST701SCREEN ITALIA S.r.l.Italywww.screenitalia.itYesCommercialisedNoNoNear POC / POCAntigenNasal swabOthernucleocapsid protein2022-08-24 09:08:01 CET1360Immuno-AntigenYesNoImmunoassayQualitative15LOD50AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives1.23%1 on 81False negatives2.44%3 on 123PrecisionEvaluatedAccuracy98%(95%CI: 95.1%-99.5%)ReproducibilityNot evaluatedRobustnessNot evaluatedClinical Sensitivity96.4%(95%CI: 89.8%- 99.2%)Type of antigennucleoprotein1847SCREEN TEST COVID-19 SALIVA701SCREEN ITALIA S.r.l.Italywww.screenitalia.itYesCommercialisedNoNoManualAntigenSalivaSputumnucleocapsid protein* LOD: According to the study shown above, the lowest concentration that still led to a 100% detection rate was 100 TCID50/mL of inactivated SARS-COV-2 (Swab). Conclusion: Minimal detection limits of COVID-19 Antigen Rapid Test is 100pg/ml for recombine COVID-19 protein and 100TCID50/mL for inactivated SARS-COV-2.2022-08-24 09:08:01 CET1527Immuno-AntigenYesNoImmunochromatographyQualitativeOther15LOD0AU0CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives2.15%2 on 93False negatives0.96%10 on 313PrecisionEvaluatedAccuracy97%(95% CI*: 94.9%~98.5%)ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity90.1%(95% CI*:82.5%~95.1%)Clinical Specificity99.3%(95% CI*: 97.7%~99.9%)Type of antigenNucleoprotein1590Screentest Covid-19+FLU A/B701SCREEN ITALIA S.r.l.Italywww.screenitalia.itYesCommercialisedNoNoNear POC / POCAntigenNasal swab2022-08-24 09:08:01 CET1270Immuno-AntigenYesNoImmunoassayQualitative15Accuracy98%ReproducibilityEvaluatedClinical Sensitivity96.4%Clinical Specificity99.2%3026Ultra COVID-19 Ag1345SD Biosensor Healthcare Private LimitedIndiawww.sdbiosensor.co.inYesCommercialisedYesYesNear POC / POCAntigenNasopharyngeal swabSARS-CoVSARS-CoV-2689B.1.1.7Alpha1032B.1.351Beta1320B.1.617.1Kappa1321B.1.617.2Deltanucleocapsid protein2022-11-14 09:02:22 CET5307Immuno-AntigenYesNoNoImmunochromatographyQualitativeMembrane-basedOther30LOD6TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives5%False negatives1%PrecisionNot evaluatedAccuracy95.6%ReproducibilityNot evaluatedRobustnessNot evaluatedClinical Sensitivity93.47%Clinical Specificity100%Type of antigenMembrane protein344STANDARD F COVID-19 Ag FIA224SD BIOSENSOR Inc.South Koreahttp://sdbiosensor.com/xe/YesCommercialisedYesYesNear POC / POCAntigenNasal swabNasopharyngeal swabBeta Coronavirus HKU1 (HCoV-HKU1)678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1137B.1.429Epsilon1224B.1.526Iota1320B.1.617.1Kappa1321B.1.617.2Delta1323B.1.621Mu2041C.37LambdaOther1495P.1Gamma1518P.2Zetanucleocapsid protein2023-03-27 15:24:21 CET21014Immuno-AntigenYesNoYesImmunoassayQualitativeMembrane-basedFluorescence15LOD202.87TCID50/mlNP SwabLOD153.89TCID50/mlNasal SwabCalibrationEvaluatedAnalytical Sensitivity92.86%NP Swab 104/102 (95% CI: 86.54 – 96.34%)Analytical Specificity99.63%NP Swab 536/538 (95% CI: 98.65 – 99.90%)Analysis of cross reactivityEvaluatedFalse positives0.37%2/538 (NP Swab)False positives%0/100 (Nasal Swab)False negatives7.14%8/112 (NP Swab)False negatives5.77%3/52 (Nasal Swab)PrecisionEvaluatedAccuracy100%according to the precision studyRobustnessEvaluatedClinical Sensitivity92.86%NP Swab 104/102 (95% CI: 86.54 – 96.34%)Clinical Sensitivity94.23%Nasal Swab - 49/52 (95% CI : 84.05% - 98.79%)Clinical Specificity99.63%NP Swab 536/538 (95% CI: 98.65 – 99.90%)Clinical Specificity100%Nasal Swab 100/100 (95% CI : 96.38% - 100.00%)24759STANDARD F COVID-19 Ag FIA224SD BIOSENSOR Inc.South Koreahttp://sdbiosensor.com/xe/YesCommercialisedYesYesNear POC / POCAntigenNasal swabNasopharyngeal swabBeta Coronavirus HKU1 (HCoV-HKU1)678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1137B.1.429Epsilon1224B.1.526Iota1320B.1.617.1Kappa1321B.1.617.2Delta1323B.1.621Mu2041C.37LambdaOther1495P.1Gamma1518P.2Zetanucleocapsid protein2023-04-03 10:04:02 CET21042Immuno-AntigenYesNoYesImmunoassayQualitativeMembrane-basedFluorescence15LOD202.87TCID50/mlNP SwabLOD153.89TCID50/mlNasal SwabCalibrationEvaluatedAnalytical Sensitivity92.86%NP Swab 104/102 (95% CI: 86.54 – 96.34%)Analytical Specificity99.63%NP Swab 536/538 (95% CI: 98.65 – 99.90%)Analysis of cross reactivityEvaluatedFalse positives0.37%2/538 (NP Swab)False positives%0/100 (Nasal Swab)False negatives7.14%8/112 (NP Swab)False negatives5.77%3/52 (Nasal Swab)PrecisionEvaluatedAccuracy100%according to the precision studyRobustnessEvaluatedClinical Sensitivity92.86%NP Swab 104/102 (95% CI: 86.54 – 96.34%)Clinical Sensitivity94.23%Nasal Swab - 49/52 (95% CI : 84.05% - 98.79%)Clinical Specificity99.63%NP Swab 536/538 (95% CI: 98.65 – 99.90%)Clinical Specificity100%Nasal Swab 100/100 (95% CI : 96.38% - 100.00%)24757STANDARD F COVID/Flu Ag Combo FIA224SD BIOSENSOR Inc.South Koreahttp://sdbiosensor.com/xe/YesCommercialisedYesYesNear POC / POCAntigenNasopharyngeal swabInfluenza AInfluenza A H1N1Influenza A H3N2Influenza BSARS-CoV678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1137B.1.429Epsilon1224B.1.526Iota1320B.1.617.1Kappa1321B.1.617.2Delta1323B.1.621Mu2041C.37Lambda1495P.1Gamma1518P.2Zetanucleocapsid protein2023-03-27 17:00:02 CET21060Immuno-AntigenYesNoYesImmunoassayQualitativeMembrane-basedFluorescence15LOD216TCID50/mlCalibrationEvaluatedAnalytical Sensitivity90.91%According to the results of clinical evaluation studyAnalytical Specificity100%According to the results of clinical evaluation studyAnalysis of cross reactivityEvaluatedFalse positivessamples0/195False negatives5samples5/55PrecisionEvaluatedAccuracy100%According to the results of the precision studyRobustnessEvaluatedClinical Sensitivity90.91%50/55 (95%CI: 80.05% - 96.98%)Clinical Specificity100%195/195 (95%CI: 98.13% - 100%)24756STANDARD i-Q COVID/Flu Ag Combo Test224SD BIOSENSOR Inc.South Koreahttp://sdbiosensor.com/xe/YesCommercialisedYesYesManualAntigenNasopharyngeal swabSARS-CoV678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1137B.1.429Epsilon1224B.1.526Iota1320B.1.617.1Kappa1321B.1.617.2Delta1323B.1.621Mu2041C.37LambdaOther1495P.1Gamma1518P.2Zetanucleocapsid protein2023-03-27 17:01:34 CET21061Immuno-AntigenYesNoNoImmunochromatographyN.A.Membrane-basedColloidal gold15LOD53.2TCID50/mlCalibrationEvaluatedAnalytical Sensitivity100%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positivessamplesFalse negativessamplesPrecisionEvaluatedAccuracy100%according to the precision test dataRobustnessEvaluatedClinical Sensitivity100%Clinical Specificity100%345STANDARD Q COVID-19 Ag Test 224SD BIOSENSOR Inc.South Koreahttp://sdbiosensor.com/xe/YesCommercialisedYesYesNear POC / POCAntigenNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta1323B.1.621Mu2041C.37Lambda1224B.1.526Iota678B.1.1.529Omicron1518P.2Zetanucleocapsid proteinhttps://bestbion.com/sars-cov-2_covid-19/2022-08-24 09:08:01 CET672Immuno-AntigenYesNoImmunochromatographyQualitativeMagnetic Electrochemical30LOD1981TCID50/mlAnalysis of cross reactivityEvaluatedClinical Sensitivity96.52%Clinical Specificity99.68%24758STANDARD Q COVID-19 Ag Test 2.0224SD BIOSENSOR Inc.South Koreahttp://sdbiosensor.com/xe/YesCommercialisedYesYesManualAntigenNasal swabNasopharyngeal swabOther678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1137B.1.429Epsilon1224B.1.526Iota1320B.1.617.1Kappa1321B.1.617.2Delta1323B.1.621Mu2041C.37LambdaOther1495P.1Gamma1518P.2Zetanucleocapsid protein2023-03-27 17:02:17 CET21062Immuno-AntigenYesNoNoImmunochromatographyQualitativeMembrane-basedColloidal gold15LOD14.6TCID50/mlNP swabLOD13TCID50/mlNS swabCalibrationEvaluatedAnalytical Sensitivity99%NP SwabAnalytical Specificity99.75%NP SwabAnalysis of cross reactivityEvaluatedFalse positives1samplesNegative Antigen: 401 out of 402 (NP)False negatives1samplesPositive Antigen: 99 out of 100 (NP)PrecisionEvaluatedAccuracy100%according to the precision dataRobustnessEvaluatedClinical Sensitivity99%NP SwabClinical Sensitivity95.8%NS swabClinical Specificity99.75%NP SwabClinical Specificity100%NS swab1895SARS-CoV-2 Antigen Rapid Test (Nasal/Saliva)230Selfdiagnostics Deutschland GmbHGermanyselfdiagnostics.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabSalivanucleocapsid proteinINTENDED USE The SARS-CoV-2 Antigen Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection the nucleocapsid protein antigen from SARS-CoV-2 in nasal and nasopharyngeal swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first seven days of the onset of symptoms. The SARSCoV- 2 Antigen Rapid Test can also be used for testing specimens from asymptomatic individuals. The SARS-CoV-2 Antigen Rapid Test does not differentiate between SARS-CoV and SARS-CoV-2. Results are for the identification of SARS-CoV-2 nucleocapsid antigen. This antigen is generally detectable in upper respiratory samples during the acute phase of infec-tion. 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 coinfection with other viruses. The agent detected may not be the definite cause of disease. Negative results, from patients with symptom beyond seven days, should be treated as presumptive and confirmed with a molecular assay, if necessary, for patient management. Negative results do not rule out SARSCoV-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 SARS-CoV-2 Antigen Rapid Test is intended for use by trained clinical laboratory personnel and individuals trained in point of care settings. SARS-CoV-2 Antigen Rapid Test is intended to be used as an aid in the diagnosis of SARS-CoV-2 infection.2022-08-24 09:08:01 CET1572Immuno-AntigenYesImmunochromatographyQualitative15 SARS-CoV-2 antigen rapid test kit is a lateral flow chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigens in nasal swab or saliva specimens. LOD160AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracy98%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.1%(95% CI: 93.1%-98.9%)Clinical Specificity99.5%(95% CI: 98.2%-99.9%)Type of antigennucleocapsid1493S1 Covid-19 Rapid Antigen Test Kit687Sensing Self Pte. Ltd.Singaporewww.sensingself.meYesCommercialisedNoNoNear POC / POCAntigenNasal swabOtherSalivanucleocapsid protein2022-08-24 09:08:01 CET1243Immuno-AntigenYesNoImmunoassayQualitative15LOD0.005AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1%False negatives5%PrecisionEvaluatedAccuracy96.9%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94%Type of antigennucleoprotein1272Sensitest Joysbio Antigen Rapid Test for Covid-19638SensitestNetherlandswww.sensitest.com/index.php?p=sensitest-covid-corona-Antigen-testYesCommercialisedNoNoNear POC / POCAntigenNasal swab2022-08-24 09:08:01 CET1048Immuno-AntigenYesImmunoassayQualitative15Clinical Specificity99%2611Sensiva Health React Rapid Antigen Test (Lateral Flow Method)1192Sensiva Health LLCUnited Stateshttps://www.sensivahealth.com/YesCommercialisedNoNoManualNear 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.2Zetanucleocapsid proteinNot Applicable2022-08-24 09:08:01 CET2316Immuno-AntigenYesNoImmunoassayQualitative10LOD156.25TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positivesLower than 24 samples per runFalse negativesLower than 24 samples per runPrecisionEvaluatedAccuracy100% IgGReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.1% IgGClinical Specificity100% IgGType of antigenNucleocapsid protein2003SG Diagnostics COVID-19 Antigen Rapid Test Kit (Colloidal Gold-Based)921SG Diagnostics Pte Ltd.Singaporewww.sgdiagnostics.comYesCommercialisedNoNoNear POC / POCAntigenDeep (cough) sputumNasal swabNasopharyngeal swabOropharyngeal swabSalivanucleocapsid proteinSG Diagnostics COVID-19 Antigen Rapid Test Kit showed no cross-reactivity with the following potentially cross-reactive common organisms - Human coronavirus (229E, HKU1, OC43 and NL63), Middle East respiratory syndrome (MERS) coronavirus, Adenovirus, Enterovirus, Influenza A (H1N1 and H3N2) and B viruses, Avian influenza virus, Parainfluenza type 1-4, Measles virus, Human metapneumovirus, Mumps virus, Rhinovirus, Epstein-Barr virus, Respiratory syncytial virus, Staphylococcus aureus, Streptococcus pneumoniae, Staphylococcus epidermidis, Mycobacterium tuberculosis, Legionella pneumophila, Haemophilus influenza, Streptococcus pyogenes, Chlamydia pneumoniae, Mycoplasma pneumoniae, Candida albicans, organisms that make up normal respiratory flora, and organism(s) that causes parapertussis and pneumocystis.2022-08-24 09:08:01 CET1680Immuno-AntigenYesNoImmunochromatographyQualitativeMembrane-basedColloidal gold10LOD75AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracy98.99%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity97.57%Clinical Specificity99.29%Type of antigenNucleoprotein2935InstaView COVID-19 Antigen1294SG Medical Inc.South Koreawww.sgmedical.krYesCommercialisedYesYesNear POC / POCAntigenNasopharyngeal swabSARS-CoV689B.1.1.7Alpha1032B.1.351Beta1321B.1.617.2Delta1495P.1Gammanucleocapsid proteinNone2022-09-20 10:56:25 CET21064Immuno-AntigenYesNoNoImmunochromatographyQualitativeN.A.Colorimetry15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.2%False negatives5%PrecisionEvaluatedAccuracy98.9%AntigenReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity95%AntigenClinical Specificity99.8%AntigenType of antigenNucleocapsid protein1319V-Chek SARS-CoV-2 Ag Rapid Test Kit (Colloidal Gold)405SGA MedikalTurkeywww.sgadx.com/YesCommercialisedYesYesNear POC / POCAntigenNasal swabnucleocapsid protein2022-08-24 09:08:01 CET560Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15False positives1%False negatives1%Accuracy98.4%Clinical Sensitivity96.6%Type of antigennucleoprotein1357V-Chek SARS-CoV-2 Rapid Ag Test (colloidal gold)405SGA MedikalTurkeywww.sgadx.com/YesCommercialisedYesYesNear POC / POCAntigenNasal swabnucleocapsid protein2022-08-24 09:08:01 CET1117Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD100AUFalse positives1%False negatives1%Accuracy98.40%Clinical Sensitivity96.60%Type of antigennucleoprotein1317V-Chek SARS-CoV-2 Rapid Ag Test (IFA)405SGA MedikalTurkeywww.sgadx.com/YesCommercialisedNoNoNear POC / POCAntigenNasal swabnucleocapsid protein2022-08-24 09:08:01 CET557Immuno-AntigenYesYesImmunoassayQualitativeFluorescence10LOD50AUFalse positives1AUFalse negatives1AUAccuracy98.5%Clinical Sensitivity97.5%Type of antigennucleoprotein5732ViruScan SARS-CoV-2 Rapid Antigen Test 3198SGA Medikal ( SGA Muhendislik Dans Egt Ic ve Dis Tic A.S.)Turkeywww.sga-as.com.trYesCommercialisedNoNoNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabOther678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1321B.1.617.2Delta2041C.37Lambda1495P.1Gammanucleocapsid protein2022-10-25 10:08:58 CET5239Immuno-AntigenYesNoNoImmunoassayQualitativeMembrane-basedColloidal gold15LOD100TCID50/mlCalibrationEvaluatedAnalytical Sensitivity97.4%Analytical Specificity99.13%Analysis of cross reactivityEvaluatedFalse positives0.87%5 out of 577 (NP swab)False negatives2.6%18 out of 692 (NP swab)PrecisionEvaluatedAccuracy98.19%NP swabRobustnessEvaluatedClinical Sensitivity97.4%NP swabClinical Specificity99.13%NP swab1366SARS-CoV-2 Antigen Rapid Test (Immunochromatography)654SHANDONG KANGHUA BIOTECHNOLOGY Co. Ltd.ChinaWWW.KHBIO.COMYesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swabOropharyngeal swabnucleocapsid protein2022-08-24 09:08:01 CET1129Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD1400AUFalse positives0.25%1 false positive to 400 negative samplesFalse negatives5%5 false negatives to 100 positive samplesAccuracy98.8%(Antigen)Clinical Sensitivity95%(Antigen)Clinical Specificity99.75%Type of antigennucleoprotein2154Coronavirus Ag Rapid Test Cassette (Swab)999Shandong ThinkLab Biotechnology Co. Ltd.ChinaYesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gammanucleocapsid proteinThe coronavirus AG rapid detection box (swab) is an in vitro immunochromatographic test for qualitative detection of the SARS-CoV-2 nuclear capsimal hemoglobin antigen in nasopharyngeal and nasal swab samples directly or to the viral transport medium of individuals whose health care providers suspect carrying COVID-19.2022-08-24 09:08:01 CET1855Immuno-AntigenYesNoImmunochromatographyQualitativeMembrane-based15LOD0AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives5.8%False negatives1.7%PrecisionEvaluatedAccuracy96.2%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.2%Clinical Specificity98.3%Type of antigenNucleoprotein3039BioGerm SARS-CoV-2 Antigen Self Test927Shanghai BioGerm Medical Technology Co. Ltd.Chinahttp://en.bio-germ.com/YesCommercialisedNoNoNear POC / POCAntigenAnterior nasal swabSARS-CoV689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1323B.1.621Mu2041C.37Lambda1224B.1.526Iota1518P.2Zeta678B.1.1.529Omicronnucleocapsid protein2022-08-24 09:08:01 CET2745Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, Double10LOD200TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracy95.05%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity97.17%Clinical Specificity99.68%Type of antigenNucleocapsid protein2313Chemtrue® COVID-19 Ag Rapid Test (Colloidal Gold)1076Shanghai Chemtron Biotech Co. Ltd.Chinahttp://www.chemtronbio.com/YesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swabnucleocapsid proteinproduct code：8040C2022-08-24 09:08:01 CET2014Immuno-AntigenYesImmunoassayQualitativeColloidal gold10LOD50AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%without false positive compared with RT-PCR in clincal datasFalse negatives5%(Nasopharyngeal swab specimens)False negatives5%(oropharyngeal swab specimens)compared with RPrecisionEvaluatedAccuracy95.19%(nasopharyngeal swab specimens)，Accuracy94.71%(oropharyngeal swab specimens）ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.96%(nasopharyngeal swab specimens)，Clinical Sensitivity92.25%(oropharyngeal swab specimens）Clinical Specificity100%(nasopharyngeal swab specimens)Clinical Specificity100%oropharyngeal swab specimens）Type of antigenNucleoprotein2512Chemtrue® COVID-19 （SARs-Cov-2）Antigen Rapid Test Kit (Nasal Swab)1076Shanghai Chemtron Biotech Co. Ltd.Chinahttp://www.chemtronbio.com/YesCommercialisedNoNoNear POC / POCAntigenNasal swabN/A2022-08-24 09:08:01 CET2216Immuno-AntigenYesImmunoassayQualitative10CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%without false positive compared with RT-PCR in clincal datasFalse negatives0.5%without false negative compared with RT-PCR in clincal datasPrecisionEvaluatedAccuracy97.07%(Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.09%(Antigen)Clinical Specificity100%(Antigen)Type of antigenNucleocapsid protein3080Chemtrue® COVID-19（SARS-CoV-2）Antigen Rapid Test Kit (Nasal Swab) - self-test1359Shanghai Chemtron Biotech Co. Ltd.Chinawww.chemtronbio.comYesCommercialisedNoNoManualAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1223B.1.525Eta1132B.1.427Epsilon3939B.1.6161321B.1.617.2Delta1322B.1.617.3B.1.526.1B.1.526.2678B.1.1.529OmicronORF1ab polyproteinChemtrue® COVID-19 （SARS-CoV-2）Antigen Rapid Test Kit(Nasal Swab); Evaluated by Centralne Laboratorium Kliniczne Uniwersyteckie Centrum Kliniczne, 80-214 Gdansk, Ul. Mariana Smoluchowskiego 17 ( University Clinical Center, 80-214 Gdansk Mariana Smoluchowskiego 17 street) Person in charge of Statistics and Unit: Pawel Chrzan PhD. Contact number: +48 5858443802022-08-24 09:08:01 CET2786Immuno-AntigenYesYesNoImmunoassayQualitativeSandwich10LOD50TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives14.55AUPrecisionEvaluatedAccuracy97.17%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity85.45%AntigenClinical Specificity100%AntigenType of