2026-10-15 07:23:51 CET1344SMARAPIDTEST650A PLUS DIAGNOSTICS LAB.SAN.TIC.A.S.Turkeywww.aplustbd.comYesCommercialisedNoNoNear POC / POCAntibodyNasal 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% IgM1004A&B RAPID TEST COVID-19 IGG/IGM CASSETTA535A&B ProfessionalItalywww.aebrapidtest.com/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET777Immuno-AntibodyNoImmunoassayQualitative10Accuracy99.6% IgGAccuracy97.8% IgMAccuracy98.2%IgG+IgMClinical Sensitivity94.1%IgG+IgMClinical Sensitivity100% IgGClinical Sensitivity91.8% IgMClinical Specificity99.2%IgG+IgMClinical Specificity99.5% IgGClinical Specificity99.2% IgM964Covid PRESTO Test rapide COVID-19 IgG/IgM519AAZFrancewww.covid19aaz.com/en/covid-19-aaz-2/YesCommercialisedNoNoNear POC / POCAntibodyWhole blood https://drive.google.com/open?id=1IYwO5TKn5M0TnyOFlPDuq5de7x-HRT5V https://www.youtube.com/watch?v=ggugEocCscg; This company has reconverted its production (HIV tests) into COVID kits production2022-08-24 09:08:01 CET865Immuno-AntibodyYesImmunoassayQualitativeNot found10Rapid diagnostic test cassette Not found 1835COVID-PRESTO837AAZ-LMBFrancehttps://www.covid19aaz.com/en/autotest-covid-viro-all-in/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET1514Immuno-AntibodyNoImmunochromatographyQualitativeMembrane-based11LOD1AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy100% IgGAccuracy100% IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100% IgGClinical Sensitivity100% IgMClinical Specificity100% IgGClinical Specificity100% IgMType of antigenNucleoprotein913abia SARS-CoV- IgG/IgM320AB Dianostic Systems GmbHGermanywww.ab-ds.de/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerum2022-08-24 09:08:01 CET739Immuno-AntibodyNoYesImmunoassayQualitativeFluorescence120Clinical Sensitivity100%Clinical Specificity95.31%701SARS-CoV-2 IgG6AbbottUnited Stateswww.abbott.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET584Immuno-AntibodyNoImmunoassayQualitativeNot found29False positivesFour false positives out of a total of 1070 negative specimens.False negativesZero false negatives for specimens collected from positive subjects >/=14 days post-symptom onset. PrecisionEvaluatedAccuracy99.45% IgGReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity100% IgGClinical Specificity99%181/1822773SARS-CoV-2 IgG II Quant1246Abbott Ireland Diagnostics DivisionIrelandwww.corelaboratory.abbottYesCommercialisedNoNoAutomatedAntibodyPlasmaSerum689B.1.1.7AlphaSARS-CoV-2 IgG II Quant (also referred to as CoV-2 IgG II or SARS-CoV-2 IgG II on the reagent bottle/cartridge label). The SARS-CoV-2 IgG II Quant assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative and quantitative determination of IgG antibodies to SARS-CoV-2 in human serum and plasma2022-08-24 09:08:01 CET2478Immuno-AntibodyNoImmunoassayQuantitative29LOD6.8AU/mLCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.45%Nine false positives out of a total of 1999 negative specimensFalse negativesOne false negative for specimens collected from positive subjects >/=15 days post-symptom onset.PrecisionEvaluatedAccuracy99.37% IgGReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.37% IgGClinical Specificity99.55% IgGType of antigenSpike protein2774SARS-CoV-2 IgM1246Abbott Ireland Diagnostics DivisionIrelandwww.corelaboratory.abbottYesCommercialisedNoNoAutomatedAntibodyPlasmaSerumSARS-CoV-2 IgM (also referred to as CoV-2 IgM). The SARS-CoV-2 IgM assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of IgM antibodies to SARS-CoV-2 in human serum and plasma2022-08-24 09:08:01 CET2479Immuno-AntibodyNoImmunoassayQualitative29CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.44%13 false positives out of a total of 2952 negative specimensFalse negatives3 false negatives for specimens collected from positive subjects 15-30 days post-symptom onset.PrecisionEvaluatedAccuracy96.67% IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.67% IgMClinical Specificity99.56% IgMType of antigenSpike protein1302Absoludy COVID-19 IgM/IgG Combo601Absology Co. Ltd.South Koreawww.absology.co.kr/YesCommercialisedNoNoAutomatedLab-basedNear POC / POCAntibodyPlasmaSerum2022-08-24 09:08:01 CET1072Immuno-AntibodyYesImmunoassayQualitative10Analytical Specificity96% IgGAnalytical Specificity97% IgGAccuracy93.48%Clinical Sensitivity91.67%Type of antigenNucleoprotein1151Absoludy COVID-19 IgM/IgG Rapid601Absology Co. Ltd.South Koreawww.absology.co.kr/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood other website http://www.absology.co.kr/2022-08-24 09:08:01 CET923Immuno-AntibodyYesNoImmunoassayQualitativeMagnetic Electrochemical15Accuracy95%Clinical Sensitivity90.24%Clinical Specificity97.82%1983Absoludy COVID-19 NAb909Absology Co. Ltd.South Koreawww.absology.co.krYesCommercialisedNoNoNear POC / POCSemi-automatedAntibodySerum689B.1.1.7Alpha1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.320A.23.1OtherAbsoludy COVID-19 NAb is intended for detection of nuetralizing antobody to SARS-CoV-2 virus (COVID-19) in human serum specimens. This product is for professional use.2022-08-24 09:08:01 CET1659Immuno-AntibodyYesYesImmunoassaySemiquantitativeNeutralization Antibody (NAb)6LOD20AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracy95%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96%Clinical Specificity100%Type of antigenOther2573CareStart(TM) COVID-19 IgM/IgG1173Access Bio Inc.United Stateswww.accessbiodiagnostics.comYesCommercialisedNoNoManualNear POC / POCAntibodyPlasmaSerumWhole bloodWhole blood with anti-coagulantsThe kit contains the following items - 25 test