antigenEnvelop protein2155LionRunTM SARS-CoV-2 Antigen Rapid Test (Lateral Flow Immunoassay)1000Shanghai Liangrun Biomedicine Technology Co. Ltd.ChinaYesCommercialisedNoNoNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gammanucleocapsid proteinLionRunTM SARS-CoV-2 Antigen Rapid Test (Lateral Flow Immunoassay) uses microsphere immunochromatography technology which is intended for the in vitro qualitative detection of the SARS-CoV-2 virus antigen nucleocapsid (N) protein in human nasal swab, nasopharyngeal swab, oropharyngeal swab samples.2022-08-24 09:08:01 CET1856Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich10LOD1AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives4.57%False negatives0.51%PrecisionEvaluatedAccuracy97.57%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.43%Clinical Specificity99.49%Type of antigenNucleoprotein3104SARS-CoV-2 (COVID-19) Antigen Rapid Detection Kit (Lateral Flow Method) (Nasal swab)1132Shen Zhen Zi Jian Biotechnology Co. Ltd.Chinahttp://www.szzijian.com/YesCommercialisedNoNoManualAntigenNasal 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 proteinhttp://www.szzijian.com/2022-08-24 09:08:01 CET2810Immuno-AntigenYesYesNoImmunochromatographyQualitative15LOD32600TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.06AUFalse negatives0AUPrecisionEvaluatedAccuracy98.5%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94%AntigenClinical Specificity100%AntigenType of antigenNucleocapsid protein2491SARS-CoV-2（ COVID-19）Antigen Rapid Detection Kit (Lateral Flow Method)993Shen Zhen Zi Jian Biotechnology Co. Ltd.Chinahttp://www.szzijian.com/YesCommercialisedYesYesManualAntigenNasopharyngeal swabOropharyngeal 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 proteinThis kit is intended to be used for in-vitro qualitative detection of SARS-CoV-2 antigens in human naso-/oropharyngeal swab . This kit uses colloidal gold immuno-lateral chromatography technology. Antigen detection is used for auxiliary diagnosis or epidemiological investigation of human infection with SARS-CoV-2.The test is for professional use only2023-05-17 17:37:00 CET21063Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich, Double15LOD326000TCID50/mlswabCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives5.35AUFalse negatives0.7AUPrecisionEvaluatedAccuracy97.46ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.65%Clinical Specificity99.3%Type of antigenNucleocapsid protein2145SARS-CoV-2（COVID-19）Antigen Rapid Detection Kit (Lateral Flow Method)993Shen Zhen Zi Jian Biotechnology Co. Ltd.Chinahttp://www.szzijian.com/YesCommercialisedNoNoNear POC / POCAntigenNasal swabOropharyngeal swabSaliva689B.1.1.7Alpha1032B.1.351Beta1495P.1Gammanucleocapsid proteinThis kit is intended to be used for in-vitro qualitative detection of SARS-CoV-2 antigens in human naso-/oropharyngeal swab and saliva samples. This kit uses colloidal gold immuno-lateral chromatography technology. Antigen detection is used for auxiliary diagnosis or epidemiological investigation of human infection with SARS-CoV-2.The test is for professional use only.2022-08-24 09:08:01 CET1835Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich, Double10LOD25.55AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2.31%False negatives2.35%PrecisionEvaluatedAccuracy97.66%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.69%Clinical Specificity97.65%Type of antigenNucleoprotein3087COVID-19/ FluA/ FluB Antigen Combo Rapid Test Kit (Colloidal Gold Method)1368Shenzhen AIVD Biotech Inc.ChinaYesCommercialisedNoNoAntigenNasopharyngeal swabOropharyngeal swabInfluenza AInfluenza BSARS-CoV678B.1.1.529Omicronnucleocapsid proteinShenzhen AIVD Biotech Inc.，founded in 2014, is a high-tech enterprise specializing in the development, production and service of in vitro diagnostic reagents, which is composed of a team of "one thousand" professors from the Organization Department of the Central Committee of the COMMUNIST Party of China and experts with rich R&D experience. The company owns 5 invention patents. The company has invested a lot of resources in the production of materials for in vitro diagnostic reagents, reagent production and technical services for the whole product system. It has a strong R&D and production capacity, and its products sell around all over the word. With the continuous expansion of the market, the output and output value have been increasing year by year, and the company has been rated as a high-tech enterprise by Shenzhen for many years.2022-08-24 09:08:01 CET2793Immuno-AntigenYesImmunoassayColloidal gold15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.18%False negatives7%PrecisionEvaluatedAccuracy95.91%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93%Clinical Specificity98.82%Type of antigenNucleocapsid protein2834SARS-CoV-2 Antigen Detection Kit (Latex Lateral Flow Assay)3201Shenzhen Aivd Biotechnology Co.LTD.ChinaYesCommercialisedNoNoManualAntigenNasal swabOropharyngeal swabSalivaInfluenza A678B.1.1.529Omicron1321B.1.617.2Deltanucleocapsid proteinShenzhen Aivd Biotechnology Co., LTD., founded in 2014, is a high-tech enterprise specializing in the development, production and service of in vitro diagnostic reagents, which is composed of a team of "one thousand" professors from the Organization Department of the Central Committee of the COMMUNIST Party of China and experts with rich R&D experience. The company owns 5 invention patents. The company has invested a lot of resources in the production of materials for in vitro diagnostic reagents, reagent production and technical services for the whole product system. It has a strong R&D and production capacity, and its products sell around all over the word. With the continuous expansion of the market, the output and output value have been increasing year by year, and the company has been rated as a high-tech enterprise by Shenzhen for many years.2022-10-26 17:17:51 CET5242Immuno-AntigenYesNoYesOtherQualitativeSandwichOtherAntigen Detection Kit15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.3AUFalse negatives7.7AUPrecisionEvaluatedAccuracy99.2%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.52%Clinical Specificity98.87%Type of antigenNucleocapsid protein365Bioeasy 2019-nCoV Ag Fluorescence Rapid Test Kit (Time-Resolved Fluorescence)393Shenzhen Bioeasy Biotechnology Co. Ltd.Chinaen.bioeasy.com.tr/YesCommercialisedNoNoNear POC / POCAntigenDeep (cough) sputumNasal swabSaliva2022-08-24 09:08:01 CET681Immuno-AntigenYesYesImmunoassayQualitativeFluorescence10689Bioeasy 2019-Novel Coronavirus (2019-nCoV) Ag GICA Rapid Test393Shenzhen Bioeasy Biotechnology Co. Ltd.Chinaen.bioeasy.com.tr/YesCommercialisedNoNoNear POC / POCAntigenWhole blood2022-08-24 09:08:01 CET541Immuno-AntigenYesNoImmunoassayQualitativeColorimetry102152SARS-CoV-2 Antigen Rapid Detection Kit997Shenzhen CAS-Envision Medical Technology Co. Ltd.Chinawww.cas-envision.comYesCommercialisedYesYesNear POC / POCAntigenNasopharyngeal swabOropharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gammanucleocapsid proteinSARS-CoV-2 Antigen Rapid Detection Kit is a colloidal gold immunochromatography intended for the qualitative detection of nucleocapsid antigens from SARS-CoV-2 in human nasopharyngeal swab or oropharyngeal swab specimen.2022-08-24 09:08:01 CET1842Immuno-AntigenYesNoImmunochromatographyQualitativeColloidal gold15LOD34AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.9%False negatives0.5%PrecisionEvaluatedAccuracy98.8%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.1%Clinical Specificity99.5%Type of antigenNucleoprotein3125COVID-19 Antigen Rapid Test1383Shenzhen Everbest Machinery lndustry Co. Ltd.Chinawww.cem-instruments.comYesCommercialisedNoNoManualAntigenNasal swab1321B.1.617.2Delta678B.1.1.529Omicronnucleocapsid proteinThe COVID-19 Antigen Rapid Test is a lateral flow chromatographic immunoassay test for detection of the Nucleocapsid (N) Protein of SARS-CoV-2 virus and used for in vitro qualitative detection of SARS-CoV-2 antigen in human anterior nasal swab specimens.2022-08-24 09:08:01 CET2833Immuno-AntigenYesYesN.A.ImmunochromatographyQualitative15LOD494TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positivesSARS-coronavirus shows 90.52% homology across 100% of the nucleocapsid sequence.False negativesNegative test results are not intended to rule in other non-SARS viral or bacterial infections.PrecisionEvaluatedAccuracy98.62%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.73%Clinical Specificity100%Type of antigenNucleocapsid protein2812SARS-CoV-2 Antigen Rapid Test Kit (Immunochromatography)1257Shenzhen Huaree Technology Co. Ltd.Chinawww.huareetech.comYesCommercialisedYesYesManualNear POC / POCAntigenNasal swab689B.1.1.7Alpha20A.23.170AT.11032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu2041C.37Lambda1439C.361224B.1.526IotaB.1.526.1B.1.526.2678B.1.1.529Omicron1518P.2Zetanucleocapsid proteinN.A.2022-08-24 09:08:01 CET2517Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich15LOD5700TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2AUPrecisionEvaluatedAccuracy99.35%95% CI: 98.78%~99.89%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98%95% CI: 97.12%~99.98%Clinical Specificity100%95% CI: 98.12%~99.99%Type of antigenNucleocapsid protein4098Rapid nCoV & Flu A/B Ag Test Kit (Colloidal Gold)1106Shenzhen Huian Biosci Technology Co. Ltd.Chinawww.huiantech.comYesCommercialisedNoNoManualNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabInfluenza AInfluenza A H1N1Influenza A H3N2Influenza BInfluenza B VictoriaInfluenza B YamagataSARS-CoV-2678B.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.2Zetanucleocapsid protein2022-09-29 09:01:44 CET3886Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD150TCID50/mlSARS-CoV-2CalibrationNot evaluatedAnalytical Sensitivity94.6%SARS-CoV-2Analytical Specificity99.1%SARS-CoV-2Analysis of cross reactivityEvaluatedFalse positives0.9%SARS-CoV-2False negatives5.4%SARS-CoV-2PrecisionEvaluatedAccuracy97.6%SARS-CoV-2RobustnessEvaluatedClinical Sensitivity94.6%SARS-CoV-2Clinical Specificity99.1%SARS-CoV-22414SARS-CoV-2 Antigen Test Kit (Colloidal Gold)1106Shenzhen Huian Biosci Technology Co. Ltd.Chinawww.huiantech.comYesCommercialisedYesYesManualNear POC / POCAntigenNasal swabNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1321B.1.617.2Delta1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta2041C.37LambdaB.1.526.1B.1.526.21518P.2Zetanucleocapsid proteinAll samples used in RT-PCR as a comparative method were nasopharyngeal swab specimens, and the sample collection for the SARS-CoV-2 Antigen Test Kit was carried out according to the instructions for use of the test2022-08-24 09:08:01 CET2116Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD150TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.9%Nasal swabFalse positives0.9%Nasopharyngeal swabFalse negatives5.4%Nasal swabFalse negatives5%Nasopharyngeal swabPrecisionEvaluatedAccuracy99.7%Nasopharyngeal swabAccuracy97.6%Nasal swabReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.6%Nasal swabClinical Sensitivity95%Nasopharyngeal swabClinical Specificity99.1%Nasal swabClinical Specificity99.1%Nasopharyngeal swabType of antigenNucleocapsid protein3356SARS-CoV-2 Antigen Test Kit (Colloidal Gold)1106Shenzhen Huian Biosci Technology Co. Ltd.Chinawww.huiantech.comYesCommercialisedNoNoNear POC / POCOtherAntigenAnterior nasal swabSARS-CoV20A.23.170AT.1678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1223B.1.525EtaB.1.526.1B.1.526.23939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31439C.362041C.37Lambda1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid protein2022-08-24 09:08:01 CET3096Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD150TCID50/mlAnalytical Sensitivity84%Analytical Specificity100%False positives0%False negatives17.95%Accuracy93%Clinical Sensitivity82.05%Clinical Specificity100%2166SARS-CoV-2 Antigen Rapid Test (Lateral Flow Assay)1009Shenzhen Kang Sheng Bao Bio-Technology Co. Ltd.ChinaYesCommercialisedNoNoLab-basedManualNear POC / POCAntigenAnterior nasal swabNasopharyngeal swabOropharyngeal swab689B.1.1.7Alpha1032B.1.351Betanucleocapsid proteinno additional information2022-08-24 09:08:01 CET1867Immuno-AntigenYesNoImmunochromatographyQualitative15LOD0.05AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives1%False negatives4.81%PrecisionEvaluatedAccuracy96.71%(Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.19%(Antigen)Clinical Specificity98.17%(Antigen)Type of antigenNucleoprotein2941COVID-19 Antigen Detection Kit(Quantum Dots-Based Immunofluorescence Chromatography)1297Shenzhen Kingfocus Biomedical Engineering Co. Ltd.Chinawww.king-focus.comYesCommercialisedYesYesAutomatedManualAntigenNasal swabSARS-CoV689B.1.1.7Alpha1321B.1.617.2Delta678B.1.1.529Omicronnucleocapsid proteinORF1ab polyproteinPlease be updated the Rapid antigen tests with CE Marking.2022-08-24 09:08:01 CET2647Immuno-AntigenYesNoNoImmunochromatographyQualitativeN.A.Fluorescence15LOD0.1ng/mLCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1%99.00%False negatives6.67%93.33%PrecisionEvaluatedAccuracy95.38%RobustnessEvaluatedClinical Sensitivity90.83%Clinical Specificity99.28%Type of antigenNucleocapsid protein1813SARS-CoV-2 Antigen Test Kit (GICA)824Shenzhen Kisshealth Biotechnology Co. Ltd.Chinahttp://en.kisshealth.cn/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.1.621Mu2041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.220A.23.1nucleocapsid proteinNo2022-08-24 09:08:01 CET1510Immuno-AntigenYesNoImmunochromatographyQualitativeMembrane-basedColorimetry15LOD150TCID50/mlAnalysis of cross reactivityEvaluatedFalse positives0%False negatives3.57%PrecisionEvaluatedAccuracy98.61%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.43%Clinical Specificity100%Type of antigenNucleocapsid protein2109Green Spring SARS-CoV-2 Antigen-Rapid test-Set977Shenzhen Lvshiyuan Biotechnology Co. Ltd.Chinahttps://www.lsybt.com/YesCommercialisedYesYesNear POC / POCAntigenAnterior nasal swabNasal swabNasopharyngeal swabOropharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.3nucleocapsid proteinDear colleagues, we have removed the saliva sample method from our test and the data of the sensitivity and specificity are from the newest performance evaluation. Thank you very much for the update! Best regards, Anna Zhu2022-08-24 09:08:01 CET1799Immuno-AntigenYesNoImmunochromatographyQualitativeCapture15LOD400AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%0 of 210 (100% specificity)False negatives3.23%5 of 155 (96.77% sensitivity)PrecisionEvaluatedAccuracy98.63%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.77%AntigenClinical Specificity100%AntigenType of antigenNucleoproteinType of antigenNucleocapsid protein2989SARS-CoV-2 Antigen Rapid Test Kit (Immunofluorescence Assay)1322Shenzhen Lvshiyuan Biotechnology Co. Ltd.Chinasales-tbl@lsybt.comYesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal 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 proteinThis product was developed by Shenzhen Lvshiyuan Biotechnology Co., Ltd in China and clinically tested by the University of Rome in Italy. Through instrument interpretation, it aims to improve the detection accuracy for the new variant coronavirus.2022-08-24 09:08:01 CET2695Immuno-AntigenYesNoYesImmunochromatographySemiquantitativeMembrane-basedImmunofluorescence15LOD400TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%0 false positives out of 50 negative samplesFalse negatives9%9 false negatives out of 100 positive samplesPrecisionEvaluatedAccuracy94%AntigenReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity91%AntigenClinical Specificity100%AntigenType of antigenNucleocapsid protein25672Respiratory 13 Pathogen Antigen Test Kit(Colloidal Gold Chromatographic Immunoassay)563Shenzhen Microprofit Biotech Co. Ltd.Chinawww.microprofit-bio.comYesCommercialisedNoNoManualAntigenNasopharyngeal swabOropharyngeal swabAdenovirusAdenovirus 3Adenovirus 7Human Metapneumovirus (HMPV)Influenza AInfluenza A H1N1Influenza A H3N2Influenza A H5N1Influenza BInfluenza B VictoriaInfluenza B YamagataOtherParainfluenza Virus TypeParainfluenza Virus Type 1Parainfluenza Virus Type 2Parainfluenza Virus Type 3Respiratory Syncytial V (RSV)Respiratory Syncytial V (RSV) Type ARespiratory Syncytial V (RSV) Type BRhinovirusRhinovirus ARhinovirus BSARS-CoV-2678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1321B.1.617.2Delta1495P.1Gammanucleocapsid protein Submission ID: 256702025-01-08 09:26:47 CET21176Immuno-AntigenYesNoNoImmunochromatographyQualitativeMembrane-basedColloidal gold12LOD49TCID50/mlCalibrationEvaluatedAnalytical Sensitivity100%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives%False negatives7.07%PrecisionEvaluatedAccuracy100%RobustnessEvaluatedClinical Sensitivity92.93%97.48%(RhV); 98.08%(PIV); 96.82%(Influenza A);97.47%(Influenza B);98.72%(RSV); 98.06%(ADV); 98.04%(hMPV);95.00%(S.p); 93.08%(S.aureus); 94.92%(L.p); 93.57%(M.P);96.32%(Kpn)Clinical Specificity100%98.68%(RhV); 98.75%(PIV); 99.55%(Influenza A);100%(Influenza B);100%(RSV); 100%(ADV); 100%(hMPV);99.19%(S.p); 97.14%(S.aureus); 97.89%(L.p); 95.89%(M.P);98.57%(Kpn)2233SARS-CoV-2 & Influenza A/B & RSV Antigen Combo Test Kit (Colloidal Gold Chromatographic Immunoassay)563Shenzhen Microprofit Biotech Co. Ltd.Chinawww.microprofit-bio.comYesCommercialisedYesYesManualAntigenNasal swabNasopharyngeal swabOropharyngeal 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-2678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1321B.1.617.2Delta1495P.1Gammanucleocapsid proteinwww.microprofit-bio.com2023-02-01 14:58:36 CET5464Immuno-AntigenYesNoNoImmunochromatographyQualitativeMembrane-basedColloidal gold15LOD49TCID50/mlCalibrationEvaluatedAnalytical Sensitivity100%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives%False negatives7.07%PrecisionEvaluatedAccuracy100%(SARS-CoV-2);100(Influenza A);100(Influenza B);100(RSV)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.9%(SARS-CoV-2);91.8(Influenza A);92.7(Influenza B);97(RSV)Clinical Specificity100%(SARS-CoV-2);99.6(Influenza A);100(Influenza B);100(RSV)Type of antigenOther5751SARS-CoV-2 & Influenza A/B Antigen Combo Test Kit(Colloidal Gold Chromatographic Immunoassay)563Shenzhen Microprofit Biotech Co. Ltd.Chinawww.microprofit-bio.comYesCommercialisedYesYesManualAntigenNasal swabNasopharyngeal swabOropharyngeal swabInfluenza AInfluenza A H1N1Influenza A H3N2Influenza A H5N1Influenza BInfluenza B VictoriaInfluenza B YamagataSARS-CoV-2678B.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.37Lambda1495P.1Gamma1519P.3Thetanucleocapsid protein2022-11-03 08:59:31 CET5463Immuno-AntigenYesNoNoImmunochromatographyQualitativeMembrane-basedColloidal gold15LOD49TCID50/mlCalibrationEvaluatedAnalytical Sensitivity100%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives%False negatives6.79%PrecisionEvaluatedAccuracy96.26%RobustnessEvaluatedClinical Sensitivity93.21%Clinical Specificity100%1967SARS-CoV-2 Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay)563Shenzhen Microprofit Biotech Co. Ltd.Chinawww.microprofit-bio.comYesCommercialisedYesYesManualAntigenNasal swabNasopharyngeal swabOropharyngeal swabnucleocapsid proteinwww.microprofit-bio.com2022-08-24 09:08:01 CET1643Immuno-AntibodyYesImmunochromatographyColloidal gold15LOD49AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives7%PrecisionEvaluatedAccuracy96.11%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.93%Clinical sensitivity at Ct<40=342/368=92.93% (95%CI:89.82%~95.33%)Clinical Specificity100%Clinical specificity = 300/300 = 100% (95%CI:98.78% ~100%)Type of antigenNucleoprotein1968SARS-CoV-2 Antigen Test Kit (Fluorescence Immunoassay)563Shenzhen Microprofit Biotech Co. Ltd.Chinawww.microprofit-bio.comYesCommercialisedYesYesManualAntigenNasal swabNasopharyngeal swabOropharyngeal swabwww.microprofit-bio.com2023-02-01 14:57:37 CET5462Immuno-AntibodyYesImmunochromatographyFluorescence15LOD25AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives%False negatives4.3%PrecisionEvaluatedAccuracy97.6%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.65%Clinical sensitivity at Ct<40=352/368=95.65% (95%CI:93.04%~97.49%)Clinical Specificity100%Clinical specificity = 300/300 = 100% (95%CI:98.78% ~100%)1178SARS-CoV-2 Spike Protein Test Kit (Colloidal Gold Chromatographic Immunoassay)563Shenzhen Microprofit Biotech Co. Ltd.Chinawww.microprofit-bio.comYesCommercialisedYesYesManualAntigenNasal swabNasopharyngeal swabOropharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1321B.1.617.2Delta2041C.37Lambdaspike proteinwww.microprofit-bio.com2022-08-24 09:08:01 CET960Immuno-AntigenYesYesImmunoassayQualitativeSandwich, DoubleColorimetry15LOD39TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives13.71%PrecisionEvaluatedAccuracy95.99%(Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity86.29%(Antigen)Clinical Specificity100% (Antigen)Type of antigenSpike protein1228SARS-CoV-2 Spike Protein Test Kit (Fluorescence Immunoassay)563Shenzhen Microprofit Biotech Co. Ltd.Chinawww.microprofit-bio.comYesCommercialisedYesYesAntigen2022-08-24 09:08:01 CET1013Immuno-AntigenYesImmunoassayImmunoAssay-Antigen 2978RapiSafe SARS-CoV-2 Antigen Rapid Test (Colloidal Gold)1019Shenzhen New Industries Biomedical Engineering Co. Ltd.Chinahttps://www.snibe.com/YesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swabOropharyngeal swabSARS-CoV689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta678B.1.1.529Omicronnucleocapsid proteinNone2022-08-24 09:08:01 CET2684Immuno-AntigenYesNoImmunochromatographyQualitativeSandwichColloidal gold15LOD200TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.8%False negatives3.1%PrecisionEvaluatedAccuracyNot evaluatedReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity96.9%Clinical Specificity99.2%Type of antigenNucleocapsid protein2026SARS-CoV-2 antigen IVD kit SWAB930Shenzhen Reagent Technology Co. Ltd.Chinahttps://www.reagen.cn/YesCommercialisedYesYesManualNear POC / POCAntigenNasopharyngeal swabOropharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31518P.2Zeta2041C.37Lambda678B.1.1.529Omicronnucleocapsid proteinDear Team, We would like submit additional information about the mutated varaints. eg. Omicron and Delta. Thank you for your support! For further questions, please feel free to contact us. Best regards, Team of Shenzhen Reagent Co., Ltd.2022-08-24 09:08:01 CET1704Immuno-AntigenYesNoNoImmunochromatographyQualitativeMembrane-based15LOD200TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.9%2 false positives were detected in 155 negative samplesFalse negatives4.76%5 false negatives were detected in 105 positive samplesPrecisionEvaluatedAccuracy97.31%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.23%（95%CI:85.94%-98.86%）Clinical Specificity98.71%（95%CI:86.75%-99.12%）Type of antigenNucleocapsid protein5738SARS-CoV-2 Antigen Rapid Self-test Kit (Colloidal Gold)3204SHENZHEN REETOO BIOTECHNOLOGY CO. LTDChinahttp://www.reetoo.com.cn/YesCommercialisedNoNoManualAntigenAnterior nasal swabAdenovirusAlpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Coronaviruses (HCoV)Cytomegalovirus (CMV)Epstein-Barr Virus (EBV)Human Metapneumovirus (HMPV)Influenza AInfluenza A H1N1Influenza A H3N2Influenza A H5N1Influenza BInfluenza B VictoriaInfluenza B YamagataMumps Virus (MuV)Respiratory Syncytial V (RSV)Rhinovirus678B.1.1.529Omicron689B.1.1.7Alphanucleocapsid protein2022-10-31 09:11:51 CET5252Immuno-AntigenYesYesNoImmunoassayQualitativeSandwichColloidal gold15LOD200TCID50/mlCalibrationNot evaluatedAnalytical Sensitivity90%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives0.25%False negatives3.96%PrecisionEvaluatedAccuracy99%RobustnessEvaluatedClinical Sensitivity96.04%Clinical Specificity99.75%3999 2019-nCoV Antigen Rapid Test (Immunochromatography Assay)1367Shenzhen Superbio Technology Co. Ltd.Chinahttp://superbiodx.com/YesCommercialisedNoNoNear POC / POCOtherAntigenNasal swabAdenovirusAdenovirus 3Adenovirus 7Adenovirus Subtype BAdenovirus Subtype CAlpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Bordetella PertussisCoronaviruses (HCoV)Cytomegalovirus (CMV)Hemophilus InfluenzaeInfluenza AInfluenza A H1N1Influenza A H3N2Influenza BInfluenza B VictoriaInfluenza B YamagataMERS-CoVMumps Virus (MuV)Mycoplasma PneumoniaeParainfluenza Virus Type 2Respiratory Syncytial V (RSV)RhinovirusVaricella Zoster Virus (VZV)678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526Iota1320B.1.617.1Kappa1321B.1.617.2Deltanucleocapsid protein2022-08-24 09:08:01 CET3664Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, DoubleOther15LOD80testsAnalytical Sensitivity80%Analytical Specificity100%False positives0.01%False negatives7.58%Accuracy97.69%Clinical Sensitivity92.42%Clinical Specificity100%57662019-nCOV Antigen Rapid Test1367Shenzhen Superbio Technology Co. Ltd.Chinahttp://superbiodx.com/YesCommercialisedNoNoNear POC / POCAntigenNasal swabAlpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)SARS-CoV-2678B.1.1.529Omicron1321B.1.617.2Deltanucleocapsid protein2022-11-17 10:03:50 CET5321Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwichColloidal gold15LOD80TCID50/mlCalibrationNot evaluatedAnalytical Sensitivity92%Analytical Specificity99%Analysis of cross reactivityEvaluatedFalse positivessamples122 Positive and 0 falseFalse negatives10samples300 Negative and 10 falsePrecisionNot evaluatedAccuracy97%RobustnessNot evaluatedClinical Sensitivity100%Clinical Specificity100%30862019-nCoV Antigen Rapid Test (Immunochromatography Assay)1367Shenzhen Superbio Technology Co. Ltd.Chinahttp://superbiodx.com/YesCommercialisedNoNoManualAntigenAnterior nasal swabNasopharyngeal swabOropharyngeal swabSARS-CoV-2678B.1.1.529Omicron1321B.1.617.2Deltanucleocapsid protein2023-01-09 10:10:55 CET5437Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich, DoubleOtherTest kit15Accuracy98.5%Anterior nasal site1Accuracy97.5%Nasopharyngeal site1Accuracy97.1%Oropharyngeal site1Accuracy97.7%Anterior nasal site2Clinical Sensitivity96.5%Anterior nasal site1Clinical Sensitivity93.8%Nasopharyngeal site1Clinical Sensitivity93.8%Oropharyngeal site1Clinical Sensitivity92.4%Anterior nasal site2Clinical Specificity99.7%Anterior nasal site1Clinical Specificity99.9%Nasopharyngeal site1Clinical Specificity99.4%Oropharyngeal site1Clinical Specificity99.9%Anterior nasal site23617COVID-19 Ag+Flu A/Flu B Rapid Test (Immunochromatography Assay)1367Shenzhen Superbio Technology Co. Ltd.Chinahttp://superbiodx.com/YesCommercialisedNoNoManualNear POC / POCAntigenAnterior nasal swabNasopharyngeal swabOropharyngeal swabInfluenza A H1N1Influenza A H3N2Influenza B VictoriaInfluenza B Yamagata678B.1.1.529Omicron1032B.1.351Beta1321B.1.617.2Delta1322B.1.617.3Othernucleocapsid protein2022-11-21 09:02:27 CET5334Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich, DoubleNot foundScreening Kit15LOD80TCID50/mlClinical Sensitivity96%For SARS-CoV-2 (A separate data analysis has been done for special strains, which are not included in the overall data statistics)Clinical Sensitivity93.6%For Influ AClinical Sensitivity90.7%For Influ BClinical Specificity99.9%For SARS-CoV-2 (A separate data analysis has been done for special strains, which are not included in the overall data statistics)Clinical Specificity99.9%For Influ AClinical Specificity99.9%For Influ B3270COVID-19 Ag+Flu A/Flu B Rapid Test (Immunochromatography Assay)1405Shenzhen Superbio Technology Co.,Ltd.Chinahttp://superbiodx.com/YesCommercialisedNoNoManualAntigenNasal swabNasopharyngeal swabOropharyngeal swabInfluenza AInfluenza BSARS-CoV678B.1.1.529Omicron1032B.1.351Beta1321B.1.617.2Delta1322B.1.617.3nucleocapsid protein2022-08-24 09:08:01 CET3034Immuno-AntigenYesYesYesImmunochromatographyQualitativeSandwich, DoubleOther152017SARS-CoV-2 Antigen Test Kit926Shenzhen Ultra-Diagnostics Biotec. Co. Ltd.Chinawww.ud-bio.comYesCommercialisedYesYesManualAntigenNasal swabNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31518P.2Zetanucleocapsid protein1. For in vitro diagnostic use only. 2. Proper specimen collection storage and transit are critical to the performance of this test. 3. Use only once. 4. Do not touch the reaction area of test strip. 5. Do not use test kit beyond the expiration date. 6. Do not use the kit if the pouch is punctured or sealed not well. 7. Testing should be applied by professionally trained staff working in certified laboratories or clinics. 8. The test result should be interpreted by the physician along with clinical findings and other laboratory test results. 9. Dispose of test cards and items in contact with samples as medical waste after use. 10.Do not freeze.2022-08-24 09:08:01 CET1695Immuno-AntigenYesNoImmunochromatographyQualitativeMembrane-based15LOD625AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.59%1/170 - NasopharyngealFalse positives0.97%1/103 - NasalFalse negatives4.07%5/123 - NasalFalse negatives3%8/266 - NasopharyngealPrecisionEvaluatedAccuracy97.35%95%CI:95.37%-97.74% - NasalAccuracy97.94%95%CI:96.90%-98.14% - NasopharyngealReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.48%95%CI:93.01%-96.01% - NasopharyngealClinical Sensitivity95.33%95%CI:91.31%-96.60% - NasalClinical Specificity99.61%95%CI:97.85%-99.93% - NasopharyngealClinical Specificity99.16%95%CI:95.39%-99.85% - NasalType of antigenNucleoprotein2999SARS-CoV-2 Antigen Test Kit (Colloidal Gold)1327Shenzhen Uni-medica Technology Co. Ltd.Chinawww.uni-medica.comYesNoNoManualAntigenAnterior nasal swabSARS-CoVUnknownnone2022-08-24 09:08:01 CET2705Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwichColloidal gold15CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.45%False negatives1.74%PrecisionEvaluatedAccuracy99.29%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.26%Clinical Specificity99.56%1769SARS-CoV-2 Ag Diagnostic Test Kit (Colloidal Gold)793Shenzhen Watmind Medical Co. Ltd.Chinahttp://www.watmind.comYesCommercialisedYesYesNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabnucleocapsid protein-2022-08-24 09:08:01 CET1448Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich, DoubleColorimetry10LOD150U/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1%False negatives4.85%PrecisionEvaluatedAccuracy93.7%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.15%for onset of symptoms within 7 daysClinical Specificity99.12%Type of antigenNucleocapsid protein3042SARS-CoV-2 Ag Self-test Kit (Saliva)1353Shenzhen Watmind Medical Co. Ltd.Chinahttp://www.watmind.comYesCommercialisedNoNoNear POC / POCAntigenSalivaCoronaviruses (HCoV)689B.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 proteinThis kit is used for in vitro qualitative detection of Nucleocapsid(N) Protein antigen from SARS-CoV-2 in human saliva samples.2022-08-24 09:08:01 CET2748Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, Double15LOD150TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1%False negatives9%PrecisionEvaluatedAccuracy95.5%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90.79%95%CI:85.13%-94.43%for CT values ≤36Clinical Specificity99.01%95%CI: 96.48%-99.73%Type of antigenNucleocapsid protein24740SARS-CoV-2/Influenza A/B/RSV Antigen Rapid Test Kit793Shenzhen Watmind Medical Co. Ltd.Chinahttp://www.watmind.comYesCommercialisedNoNoNear POC / POCAntigenAnterior nasal swabNasopharyngeal swabOropharyngeal 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-CoV-220A.23.170AT.1678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1224B.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 protein2023-02-23 18:19:48 CET20250Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwichColloidal gold15LOD49TCID50/mlSARS-CoV-2CalibrationEvaluatedAnalytical Sensitivity100%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives%SARS-CoV-2 - Nasal/Nasopharyngeal/Oropharyngeal SwabFalse negatives7.07%SARS-CoV-2 - Nasal SwabFalse negatives9.42%SARS-CoV-2 - Oropharyngeal SwabFalse negatives8.26%SARS-CoV-2 - Nasopharyngeal SwabPrecisionEvaluatedAccuracy96.82%SARS-CoV-2 - Nasal SwabAccuracy96.17%SARS-CoV-2 - Nasopharyngeal SwabAccuracy95.61%SARS-CoV-2 - Oropharyngeal SwabRobustnessEvaluatedClinical Sensitivity92.93%SARS-CoV-2 - Nasal SwabClinical Sensitivity91.74%SARS-CoV-2 - Nasopharyngeal SwabClinical Sensitivity90.58%SARS-CoV-2 - Oropharyngeal SwabClinical Specificity100%SARS-CoV-2/Influenza A/Influenza B/RSV1347GLINE-2019-nCoV Ag379SHENZHEN YHLO BIOTECH Co. Ltd.Chinahttp://www.szyhlo.comYesCommercialisedYesYesManualNear POC / POCAntigenNasal swabNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.3nucleocapsid proteinThe GLINE-2019-nCoV Ag has obtained the CE marking, and its clinical performance verification and analytical performance verification has also been completed.2022-08-24 09:08:01 CET1849Immuno-AntigenYesImmunoassayQualitativeSandwich15LOD200AUAnalysis of cross reactivityEvaluatedFalse positives0.75%(3/400)False negatives3.5%(4/114)RobustnessEvaluatedClinical Sensitivity97.37% (95%CI: 92.50% - 99.45%)Clinical Specificity99.25% (95%CI: 97.82% - 99.85%)Type of antigenNucleoprotein24753GLINE-2019-nCoV Ag & Influenza A/B Ag Combo Rapid Test (Colloidal Gold Assay)379SHENZHEN YHLO BIOTECH Co. Ltd.Chinahttp://www.szyhlo.comYesCommercialisedNoNoManualNear POC / POCAntigenNasal swabNasopharyngeal swabInfluenza AInfluenza A H1N1Influenza A H3N2Influenza BInfluenza B VictoriaInfluenza B YamagataSARS-CoV-2678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1223B.1.525Eta1224B.1.526Iota1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu2041C.37Lambda1495P.1Gammanucleocapsid protein2023-03-14 11:20:03 CET20265Immuno-AntigenYesNoNoImmunoassayQualitativeSandwichColloidal goldcolloidal gold immunoassay15LOD200TCID50/mlCalibrationNot evaluatedAnalytical Sensitivity%Analytical Specificity%Analysis of cross reactivityEvaluatedFalse positives0.44%False negatives13.04%PrecisionEvaluatedAccuracy97.03%RobustnessEvaluatedClinical Sensitivity86.96%Clinical Specificity99.56%1893GLINE-2019-nCoV Ag Saliva379SHENZHEN YHLO BIOTECH Co. Ltd.Chinahttp://www.szyhlo.comYesCommercialisedNoNoManualNear POC / POCAntigenSaliva689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.3nucleocapsid proteinThe GLINE-2019-nCoV Ag Saliva has obtained CE marking, and its clinical performance verification and analytical performance verification has also been completed.2022-08-24 09:08:01 CET1850Immuno-AntigenYesImmunoassayQualitativeSandwich20LOD425TCID50/mlAnalysis of cross reactivityEvaluatedFalse positives0%(0 out of 123)False negatives5.2%(26 out of 500)RobustnessEvaluatedClinical Sensitivity95.27% (95%CI: 93.15%-96.89%)Clinical Specificity100% (95%CI: 97.05%-100%)Type of antigenNucleoprotein1169iFlash-2019-nCoV Antigen379SHENZHEN YHLO BIOTECH Co. Ltd.Chinahttp://www.szyhlo.comYesCommercialisedNoNoAutomatedAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.3nucleocapsid proteinThe iFlash-2019-nCoV Antigen has obtained the CE marking, and its clinical performance verification and analytical performance verification has also been completed.2022-08-24 09:08:01 CET948Immuno-AntigenYesYesImmunoassayQualitativeSandwichChemiluminescence30LOD120AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.46%(1/215)False negatives2.94%(1/34)PrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.1%Clinical Specificity99.5%Type of antigenNucleoprotein1170UNICELL-2019-nCoV Ag379SHENZHEN YHLO BIOTECH Co. Ltd.Chinahttp://www.szyhlo.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabNasopharyngeal swab2022-08-24 09:08:01 CET954Immuno-AntigenYesYesImmunoassayQualitativeFluorescence15LOD160TCID50/mlFalse positives2%False negatives3%Accuracy99.03%Clinical Sensitivity97.37%2333COVID-19 Antigen Test Kit (Colloidal Gold)1085Shenzhen Yilifang Biotech Co. Ltd.Chinahttp://www.yilifangbio.com/en/YesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swabOropharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.320A.23.11224B.1.526IotaB.1.526.1nucleocapsid proteinPlease check the official website for details. http://www.yilifangbio.com/en/2022-08-24 09:08:01 CET2034Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD35AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives7.18%(12 false positives in 167 sample)False negatives1.5%(5 false negatives in 333 sample)PrecisionEvaluatedAccuracy97%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.88%Clinical Specificity96.47%Type of antigenNucleoprotein1095Automatic ImmunoAssay System - HP-AFS/1587Shijiazhuang Hipro Biotechnology Co. Ltd.Chinawww.hipro.usYesCommercialisedNoNoAutomatedNear POC / POCAntigenAnterior nasal swabNasal swabNasopharyngeal swabnucleocapsid proteinThis product already registed on Netherlands.2022-08-24 09:08:01 CET875Immuno-AntigenYesYesNephelometryQuantitativeCapture6CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1False negatives1PrecisionEvaluatedAccuracy90ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90Clinical Specificity95Type of antigenNucleocapsid protein1094POCT Immunoassay System - HP-083/4587Shijiazhuang Hipro Biotechnology Co. Ltd.Chinawww.hipro.usYesCommercialisedNoNoNear POC / POCSemi-automatedAntigenAnterior nasal swabNasal swabNasopharyngeal swabnucleocapsid proteinThis product already registered in Netherlands2022-08-24 09:08:01 CET874Immuno-AntigenYesYesNephelometryQuantitativeCapture6CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1%False negatives1%PrecisionEvaluatedAccuracy90%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92%Clinical Specificity97%Type of antigenNucleocapsid protein1659SARS-Cov-2 Antigen Assay kit by Immunofluorescence Chromatography method743Sichuan Xincheng Biological Co. Ltd.Chinawww.xinchengbio.com/en/YesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swabOropharyngeal swabnucleocapsid proteinNone2022-08-24 09:08:01 CET1338Immuno-AntigenYesYesImmunoassaySemiquantitativeFluorescence15LOD500AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.5%False negatives3.8%PrecisionEvaluatedAccuracy98.1%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.2%Clinical Specificity99.5%Type of antigenNucleocapsid protein1660SARS-Cov-2 Antigen Assay kit by Latex Immunochromatography method743Sichuan Xincheng Biological Co. Ltd.Chinawww.xinchengbio.com/en/YesCommercialisedNoNoNear POC / POCAntigenNasal swabnucleocapsid protein2022-08-24 09:08:01 CET1339Immuno-AntigenYesNoImmunoassayQualitative15LOD500AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.95%False negatives5.7%PrecisionEvaluatedAccuracy96.9%(Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.2%(Antigen)Type of antigennucleoprotein1218CLINITEST Rapid Covid-19 Antigen Test444Siemens HealthineersGermanywww.siemens-healthineers.comYesCommercialisedYesYesNear POC / POCAntigenNasal swabNasopharyngeal swabnucleocapsid proteinspike protein2022-08-24 09:08:01 CET1002Immuno-AntigenYesNoImmunochromatographyQualitative15False positives0.23%2 out of 865False negatives0%0Accuracy99.42%Nasopharyngeal swabAccuracy98.73%Nasal swabClinical Sensitivity98.32%Nasopharyngeal SwabClinical Sensitivity97.25%Nasal swabClinical Specificity99.6%Nasopharyngeal SwabClinical Specificity100%Nasal swabType of antigenS1, S1-RBD, S2, N proteins1650SINGUWAY COVID-19 Ag Test604SINGUWAY BIOTECH Inc.Chinawww.singuway.com/english/index.phpYesCommercialisedNoNoNear POC / POCAntigenNasal swabOtherSalivanucleocapsid protein2022-08-24 09:08:01 CET1331Immuno-AntigenYesYesImmunoassayQualitativeColorimetry15LOD1.25AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracy96%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.59%Type of antigennucleoprotein502Sona Nanotech COVID-19 Lateral Flow Assay Lateral flow screening test for S1 domain of SARS-CoV-2 S1 protein301Sona NanotechCanadasonanano.com/YesIn developmentNoNoNear POC / POCAntigenNasopharyngeal swab2022-08-24 09:08:01 CET396Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD214TCID50/mlClinical Sensitivity84.6%Clinical Specificity90%2817COVID-19 Antigen Rapid Test1252SPAN BIOTECH Ltd.Chinawww.spanbio.