devices - 1 assay buffer vial - 25 blood transfer pipettes - 1 instructions for use2022-08-24 09:08:01 CET2278Immuno-AntibodyNoImmunochromatographyQualitative10CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives6AU (IgG-/IgM-)False negatives0AU (IgG+/IgM+)False negatives1AU(IgG+/IgM-)False negatives1AU(IgG-/IgM+)PrecisionEvaluatedAccuracy94.2%ReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity91.2%Clinical Specificity97.1%Type of antigenOther14Accu-Tell COVID-19 IgG/IgM Cassette11AccuBioTech Co. Ltd.Chinawww.accubiotech.comYesCommercialisedNoNoNear POC / POCAntibodySerumWhole blood1321B.1.617.2DeltaACCU-TELL® COVID-19 IgG/IgM Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to SARS-CoV-2 in human whole blood, serum, or plasma as an aid in the diagnosis of SARS-COV-2 infections.2022-08-24 09:08:01 CET14Immuno-AntibodyYesNoImmunochromatographyQualitativeOther10CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracy95.5% IgGAccuracy95.5% IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.5% IgGClinical Sensitivity93.5% IgMClinical Specificity97.5% IgGClinical Specificity97.5% IgM2581ACCU-TELL® SARS-CoV-2 Neutralizing Antibody Cassette1176AccuBioTech Co. Ltd.Chinawww.accubiotech.comYesCommercialisedNoNoNear POC / POCAntibodySerumWhole blood1321B.1.617.2DeltaACCU-TELL® SARS-CoV-2 Neutralizing Antibody Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of neutralizing antibodies to SARS-CoV-2 in human whole blood, serum, or plasma as an aid in the diagnosis of the presence of neutralizing antibodies to SARS-CoV-22022-08-24 09:08:01 CET2286Immuno-AntibodyNoImmunochromatographyQualitativeOther10CalibrationNot evaluatedAnalysis of cross reactivityNot evaluatedFalse positives0%No False positive ( using Elisa kit as the comparator method)False negatives0%No False positive ( using Elisa kit as the comparator method)PrecisionEvaluatedAccuracy100%(Neutralizing Antibody)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%(Neutralizing Antibody)Clinical Specificity100%(Neutralizing Antibody)762COVID-19 RAPID IgG/IgM test kit452Accuster Technologies Pvt Ltd.Indiawww.accuster.com/YesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET618Immuno-AntibodyYesNoImmunoassayQualitative15Clinical Sensitivity98%Clinical Specificity97%2951Flowflex Anti-SARS-CoV-2 S Antibody Rapid Test1117Acon Biotech (Hangzhou) Co. Ltd.Chinahttps://www.aconbio.com/YesCommercialisedNoNoLab-basedNear POC / POCAntibodyPlasmaSerumVenous whole bloodWhole bloodWhole blood with anti-coagulantsspike protein2022-08-24 09:08:01 CET2657Immuno-AntibodyNoNoImmunochromatographyQualitativeMembrane-based15CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.96%2 out of 208False negatives1.37%2 out of 145PrecisionEvaluatedAccuracy98.87%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.65%Clinical Specificity99.04%1424Foresight SARS-CoV-2 IgG565Acon Biotech (Hangzhou) Co. Ltd.Chinahttps://www.aconbio.com/YesCommercialisedNoNoFingertipLab-basedAntibodyPlasmaSerum https://www.aconlabs.com.cn/en/ACON/687.html2022-08-24 09:08:01 CET1183Immuno-AntibodyYesImmunoassayQualitativeMagnetic Electrochemical75Accuracy99.6%Clinical Sensitivity99.9%Clinical Specificity99.4%1425Foresight SARS-CoV-2 IgM565Acon Biotech (Hangzhou) Co. Ltd.Chinahttps://www.aconbio.com/YesCommercialisedNoNoLateral flowLab-basedAntibodyPlasmaSerum https://www.aconlabs.com.cn/en/ACON/687.html2022-08-24 09:08:01 CET1184Immuno-AntibodyYesImmunoassayQualitativeMagnetic Electrochemical75Accuracy96.1%Clinical Sensitivity88.6%Clinical Specificity97.8%828SARS-CoV-2 IgG/IgM Rapid Test (CE-IVD)565Acon Biotech (Hangzhou) Co. Ltd.Chinahttps://www.aconbio.com/YesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET1548Immuno-AntibodyImmunoassay2603SARS-CoV-2 Neutralizing Antibody Rapid Test1117Acon Biotech (Hangzhou) Co. Ltd.Chinahttps://www.aconbio.com/YesCommercialisedNoNoLab-basedNear POC / POCAntibodyPlasmaSerumVenous whole bloodWhole bloodWhole blood with anti-coagulantsNA2022-08-24 09:08:01 CET2308Immuno-AntibodyNoImmunochromatographyQualitativeNeutralization Antibody (NAb)10CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives1%False positives1.33%(Fingertip Blood)False negatives4.35%False negatives2.63%(Fingertip Blood)PrecisionEvaluatedAccuracy97.78%Accuracy98.23%(Fingertip Blood)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.65%Clinical Sensitivity97.37%(Fingertip Blood)Clinical Specificity99%Clinical Specificity98.67%(Fingertip Blood)Type of antigenOther1671Foresight SARS-CoV-2 IgG EIA Test Kit683ACON Laboratories Inc.United Stateswww.aconlabs.comYesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET1350Immuno-AntibodyYesImmunoassayQualitativeOther30LOD0.67AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracy97.21%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity91.64%1672Foresight SARS-CoV-2 IgM EIA Test Kit683ACON Laboratories Inc.United Stateswww.aconlabs.comYesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET1351Immuno-AntibodyYesImmunoassayQualitativeOther30Manual or automated other LOD1AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracy97.72%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90.14%16962019-nCoV IgG/IgM Rapid Test Cassette890Acro Biotech Inc.United Stateswww.acrobiotech.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET1375Immuno-AntibodyYesNoImmunoassayQualitative10LOD0AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives2% IgGFalse positives4% IgMFalse positives3.7%IgG, IgMFalse negatives15% IgMFalse negatives0% IgGFalse negatives3.1%IgG, IgMPrecisionEvaluatedAccuracy92.9% IgMAccuracy96.4%IgG, IgMAccuracy98.6% IgGReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100% IgGClinical Sensitivity85% IgMClinical Sensitivity96.9%IgG, IgM24342019-nCoV IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)890Acro Biotech Inc.United Stateswww.acrobiotech.