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.1.526.1B.1.526.21518P.2Zetanucleocapsid protein2022-08-24 09:08:01 CET2522Immuno-AntigenYesNoImmunoassayQualitativeSandwich, Double15LOD250TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy99.6%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.8%Clinical Specificity99.8%Type of antigenNucleocapsid protein1196CoV-Check DIRECT Covid-19 Antigen Test623Spark Diagnostics LLCIndiawww.sparkdiagnostics.comYesCommercialisedNoNoNear POC / POCAntigenNasal swab2022-08-24 09:08:01 CET981Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD380AUFalse positives0.9%False negatives8.6%Accuracy95.7%Clinical Sensitivity93.1%2185COVID-19 Antigen Rapid Test1018Spartacus-BiomedFrancewww.spartacus-biomed.frYesCommercialisedNoNoManualAntigenNasopharyngeal 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 protein.2022-08-24 09:08:01 CET1886Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich10LOD1250TCID50/mlFalse positives0%False negatives4%PrecisionEvaluatedAccuracy98.6%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.4%Clinical Specificity100%Type of antigenNucleocapsid protein1114SGTi-flex COVID-19 Ag261Sugentech Inc.South Koreawww.sugentech.comYesCommercialisedYesYesNear POC / POCAntigenNasal swabNasopharyngeal swabSARS-CoV689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1132B.1.427Epsilon1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.3678B.1.1.529Omicronnucleocapsid proteinThe omicron (B.1.1.529/BA.1) do not affect our product.2022-08-24 09:08:01 CET1019Immuno-AntigenYesNoImmunochromatographyQualitativeMagnetic Electrochemical15LOD350TCID50/mldirect swabLOD2800TCID50/mlSwab in VTMCalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.07%NasopharyngealClinical Sensitivity95.06NasalClinical Specificity99.38%NasopharyngealClinical Specificity99.29NasalType of antigenNucleocapsid protein12732019-nCoV Antigen Rapid Test (Colloidal Gold)262Sure Bio-Tech (USA) Co. Ltd.United Stateswww.surebiotech.com/YesCommercialisedNoNoNear POC / POCAntigenNasal swabThroat swab2022-08-24 09:08:01 CET1047Immuno-AntigenYesImmunoassayQualitativeColorimetry15Clinical Sensitivity92.5%Clinical Specificity99.16%1274Diagnostic Kit for SARS-CoV-2 Ag (Fluorescence Immunochromatographic Assay)262Sure Bio-Tech (USA) Co. Ltd.United Stateswww.surebiotech.com/YesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swabOropharyngeal swab2022-08-24 09:08:01 CET1049Immuno-AntigenYesImmunoassayFluorescence2297SARS-CoV-2 Rapid Antigen Test Cassette288SureScreen DiagnosticsUnited Kingdomwww.surescreen.comYesCommercialisedYesYesManualNear POC / POCAntigenAnterior nasal swabOther689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.320A.23.11224B.1.526IotaB.1.526.1B.1.526.21518P.2Zetanucleocapsid proteinValidated via UK Porton Down PHE process: https://www.gov.uk/government/news/british-manufacturer-surescreen-diagnostics-to-supply-20-million-rapid-lateral-flow https://www.gov.uk/government/publications/sars-cov-2-lateral-flow-antigen-tests-evaluation-of-voc1-and-voc2/sars-cov-2-lateral-flow-antigen-tests-evaluation-of-voc1-kent-uk-and-voc2-south-africa https://www.gov.uk/government/publications/assessment-and-procurement-of-coronavirus-covid-19-tests/outcome-of-the-evaluation-of-rapid-diagnostic-assays-for-specific-sars-cov-2-antigens-lateral-flow-devices2022-08-24 09:08:01 CET1998Immuno-AntigenYesNoImmunoassayQualitative10LOD90AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1%False negatives3.9%PrecisionEvaluatedAccuracy98.3%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.1%Clinical Specificity99%Type of antigenNucleoprotein1275SureScreen COVID-19 Antigen Rapid Test Cassette288SureScreen DiagnosticsUnited Kingdomwww.surescreen.comYesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swabOropharyngeal swab2022-08-24 09:08:01 CET1050Immuno-AntigenYesImmunoassayQualitative151942COVID-19 Antigen Test Kit884Surge Medical Inc.Chinawww.surgemedical.cnYesCommercialisedYesYesManualAntigenNasal swabNasopharyngeal swabOropharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gammanucleocapsid proteinIn addition to the European Union's CE certification, our products have also passed the German government's "BfArM" and "PEI" certification and the British government's "DHSC" testing certification.2022-08-24 09:08:01 CET1618Immuno-AntigenYesN.A.ImmunochromatographyQualitativeSandwich, Double15LOD100000AU/mLCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1%99 % clinical specificityFalse negatives6.67%93.33% clinical sensitivityPrecisionEvaluatedAccuracy99%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.33%Clinical Specificity97.69%Type of antigenNucleoproteinType of antigenNucleocapsid protein1943COVID-19/Influenza A+ B Antigen Test Kit884Surge Medical Inc.Chinawww.surgemedical.cnYesCommercialisedNoNoLab-basedAntigenNasal swabSaliva689B.1.1.7Alpha1032B.1.351Beta1518P.2Zetanucleocapsid proteinI updated the website, country, and variants detection. Thanks.2022-08-24 09:08:01 CET1619Immuno-AntigenYesYesImmunoassayQualitative15LOD100000AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.9%98.1 % sensitivityFalse negatives3.23%96.77 % specificityPrecisionEvaluatedAccuracy97.79%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.1%Clinical Specificity96.77%Type of antigenNucleoproteinType of antigenNucleocapsid protein3015InstantSure Covid-19 Ag CARD1340Suzhou Soochow University Saier Immuno Biotech Co. Ltd.ChinaYesCommercialisedYesYesNear 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.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.2678B.1.1.529Omicron1518P.2Zetanucleocapsid proteinThis kit is used for in vitro qualitative detection of SARS-CoV-2 antigen in human nasopharyngeal swabs, nasal swabs within 7 days after clinical symptoms. This test is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of in vitro diagnostic procedures, and proper infection control procedures and individuals similarly trained in point of care settings.2022-08-24 09:08:01 CET2721Immuno-AntigenYesNoNoImmunoassayQualitativeSandwich, Double15LOD160TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives3AUFalse negatives38AUPrecisionEvaluatedAccuracy96.58%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.69%Clinical Specificity99.52%Type of antigenNucleocapsid protein1467Covid-19 Antigen Rapid Test Cassette682Swedicine ABSwedenwww.swedicine.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabnucleocapsid protein2022-08-24 09:08:01 CET1218Immuno-AntigenYesNoImmunoassayQualitative15LOD5.07AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracy98%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.4%Type of antigennucleoprotein2884Q-Check Rapid Lateral Flow Assay for SARS-CoV-2 Antigen Detection1280Synbiotik BiotechnologyTurkeyhttps://synbiotiktr.comYesCommercialisedNoNoManualNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabnucleocapsid proteinRapid Lateral Flow Assay is designed to qualitatively detect the presence of Nucleocapsid protein (N protein), an antigen that is specific to SARS-CoV-2 in patients' swab samples. This test is developed to diagnose the presence of Nucleocapsid protein in human swab samples during the SARS-CoV-2 infection. Designed for in vitro diagnosis only.2022-08-24 09:08:01 CET2589Immuno-AntigenYesNoImmunoassayQualitativeSandwich20LOD27ctCt ≤27CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2.6%8 false positive out of 300False negatives2%6 false negative out of 300PrecisionEvaluatedAccuracy96.14%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90.7%AntigenClinical Specificity97.3%AntigenType of antigenNucleocapsid protein1598COVID-19 Antigen Rapid Test, Sienna873T&D diagnostics Canada Pvt. CanadaCanadawww.td-diagnostics.comYesCommercialisedNoNoNear POC / POCAntigen2022-08-24 09:08:01 CET1279Immuno-AntigenYesImmunoassay1192FORA COVID-19 Antigen Rapid Test588TaiDoc Technology Corp.Taiwan ROChttps://taidoc.com/YesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swabnucleocapsid protein https://www.testlinecd.com/file/1580/COVID-19_AN_NEW%20(002).pdf?version=202008131535 https://www.foracare.ch/covid-19-Antigen-rapid-test/; https://www.foracare.ch/wp-content/uploads/2020/11/20201104_FORA_TD-4531_Covid-19_quick-user-guide_EN_V3.pdf2022-08-24 09:08:01 CET978Immuno-AntigenYesImmunoassayQualitativeMagnetic Electrochemical15LOD126TCID50/mlClinical Sensitivity91.3%(CT<30)Clinical Specificity98.6%Type of antigennucleocapsid recombinant Antigen1096VTRUST COVID-19 Antigen Rapid Test TD-4531588TaiDoc Technology Corp.Taiwan ROChttps://taidoc.com/YesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swabnucleocapsid protein https://www.testlinecd.com/file/1580/COVID-19_AN_NEW%20(002).pdf?version=202008131535 https://taidoc.com/covid-19-Antigen-rapid-test-td-4531/; https://taidoc.com/wp-content/uploads/2020/08/Covid-19-Antigen-rapid-test.pdf2022-08-24 09:08:01 CET877Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD126TCID50/mlAnalysis of cross reactivity0% for virus, microorganisms and negatives matrices tested; EvaluatedClinical Sensitivity93.1%Clinical Specificity99.6%Type of antigennucleocapsid recombinant Antigen (NP)3066TARGETINGONE® SARS-CoV-2 Antigen Test1356TargetingOne Technology (Beijing) CorporationChinahttp://www.targetingone.com/en/CompanyProfile/index.aspxYesCommercialisedNoNoNear POC / POCAntigenAnterior nasal swabSARS-CoV689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1321B.1.617.2Delta1323B.1.621Mu2041C.37Lambda678B.1.1.529Omicronnucleocapsid proteinSARS-CoV-2 Antigen Test is used for in vitro qualitative detection of the SARS-CoV-2 N antigen in human nasal secretions. Antigen testing is generally conducted in the acute infection period, that is, within 7 days of the onset of symptoms. Positive results from the antigen test can be used for early triage and rapid management of patients with suspected infections. However, a positive result only indicates the presence of SARS-CoV-2 N antigen in the sample, and cannot be used as a basis for the diagnosis of SARS-CoV-2 infection. Negative results do not rule out SARS-CoV-2 infection and may not be used as the sole basis for treatment and disease management decisions. Further nucleic acid testing should be performed for both antigen positive and negative results in the suspected population. SARS-CoV-2 Antigen Test is used for latex immunochromatography for the detection of SARS-CoV-2 N antigen in human nasal secretions. The SARS-CoV-2 monoclonal antibody 2 is fixed in the detection zone (T line) of the nitrocellulose (NC) membrane,and a Goat anti-mouse polyclonal antibody is fixed in the quality control zone (C line) of the NC membrane. A mixture of SARS-CoV-2 monoclonal antibody 1 labeled with red latex was immobilized on a fiberglass membrane.2022-08-24 09:08:01 CET2772Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich15field_variants_detected B.1.604LOD100TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.98%False negatives12.26%PrecisionEvaluatedAccuracy96.69%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity87.74%AntigenClinical Specificity99.02%AntigenType of antigenNucleocapsid protein2584INFO Covid-19 Ag Test1178Türklab Tibbi Mal. San. ve Tic. A.S.TurkeyYesCommercialisedYesYesNear POC / POCAntigenNasal swab689B.1.1.7Alpha1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.3nucleocapsid protein2022-08-24 09:08:01 CET2289Immuno-AntigenYesImmunochromatographyQualitative20CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives5AUFalse negatives43AUPrecisionEvaluatedAccuracy97.14%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.71%Clinical Specificity99.54%Type of antigenNucleocapsid protein1751RAPIDAN TESTER Covid-19 Ag Test1178Türklab Tibbi Mal. San. ve Tic. A.S.TurkeyYesCommercialisedYesYesNear POC / POCAntigenNasal swab689B.1.1.7Alpha1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.3nucleocapsid protein2022-08-24 09:08:01 CET1429Immuno-AntigenYesNoImmunochromatographyQualitative20LOD30U/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives5AUFalse negatives43AUPrecisionEvaluatedAccuracy97.14%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.71%Clinical Specificity99.54%Type of antigenNucleocapsid protein1689TEST IT Covid-19 Ag Test1178Türklab Tibbi Mal. San. ve Tic. A.S.TurkeyYesCommercialisedYesYesNear POC / POCAntigenNasal swab689B.1.1.7Alpha1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.3nucleocapsid proteinN/A2022-08-24 09:08:01 CET1368Immuno-AntigenYesNoImmunochromatographyQualitative20LOD30AUAnalysis of cross reactivityEvaluatedFalse positives5AUFalse negatives43AUPrecisionEvaluatedAccuracy97.14%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.71%Clinical Specificity99.54%Type of antigenNucleocapsid protein1722TOYO Covid-19 Ag Test1178Türklab Tibbi Mal. San. ve Tic. A.S.TurkeyYesCommercialisedYesYesNear POC / POCAntigenNasal swab689B.1.1.7Alpha1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.3nucleocapsid protein2022-08-24 09:08:01 CET1402Immuno-AntigenYesNoImmunochromatographyQualitative20LOD0AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives5AUFalse negatives43AUPrecisionEvaluatedAccuracy97.14%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.71%Clinical Specificity99.54%Type of antigenNucleocapsid protein1338SARS-CoV-2 Antigen Rapid Test649TBG BIOTECHNOLOGY XIAMEN Inc.Chinawww.tbgxm.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabnucleocapsid protein2022-08-24 09:08:01 CET1107Immuno-AntigenYesNoImmunoassayQualitative20Type of antigennucleoprotein2215Viraspec SARS-CoV-2 Antigen Rapid Test1030Thyrolytics ABSwedenwww.thyrolytics.comYesCommercialisedNoNoNear POC / POCAntigenSaliva689B.1.1.7Alphanucleocapsid proteinNA2022-08-24 09:08:01 CET1916Immuno-AntigenYesNoImmunochromatographyQualitative10LOD1000AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%(0 out of 162)False negatives10%(12 out of 120)PrecisionEvaluatedAccuracy95.7%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90%Clinical Specificity99.9%Type of antigenNucleoprotein2054TODA Autotest Nasal Covid-19681TODA PHARMAFrancehttps://www.todapharma.com/YesCommercialisedNoNoNear POC / POCAntigenAnterior nasal swabNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.3nucleocapsid proteinPlease kindly note that the above mentioned performance rates are based on nasal swab.2022-08-24 09:08:01 CET1734Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, Double15LOD0AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives3.38%On 59 negative samples confirmed by RT-PCR, 57 were also negative with our test : 2 false positivesFalse negatives0%On 34 positive samples confirmed by RT-PCR, 34 were also negative with our test : 0 false negativePrecisionEvaluatedAccuracy97%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94%Clinical Specificity99%Type of antigenNucleocapsid protein1466TODA CORONADIAG Ag681TODA PHARMAFrancehttps://www.todapharma.com/YesCommercialisedYesYesNear POC / POCAntigenNasal swabNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.3nucleocapsid proteinPlease kindly note that the above mentioned figures are based on patients having symptoms between 1 and 4 days after its onset.2022-08-24 09:08:01 CET1216Immuno-AntigenYesNoImmunoassayQualitativeSandwich, Double15LOD502.377AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%(On 129 negative samples confirmed by RT-PCR, 129 were also negative with our test : 0 false positive)False negatives1.37%On 73 positive samples confirmed by RT-PCR, 72 were also negative with our test : 1 false negativePrecisionEvaluatedAccuracy99.5%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.6%Clinical Specificity100%Type of antigenNucleocapsid protein1913TODA Covdiag Saliva681TODA PHARMAFrancehttps://www.todapharma.com/YesCommercialisedNoNoNear POC / POCAntigenSalivaSputum689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.3nucleocapsid proteinspike proteinPlease kindly note that the above mentioned performance rates were assessed on saliva specimens.2022-08-24 09:08:01 CET1590Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich, DoubleColorimetry10LOD125AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.42%On 236 negative samples confirmed by RT-PCR, 235 were also negative with our test : 1 false positiveFalse negatives7.1%On 169 positive samples confirmed by RT-PCR,157 were also positive with our test: 12 false negativesPrecisionEvaluatedAccuracy96%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.9%Clinical Specificity99.9%Type of antigenNucleocapsid protein1934Coronavirus (SARS-CoV 2) Antigen - Oral Fluid885Tody Laboratories Int.Romaniawww.todylaboratories.com/YesCommercialisedNoNoManualAntigenDeep (cough) sputumSalivaSputumnucleocapsid proteinMinimum detection limit = 100 pg/ml2022-08-24 09:08:01 CET1610Immuno-AntigenYesNoImmunochromatographyQualitativeMembrane-based15LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positivesFrom studies performed by manufacturer, the false positive rate is 0.7% (specificity = 99.3%)False negativesFrom studies performed by manufacturer, the false negative rate is 9.9% (sensitivity = 90.1%)PrecisionEvaluatedAccuracy97%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90.1%Clinical Specificity99.3%Type of antigenNucleoprotein1935Coronavirus (SARS-CoV 2) Antigen - Swab Specimen885Tody Laboratories Int.Romaniawww.todylaboratories.com/YesCommercialisedNoNoManualAntigenNasal swabNasopharyngeal swabnucleocapsid proteinDetection limit: 100 TCID50/ml. Performance characteristics using the nasal swab specimen: Sensitivity: 92.9% Specificity: >99.9% Accuracy: 96.2% False positives (nasal swab specimen): From studies performed by manufacturer, the false positive rate is <0.1% (specificity = >99.9%) False negatives (nasal swab specimen): From studies performed by manufacturer, the false negative rate is 7.1% (sensitivity = 92.9%)2022-08-24 09:08:01 CET1611Immuno-AntigenYesNoImmunochromatographyQualitativeMembrane-based15LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1%From studies performed by manufacturer, the false positive rate is 1.0% (specificity = 99.0%)False negatives3.6%From studies performed by manufacturer, the false negative rate is 3.6% (sensitivity = 96.4%)PrecisionEvaluatedAccuracy98.2%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.4%Clinical Specificity99%Type of antigenNucleocapsid (N) protein1497Trueline COVID-19 Ag Rapid Test689TP Medicare GmbHGermanywww.tp-medicare.de/YesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swabnucleocapsid protein2022-08-24 09:08:01 CET1247Immuno-AntigenYesNoImmunoassayQualitative15False positives0%0 of 21False negatives2.7%1 of 37Accuracy98.1%Clinical Sensitivity93.8%Clinical Specificity100%Type of antigennucleocapside1465SARS-CoV-2 Antigen Rapid Test Kit677Triplex International Biosciences (China) Co. Ltd.Chinawww.tibchina.com/index_en.aspxYesCommercialisedYesYesNear POC / POCAntigenNasal swabnucleocapsid protein2022-08-24 09:08:01 CET1207Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD0AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives1.49%PrecisionEvaluatedAccuracy99.52%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.51Type of antigennucleoprotein2074SARS-CoV-2 Antigen Rapid Test Kit959Triplex International Biosciences (China) Co. Ltd.Chinawww.tibchina.comYesCommercialisedYesYesNear POC / POCOtherAntigenNasal swabNasopharyngeal swabOropharyngeal swabOtherSaliva689B.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 proteinLineages detected: A.23.1; AT.1;B.1.1.7(Alpha); B.1.351 (Beta); B.1.427(Epsilon); B.1.429(Epsilon); B.1.525 (Eta); B.1.526(Iota); B.1.617.1(Kappa); B.1.617.2 (Delta); B.1.617.3;B.1.621 (Mu); C.36;P.1(Gamma); P.2(Zeta); P.3 (Theta); C.37 (Lambda); B.1.616; B.1.1.529 (Omicron); B.1.526.1; B.1.526.2;2022-08-24 09:08:01 CET1756Immuno-AntigenYesNoNoImmunoassayQualitativeSandwich, Double15LOD40TCID50/ml40-100TICD 50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.49%False negatives0.09%PrecisionEvaluatedAccuracy99.54%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.51%Clinical Specificity99.91%Type of antigenNucleocapsid protein1391COVID-19 and Influenza A+B Antigen Combo Rapid Test (Nasopharyngeal Swab)657Ulti Med Products GmbHGermanywww.ultimed.orgYesCommercialisedNoNoNear POC / POCAntigenNasal swab2022-08-24 09:08:01 CET1157Immuno-AntigenYesNoImmunoassayQualitative15LOD100AUFalse positives0.82%False negatives3.61%Accuracy98%Clinical Sensitivity96.4%Clinical Specificity99.2%1378COVID-19 Antigen test657Ulti Med Products GmbHGermanywww.ultimed.orgYesCommercialisedNoNoNear POC / POCAntigenNasal swab2022-08-24 09:08:01 CET1143Immuno-AntigenYesNoImmunoassayQualitative15LOD100AUAnalysis of cross reactivityEavaluatedFalse positives1.23%False negatives2.44%Accuracy98%Clinical Sensitivity96.4%Clinical Specificity99.2%1455COVID-19 Antigen Test (Nasopharyngeal Swab)657Ulti Med Products GmbHGermanywww.ultimed.orgYesCommercialisedNoNoNear POC / POCAntigenNasal swab2022-08-24 09:08:01 CET1205Immuno-AntigenYesNoImmunoassayQualitative15LOD100AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.61%2 from 330False negatives6.01%8 from 133PrecisionEvaluatedAccuracy97.8%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94%2523Unibioscience Covid-19 Nasopharynx Antigen Test1150Unibioscience ASTurkeywww.unibioscience.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta1320B.1.617.1Kappa1321B.1.617.2Delta1323B.1.621Mu678B.1.1.529Omicronnucleocapsid proteinThe SARS CoV-2 Antigen Rapid Test is a lateral flow immunoassay for the rapid qualitative detection of the N-protein antigen of SARS CoV-2 in swab specimens from both symptomatic and asymptomatic COVID- 19 infected individuals.2022-08-24 09:08:01 CET2227Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich, Double15LOD2870TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.42%5/350False negatives0.85%3/350PrecisionEvaluatedAccuracy98.86%ReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity98.57%Clinical Specificity99.14%Type of antigenNucleocapsid protein2522Unibioscience Covid-19 Rapid Antigen Saliva Test1150Unibioscience ASTurkeywww.unibioscience.comYesCommercialisedNoNoManualNear POC / POCAntigenSalivaSputum689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta1320B.1.617.1Kappa1321B.1.617.2Delta678B.1.1.529Omicron1518P.2Zetanucleocapsid proteinSaliva tests are self-administered; this means that after you are shown how to perform the test, you’ll do it by yourself. You will spit several times into a funnel attached to a tube, and then screw on a cap to complete the sample collection. Saliva tests are more comfortable than nasal swabs and just as accurate.2022-08-24 09:08:01 CET2226Immuno-AntigenYesYesNoImmunoassayQualitativeSandwich, Double20LOD2870TCID50/mlAnalysis of cross reactivityEvaluatedFalse positives1.33%4/300False negatives0.33%1/300PrecisionEvaluatedAccuracy99.17%ReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity98.67%Clinical Specificity99.67%Type of antigenNucleocapsid proteinType of antigenNucleocapsid protein2249COVID-19 ANTIGEN RAPID TEST NASAL1047Unioninvest Ltd.Turkeywww.unibioscience.comYesCommercialisedNoNoManualAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1518P.2Zetanucleocapsid proteinValidation of the Unibioscience SARS CoV-2 Antigen Rapid Nasal Test was performed in correlation with the respective Ct values of the positive PCR samples, including clinical data on the duration of disease symptoms. Validation tests of PCR samples from symptomatic individuals with symptom onset before 5 days (N=400) resulted in a sensitivity of 99.00% (95% CI: 97.46%-99.73%) with a mean Ct value of 26.17 (Min 17.2 - Max 39.4). From the validation tests of PCR samples with a Ct value < 30 (N=250), a mean Ct value of 22.30 (Min 17.20-Max 29.90) resulted in a sensitivity of 99.60% (95% CI: 97.79%-99.9%). From the validation tests of PCR samples with a Ct value ≥ 30 (N=150), a mean Ct value of 32.60 (Min 30.1-Max 39.4) resulted in a sensitivity of 98.00% (95% CI: 94.27%-99.59%) The PCR test used in the validations was real-time PCR. The EasyprepFast real-time PCR kit was used. SARS-Cov-2 was the target genome. The corresponding target gene was the N1 and the E gene with the following primers: SARS-CoV-2_IBS_N1 / SARS-CoV-2_IBS_E2For the internal positive control (IPC), a GAPDH primer set was used. FAM, HEX and Cy5 dyes were applied for staining.2022-08-24 09:08:01 CET1950Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich, Double15LOD7.57AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.25%1/400False negatives1%4/400PrecisionEvaluatedAccuracy99 (Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99% (Antigen)Clinical Specificity99% (Antigen)Type of antigenNucleoprotein1831Coronavirus Ag Rapid Test Cassette (Swab)836Van Oostveen Medical B.V.Netherlandswww.romed.nl/enYesCommercialisedNoNoManualNear POC / POCAntigenNasal swabNasopharyngeal swabnucleocapsid protein2022-08-24 09:08:01 CET1509Immuno-AntigenYesNoImmunochromatographyQualitativeColorimetry15LOD115AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.34%3 false positives / 874 true negative (sum of nasopharyngeal and nasal swab samples)False negatives2.19%5 false negatives / 228 true positive (sum of nasopharyngeal and nasal swab samples)PrecisionEvaluatedAccuracy99.42%99.42 (antigen-nasopharyngeal), 98.73 (antigen-nasal)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.32%98.32 (antigen-nasopharyngeal), 97.25 (antigen-nasal)Clinical Specificity99.6%99.60 (antigen-nasopharyngeal), 100 (antigen-nasal)Type of antigenNucleoprotein1956COVID19-CHECK1 ANTIGEN574VEDALABFrancewww.vedalab.comYesCommercialisedNoNoManualAntigenNasal swabNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1321B.1.617.2Delta678B.1.1.529Omicronnucleocapsid proteinProfessional version is also CE marked and available2022-08-24 09:08:01 CET1632Immuno-AntigenYesYesNoImmunochromatographyQualitative20LOD0.05ng/mLrecombinant nucleoproteinAnalysis of cross reactivityEvaluatedFalse positives0.33%specificity 99.67%False negatives0.92%sensitivity 99.08% (Ct value <=25)PrecisionEvaluatedAccuracy99.51%95% IC [98.14 - 100.00] (overall agreement)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.08%95% IC [94.67 - 100.00] for Ct<=25 (109 tested samples)Clinical Specificity99.67%95% IC [98.03 - 100.00] (300 tested samples)Type of antigenNucleoproteinType of antigenNucleocapsid protein3147PerkinElmer® COVID-19 Antigen Test1392Viola Diagnostics Systems-Tulip DiagnosticsIndiahttp://www.tulipgroup.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.1.526.2678B.1.1.529Omicron1518P.2Zetaspike proteinN/A2022-08-24 09:08:01 CET2855Immuno-AntigenYesYesNoImmunoassayQualitativeSandwich, Double15All Known VoCs detected CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity86.11%Clinical Specificity99%Type of antigenNucleocapsid protein2650Vision Biyoteknoloji Araştırma Geliştirme Laboratuvar Sistemleri Sanayi ve Ticaret Limited Şirketi1211Vision BiotechnologyTurkeywww.visionbiotechnology.comYesCommercialisedNoNoManualNear 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 CET2355Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich15LOD100TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2%False negatives2%PrecisionEvaluatedAccuracy99.4%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.3%Clinical Specificity99.4%Type of antigenNucleocapsid protein5829Vision Biyoteknoloji Araştırma Geliştirme Laboratuvar Sistemleri Sanayi ve Ticaret Limited Şirketi 957Vision Biyoteknoloji AraÅŸtırma GeliÅŸtirme Laboratuvar Sistemleri Sanayi ve Ticaret Limited ÅžirketiTurkeywww.visionbiotechnology.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 11:20:00 CET5434Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD3200TCID50/ml(for Covid19)CalibrationEvaluatedAnalytical Sensitivity100%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives0.32%1 out of 306False negatives0.49%2 out of 407PrecisionEvaluatedAccuracy99.25%ADENORobustnessEvaluatedClinical Sensitivity99.26%ADENOClinical Specificity99.06%ADENO2734VISION COVID-19 AG RAPID TEST KIT957Vision Biyoteknoloji AraÅŸtırma GeliÅŸtirme Laboratuvar Sistemleri Sanayi ve Ticaret Limited ÅžirketiTurkeywww.visionbiotechnology.comYesCommercialisedNoNoManualNear POC / POCAntigenNasopharyngeal swab1495P.1Gamma689B.1.1.7Alpha1032B.1.351Betanucleocapsid proteinThis kit is used for the in vitro qualitative detection of the SARS-CoV-2 antigen.2022-08-24 09:08:01 CET2439Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich, Double15LOD100TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityNot evaluatedFalse positives2AUFalse negatives2AUPrecisionEvaluatedAccuracy99.4%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.3%Clinical Specificity99.4%Type of antigenNucleocapsid protein5831VISION COVID-INF A/B- RSV- ADENO MULTI RAPID TEST KIT957Vision Biyoteknoloji AraÅŸtırma GeliÅŸtirme Laboratuvar Sistemleri Sanayi ve Ticaret Limited ÅžirketiTurkeywww.visionbiotechnology.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 11:26:28 CET5435Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD3200TCID50/ml(for Covid19)CalibrationEvaluatedAnalytical Sensitivity100%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives4samples4 out of 205False negatives2samples2 out of 200PrecisionEvaluatedAccuracy98.98%rsvAccuracy98.09%ınfaAccuracy98.18%ınfbAccuracy98.98%covid19RobustnessEvaluatedClinical Sensitivity98.13%ınfbClinical Sensitivity98.04%ınfaClinical Sensitivity99.03%covid19Clinical Sensitivity99.03%rsvClinical Specificity99.04%ınfbClinical Specificity98.04%covid19Clinical Specificity99.01%ınfaClinical Specificity98.04%rsv2836VISION® COVID-19 AG RAPID TEST1264Vision Biyotenoloji Ar-Ge Lab Sist. San. Ve Tic. Ltd. ÅžTÄ°Turkeyhttps://visionbiotechnology.com/YesCommercialisedNoNoManualNear POC / POCAntigenNasal swabNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1GammaThis kit is used for the in vitro qualitative detection of SARS-CoV-2 antigen. This test is for clinical laboratory use or emergency medical examination only, not for home testing. It cannot be used as a basis for pneumonia caused by a new coronavirus infection. A positive test result must be further confirmed. The kit and test results are intended for clinical reference only.2022-08-24 09:08:01 CET2541Immuno-AntigenYesNoChromatographyQualitativeOther15LOD100TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positivesIf you react later than 15 minutes, this can lead to a false positive result.False negativesReacting earlier than 15 minutes can lead to a false negative result.PrecisionEvaluatedAccuracy98.47%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.57%Clinical Specificity99.6%Type of antigenNucleocapsid protein2835VISION® SARS-COV-2 AG RAPID NASOPHARYNGEAL TEST KIT1264Vision Biyotenoloji Ar-Ge Lab Sist. San. Ve Tic. Ltd. ÅžTÄ°Turkeyhttps://visionbiotechnology.com/YesCommercialisedNoNoManualNear POC / POCAntigenNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1GammaThis kit is used for the in vitro qualitative detection of SARS-CoV-2 antigen. This test is for clinical laboratory use or emergency medical examination only, not for home testing. It cannot be used as a basis for pneumonia caused by a new coronavirus infection. A positive test result must be further confirmed. The kit and test results are intended for clinical reference only.2022-08-24 09:08:01 CET2540Immuno-AntigenYesNoChromatographyQualitativeOther15LOD100TCID50/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.PrecisionEvaluatedAccuracy98.7%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.3%Clinical Specificity99.4%Type of antigenNucleocapsid protein2268Vitassay SARS-CoV-21058VITASSAY HEALTHCARE SLSpainwww.vitassay.comYesCommercialisedNoNoManualAntigenNasal swabNasopharyngeal swabMERS-CoVSARS-CoV689B.1.1.7Alpha1032B.1.351Beta1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31518P.2Zeta1495P.1Gamma678B.1.1.529Omicronnucleocapsid proteinMore details on our website.2022-08-24 09:08:01 CET1969Immuno-AntigenYesNoNoImmunochromatographyQualitative10LOD125PFU/mLCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives1AUFalse negatives4AUPrecisionEvaluatedAccuracy99%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.9%Nasal (positive samples with Ct< 28)Clinical Sensitivity95.1%Nasopharyngeal Clinical Specificity99.2%Nasal (positive samples with Ct< 28)Clinical Specificity99.8%Nasopharyngeal Type of antigenNucleoproteinType of antigenNucleocapsid protein2272Vitassay SARS-CoV-2+Influenza A+B+RSV+Adenovirus Resp.1058VITASSAY HEALTHCARE SLSpainwww.vitassay.comYesCommercialisedNoNoManualAntigenNasal swabNasopharyngeal swabMERS-CoVSARS-CoV689B.1.1.7Alpha1032B.1.351Beta1137B.1.429Epsilon1320B.1.617.1Kappa1495P.1Gamma1321B.1.617.2Delta678B.1.1.529Omicronnucleocapsid proteinMore details on our website.2022-08-24 09:08:01 CET1973Immuno-AntigenYesNoNoImmunochromatographyQualitative10LOD125PFU/mLCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives7AUFalse negatives3AUPrecisionEvaluatedAccuracy92%Accuracy99%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.9%Nasal (positive samples with Ct< 28)Clinical Sensitivity95.1%NasopharyngealClinical Specificity99.2%Nasal (positive samples with Ct< 28)Clinical Specificity99.8%NasopharyngealType of antigenNucleocapsid protein4083ENMED SARS-CoV-2 Rapid Antigen Test Kit678Vitrosens Biotechnology Co. Ltd.Turkeywww.vitrosens.comYesCommercialisedYesYesManualNear POC / POCAntigenAnterior nasal swabNasal swabNasopharyngeal swabOropharyngeal swabThroat 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 protein2.Twin test of this product was evaluated and approved by Paul-Ehrlich-Institute in Germany in March 2021. 3.The LOD for this product is 50 TCID50/mL.2022-09-29 09:41:24 CET5312Immuno-AntigenYesNoNoImmunochromatographyQualitativeMembrane-basedColorimetry-15LOD50%for SARS-CoV-2CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.95%5 out of 525 (Nasopharyngeal Swab)False negatives2.7%17 out of 630 (Nasopharyngeal Swab)PrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.3%NP swab:(SARS-CoV-2)Clinical Specificity99.05%NP swab:(SARS-CoV-2)1444Instant SARS-CoV-2 Rapid Ag Test678Vitrosens Biotechnology Co. Ltd.Turkeywww.vitrosens.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabOtherSalivanucleocapsid protein2022-08-24 09:08:01 CET1195Immuno-AntigenYesNoImmunoassayQualitativeColorimetry5LOD100IU/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1AUFalse negatives1AUPrecisionEvaluatedAccuracy98.3%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.3%Type of antigennucleoprotein1458RapidFor SARS-CoV-2 Antigen Test Kit678Vitrosens Biotechnology Co. Ltd.Turkeywww.vitrosens.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabSalivanucleocapsid protein2022-08-24 09:08:01 CET1210Immuno-AntigenYesNoImmunoassayQualitativeColorimetry10LOD100IU/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1%False negatives1%PrecisionEvaluatedAccuracy98%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.3%Type of antigennucleoprotein1443RapidFor SARS-CoV-2 Rapid Ag Test678Vitrosens Biotechnology Co. Ltd.Turkeywww.vitrosens.comYesCommercialisedYesYesManualNear POC / POCAntigenAnterior nasal swabNasal swabNasopharyngeal swabOropharyngeal swabThroat 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 protein1.This product was evaluated and approved by Ministry of Health Turkey in December 2020. 2.This product was evaluated and approved by Paul-Ehrlich-Institute in Germany in March 2021 3. Twin test of this product evaluated and approved by Therapeutic Goods Administration (TGA) in Australia in 2022. 4.The LOD for this product is 50 TCID50/mL.2022-09-30 09:55:16 CET3915Immuno-AntigenYesNoNoImmunochromatographyQualitativeMembrane-basedColorimetry15LOD50TCID50/mlfor SARS-CoV-2CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.95%5 out of 525 (Nasopharyngeal Swab)False negatives2.7%17 out of 630 (Nasopharyngeal Swab)PrecisionEvaluatedAccuracy98.09%NP swab:(SARS-CoV-2ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.3%NP swab:(SARS-CoV-2)Clinical Specificity99.05%NP swab:(SARS-CoV-2)Type of antigenNucleocapsid protein3611RapidFor SARS-CoV-2 Rapid Antigen Test Kit (Nasal)1016Vitrosens Biotechnology Co. Ltd.Turkeywww.vitrosens.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabSARS-CoV678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1223B.1.525Eta1321B.1.617.2Delta1495P.1Gammanucleocapsid protein2022-08-24 09:08:01 CET3327Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD100TCID50/mlAnalytical Sensitivity100%Analytical Specificity100%False positives0.65%False negatives2.94%Accuracy98.64%Clinical Sensitivity97.06%Clinical Specificity99.35%4065RapidFor™ SARS-CoV-2 & FLU A/B Antigen Combo Test678Vitrosens Biotechnology Co. Ltd.Turkeywww.vitrosens.comYesCommercialisedNoNoManualNear POC / POCAntigenAnterior nasal swabNasal swabNasopharyngeal swabOropharyngeal swabThroat 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 protein1. Twin test of this product was evaluated and approved by Paul-Ehrlich-Institute in Germany in March 2021 and Therapeutic Goods Administration (TGA) in Australia at 2022 for SARS-CoV-2. 