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThe 2019-nCoV IgG/IgM Rapid Test Cassette is a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to 2019-nCoV in human whole blood, serum or plasma specimen.2022-08-24 09:08:01 CET2137Immuno-AntibodyImmunoassayQualitativeSandwich10LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0AU(IgG);False positives0.031AU(2019-nCoV IgG/IgM )False positives0.15AU(IgM);False negatives0.02AU(IgG);False negatives0.04AU(IgM);0.037(2019-nCoV IgG/IgM )False negatives0.04AU(IgM);0.037(2019-nCoV IgG/IgM )PrecisionEvaluatedAccuracy98.6%(IgG/IgM)(IgG);Accuracy96.4%(IgG/IgM)(2019-nCoV IgG/IgM )Accuracy92.9%(IgG/IgM)(IgM);ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%(IgG/IgM)(IgG);Clinical Sensitivity85%(IgG/IgM)(IgM);Clinical Sensitivity96.9%(IgG/IgM)(2019-nCoV IgG/IgM )Clinical Specificity96%(IgG/IgM)(IgM);Clinical Specificity96.3%(IgG/IgM)(2019-nCoV IgG/IgM )Clinical Specificity98%(IgG/IgM)(IgG);Type of antigenNucleoprotein1698COVID-19 and M.pneumoniae IgG Combo Rapid Test890Acro Biotech Inc.United Stateswww.acrobiotech.comYesCommercialisedNoNoStripNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET1377Immuno-AntibodyYesNoImmunoassayQualitative10LOD0CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives2False negatives0PrecisionEvaluatedAccuracy100% IgGReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100% IgG2420COVID-19 and M.pneumoniae IgG Combo Rapid Test (Whole Blood/Serum/Plasma) Package Insert890Acro Biotech Inc.United Stateswww.acrobiotech.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1132B.1.427Epsilon1223B.1.525Eta1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThe COVID-19 and M.pneumoniae IgG Combo Rapid Test (Whole Blood/ Serum/Plasma) is a lateral flow chromatographic immunoassay for the qualitative detection of IgG antibodies to SARS-COV-2 and Mycoplasma pneumoniae in human whole blood, serum or plasma specimen. The COVID-19 and M.pneumoniae IgG Combo Rapid Test is for professional use only and is intended to be used as an aid in the diagnosis of patients with suspected SARS-CoV2/M.pneumoniae infection in conjunction with clinical presentation and the results of other laboratory tests. The product is intended to be used by trained laboratory personnel. Negative results will not preclude SARS-COV-2/M.pneumoniae infection and they cannot be used as the sole basis for treatment or other management decision. False positive results for IgG antibodies may occur due to cross-reactivity from preexisting antibodies or other possible causes.2022-08-24 09:08:01 CET2122Immuno-AntibodyNoImmunoassayQualitativeSandwich15LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0AU(COVID-19 IgG),False positives0.078AU(Mycoplasma pneumoniae IgG)False negatives0.02AU(COVID-19 IgG),False negatives0.054AU(Mycoplasma pneumoniae IgG)PrecisionEvaluatedAccuracy98.6% IgG(COVID-19 IgG);Accuracy93.7% IgG(Mycoplasma pneumoniae IgG).ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100% IgG(COVID-19 IgG);Clinical Sensitivity92.2% IgG(Mycoplasma pneumoniae IgG).Clinical Specificity98% IgG(COVID-19 IgG);Clinical Specificity94.6% IgG(Mycoplasma pneumoniae IgG).Type of antigenNucleoprotein1697COVID-19 and M.pneumoniae IgG/IgM Combo Rapid Test890Acro Biotech Inc.United Stateswww.acrobiotech.comYesCommercialisedNoNoN.A.Near POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET1376Immuno-AntibodyYesNoImmunoassayQualitative10LOD0AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives2AU(IgG)False positives4AU(IgM)False negatives0AU(IgG)False negatives15AU(IgM)PrecisionEvaluatedAccuracy98.6% IgG98.6 (COVID-Accuracy92.9% IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100% IgGClinical Sensitivity85% IgM1695COVID-19 IgG Rapid Test890Acro Biotech Inc.United Stateswww.acrobiotech.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET1374Immuno-AntibodyYesNoImmunoassayQualitative10LOD0AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives4.7AUFalse negatives5.7AUPrecisionEvaluatedAccuracy95% IgGReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.3% IgG2427COVID-19 IgG Rapid Test (Whole Blood/Serum/Plasma)890Acro Biotech Inc.United Stateswww.acrobiotech.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThe COVID-19 IgG Rapid Test (Whole Blood/Serum/Plasma) is a lateral flow chromatographic immunoassay for the qualitative detection of IgG antibodies to SARS-CoV-2 spike (S) protein receptor binding domain (RBD) in human whole blood, serum or plasma specimen. The COVID-19 IgG Rapid Test (Whole Blood/Serum/Plasma) is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2. False positive results may occur due to cross-reactivity from pre-existing antibodies or other possible causes. Due to the risk of false positive results, confirmation of positive results should be considered using second, different IgG assay.2022-08-24 09:08:01 CET2130Immuno-AntibodyNoImmunoassayQualitativeSandwich10LOD100CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.071AU(SARS-CoV-2);False positives0.015AU(vaccination)False negatives0AU(SARS-CoV-2);False negatives0.001AU>0.001(vaccination)PrecisionEvaluatedAccuracy97.4% IgG(SARS-CoV-2);Accuracy98.9% IgG(vaccination).ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.9% IgG(SARS-CoV-2);Clinical Sensitivity98.5% IgG(vaccination).Clinical Specificity100% IgG(SARS-CoV-2);Clinical Specificity99.9% IgG(vaccination)Type of antigenNucleoprotein1677COVID-19 IgG/IgM Rapid Test (For Reader)890Acro Biotech Inc.United Stateswww.acrobiotech.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET1356Immuno-AntibodyYesYesImmunoassayQualitative10LOD0AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives5.6AUFalse negatives5AUPrecisionEvaluatedAccuracy94.9% (IgG/IgM)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.4%2433COVID-19 IgG/IgM Rapid Test (Whole Blood/Serum/Plasma)890Acro Biotech Inc.United Stateswww.acrobiotech.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThe COVID-19 IgG/IgM Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to SARS-CoV-2 in human whole blood, serum or plasma specimen from patients suspected of COVID-19 infection by a healthcare provider. The COVID-19 IgG/IgM Rapid Test is an aid in the diagnosis of patients with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results from the COVID-19 IgG/IgM Rapid Test should not be used as the sole basis for diagnosis. Results are for the detection of SARS-CoV-2 antibodies. IgM antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, although levels over the course of infection are not well characterized. IgG antibodies to SARS-CoV-2 become detectable later following infection. Positive results for both IgG and IgM could occur after infection and can be indicative of acute or recent infection. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. IgM antibodies may not be detected in the first few days of infection; the sensitivity of the COVID-19 IgG/IgM Rapid Test early after infection is unknown. False positive results for IgM and IgG antibodies may occur due to cross-reactivity from pre-existing antibodies or other possible causes. At this time, it is unknown for how long IgM or IgG antibodies may persist following infection.2022-08-24 09:08:01 CET2136Immuno-AntibodyYesImmunoassayQualitativeSandwich10LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.056AUFalse negatives0.05AUPrecisionEvaluatedAccuracy94.9%(IgG/IgM)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.4%(IgG/IgM)Clinical Specificity95%(IgG/IgM)Type of antigenNucleoprotein465COVID-19 IgG/IgM Rapid Test Cassette890Acro Biotech Inc.United Stateswww.acrobiotech.comYesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET712Immuno-AntibodyYesNoImmunoassayQualitativeColloidal gold10False positivesEvaluatedFalse negativesEvaluatedAccuracy98.6% IgGAccuracy92.9% IgMRobustnessEvaluatedClinical Sensitivity100% IgGClinical Sensitivity85% IgMClinical Specificity98% IgGClinical Specificity96% IgM1694COVID-19 IgG/IgM Rapid Test Dipstick890Acro Biotech Inc.United Stateswww.acrobiotech.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET1373Immuno-AntibodyYesNoImmunoassayQualitative10LOD0AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives2AU(IgG)False positives3AU(IgM)False negatives0.1AU(IgG)False negatives9.1AU(IgM)PrecisionEvaluatedAccuracy98.4% IgGAccuracy95.9% IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.9% IgGClinical Sensitivity90.9% IgM2459Acura Speichel-Test Diagnos COVID-19 Antigen Saliva Test Kit1122Acura Kliniken Baden-Baden GmbHGermanyhttps://acura-kliniken.com/YesCommercialisedNoNoManualAntibodyDeep (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 antigenNucleoprotein1091AESKULISA SARS-CoV-2 NP IgA586Aesku.DiagnosticsGermanywww.aesku.comYesCommercialisedNoNoAutomatedManualAntibody Additional info: http://en.diagreat.com/Private/Files/20200402/6372142236666949104672720.pdf https://www.aesku.com/index.php/diagnostics/aeskulisa-elisa-test-kits/infectious-serology-elisa/item/3972022-08-24 09:08:01 CET871Immuno-AntibodyYesImmunoassayQuantitativeMagnetic ElectrochemicalClinical Sensitivity98.3%Clinical Specificity99%1092AESKULISA SARS-CoV-2 NP IgG586Aesku.DiagnosticsGermanywww.aesku.comYesCommercialisedNoNoAutomatedManualAntibody Additional info: http://en.diagreat.com/Private/Files/20200402/6372142198788930846626315.pdf https://www.aesku.com/index.php/diagnostics/aeskulisa-elisa-test-kits/infectious-serology-elisa/item/3982022-08-24 09:08:01 CET872Immuno-AntibodyYesImmunoassayQuantitativeMagnetic ElectrochemicalClinical Sensitivity95.2%Clinical Specificity99%1093AESKULISA SARS-CoV-2 NP IgM586Aesku.DiagnosticsGermanywww.aesku.comYesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerumhttps://www.aesku.com/index.php/diagnostics/aeskulisa-elisa-test-kits/infectious-serology-elisa/item/3992022-08-24 09:08:01 CET873Immuno-AntibodyYesImmunoassayQuantitativeMagnetic Electrochemical994Acro 2019-nCoV IgG/IgM pikatesti594AIDIANFinlandwww.aidian.eu/YesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET902Immuno-AntibodyYesNoImmunoassayQualitative2010022019nCoV IgG/IgM Rapid test Device534AkralabSpainwww.akralab.es/YesCommercialisedNoNoNear POC / POCAntibodyWhole bloodnucleocapsid protein http://en.keweidiagnostic.com/uploadfile/2020/0721/20200721032246798.pdf 2022-08-24 09:08:01 CET776Immuno-AntibodyYesNoImmunoassayQualitative15Type of antigennucleocapsid protein from SARS-CoV-2 COVID-1921DrivenFlow COVID-1917Alfa Scientific Designs Inc.United Stateswww.alfascientific.com/YesCommercialisedNoNoNear POC / POCAntibody2022-08-24 09:08:01 CET21Immuno-AntibodyYesImmunoassay958Instant-view PLUS COVID-19 Test17Alfa Scientific Designs Inc.United Stateswww.alfascientific.com/YesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET754Immuno-AntibodyYesNoImmunoassayQualitative7Analysis of cross reactivityEvaluatedAccuracy96.7%900AlphaBiolabs