2.The LOD for this product is 50 TCID50/mL. 2022-09-29 09:43:02 CET20283Immuno-AntigenYesNoNoImmunochromatographyQualitativeMembrane-basedColorimetry-15LOD50%for SARS-CoV-2CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.95%5 out of 525 (NP Swab for SARS-CoV-2)False positives0.79%3 out of 379 (NP Swab for InfB)False positives0.53%2 out of 375 (NP Swab for InfA)False negatives2.7%17 out of 630 (NP Swab for SARS-CoV-2)False negatives3.03%5 out of 165 (NP Swab for InfB)False negatives2.56%4 out of 156 (NP Swab for InfA)PrecisionEvaluatedAccuracy98.53%NP swab:(Inf B)Accuracy98.87%NP swab:(Inf A)Accuracy98.09%NP swab:(SARS-CoV-2)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.44%NP swab:(Inf A)Clinical Sensitivity97.3%NP swab:(SARS-CoV-2)Clinical Sensitivity96.97%NP swab:(Inf B)Clinical Specificity99.47%NP swab:(Inf A)Clinical Specificity99.05%NP swab:(SARS-CoV-2)Clinical Specificity99.21%NP swab:(Inf B)4063RapidFor™ SARS-CoV-2 & FLU A/B Rapid Antigen Test678Vitrosens Biotechnology Co. Ltd.Turkeywww.vitrosens.comYesCommercialisedNoNoManualNear POC / POCAntigenNasal swabNasopharyngeal 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 protein1. Twin test of this product was evaluated and approved by Paul-Ehrlich-Institute in Germany in March 2021 and Therapeutic Goods Administration (TGA) in Australia at 2022 for SARS-CoV-2. 2.The LOD for this product is 50 TCID50/mL. 2022-11-17 10:04:42 CET5331Immuno-AntigenYesNoNoImmunochromatographyQualitativeMembrane-basedColorimetry()15LOD50TCID50/mlfor SARS-CoV-2CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.95%5 out of 525 (NP Swab for SARS-CoV-2)False positives0.53%2 out of 375 (NP Swab for InfA)False positives0.79%3 out of 379 (NP Swab for InfB)False negatives2.7%17 out of 630 (NP Swab for SARS-CoV-2)False negatives3.03%5 out of 165 (NP Swab for InfB)False negatives2.56%4 out of 156 (NP Swab for InfA)PrecisionEvaluatedAccuracy98.09%NP swab:(SARS-CoV-2)Accuracy98.53%NP swab:(Inf B)Accuracy98.87%NP swab:(Inf A)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.3%NP swab:(SARS-CoV-2)Clinical Sensitivity97.44%NP swab:(Inf A)Clinical Sensitivity96.97%NP swab:(Inf B)Clinical Specificity99.05%NP swab:(SARS-CoV-2)Clinical Specificity99.47%NP swab:(Inf A)Clinical Specificity99.21%NP swab:(Inf B)5804RapidFor™ SARS-CoV-2 + FLU A/B + RSV Combo Test Kit678Vitrosens Biotechnology Co. Ltd.Turkeywww.vitrosens.comYesCommercialisedNoNoManualNear POC / POCAntigenAnterior nasal swabNasal swabNasopharyngeal swabOropharyngeal swabThroat 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 protein1. Twin test of this product was evaluated and approved by Paul-Ehrlich-Institute in Germany in March 2021 and Therapeutic Goods Administration (TGA) in Australia at 2022 for SARS-CoV-2. 2.The LOD for this product is 50 TCID50/mL. 2022-12-22 08:49:09 CET20282Immuno-AntigenYesYesNoImmunochromatographyQualitativeMembrane-basedColorimetry-15LOD50%for SARS-CoV-2CalibrationEvaluatedAnalytical Sensitivity100%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives0.95%5 out of 525 (NP Swab for SARS-CoV-2)False positives0.87%2 out of 231(NP Swab for RSV)False positives0.79%3 out of 379 (NP Swab for InfB)False positives0.53%2 out of 375 (NP Swab for InfA)False negatives2.7%17 out of 630 (NP Swab for SARS-CoV-2)False negatives2.24%5 out of 223 (NP Swab for RSV)False negatives3.03%5 out of 165 (NP Swab for InfB)False negatives2.56%4 out of 156 (NP Swab for InfA)PrecisionEvaluatedAccuracy98.09%NP swab:(SARS-CoV-2)Accuracy98.87%NP swab:(Inf A)Accuracy98.53%NP swab:(Inf B)Accuracy98.46%NP swab:(RSV)RobustnessEvaluatedClinical Sensitivity97.3%NP swab:(SARS-CoV-2)Clinical Sensitivity97.44%NP swab:(Inf A)Clinical Sensitivity96.97%NP swab:(Inf B)Clinical Sensitivity97.76%NP swab:(RSV)Clinical Specificity99.05%NP swab:(SARS-CoV-2)Clinical Specificity99.47%NP swab:(Inf A)Clinical Specificity99.21%NP swab:(Inf B)Clinical Specificity99.13%NP swab:(RSV)5816RapidFor™ SARS-CoV-2 + FLU A/B + RSV+ADV Combo Test Kit678Vitrosens Biotechnology Co. Ltd.Turkeywww.vitrosens.comYesCommercialisedNoNoManualNear POC / POCAntigenAnterior nasal swabNasal swabNasopharyngeal swabOropharyngeal swabThroat 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 protein1. Twin test of this product was evaluated and approved by Paul-Ehrlich-Institute in Germany in March 2021 and Therapeutic Goods Administration (TGA) in Australia at 2022 for SARS-CoV-2. 2.The LOD for this product is 50 TCID50/mL. 2023-01-09 10:06:31 CET5418Immuno-AntigenYesYesNoChromatographyQualitativeMembrane-basedColorimetry-15LOD50TCID50/mlfor SARS-CoV-2CalibrationEvaluatedAnalytical Sensitivity100%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives0.95%5 out of 525 (NP Swab for SARS-CoV-2)False positives0.82%2 out of 223 (NP Swab for ADV)False positives0.53%2 out of 375 (NP Swab for InfA)False positives0.79%3 out of 379 (NP Swab for InfB)False positives0.87%2 out of 231(NP Swab for RSV)False negatives2.7%17 out of 630 (NP Swab for SARS-CoV-2)False negatives1.78%4 out of 225 (NP Swab for ADV)False negatives2.24%5 out of 223 (NP Swab for RSV)False negatives3.03%5 out of 165 (NP Swab for InfB)False negatives2.56%4 out of 156 (NP Swab for InfA)PrecisionEvaluatedAccuracy98.09%NP swab:(SARS-CoV-2)RobustnessEvaluatedClinical Sensitivity97.3%NP swab:(SARS-CoV-2)Clinical Sensitivity97.44%NP swab:(Inf A)Clinical Sensitivity96.97%NP swab:(Inf B)Clinical Sensitivity97.76%NP swab:(RSV)Clinical Sensitivity98.22%NP swab:(ADV)Clinical Specificity99.05%NP swab:(SARS-CoV-2)Clinical Specificity99.47%NP swab:(Inf A)Clinical Specificity99.21%NP swab:(Inf B)Clinical Specificity99.13%NP swab:(RSV)Clinical Specificity99.18%NP swab:(ADV)5834RapidFor™ SARS-CoV-2 +FLUA/B + RSV + ADV + M. Pneumoniae Combo Test Kit678Vitrosens Biotechnology Co. Ltd.Turkeywww.vitrosens.comYesCommercialisedNoNoManualNear POC / POCAntigenAnterior nasal swabNasal swabNasopharyngeal swabOropharyngeal swabThroat 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 protein1. Twin test of this product was evaluated and approved by Paul-Ehrlich-Institute in Germany in March 2021 and Therapeutic Goods Administration (TGA) in Australia at 2022 for SARS-CoV-2. 2.The LOD for this product is 50 TCID50/mL. 2023-01-13 13:46:41 CET5441Immuno-AntigenYesYesNoChromatographyQualitativeMembrane-basedColorimetry-15LOD50%for SARS-CoV-2CalibrationEvaluatedAnalytical Sensitivity100%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives0.95%5 out of 525 (NP Swab for SARS-CoV-2)False positives1.19%3 out of 108 (NP Swab for M. Pneumoniae )False positives2.24%5 out of 223 (NP Swab for RSV)False positives0.53%2 out of 375 (NP Swab for InfA)False positives0.79%3 out of 379 (NP Swab for InfB)False positives0.87%2 out of 231(NP Swab for RSV)False positives0.82%2 out of 223 (NP Swab for ADV)False negatives2.7%17 out of 630 (NP Swab for SARS-CoV-2)False negatives2.78%3 out of 108 (NP Swab for M. Pneumoniae )False negatives1.78%4 out of 225 (NP Swab for ADV)False negatives3.03%5 out of 165 (NP Swab for InfB)False negatives2.56%4 out of 156 (NP Swab for InfA)PrecisionEvaluatedAccuracy98.09%NP swab:(SARS-CoV-2)RobustnessEvaluatedClinical Sensitivity97.3%NP swab:(SARS-CoV-2)Clinical Sensitivity97.22%NP Swab for M. Pneumoniae Clinical Specificity99.05%NP swab:(SARS-CoV-2)Clinical Specificity98.81%NP Swab for M. Pneumoniae 5810RapidFor™ SARS-CoV-2+RSV Combo Test Kit678Vitrosens Biotechnology Co. Ltd.Turkeywww.vitrosens.comYesCommercialisedNoNoManualNear POC / POCAntigenAnterior nasal swabNasal swabNasopharyngeal swabOropharyngeal swabThroat 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 protein1. Twin test of this product was evaluated and approved by Paul-Ehrlich-Institute in Germany in March 2021 and Therapeutic Goods Administration (TGA) in Australia at 2022 for SARS-CoV-2. 2.The LOD for this product is 50 TCID50/mL. 2023-01-09 10:03:07 CET5413Immuno-AntigenYesYesNoImmunochromatographyQualitativeMembrane-basedColorimetry-15LOD50%for SARS-CoV-2CalibrationEvaluatedAnalytical Sensitivity100%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives0.95%5 out of 525 (NP Swab for SARS-CoV-2)False negatives2.7%17 out of 630 (NP Swab for SARS-CoV-2)False negatives0.87%2 out of 231(NP Swab for RSV)PrecisionEvaluatedAccuracy98.09%NP swab:(SARS-CoV-2)Accuracy98.46%NP swab:(RSV)RobustnessEvaluatedClinical Sensitivity97.3%NP swab:(SARS-CoV-2)Clinical Sensitivity97.76%NP swab:(RSV)Clinical Specificity99.05%NP swab:(SARS-CoV-2)Clinical Specificity99.13%NP swab:(RSV)4058RAPIDNEXT™ SARS-CoV-2 Rapid Antigen Test Kit678Vitrosens Biotechnology Co. Ltd.Turkeywww.vitrosens.comYesCommercialisedYesYesManualNear POC / POCAntigenAnterior nasal swabNasal swabNasopharyngeal swabOropharyngeal swabThroat 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 protein1. Twin test of this product was evaluated and approved by Paul-Ehrlich-Institute in Germany in March 2021 and Therapeutic Goods Administration (TGA) in Australia in 2022. 2.The LOD for this product is 50 TCID50/mL. 2022-09-29 09:41:53 CET5313Immuno-AntigenYesNoNoImmunochromatographyQualitativeMembrane-basedColorimetry()15LOD50TCID50/mlfor SARS-CoV-2CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.95%5 out of 525 (Nasopharyngeal Swab)False negatives2.7%17 out of 630 (Nasopharyngeal Swab)PrecisionEvaluatedAccuracy98.09%NP swab:(SARS-CoV-2)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.3%NP swab:(SARS-CoV-2)Clinical Specificity99.05%NP swab:(SARS-CoV-2)4059RapidSens™ SARS-CoV-2 Rapid Antigen Test Kit678Vitrosens Biotechnology Co. Ltd.Turkeywww.vitrosens.comYesCommercialisedYesYesManualNear POC / POCAntigenAnterior nasal swabNasal swabNasopharyngeal swabOropharyngeal swabThroat 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 protein1. Twin test of this product was evaluated and approved by Paul-Ehrlich-Institute in Germany in March 2021 and Therapeutic Goods Administration (TGA) in Australia at 2022. 2.The LOD for this product is 50 TCID50/mL. 2022-09-29 09:42:19 CET5314Immuno-AntigenYesNoNoImmunochromatographyQualitativeMembrane-basedColorimetry()15LOD50TCID50/mlfor SARS-CoV-2CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.95%5 out of 525 (Nasopharyngeal Swab)False negatives2.7%17 out of 630 (Nasopharyngeal Swab)PrecisionEvaluatedAccuracy98.09%NP swab:(SARS-CoV-2)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.3%NP swab:(SARS-CoV-2)Clinical Specificity99.05%NP swab:(SARS-CoV-2)3143Rapid Gold Pro SARS-CoV-2 AG Test175VivaChek Biotech (Hangzhou) Co. Ltd.Chinawww.vivachek.comYesCommercialisedYesYesManualNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabSARS-CoV-2678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta1323B.1.621Mu2041C.37Lambda1495P.1Gammanucleocapsid proteinRapid Gold Pro CoV-2 Ag Test is for the rapid, qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in human nasal swab, oropharyngeal swab or nasopharyngeal swab specimen2022-10-17 13:01:01 CET5208Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwichColloidal gold15LOD75.5AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.62%Nasal swabFalse positives0.01%Oropharyngeal swabFalse positives0.32%Nasopharyngeal swabFalse negatives1.24%Nasal swabFalse negatives0.65%Oropharyngeal swabFalse negatives0.63%Nasopharyngeal swabPrecisionEvaluatedAccuracy99.78%Oropharyngeal swabAccuracy99.17%Nasal swabAccuracy99.58%Nasopharyngeal swabReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity99.37%Nasopharyngeal swabClinical Sensitivity99.35%Oropharyngeal swabClinical Sensitivity98.76%Nasal swabClinical Specificity99.68%Nasopharyngeal swabClinical Specificity99.99%Oropharyngeal swabClinical Specificity99.38%Nasal swabType of antigenNucleocapsid protein2100Verino Pro SARS CoV 2 Ag Rapid Test1006VivaChek Biotech (Hangzhou) Co. Ltd.Chinawww.vivachek.comYesCommercialisedYesYesManualNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabSARS-CoV689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1132B.1.427Epsilon1137B.1.429Epsilon1321B.1.617.2Delta1323B.1.621Mu2041C.37Lambda678B.1.1.529Omicronnucleocapsid proteinVerino® Pro SARS-CoV-2 Ag Rapid Test 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 . The test is for in vitro diagnostic use only. It provides only an initial screening test result. More specific alternative diagnosis methods (molecular diagnostic and / or CT) should be performed in order to obtain the confirmation of SARS-CoV-2 infection.2022-08-24 09:08:01 CET1783Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich15LOD75.5TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.01%False negatives2.58%PrecisionEvaluatedAccuracy99.32%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity97.42%Clinical Specificity99.99%Type of antigenNucleocapsid protein2759Verino Pro SARS CoV 2 Ag Rapid Test （self test）175VivaChek Biotech (Hangzhou) Co. Ltd.Chinawww.vivachek.comYesCommercialisedNoNoManualNear POC / POCAntigenAnterior nasal swabSARS-CoV689B.1.1.7Alpha1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31032B.1.351Beta678B.1.1.529Omicronnucleocapsid proteinself test and home test2022-08-24 09:08:01 CET2464Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich15LOD75.5AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0.97%PrecisionEvaluatedAccuracy99.83%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity99.13%Clinical Specificity99.99%Type of antigenNucleocapsid protein2103VivaDiag Pro SARS CoV 2 Ag Rapid Test1006VivaChek Biotech (Hangzhou) Co. Ltd.Chinawww.vivachek.comYesCommercialisedNoNoManualNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1132B.1.427Epsilon1137B.1.429Epsilon1321B.1.617.2Delta1323B.1.621Mu2041C.37Lambda678B.1.1.529Omicronnucleocapsid proteinVivaDiagTM Pro SARS-CoV-2 Ag Rapid Test 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. The test is for in vitro diagnostic use only.2022-08-24 09:08:01 CET1786Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich15LOD75.5AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.48%Nasal swabFalse positives0.16%Nasopharyngeal swabFalse positives0.74%Oropharyngeal swabFalse negatives5.75%Oropharyngeal swabFalse negatives5.56%Nasal swabFalse negatives4.71%Nasopharyngeal swabPrecisionEvaluatedAccuracy98.37%Nasal swabAccuracy98.76%Nasopharyngeal swabAccuracy98.04%OropharyngealAccuracy98.08%Oropharyngeal swabReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity95.29%Nasopharyngeal swabClinical Sensitivity94.25%Oropharyngeal swabClinical Sensitivity94.44%Nasal swabClinical Specificity99.26%Oropharyngeal swabClinical Specificity99.84%Nasopharyngeal swabClinical Specificity99.52%Nasal swabType of antigenNucleocapsid protein2099VivaDiag Pro SARS CoV 2 Ag Rapid Test (self test)1006VivaChek Biotech (Hangzhou) Co. Ltd.Chinawww.vivachek.comYesCommercialisedNoNoManualNear POC / POCAntigenAnterior nasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1132B.1.427Epsilon1137B.1.429Epsilon1321B.1.617.2Delta1323B.1.621Mu2041C.37Lambda678B.1.1.529Omicronnucleocapsid proteinVivaDiag Pro SARS CoV 2 Ag Rapid Test (self test) is for self test and home test.2022-08-24 09:08:01 CET1782Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich15LOD75.5AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0.97%PrecisionEvaluatedAccuracy99.83%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity99.13%Clinical Specificity99.99%Type of antigenNucleocapsid protein2768VivaDiag Pro SARS-CoV-2 Ag175VivaChek Biotech (Hangzhou) Co. Ltd.Chinawww.vivachek.comYesCommercialisedNoNoNear POC / POCAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1132B.1.427Epsilon1137B.1.429Epsilon1321B.1.617.2DeltaFor rapid, qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in human nasal swab,2022-08-24 09:08:01 CET2473Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich15LOD75.5AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.01%<0.01%False negatives0.87%PrecisionEvaluatedAccuracy99.83%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity99.13%Clinical Specificity99.99%Type of antigenNucleocapsid protein1246VivaDiag SARS CoV 2 Ag Rapid Test175VivaChek Biotech (Hangzhou) Co. Ltd.Chinawww.vivachek.comYesCommercialisedNoNoManualNear POC / POCAntigenNasal swabNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1132B.1.427Epsilon1137B.1.429Epsilon1321B.1.617.2Deltanucleocapsid proteinVivaDiag SARS-CoV-2 Ag Rapid Test is for the rapid, qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in human nasal swab, nasopharyngeal swab specimen. The test is for in vitro diagnostic use only. For professional use only. It is intended for clinical laboratories and healthcare professional use only for point-of-care testing. It provides only an initial screening test result. More specific alternative diagnosis methods (molecular diagnostic and / or CT) should be performed in order to obtain the confirmation of SARS-CoV-2 infection2022-08-24 09:08:01 CET1075Immuno-AntigenYesYesImmunochromatographyQualitativeSandwichColorimetry15LOD675AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.43%Nasal swabFalse positivesNasopharyngeal swabFalse negatives1.16%Nasal swabFalse negativesNasopharyngeal swabPrecisionEvaluatedAccuracy99.26%Nasopharyngeal swabAccuracy99.26%Nasal swabReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity98.84Nasal swabClinical Sensitivity98.84%Nasopharyngeal swabClinical Specificity99.57Nasal swabClinical Specificity99.57%Nasopharyngeal swabType of antigenNucleocapsid protein2105VivaDiag SARS-CoV-2 Ag FIA Test175VivaChek Biotech (Hangzhou) Co. Ltd.Chinawww.vivachek.comYesCommercialisedNoNoNear POC / POCSemi-automatedAntigenNasal swabNasopharyngeal swabOropharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.3nucleocapsid proteinThe VivaDiag SARS-CoV-2 Ag FIA Test is a fluorescent immunochromatographic assay for the rapid and qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in human nasal swab or throat swab specimen that is automatically analyzed.2022-08-24 09:08:01 CET1788Immuno-AntigenYesYesImmunochromatographyQualitativeSandwichFluorescence15LOD135AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%431 negative Sample were tested and 0 of them were false positiveFalse negatives3.03%66 positive Sample were tested and 2 of them were false negative.PrecisionEvaluatedAccuracy99.6% (Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.97%(Antigen)Clinical Specificity99.9%(Antigen)Type of antigenNucleoprotein2163VivaDiag Wellion SARS-CoV-2 Antigen Rapid Test1006VivaChek Biotech (Hangzhou) Co. Ltd.Chinawww.vivachek.comYesCommercialisedNoNoNear 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.2022-08-24 09:08:01 CET1864Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich15LOD675AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives4.54%(154 positive samples were tested and 7 of them were false negative)False negatives0%(431 negative samples were tested and 0 of them were false positive)PrecisionNot evaluatedAccuracy98.8% (Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.45% (Antigen)Clinical Specificity99.99% (Antigen)Type of antigenNucleoprotein1453RAPIDTECH Test Rapide Antigène SARS-CoV-2675Weifang Kanghua BiotechChinawww.khbio.com/EN/yxwl.aspxYesCommercialisedNoNoNear POC / POCAntigenNasal swabOthernucleocapsid protein2022-08-24 09:08:01 CET1202Immuno-AntigenYesNoImmunoassayQualitative15LOD2000IU/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives9.1%3/33False negatives0.1%1/1002PrecisionEvaluatedAccuracy97%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity91%Type of antigennucleoprotein2804SARS-CoV-2 Antigen Test Kit (LFIA)1255Weihai Dishang Medical Technology Co. Ltd.Chinahttps://dsmedicaltech.comYesCommercialisedNoNoLab-basedManualAntigenNasal swabNA2022-08-24 09:08:01 CET2509Immuno-AntigenYesNoImmunochromatographyQualitative15LOD312AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2%False negatives6.67%PrecisionEvaluatedAccuracy96.05%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.33%Clinical Specificity98%Type of antigenORF1a protein2688COVID-19 Antigen Rapid Test1230WEIHAI KANGZHOU BIOTECHNOLOGY ENGINEERING Co. Ltd.Chinawww.whkangzhou.comYesCommercialisedNoNoManualAntigenAnterior nasal swabNasopharyngeal swabOropharyngeal swabSalivaSputum689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1321B.1.617.2Delta2041C.37Lambdanucleocapsid proteinNone2022-08-24 09:08:01 CET2393Immuno-AntigenYesYesImmunochromatographyQualitativeSandwich, Double15LOD860TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives3.2%False negatives0.4%PrecisionEvaluatedAccuracy93.6%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.8%Clinical Specificity99.6%Type of antigenNucleocapsid protein1724First Sign SARS-CoV-2-Antigen-Test726WHPMUnited Stateswww.whpm.