IgM-IgG Combined Antibody Rapid Test581AlphaBiolabsUnited Kingdomwww.alphabiolabs.co.ukYesCommercialisedNoNoAutomatedManualAntibodyWhole blood2022-08-24 09:08:01 CET856Immuno-AntibodyNoImmunoassayQualitative15Type of antigenNucleocapsid (N) antigen993AMP Rapid Test SARS-CoV-2 IgG/IgM531AMEDA Labordiagnostik GmbHAustriawww.amp-med.com/YesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET1551Immuno-AntibodyImmunoassay830Amela Covid-19 IgM IgG Combo test kit478Amedica SANetherlandswww.amedicagroup.com/YesCommercialisedNoNoAutomatedManualAntibodyWhole blood Name from the website is "Rapid SARS-CoV-2 Antibody (IgM/IgG) Test"2022-08-24 09:08:01 CET830Immuno-AntibodyNoImmunoassayQualitativeColorimetryManual or automated cassette Colloidal Gold 2873AMPER COVID-19 Neutralizing Antibody Rapid Testing kit (Colloidal Gold)1275AMPER Inc.United Stateshttp://www.amperbio.comYesCommercialisedNoNoManualNear POC / POCAntibodySerumangiotensin-converting enzyme 2See IFU2022-08-24 09:08:01 CET2578Immuno-AntibodyYesYesImmunochromatographyQualitativeNeutralization Antibody (NAb)Colloidal gold30LODNot evaluatedCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives5%False negatives6%PrecisionEvaluatedAccuracy93.5%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90%Clinical Specificity97%10482019-nCoV IgG/IgM Device561AMS UK (NI) Ltd.United Kingdomwww.amslabs.co.ukYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET819Immuno-AntibodyYesNoImmunoassayQualitative10Analysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracy95% IgGAccuracy96.7% IgMClinical Sensitivity91.8% IgGClinical Sensitivity95.7% IgMClinical Specificity96.4% IgGClinical Specificity97.3% IgM22252019-nCoV Neutralising Antibody561AMS UK (NI) Ltd.United Kingdomwww.amslabs.co.ukYesCommercialisedNoNoLab-basedManualNear POC / POCAntibodyPeripheral bloodPlasmaSerumVenous whole bloodWhole bloodWhole blood with anti-coagulantsThe 2019-nCoV Neutralization Antibody device is a rapid chromatographic immunoassay intended for the qualitative detection of neutralization antibodies against viral spike glycoprotein.2022-08-24 09:08:01 CET1926Immuno-AntibodyNoImmunochromatographyQualitativeNeutralization Antibody (NAb)15LOD500AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2.29%(3/131)False negatives2.27%(2/88)PrecisionEvaluatedAccuracy97.7%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.6%Clinical Specificity98.5%Type of antigenOther510COVID-19 (SARS-CoV-2) IgG/IgM Antibody Test Kit24Anhui Deep Blue Medical Technology Co. Ltd.Chinawww.dbluemedical.comYesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET404Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15Rapid diagnostic test Strip Colloidal Gold 2189COVID-19 (SARS-CoV-2) Neutralizing Antibody (Double Antigen Sandwich) Test Kit (Colloidal Gold)1020Anhui Deep Blue Medical Technology Co. Ltd.Chinawww.dbluemedical.comYesCommercialisedNoNoManualAntibodyPlasmaSerumVenous whole bloodWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThis product is used for in vitro qualitative detection of novel coronavirus(COVID-19)(Sars-CoV-2) neutralizing antibody in human serum, plasma, whole blood and/or fingertip blood. This product uses double antigen sandwich method for detection. The gold label pad is marked with S-RBD-mFc C-terminal, and the detection line is coated with S-RBD-mFc N-terminal. When the sample contains neutralizing antibody, it will bind to S-RBD-mFc C-terminal, then the complex will be captured by pre-coated S-RBD-mFc N-terminal and the T line will show color. When the sample does not contain neutralizing antibodies, the T line will not show color. The quality control line is coated with goat anti-mouse polyclonal antibody. The C line will show color regardless of whether the sample contains neutralizing antibody.2022-08-24 09:08:01 CET1890Immuno-AntibodyImmunochromatographyQualitativeNeutralization Antibody (NAb)Colloidal gold15LOD20AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives3%False negatives7%PrecisionEvaluatedAccuracy95%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93%Clinical Specificity97%Type of antigenOther914SARS-CoV IgG ELISA512Ansh LabsUnited Stateswww.anshlabs.com/YesCommercialisedNoNoLab-basedAntibodyPlasmaSerum2022-08-24 09:08:01 CET740Immuno-AntibodyNoYesELISAQualitativeFluorescence120Analysis of cross reactivityEvaluatedClinical Sensitivity95%Clinical Specificity98.3%915SARS-CoV IgM ELISA512Ansh LabsUnited Stateswww.anshlabs.com/YesCommercialisedNoNoLab-basedAntibodyPlasmaSerum2022-08-24 09:08:01 CET741Immuno-AntibodyNoYesELISAQualitativeFluorescence120Analysis of cross reactivityEvaluatedClinical Sensitivity100%Clinical Specificity98.5%917GenomeCov9 IgM/IgG Rapid Test Kit504Applied Biological Materials Inc.Canadawww.abmgood.com/YesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET743Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15Rapid diagnostic test Lateral flow Colloidal Gold PrecisionCV < 5%Clinical Sensitivity91%Clinical Specificity99%2633Anti-SARS-CoV-2-Multi-Antikörper IgG/Nab-Test (IgG-Antikörper/neutralisierende Antikörper) (LFIA)1011Aripa Biotec GmbHGermanywww.aripa-biotec.comYesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerumVenous whole bloodWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThe anti-SARS-CoV-2 multi-antibody IgG/Nab Tests (IgG antibody/neutralising antibody) is suitable for the qualitative in vitro detection of SARS-CoV-2 neutralising antibodies and nucleocapsid protein IgG antibodies in human serum, plasma or whole blood. for vaccinated persons and