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabnucleocapsid protein2022-08-24 09:08:01 CET1404Immuno-AntigenYesNoImmunoassayQualitative15LOD160000AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives98.82%2/170False negatives98.82%2/170PrecisionEvaluatedAccuracy97.6%AntigenReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity94.6%AntigenType of antigennucleoprotein2661COVICHEK COVID-19 Ag KIT1212WIZCHEM Co. Ltd.South Koreawww.wizchem.comYesCommercialisedNoNoNear 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.2Zetanucleocapsid proteinSince its establishment in 2008, WIZCHEM CO., LTD. has been researching, developing, and producing products with global competitiveness to meet customer needs in various fields such as functional chemical materials, biomedical cosmetics, hydrogel wound dressing and medical care. Based on these accumulated technology, for testing various viruses such as coronavirus, we have recently developed and produced in vitro diagnostic products such as viral transport medium(VTM) and swabs that collect and transport infectious virus samples, also viral DNA/RNA extraction kit and saliva collection kit for rapid and accurate diagnosis of diseases.2022-08-24 09:08:01 CET2366Immuno-AntigenYesNoImmunochromatographyQualitative15LOD0.011ng/mL1) Inactivated SARS-CoV-2 Virus 200-TCID50/mL, 2) Nucleocapid protein 0.011-ng/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy99.02%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.11%Clinical Specificity99.78%Type of antigenNucleocapsid protein3987COVID-19 and Influenza A+B Antigen Combo Test Kit Plus973Wuhan EasyDiagnosis Biomedicine Co. Ltd.Chinahttp://www.easydiagnosis.com.cn/YesCommercialisedNoNoNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabSalivaInfluenza AInfluenza BSARS-CoV678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta2041C.37Lambda1495P.1Gammanucleocapsid protein2022-08-24 09:08:01 CET3652Immuno-AntigenYesNoN.A.ImmunochromatographyQualitativeSandwichColloidal gold15LOD500AUAnalytical Sensitivity100%Analytical Specificity100%False positives0%False negatives0%Accuracy98.5%Clinical Sensitivity96.15%Clinical Specificity99.26%3985COVID-19 Antigen Rapid Test Kit (Saliva/Swabs)973Wuhan EasyDiagnosis Biomedicine Co. Ltd.Chinahttp://www.easydiagnosis.com.cn/YesCommercialisedNoNoNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabSalivaSARS-CoV678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta2041C.37Lambda1495P.1Gammanucleocapsid protein2022-08-24 09:08:01 CET3650Immuno-AntigenYesNoN.A.ImmunochromatographyQualitativeSandwichColloidal gold15LOD500AUAnalytical Sensitivity100%Analytical Specificity100%False positives0%False negatives0%Accuracy98.5%Clinical Sensitivity96.15%Clinical Specificity99.26%3986SARS-CoV-2 and Influenza A+B Antigen Combo Test Kit (Colloidal Gold)973Wuhan EasyDiagnosis Biomedicine Co. Ltd.Chinahttp://www.easydiagnosis.com.cn/YesCommercialisedNoNoNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabInfluenza AInfluenza BSARS-CoV678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta2041C.37Lambda1495P.1Gammanucleocapsid protein2022-08-24 09:08:01 CET3651Immuno-AntigenYesNoN.A.ImmunochromatographyQualitativeSandwichColloidal gold15LOD500AUAnalytical Sensitivity100%Analytical Specificity100%False positives0%False negatives0%Accuracy98.5%Clinical Sensitivity96.15%Clinical Specificity99.26%2444SARS-CoV-2 Antigen Test Kit (Colloidal Gold)1112Wuhan Healthcare Biotech Co. Ltd.Chinahttp://www.healthcare-biotech.com/YesCommercialisedNoNoManualAntigenAnterior nasal swabNasopharyngeal swabnucleocapsid proteinProduct already tested by customers with positive outcomes2022-08-24 09:08:01 CET2147Immuno-AntigenYesNoImmunochromatographyQualitativeMembrane-basedColloidal gold15LODAU1500CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives3.2%PrecisionEvaluatedAccuracy96.8%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.8%Clinical Specificity100%Type of antigenNucleoprotein2742SARS-CoV-2 Antigen Test Kit (Colloidal Gold)863Wuhan HealthCare Biotechnology Co. Ltd.Chinahttp://www.healthcare-biotech.com/YesCommercialisedYesYesManualNear POC / POCAntigenNasal swabNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1321B.1.617.2Delta678B.1.1.529Omicronnucleocapsid proteinEvaluated in Germany (approved by BFARM/PEI AT997/21) and Italy (approved by Ministry of Health). The antigen test is not affected by the variants, and there is no reduction in Sensitivity, Specificity, Cross reactions, Precision and Limit of Detection (LoD) compared to the information stated in the production phase and in the technical file.2022-08-24 09:08:01 CET2447Immuno-AntigenYesNoNoImmunochromatographyQualitativeMembrane-basedColloidal gold15LOD150TCID50/mlSwab (mL) - rNp 10 pg/mLCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%Nasal SwabFalse positives0%Nasopharyngeal SwabFalse negatives3.3Nasopharyngeal SwabFalse negatives3.2%Nasal SwabPrecisionEvaluatedAccuracy98.6Nasopharyngeal SwabAccuracy98.4%Nasal SwabReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.8%Nasal SwabClinical Sensitivity96.7%Nasopharyngeal SwabClinical Specificity100%Nasal SwabClinical Specificity100%Nasopharyngeal SwabType of antigenNucleocapsid protein2991SARS-CoV-2 Antigen Rapid Test Kit ( Colloidal Gold )1324Wuhan J.H. Bio-Tech. Co. Ltd.ChinaYesCommercialisedNoNoNear POC / POCAntigenNasal swabOropharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.32041C.37Lambda1224B.1.526Iota678B.1.1.529Omicron1518P.2Zetanucleocapsid proteinN/A2022-08-24 09:08:01 CET2697Immuno-AntigenYesYesImmunochromatographyQualitativeOtherColloidal gold10LOD100TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%Based on the cross-reactivity, there is no false positives.False negatives0%There is no false negative.PrecisionEvaluatedAccuracy98.4%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.27AntigenClinical Specificity99.29AntigenType of antigenNucleocapsid protein1774SARS-CoV-2 / Influenza Virus A/ Influenza Virus B Antigen Assay Kit (Immunochromatography)792Wuhan Life Origin Biotech Joint Stock Co. Ltd.Chinawww.szybio.comYesCommercialisedNoNoNear POC / POCAntigenNasal swab2022-08-24 09:08:01 CET1453Immuno-AntigenYesYesImmunochromatographyQualitative15LOD0U/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.7%PrecisionEvaluatedAccuracy96.6%(483/500), 95%CI(94.61%-98.01%).ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.67%(139/150), 95%CI(87.26%-96.28%).1773The SARS-CoV-2 Antigen Assay Kit (Immunochromatography)792Wuhan Life Origin Biotech Joint Stock Co. Ltd.Chinawww.szybio.comYesCommercialisedYesYesNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal 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.1.617.32041C.37Lambda1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid protein2022-10-12 09:40:03 CET3964Immuno-AntigenYesNoNoImmunochromatographyQualitativeMembrane-basedColloidal gold15LOD400TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.87%False negatives4.76%PrecisionEvaluatedAccuracy98.08%(920/938), 95%CI (96.98%-98.86%)Clinical Sensitivity95.24%(240/252), 95%CI (91.83%-97.52%)Clinical Specificity99.13%Evaluated1756COVID-19 Antigen/Flu A+B Antigen Combo Rapid Test Cassette840Wuhan NanoDiagnosis for Health Biotechnology Co. Ltd.Chinandh-biotech.comYesCommercialisedNoNoNear POC / POCAntigenNasal swab2022-08-24 09:08:01 CET1434Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD1774TCID50/mlSARS-CoV-2 CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives1AUFalse negatives0AUPrecisionEvaluatedAccuracy100AntigenRobustnessNot evaluatedClinical Sensitivity96.88%Antigen1749Mednano840Wuhan NanoDiagnosis for Health Biotechnology Co. Ltd.Chinandh-biotech.comYesCommercialisedNoNoNear POC / POCAntigen2022-08-24 09:08:01 CET1427Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD3581.5AUAnalysis of cross reactivity0AUFalse positives1AUFalse negatives0AUPrecision0AUAccuracy100%Clinical Sensitivity96.88%4111SARS-CoV-2 Antigen Rapid Test Kit16255Wuhan Uni-science Biotechnology Co. Ltd.Chinawww.uni-science.comYesCommercialisedYesYesManualAntigenNasal 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 protein2023-03-15 16:39:45 CET20274Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD980TCID50/mlCalibrationEvaluatedAnalytical Sensitivity94.23%Analytical Specificity99.9%Analysis of cross reactivityEvaluatedFalse positivessamplesFalse negatives6samplesPrecisionEvaluatedAccuracy98.51%RobustnessEvaluatedClinical Sensitivity94.23%Clinical Specificity99.9%3853SARS-CoV-2 Antigen Rapid Test Kit (Nasal swab)1435Wuhan Uni-science Biotechnology Co., Ltd.Chinawww.uni-science.comYesCommercialisedNoNoManualAntigenNasal 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-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.37LambdaOther1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid protein2022-08-24 09:08:01 CET3525Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD980TCID50/mlAnalytical Sensitivity94.23%Analytical Specificity100%False positives0%False negatives6%Accuracy98.51%Clinical Sensitivity94.23%Clinical Specificity100%2090SARS-CoV-2 Antigen Rapid Test Kit968Wuhan UNscience Biotechnology Co. Ltd.Chinawww.uni-science.comYesCommercialisedYesYesLab-basedManualAntigenMid-turbinates swabNasal swabNasopharyngeal swabOropharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.320A.23.11224B.1.526IotaB.1.526.1B.1.526.21518P.2Zetanucleocapsid protein2022-08-24 09:08:01 CET1773Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich10LOD50000AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.43%False negatives3.67%PrecisionEvaluatedAccuracy100% (Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.33% (Antigen)Clinical Specificity99.57% (Antigen)Type of antigenNucleoprotein1655SARS-CoV-2 Antigen Rapid Test Kit (Colloidal gold Immunoassay)376Wuhan UNscience Biotechnology Co. Ltd.Chinawww.uni-science.comYesCommercialisedNoNoManualAntigenNasal swabOthernucleocapsid protein2022-08-24 09:08:01 CET1334Immuno-AntigenYesNoImmunoassayQualitativeColorimetry10LOD0.001AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.43%False negatives3.67%PrecisionEvaluatedAccuracy98.53%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.33%Type of antigennucleoprotein2143SARS-CoV-2 Antigen Test Kit（Lateral Flow Assay）991Wuxi Biohermes Bio & Medical Technology Co. Ltd.Chinawww.biohermes.comYesCommercialisedYesYesNear POC / POCAntigenNasopharyngeal swabOropharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gammanucleocapsid proteinBioHermes SARS-CoV-2 Antigen Test is a lateral flow immunoassay intended for the qualitative detection of antigen to SARS-CoV-2 in naso-/oropharyngeal swab. The test is to be used as an aid in the diagnosis of Coronavirus infection disease (COVID-19).2022-08-24 09:08:01 CET1833Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich15LOD2.5AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives4.69%False negatives1.98%PrecisionEvaluatedAccuracy97.11%(Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.31%(Antigen)Clinical Specificity98.02%(Antigen)Type of antigenNucleoprotein1763COVID-19 Antigen Rapid Test Kit (Colloidal Gold)790Xiamen AmonMed Biotechnology Co. Ltd.Chinawww.amonmed.comYesCommercialisedYesYesNear POC / POCAntigenAnterior nasal swabNasopharyngeal swabOropharyngeal swabnucleocapsid proteinNone2022-08-24 09:08:01 CET1444Immuno-AntigenYesNoImmunochromatographyQualitativeColloidal gold15LOD500TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.45%False negatives1.98%Accuracy99.07%ReproducibilityNot evaluatedRobustnessNot evaluatedClinical Sensitivity98.02%Clinical Specificity99.55Type of antigenNucleoprotein1279COVID-19 Antigen Test Kit (Rare Earth Nano Fluorescence Immunochromatography)790Xiamen AmonMed Biotechnology Co. Ltd.Chinawww.amonmed.comYesCommercialisedNoNoNear POC / POCAntigen2022-08-24 09:08:01 CET1054Immuno-AntigenYesImmunoassayFluorescenceRapid diagnostic test 5720COVID-19 Ag & Flu A/B Combo Self Test756Xiamen Biotime Biotechnology Co. Ltd.Chinawww.biotime.cn/En_YesCommercialisedNoNoManualAntigenNasal swabInfluenza AInfluenza BSARS-CoV-2689B.1.1.7Alpha1132B.1.427Epsilon1137B.1.429Epsilon1322B.1.617.32041C.37Lambdanucleocapsid protein2022-10-18 08:52:39 CET5211Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwichImmunofluorescence15LOD27900000TCID50/mlCalibrationEvaluatedAnalytical Sensitivity95%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives0samplesFalse negatives0samplesPrecisionEvaluatedAccuracy97.3%RobustnessEvaluatedClinical Sensitivity85.71%Clinical Specificity99.99%5787Flu A/B & COVID-19 Ag Combo Test756Xiamen Biotime Biotechnology Co. Ltd.Chinawww.biotime.cn/En_YesCommercialisedNoNoNear POC / POCAntigenNasal swabInfluenza AInfluenza BSARS-CoV-2689B.1.1.7Alpha1132B.1.427Epsilon1137B.1.429Epsilon1322B.1.617.32041C.37Lambdanucleocapsid protein2022-11-29 09:16:30 CET5347Immuno-AntigenYesNoYesImmunochromatographyQualitativeSandwichColloidal gold15LOD349TCID50/mlCalibrationEvaluatedAnalytical Sensitivity95%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positivessamplesFalse negativessamplesPrecisionEvaluatedAccuracy97.3%RobustnessEvaluatedClinical Sensitivity85.71%Clinical Specificity100%1685SARS-CoV-2 Antigen Rapid Qualitative Test756Xiamen Biotime Biotechnology Co. Ltd.Chinawww.biotime.cn/En_YesCommercialisedNoNoNear POC / POCAntigenNasal swabOthernucleocapsid protein2022-08-24 09:08:01 CET1364Immuno-AntigenYesNoImmunoassayQualitativeColorimetry20LOD0AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0False negatives4%PrecisionEvaluatedAccuracy98.98%(95%CI: 97.06%-99.79%)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96%(95%CI: 88.75%-99.17%)Type of antigennucleoprotein5746SARS-CoV-2 Antigen Rapid Qualitative Test756Xiamen Biotime Biotechnology Co. Ltd.Chinawww.biotime.cn/En_YesCommercialisedNoNoManualAntigenNasal swabSARS-CoV-2689B.1.1.7Alpha1132B.1.427Epsilon1137B.1.429Epsilon1322B.1.617.32041C.37Lambdanucleocapsid protein2022-11-03 08:43:19 CET5276Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwichColloidal gold20LOD1600TCID50/mlCalibrationEvaluatedAnalytical Sensitivity95%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positivessamplesFalse negativessamplesPrecisionEvaluatedAccuracy97.72%RobustnessEvaluatedClinical Sensitivity88.18%Clinical Specificity99.99%1278Rapid SARS-CoV-2 Antigen Test Card277Xiamen Boson Biotech Co. Ltd.Chinahttp://www.bosonbio.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.1.526Iota678B.1.1.529Omicron1518P.2Zetanucleocapsid protein2022-08-24 09:08:01 CET1053Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich15LOD130TCID50/mlAnalysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracy97.83%Nasal swabAccuracy98.59%Nasopharyngeal swabAccuracy97.84%Oropharyngeal swabReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.19%Nasal swabClinical Sensitivity96.08%Nasopharyngeal swabClinical Sensitivity96.23%Oropharyngeal swabClinical Specificity99.2%Nasal swabClinical Specificity99.14%Nasopharyngeal swabClinical Specificity99.2%Oropharyngeal swabType of antigenNucleocapsid protein2264Rapid SARS-CoV-2 Antigen Test Card1055Xiamen Boson Biotech Co. Ltd.Chinahttp://www.bosonbio.comYesCommercialisedNoNoManualNear POC / POCAntigenAnterior nasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1519P.3Theta1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31224B.1.526Iota1518P.2Zetanucleocapsid proteinCE0123 by notified body TUV SUD Product Service GmbH Please set HSC to yes.2022-08-24 09:08:01 CET1965Immuno-AntigenYesNoImmunoassayQualitativeMembrane-based15LOD130AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.8%False negatives3.23%PrecisionEvaluatedAccuracy98.72%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.77% (Antigen)Clinical Specificity99.2%Type of antigenNucleoprotein3051SARS-CoV-2 Antigen Rapid Test Kit1355Xiamen Higia Medical Technology Co. Ltd.Chinawww.ivdtestkit.comYesCommercialisedNoNoNear POC / POCAntigenAnterior nasal swabEnterovirus A71 (EV-A71)Human Metapneumovirus (HMPV)Mycobacterium TuberculosisMycoplasma PneumoniaeParainfluenza Virus Type 1Parainfluenza Virus Type 2Parainfluenza Virus Type 3Rhinovirus ARhinovirus B1321B.1.617.2Delta678B.1.1.529Omicronnucleocapsid proteinWe are registered with the Italian Ministry of Health, and CE certified in the Netherlands2022-08-24 09:08:01 CET2757Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich, Double20LOD2000TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.22%1 false positives out of 450 negative samplesFalse negatives7.8%9 false negatives out of 115 positive samplesPrecisionEvaluatedAccuracy98.2%AntigenReproducibilityNot evaluatedRobustnessNot evaluatedClinical Sensitivity92.2%AntigenClinical Specificity99.8AntigenType of antigenNucleocapsid protein1588SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Method)699Xiamen Jiqing Biomedical Technology Co. Ltd.Chinawww.wikang.com.cnYesCommercialisedYesYesManualNear POC / POCAntigenNasal swabCoronaviruses (HCoV)678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.32041C.37Lambda1495P.1Gammanucleocapsid proteinUpdate the date2023-01-13 13:47:43 CET21093Immuno-AntigenYesNoNoImmunoassayQualitativeMembrane-basedColloidal gold10Analytical Sensitivity%Analytical Specificity%Accuracy96.67%95% CI: 94.56% to 98.12%Clinical Sensitivity85.15%95% CI: 76.69% to 91.44%Clinical Specificity100%95% CI: 98.95% to 100.00%1886SARS-CoV-2 Antigen Rapid Test (Saliva)862Xiamen Wiz Biotech Co. Ltd.Chinawww.wizbiotech.comYesCommercialisedNoNoManualAntigenSalivaNO.2022-08-24 09:08:01 CET1565Immuno-AntigenYesImmunochromatographyQualitativeColorimetry20LOD170AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%No false positives were found in 899 samples tested.False negatives1.78%16 false negatives were found in 899 samples tested.PrecisionEvaluatedAccuracy98.22%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.35%Clinical Specificity100%1887SARS-CoV-2 Antigen Rapid Test (Sputum/Saliva/Stool)862Xiamen Wiz Biotech Co. Ltd.Chinawww.wizbiotech.comYesCommercialisedNoNoManualAntigenSalivaSputumStoolOtherNo2022-08-24 09:08:01 CET1566Immuno-AntigenYesImmunochromatographyQualitativeColorimetry15LOD170AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluatedType of antigenOther2510AgiAccu COVID-19 Antigen Test Cassette1146Xiamen Zhongsheng Langjie Biotechnology Co. Ltd.Chinawww.agiaccu.comYesCommercialisedNoNoManualAntigenDeep (cough) sputumSalivaSputum689B.