recovered persons.2022-08-24 09:08:01 CET2338Immuno-AntibodyYesImmunochromatographyQuantitativeNeutralization Antibody (NAb)15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracy98.34%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.67%Clinical Specificity98.01%Type of antigenSpike protein1729Artron COVID-19 IgM/IgG Antibody Test721Artron Laboratories Inc.Canadahttp://www.artronlab.com/YesCommercialisedNoNoAutomatedManualNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET1409Immuno-AntibodyNoImmunoassayQualitative30Manual or automated lateral flow LOD0AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.72% IgMcombined data from 6 centersFalse positives0.22% IgGcombined data from 6 centersFalse negatives14.83% IgMcombined data from 6 centersFalse negatives6.01% IgGcombined data from 6 centersPrecisionEvaluatedAccuracy93.64% IgMcombined data from 6 centersAccuracy94.2% IgGcombined data from 6 centersReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity85.17% IgMcombined data from 6 centersClinical Sensitivity83.99% IgGcombined data from 6 centers1410Immuno-AntibodyYesNoImmunoassayQualitative15rapid diagnostic test lateral flow LOD0CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives1.87%26 false positives out of a total of 1393 RT-PCR confirmed non-COVID-19 specimensFalse negatives7.7%59 false negatives out of a total of 762 RT-PCR confirmed COVID-19 specimensPrecisionEvaluatedAccuracy96.06 (IgG+IgM)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.49 (IgG+IgM) 14 days post infection664COVID-19 IgG/IgM Rapid Test Device455Assure Tech (Hangzhou) Co. Ltd.Chinawww.diareagent.comYesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET799Immuno-AntibodyYesNoImmunoassayQualitativeNot found15Rapid diagnostic test cassette Not found 1577COVID-19 Neutralizing Antibody FIA455Assure Tech (Hangzhou) Co. Ltd.Chinawww.diareagent.comYesCommercialisedNoNoLab-basedAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET1256Immuno-AntibodyYesYesImmunoassayQualitativeFluorescence15LOD0CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positivesNot availableFalse negativesNot availablePrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%1584SARS-CoV-2 Neutralizing Antibody Rapid Test455Assure Tech (Hangzhou) Co. Ltd.Chinawww.diareagent.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood no info on website about preformance (LOD=0) 2022-08-24 09:08:01 CET1264Immuno-AntibodyYesYesImmunoassayQualitative15Rapid diagnostic test cassette LOD0CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positivesNot availableFalse negativesNot availablePrecisionEvaluatedAccuracy98.1%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.7%2195COVID-19 N.A.T. Neutralizing Antibodies Test1023ASSUT EUROPE SPAItalywww.assuteurope.comYesCommercialisedNoNoManualAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET1896Immuno-AntibodyYesOtherQuantitativeNeutralization Antibody (NAb)15LOD0.01AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives6AUFalse negatives4AUPrecisionEvaluatedAccuracy93.79%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.44%Clinical Specificity92.45%MAGLIANO DEI MARSI (AQ)Type of antigenOther515Atlas COVID-19 IgG/IgM Test Cassette314Atlas Medical GmbHUnited Kingdomatlas-medical.com/YesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET415Immuno-AntibodyYesNoImmunoassayQualitative10773Atlas COVID-19 IgM Elisa Kit314Atlas Medical GmbHUnited Kingdomatlas-medical.com/YesCommercialisedNoNoAutomatedManualAntibodySerum2022-08-24 09:08:01 CET627Immuno-AntibodyYesELISAQualitative70Manual or automated 772Atlas COVID-19 S1-RBD IgG Elisa Kit314Atlas Medical GmbHUnited Kingdomatlas-medical.com/YesCommercialisedNoNoAutomatedManualAntibodySerum2022-08-24 09:08:01 CET626Immuno-AntibodyNoYesELISAQualitative70Manual or automated 771Atlas COVID-19 Total Antibody Elisa Kit314Atlas Medical GmbHUnited Kingdomatlas-medical.com/YesCommercialisedNoNoAutomatedManualAntibodySerum2022-08-24 09:08:01 CET625Immuno-AntibodyYesELISAQualitativeSandwich, Double70Manual or automated Sandwich, Double 2335Attana AVA SARS-CoV-2 IgG Immunoassay1086Attana ABSwedenwww.attana.comYesCommercialisedNoNoAutomatedLab-basedSemi-automatedAntibodySerumReceptor-binding domain (RBD) of the Spike protein. Attana AVA SARS-CoV-2 IgG Immunoassay for use with the Attana Cell 250 or Cell 200 systems to measure SARS-CoV-2 IgG in patient serum samples. CE-IVD registered. Ability to measure affinity of antibody interactions to RBD target2022-08-24 09:08:01 CET2036Immuno-AntibodyNoYesImmunoassayQuantitativeSandwich, Double17LOD1CalibrationEvaluatedAnalysis of cross reactivityNot evaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy100% IgGReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100% IgGClinical Specificity100% IgGType of antigenOther665Anti-SARS-CoV-2 Rapid Test513Autobio Diagnostics Co. Ltd.Chinahttps://www.autobio.com.cn/YesCommercialisedNoNoManualAntibodyPlasmaSerumWhole bloodnucleocapsid proteinThis assay is based on a colloidal gold method for the rapid, qualitative determination of Anti-SARS-CoV-2 (IgG/IgM antibodies of Severe Acute Respiratory Syndrome Coronavirus 2) in human serum, plasma or whole blood. IgM Positive Percent Agreement of Anti-SARS-CoV-2 Rapid Test was 85.43% (346/405), (95%CI: 81.7% - 88.5%), IgM Negative Percent Agreement was 99.68% (311/312), (95%CI: 98.2% - 99.9%). IgG Positive Percent Agreement of Anti-SARS-CoV-2 Rapid Test was 86.17% (349/405), (95%CI: 82.5% - 89.2%), IgG Negative Percent Agreement was 99.36% (310/312), (95%CI: 97.7% - 99.8%).2022-08-24 