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 proteinXiamen Zhongsheng Langjie Biotechnology Co., Ltd, which is the first one manufacturer of saliva based COVID-19 rapid antigen test kits in China. We have more than 20 years of experience in the field of saliva testing. Totally non-invasive, more convenient, higher sensitivity and accuracy, the most suitable for home test.2022-08-24 09:08:01 CET2214Immuno-AntigenYesNoImmunochromatographyQualitative15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy96.8%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity91.7% (Antigen)Clinical Specificity99.6%Type of antigenNucleocapsid protein2912AnyLab COVID-19 Ag Nasal Test Kit1185Z Biotech Inc.South Koreahttp://zetbio.com/YesNoNoManualAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1132B.1.427Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta1224B.1.526Iota678B.1.1.529Omicronnucleocapsid proteinNot Applicable2022-08-24 09:08:01 CET2617Immuno-AntigenYesNoNoImmunochromatographyQualitative15LOD1150TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positivesNot ApplicableFalse negativesNot ApplicablePrecisionEvaluatedAccuracy100%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96%AntigenClinical Specificity100%AntigenType of antigenNucleocapsid protein2599AnyLab COVID-19 Ag Test Kit1185Z Biotech Inc.South Koreahttp://zetbio.com/YesNoNoManualNear POC / POCAntigenNasopharyngeal swabSARS-CoV689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1132B.1.427Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta1224B.1.526Iota678B.1.1.529Omicronnucleocapsid proteinCoronavirus (COVID-19) Nucleocapsid Protein Recombinant Antigen2022-08-24 09:08:01 CET2304Immuno-AntigenYesNoNoImmunochromatographyQualitative15LOD1150TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positivesNot ApplicableFalse negativesNot ApplicablePrecisionEvaluatedAccuracy100%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.2%AntigenClinical Specificity100%AntigenType of antigenNucleocapsid protein2842ZEKMED LUNA Ag Antigen Rapid Test Kit1265ZEKMED Ltd.United Kingdomhttps://zekmed.comYesCommercialisedNoNoManualNear POC / POCAntigenNasal 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.2ZetaAccuracy: (98+210)/ (98+0+2+210) *100%=99.35% (95%CI* 97.58% to 99.43%) Pe= (100*98+210*212)/ (310*310) =0.557 Kappa:( P0 - Pe)/(1-pe) =0.9922022-08-24 09:08:01 CET2547Immuno-AntigenYesNoImmunochromatographyQualitativeMembrane-based15LOD400TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2AUFalse negatives0AUPrecisionEvaluatedAccuracy99.35%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98%AntigenClinical Specificity100%AntigenType of antigenSpike protein2854ZEKMED LUNA Ag Antigen Rapid Test Kit (N)1265ZEKMED Ltd.United Kingdomhttps://zekmed.comYesCommercialisedNoNoManualNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabSalivaSARS-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 SARS-CoV-2 virus has the characteristics of strong nucleocapsid (N) protein stability. The mutant virus strains that have been found worldwide are derived from the SARS-CoV-2 20B/GR evolutionary strain (lineage B.1.1.7), including many mutation, the mutation location is the spike (S) protein of the new coronavirus, which is the location where the SARS-CoV-2 virus uses to bind to the cell's ACE2 receptor. The ZEKMED LUNA Ag Antigen Rapid Test Kit (N) produced by ZEKMED Ltd, is used for in vitro qualitative detection of SARS-CoV-2 virus nucleocapsid (N) protein in human nasopharyngeal , oropharyngeal , anterior -nasal or saliva samples. It can be seen that the mutation sites of mutated virus strains including Omicron strain have no effect on the detection rate of the kits produced by our company. The kit is suitable for assay of the SARS-CoV-2 variant virus called 'Omicron '.2022-08-24 09:08:01 CET2559Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich15Legionella pneumophila, Streptococcus pneumonia, Streptococcus pyrogens, Human etapneumovirus (hMPV) 3 Type B1LOD400TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy99.35%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98%AntigenClinical Specificity100%AntigenType of antigenNucleocapsid protein2687PerkinElmer COVID-19 Antigen Test (NS,NP)1229Zephyr Biomedicals-Tulip DiagnosticsIndiahttp://www.tulipgroup.com/YesCommercialisedYesYesManualNear POC / POCAntigenNasal swabNasopharyngeal swab2022-08-24 09:08:01 CET3676Immuno-AntigenYesNoImmunoassayQualitativeSandwich, Double15CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97%Clinical Specificity100%3515SOFTEC Covid-19 Antigen Test Kit1419ZET medical textile foreign trade Co LTDTurkeyhttps://www.zetmedikal.com/enYesCommercialisedNoNoNear POC / POCAntigenNasal swabNasopharyngeal swabSARS-CoV678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta1323B.1.621Mu2041C.37Lambda1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid protein2022-08-24 09:08:01 CET3234Immuno-AntigenYesYesNoImmunochromatographyQualitativeMembrane-basedColloidal gold152226SOFTEC SARS COV-2 COVID-19 ANTIGEN TEST KIT1034ZET medikal tekstil dis tic Ltd. stiTurkeywww.zetmedikal.com/enYesCommercialisedYesYesNear POC / POCAntigenNasal swabNasopharyngeal swabInfluenza A H1N120A.23.1678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon3939B.1.6161321B.1.617.2Delta1323B.1.621Mu2041C.37Lambda1495P.1Gamma1518P.2Zetanucleocapsid proteinIntended Use:The SOFTEC SARS COV-2 COVID-19 ANTIGEN TEST KIT is an immunochromatographic test kit, which contains specific antibodies for qualitative detection of (Covid-19) SARS COV-2 antigen in human nasal swab samples. This test kit is used to detect the SARS-CoV-2 N-protein antigen that occurs in the acute phase of an infection. The SOFTEC SARS COV-2 COVID-19 ANTIGEN TEST KIT can be used in symptomatic and asymptomatic people for lay users.2022-09-30 09:55:48 CET5467Immuno-AntigenYesNoNoImmunochromatographyQualitativeN.A.Colloidal gold15LOD2300AUAnalysis of cross reactivityEvaluatedFalse positives2.27%3/132False negatives0.4%1/248PrecisionEvaluatedAccuracy98.6%ReproducibilityNot evaluatedRobustnessNot evaluatedClinical Sensitivity97.7%Clinical Specificity99.5%Type of antigenNucleocapsid protein2780Pluridiag SARS-COV-2 Ag Rapid Test1248Zhejiang Aibu Biotech Co. Ltd.ChinaYesCommercialisedNoNoManualNear POC / POCAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1132B.1.427Epsilon1137B.1.429Epsilon1321B.1.617.2Delta1323B.1.621Mu2041C.37Lambda678B.1.1.529Omicronnucleocapsid proteinPluridiagTM SARS-CoV-2 Ag Rapid Test 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[1]. The test is for in vitro diagnostic use only. For professional use only. It is intended for clinical laboratories and healthcare professional use only for point-of-care testing[3].It provides only an initial screening test result. More specific alternative diagnosis methods (molecular diagnostic and / or CT) should be performed in order to obtain the confirmation of SARS-CoV-2 infection. Not for at-home testing.2022-08-24 09:08:01 CET2485Immuno-AntigenYesYesImmunochromatographyQuantitativeSandwich15LOD75.5AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives1.28False negatives3.9PrecisionEvaluatedAccuracy97.86%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.1%AntigenClinical Specificity98.72%AntigenType of antigenNucleocapsid protein1843AndLucky SARS-CoV-2 Antigen SPUTUM Rapid Test Kit (non-invasive)624Zhejiang Anji Saianfu Biotech Co. Ltd.Chinawww.reopentest.comYesCommercialisedNoNoManualAntigenOropharyngeal swabSputumThroat secretionThroat swabnucleocapsid proteinBfArM Listed, PEI Evaluated2022-08-24 09:08:01 CET1520Immuno-AntigenYesNoImmunochromatographyQualitative10LOD6AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives6.5%93,5False negatives0.6%99,40PrecisionEvaluatedAccuracy97%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93%Clinical Specificity99%Type of antigenNucleoprotein1296Andlucky™ COVID-19 Antigen Rapid Test624Zhejiang Anji Saianfu Biotech Co. Ltd.Chinawww.reopentest.comYesCommercialisedYesYesLab-basedAntigenNasal 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.2ZetaORF1ab polyproteinORF1b polyproteinmore information please visit www.seinofy.com2022-08-24 09:08:01 CET1102Immuno-AntibodyYesNoImmunochromatographyQualitativeSandwich, DoubleColorimetry15LOD116TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.88%3/340False negatives3%7/228PrecisionEvaluatedAccuracy98.24%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.93%Clinical Specificity99.12%Type of antigenORF1b protein1198COVID-19 Antigen Rapid Test624Zhejiang Anji Saianfu Biotech Co. Ltd.Chinawww.reopentest.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabOtherSaliva http://www.reopentest.com/ifu2022-08-24 09:08:01 CET984Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD7200AU/mLAccuracy91%Clinical Sensitivity90%Clinical Specificity98%1295reOpenTest COVID-19 Antigen Rapid Test624Zhejiang Anji Saianfu Biotech Co. Ltd.Chinawww.reopentest.comYesCommercialisedYesYesAutomatedNear 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 proteinLoD 5.75 x 10^2 TCID50/ml2022-08-24 09:08:01 CET1094Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD575TCID50/mlAnalysis of cross reactivityEvaluatedFalse positives2%False negatives4AUPrecisionEvaluatedAccuracy98.47%AntigenReproducibilityEvaluatedClinical Sensitivity97.52%AntigenClinical Specificity99.13%AntigenType of antigenNucleocapsid protein2557Novel Coronavirus (COVID-19) Antigen Detection Kit (Latex Immunochromatography)282Zhejiang Gene Science Co. Ltd.Chinahttp://www.gene-science.com/YesCommercialisedNoNoManualNear POC / POCAntigenNasopharyngeal swabOropharyngeal swab1321B.1.617.2Delta689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1320B.1.617.1Kappa1323B.1.621Mu2041C.37Lambda1224B.1.526Iota678B.1.1.529Omicron1518P.2Zetanucleocapsid proteinNone2022-08-24 09:08:01 CET2262Immuno-AntigenYesNoImmunochromatographyQualitative15LOD180TCID50/mlAnalysis of cross reactivityEvaluatedFalse positives1.27%False negatives5.42%PrecisionEvaluatedAccuracy96.81%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.58%Clinical Specificity98.73%Type of antigenNucleocapsid protein2878NADAL SARS-COV-2 Ag Rapid Test1278Zhejiang Greylynx Biotech Co. Ltd.ChinaYesCommercialisedNoNoManualNear POC / POCAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1132B.1.427Epsilon1137B.1.429Epsilon1321B.1.617.2Delta1323B.1.621Mu2041C.37Lambda678B.1.1.529Omicronnucleocapsid proteinNADAL® SARS-CoV-2 Ag Rapid Test is for the rapid, qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in human nasal swab specimen[1]. The test is for in vitro diagnostic use only. For professional use only. It is intended for clinical laboratories and healthcare professional use only for point-of-care testing[3].It provides only an initial screening test result. More specific alternative diagnosis methods (molecular diagnostic and / or CT) should be performed in order to obtain the confirmation of SARS-CoV-2 infection. Not for at-home testing.2022-08-24 09:08:01 CET2583Immuno-AntigenYesYesImmunochromatographyQuantitativeSandwich15LOD75.5AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.93%False negatives3.21%PrecisionEvaluatedAccuracy98.46%AntigenReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity96.79%AntigenClinical Specificity99.07%AntigenType of antigenNucleocapsid protein3097NADAL GX COVID-19 Ag Test 1447Zhejiang Greylynx Biotech Co.,Ltd.ChinaYesCommercialisedNoNoManualNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabSARS-CoV678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1321B.1.617.2Delta1323B.1.621Mu2041C.37Lambda1495P.1Gammanucleocapsid protein2022-08-24 15:32:47 CET3731Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwichColloidal gold15LOD75.5AUAnalytical Specificity99.07%False positives0.93%False negatives3.21%Accuracy98.46%Clinical Sensitivity96.79%1343Coronavirus Ag Rapid Test Cassette (Swab)1184Zhejiang Orient Gene Biotech Co. Ltd.YesCommercialisedYesYesManualNear POC / POCAntigenNasal swabNasopharyngeal swabnucleocapsid protein2022-08-24 09:08:01 CET1124Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD115AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives2.5%2/120False negatives0.27%2/745PrecisionEvaluatedAccuracy99.42%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.32%Clinical Specificity99.6%Type of antigennucleoprotein1240RAPID TEST AntigenE GCCOV-502a1184Zhejiang Orient Gene Biotech Co. Ltd.YesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swabspike proteinhttps://www.innoliving.it/nuovo-test-rapido-Antigene-naso-faringeo-presentato-da-innoliving/2022-08-24 09:08:01 CET1022Immuno-AntigenYesNoImmunoassayQualitative15Clinical Sensitivity86.7%Clinical Specificity100%Type of antigenspike proteins25624COVID-19 /Flu A&B /RSV Ag Rapid Test Cassette (Swab) 17383Zhejiang Orient Gene Biotech Co.,LTDChinaYesCommercialisedNoNoLab-basedManualNear POC / POCAntigenNasal swabAdenovirus 3Adenovirus 7Chlamydia PneumoniaeCoronaviruses (HCoV)Mycobacterium TuberculosisMycoplasma Pneumoniae678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1320B.1.617.1Kappa1321B.1.617.2Deltanucleocapsid proteinN/A2023-11-22 09:19:40 CET21130Immuno-AntigenYesNoNoImmunochromatographyQualitativeMembrane-basedColloidal gold15LOD115TCID50/mlCalibrationNot evaluatedAnalytical Sensitivity88.24%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives11.76%False negatives%PrecisionEvaluatedAccuracy97.04%RobustnessEvaluatedClinical Sensitivity88.24%Clinical Specificity100%1322Kwork Covid-19 Ag Rapid Test Device(Saliva/Sputum/Feces)648Zhejiang Quark Biotechnology Co. Ltd.Chinawww.zjkuake.comYesCommercialisedNoNoNear POC / POCAntigenSaliva2022-08-24 09:08:01 CET1088Immuno-AntigenYesNoImmunoassayQualitative15Accuracy96.7%Clinical Sensitivity90%1902ENCODE SARS-COV-2 Antigen rapid Test Device719Zhuhai Encode Medical Engineering Co. Ltd.Chinahttp://www.encode.com.cn/YesCommercialisedYesYesNear POC / POCAntigenAnterior nasal swabNasal swabThroat swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.32041C.37Lambdanucleocapsid proteinWe add some information of our product. Thank you very much.2022-08-24 09:08:01 CET1578Immuno-AntigenYesNoImmunochromatographyQualitativeSandwichColorimetry20LOD530AULOD530TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives4AUPrecisionEvaluatedAccuracy98.37%Nasal swabsAccuracy97.55%Anterior nasal swabsAccuracy98.37Throat swabsReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.74%Anterior nasal swabsClinical Sensitivity96.49%Nasal swabsClinical Sensitivity96.49Throat swabsClinical Specificity100Throat swabsClinical Specificity100%Nasal swabsClinical Specificity100%Anterior nasal swabsType of antigenNucleocapsid protein1616SARS-COV-2 Antigen Rapid Test (Saliva)719Zhuhai Encode Medical Engineering Co. Ltd.Chinahttp://www.encode.com.cn/YesCommercialisedNoNoNear POC / POCAntigenSalivanucleocapsid proteinWe update the information of our product2022-08-24 09:08:01 CET1296Immuno-AntigenYesNoImmunochromatographyQualitativeSandwichColorimetry15LOD530AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracy97.14%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.86%Clinical Specificity100%Type of antigenNucleocapsid protein1957COVID-19 Antigen Detection Kit (Colloidal Gold)619Zhuhai Lituo Biotechnology Co. Ltd.Chinawww.lituo.com.cnYesCommercialisedYesYesNear POC / POCAntigenNasal swabNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.320A.23.1nucleocapsid proteinUpdated on 12th July 2021. PEI positive evaluation.2022-08-24 09:08:01 CET1633Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold10The microbial interference and endogenous interference study are also evaluated. LOD428AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.41%False negatives1%PrecisionEvaluatedAccuracy99.42%NP swab: Accuracy98.87%Nasal swab: ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99%NP swab Clinical Sensitivity96.12%Nasal swab (CT<= 33)Clinical Specificity99.59%NP swab Clinical Specificity100%Nasal swab (CT<= 33)Type of antigenNucleoprotein1187COVID-19 Antigen Detection Kit (Immunofluorescence Assay)619Zhuhai Lituo Biotechnology Co. Ltd.Chinawww.lituo.com.cnYesCommercialisedNoNoNear POC / POCAntigenNasal swabnucleocapsid protein http://www.lituo.com.cn/en/showpro.php?id=3272022-08-24 09:08:01 CET971Immuno-AntigenYesYesImmunoassayQualitativeFluorescence15Type of antigennucleoprotein5792COVID-19/FluA/FluB Antigen Detection Kit (Colloidal Gold) 619Zhuhai Lituo Biotechnology Co. Ltd.Chinawww.lituo.com.cnYesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swabInfluenza AInfluenza BSARS-CoV689B.1.1.7Alpha1032B.1.351Beta1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.3nucleocapsid protein2022-12-02 10:42:50 CET5353Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwichColloidal gold10LOD570TCID50/mlCalibrationEvaluatedAnalytical Sensitivity100%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives%False negatives1.4%PrecisionEvaluatedAccuracy99.55%RobustnessEvaluatedClinical Sensitivity99%Clinical Specificity99.71%1441Livzon Rapid Test for SARS-CoV-2 Antigen (Lateral Flow)225Zhuhai Livzon Diagnostics Inc.Chinahttp://www.livzondiagnostics.com/YesCommercialisedNoNoLab-basedManualNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1321B.1.617.2Delta1322B.1.617.3678B.1.1.529Omicronnucleocapsid proteinWe did a prospective clinical study in US with 221 mid-turbinate nasal samples collected within 7 days of symptom onset, to compare Livzon Rapid Test for 2019-nCoV Antigen (Lateral Flow) with the Roche SARS-CoV-2 RT-PCR test (comparator method). The positive percent agreement is 90% (95%CI: 74.4%-96.5%), the negative percent agreement is 100% (95%CI: 98.0%-100.0%), the overall agreement is 98.6% (95%CI: 96.1%-99.5%).2022-08-24 09:08:01 CET1192Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich30LOD3000TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.68%Nasal：1/147False positives0.34%Oropharyngeal：1/288 False positives0.34%Nasopharyngeal：1/288 False negatives0.3Nasopharyngeal：ct≤25 2/162 False negatives6.19Nasopharyngeal ct≤30 15/242 False negatives0.3Oropharyngeal：ct≤25 2/162False negatives6.19Oropharyngeal：ct≤30 15/242 False negatives1.63Nasal：ct≤25 2/122 False negatives4.57%Nasal：ct≤30 7/153PrecisionEvaluatedAccuracy97.3%NasopharyngealAccuracy97.7%NasalAccuracy97.3%OropharyngealReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.8%Nasopharyngeal：ct≤30 Clinical Sensitivity98.8%Nasopharyngeal：ct≤25 Clinical Sensitivity98.4%Nasal：ct≤25 Clinical Sensitivity95.4%Nasal：ct≤30 Clinical Sensitivity98.8%Oropharyngeal：ct≤25 Clinical Sensitivity93.8%Oropharyngeal：ct≤30Clinical Specificity99.7%NasopharyngealClinical Specificity99.7%OropharyngealClinical Specificity99.5%NasalType of antigenNucleocapsid protein1442Livzon Test for SARS-CoV-2 Antigen (Fluorescence Immunochromatographic Assay)225Zhuhai Livzon Diagnostics Inc.Chinahttp://www.livzondiagnostics.com/YesCommercialisedNoNoNear POC / POCAntigenNasal swabnucleocapsid protein2022-08-24 09:08:01 CET1193Immuno-AntigenYesYesImmunoassayQualitativeFluorescence15Rapid diagnostic test lateral flow fluorescence LOD100AU100CalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracynot foundReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity97%Clinical Specificity98.3%Type of antigennucleoprotein2201SARS-CoV-2 Antigen Assay Kit (Colloidal Gold Method)1028Zybio Inc.Chinahttps://www.zybio.com/en/YesCommercialisedYesYesManualAntigenAnterior nasal swabnucleocapsid proteinNA2022-08-24 09:08:01 CET1902Immuno-AntigenYesNoImmunoassayQualitativeSandwichColloidal gold15LOD70AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.38%False negatives2.13%PrecisionEvaluatedAccuracy98.9%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.87%Clinical Specificity99.62%Type of antigenNucleoprotein