09:08:01 CET800Immuno-AntibodyYesImmunoassayQualitativeCaptureColloidal gold15Analysis of cross reactivityEvaluatedPrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity88.15% (357/405) (95%CI: 84.6%-90.9%)Clinical Specificity99.04% (309/312), (95%CI: 97.2%-99.7%)Type of antigenSARS-CoV-2 nucleocapsid919SARS-CoV-2 IgG II CLIA Microparticles513Autobio Diagnostics Co. Ltd.Chinahttps://www.autobio.com.cn/YesCommercialisedNoNoAutomatedNear POC / POCAntibodyPlasmaSerumNo cross-reaction with Influenza A, Influenza B,RSV, Adenovirus, Enterovirus 71, Coxsackie virus B, Chlamydia pneumonia, M. pneumoniae IgG, L. pneumophila, Toxo IgG, Rubella IgG, CMV IgG, HSV IgG, RF.2022-08-24 09:08:01 CET744Immuno-AntibodyNoCLIAQualitativeOtherChemiluminescence40Rapid diagnostic test Not found Chemiluminescence Analysis of cross reactivityEvaluatedPrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%≥15days after infection:100%(51/51), 8-14days after infection:79.3%(23/29),≤7days after infection:26.9%(7/26)Clinical Specificity99%(1063/1074)2429Anti-SARS-CoV-2 RBD CLIA Microparticles1038AUTOBIO DIAGNOSTICS. Ltd.Chinahttps://www.autobio.com.cn/YesCommercialisedNoNoAutomatedAntibodyPlasmaSerumThe unit of LOD is AU/mL.2022-08-24 09:08:01 CET2132Immuno-AntibodyCLIAQuantitativeSandwich17LOD3AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.22% from 1334 samples before the outbreak of COVID-19False negatives3.72% from 215 samples after inoculation from 15 to 75 daysPrecisionEvaluatedAccuracy99.29%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity79.49%Clinical Specificity99.78%Type of antigenOther2430Anti-SARS-CoV-2 RBD ELISA1038AUTOBIO DIAGNOSTICS. Ltd.Chinahttps://www.autobio.com.cn/YesCommercialisedNoNoManualAntibodyPlasmaSerumThe unit of LOD is AU/mL.2022-08-24 09:08:01 CET2133Immuno-AntibodyELISAQuantitativeSandwich40LOD2AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.29%from 686 samples before the outbreak of COVID-19False negatives1.47% from 68 samples after inoculation from 14 to 28 daysPrecisionEvaluatedAccuracy99.6%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.89%Clinical Specificity99.71%Type of antigenOther2431SARS-CoV-2 NAb ELISA1038AUTOBIO DIAGNOSTICS. Ltd.Chinahttps://www.autobio.com.cn/YesCommercialisedNoNoManualAntibodyPlasmaSerumThe unit of LOD is AU/mL.2022-08-24 09:08:01 CET2134Immuno-AntibodyELISAQuantitativeNeutralization Antibody (NAb)40LOD10AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.29% from 680 samples before the outbreak of COVID-19False negatives4.6% from 87 samples after inoculation from 14 to 28 daysPrecisionEvaluatedAccuracy99.22%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.04%Clinical Specificity99.71%Type of antigenNucleoprotein1912COVID-19 IgG/IgM Rapid Test Device871Azure Biotech Inc.United Stateswww.azure.bioYesCommercialisedNoNoManualNear POC / POCAntibodyPlasmaSerumWhole bloodNot available2022-08-24 09:08:01 CET1587Immuno-AntibodyImmunoassayQualitativeColorimetry15Analysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracy98.7% IgGAccuracy97.7% IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.7% IgMClinical Sensitivity98.8% IgGClinical Specificity99.1% IgMClinical Specificity98.7% IgGType of antigenOther1910COVID-19 Neutralizing Antibody FIA871Azure Biotech Inc.United Stateswww.azure.bioYesCommercialisedNoNoManualNear POC / POCAntibodyPlasmaSerumWhole bloodNot available2022-08-24 09:08:01 CET1585Immuno-AntibodyYesImmunoassayQualitativeNeutralization Antibody (NAb)15Fluorescence detectionLOD0AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%Clinical Specificity100%Type of antigenOther1613ChekR™ COVID-19 IgM/IgG Rapid test717B-bio Co. Ltd.South Koreawww.b-bio.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET1293Immuno-AntibodyYesNoImmunoassayQualitative15LOD0CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positivesnot foundFalse negativesnot foundPrecisionEvaluatedAccuracy97.9%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity95.5%1615INNOGEN-B™ COVID-19 IgM/IgG Rapid test717B-bio Co. Ltd.South Koreawww.b-bio.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET1295Immuno-AntibodyYesNoImmunoassayQualitative15LOD1CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positivesnot foundPrecisionEvaluatedAccuracy97.9%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity95.5%30482019-nCoV Neutralization Antibody Rapid Test Cassette (Colloidal Gold Method)1354Beijing Applied Biological Technologies Co. Ltd.Chinahttps://www.x-abt.com/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta2041C.37Lambda70AT.1678B.1.1.529Omicronnucleocapsid protein/2022-08-24 09:08:01 CET2754Immuno-AntibodyYesNoNoImmunoassayQualitativeSandwich15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%Clinical Specificity100%Type of antigenNucleocapsid protein3064SARS-CoV-2 Neutralization Antibody Rapid Test Cassette (FIA)1354Beijing Applied Biological Technologies Co. Ltd.Chinahttps://www.x-abt.com/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta2041C.37Lambda70AT.1678B.1.1.529Omicronnucleocapsid protein2022-08-24 09:08:01 CET2770Immuno-AntibodyYesNoNoImmunoassayQualitativeSandwichFluorescence15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy100%100%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%Clinical Specificity100%Type of antigenNucleocapsid protein3065SARS-CoV-2 Neutralization Antibody Rapid Test Cassette (Lateral Flow Method)1354Beijing Applied Biological Technologies Co. Ltd.Chinahttps://www.x-abt.com/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumVenous whole bloodWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta2041C.37Lambda70AT.1678B.1.1.529Omicronnucleocapsid protein2022-08-24 09:08:01 CET2771Immuno-AntibodyYesNoNoImmunoassayQualitativeSandwich15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%Clinical Specificity100%Type of antigenNucleocapsid protein13592019-New Coronavirus IgM/IgG Rapid Test Cassette (WB/S/P)35Beijing Beier Bioengineering Co. Ltd.Chinahttps://www.beierbio.comYesCommercialisedNoNoManualAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET1130Immuno-AntibodyYesYesImmunoassayQualitativeColorimetry15Manual NAT cassette colloidal gold LOD131False positivesRequire clinical data comparisonFalse negativesRequire clinical data comparisonAccuracy96.77%Clinical Sensitivity94.12% IgMClinical Sensitivity95.1% IgG2055COVlD-19 IgM/IgG Antibodies Rapid Test(Colloidal GoId Method)946Beijing Bohui Innovation Biotechnology Co. Ltd.Chinahttp://www.bohui-tech.com/YesUnknownNoNoLab-basedAntibodyPlasmaSerumWhole blood1223B.1.525Eta2022-08-24 09:08:01 CET1735Immuno-AntibodyImmunochromatographyColloidal gold15LOD0AU/mLCalibrationNot evaluatedAnalysis of cross reactivityNot evaluatedFalse positives0%False negatives0%PrecisionNot evaluatedReproducibilityNot evaluatedRobustnessNot evaluatedClinical Sensitivity100% IgGClinical Sensitivity100% IgMClinical Specificity97.1% IgGClinical Specificity97.1% IgMType of antigenOther2046Anti-SARS-CoV-2 Neutralizing Antibody ELISA Kit943Beijing Bohui Innovative Biotechnology Co. Ltd.Chinahttp://www.bohui-tech.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerumWhole blood1223B.1.525EtaWe have CE marking, registered in Spanien. The products was registered in Spanish MOH with number RPS/294/2021.2022-08-24 09:08:01 CET1724Immuno-AntibodyImmunochromatographyNeutralization Antibody (NAb)120LOD20AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.47%Serum: 3/204;False positives1.98%Whole blood:4/202False positives1.47%Plasma: 3/203False negatives0.96%Plasma: 4/414False negatives1.44%Whole blood:6/415False negatives0.72%Serum: 3/413;PrecisionEvaluatedAccuracy97%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.06%Whole blood: (95% CI: 93.73%~98.65%)Clinical Sensitivity98.04%Plasma:(95% CI: 95.07%~99.23%) Clinical Sensitivity98.53%Serum: (95% CI: 95.77%~99.50%) Clinical Specificity99.27%Plasma: (95% CI: 97.89%~99.75%). Clinical Specificity99.03%Whole blood: (95% CI: 97.54%~99.62%).Clinical Specificity99.27%Serum: (95% CI: 97.89%~99.75%) Type of antigenOther2044Novel Coronavirus (SARS-CoV-2) Neutralizing Antibodies Test (Colloidal Gold)943Beijing Bohui Innovative Biotechnology Co. Ltd.Chinahttp://www.bohui-tech.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerumWhole blood1223B.1.525EtaWe have CE marking, registered in Spanien. The products was registered in Spanish MOH with number RPS/294/2021.2022-08-24 09:08:01 CET1722Immuno-AntibodyImmunochromatographyNeutralization Antibody (NAb)Colloidal gold15LOD20AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives3.41%serum:7/205False positives1.94%whoreblood:5/257False positives2.67%plasma:7/262False negatives1.45%serum:6/412False negatives1.81%plama:8/440False negatives2.47%whoreblood(11/445)PrecisionEvaluatedAccuracy98%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.82whoreblood: (95%CI: 92.67%-97.65%)Clinical Sensitivity96.96plasma: (95%CI: 94.11%-98.45%)Clinical Sensitivity97.06%serum:(95%CI: 93.73-98.65%)Clinical Specificity98.41plasma:(95% CI: 96.75%~99.23%)Clinical Specificity98.86whoreblood: (95% CI: 97.36%~99.51%).Clinical Specificity98.31%serum (95% CI:96.54%~99.18%)Type of antigen%Other2048Novel Coronavirus (SARS-CoV-2) Neutralizing Antibodies Test (Double Antigen Sandwich Colloidal Gold Immunochromatography)943Beijing Bohui Innovative Biotechnology Co. Ltd.Chinahttp://www.bohui-tech.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerumWhole blood1223B.1.525EtaWe have CE marking, registered in Spanien. The products was registered in Spanish MOH with number RPS/803/2021.2022-08-24 09:08:01 CET1726Immuno-AntibodyImmunochromatographyNeutralization Antibody (NAb)Colloidal gold15LOD20AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.76%Serum: 6/340False positives2.06%Whole blood:7/339False positives1.19%Plasma: 4/337False negatives1.04%Serum: 5/477False negatives1.25%Plasma: 6/480False negatives1.46%Whole blood:7/478PrecisionEvaluatedAccuracy99%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.94%Whole blood:(95%CI：95.80%~99.00%)Clinical Sensitivity98.23%Plasma:(95%CI：96.19%~99.19%) Clinical Sensitivity98.53%Serum: (95%CI：96.59%~99.37%) Clinical Specificity99.16%Plasma:(95%CI：97.87%~99.67%). Clinical Specificity98.54%Whole blood: (95%CI：97.01%~99.29%).Clinical Specificity98.74%Serum: (95%CI：97.29%~99.42%) . Type of antigenOther2047Novel Coronavirus (SARS-CoV-2) Neutralizing Antibodies Test (Quantum Dots Fluorescence Immunoassay)943Beijing Bohui Innovative Biotechnology Co. Ltd.Chinahttp://www.bohui-tech.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerumWhole blood1223B.1.525EtaWe have CE marking, registered in Spanien. The products was registered in Spanish MOH with number RPS/294/2021.2022-08-24 09:08:01 CET1725Immuno-AntibodyImmunochromatographyNeutralization Antibody (NAb)Fluorescence15LOD20AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.95%Serum：4/205False positives1.47%Whole blood:3/204False positives0.98%Plasma:2/204False negatives0.73%Serum：3/412False negatives0.48%Plasma:2/413False negatives0.72%Whole blood:3/413PrecisionEvaluatedAccuracy97%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.53%Whole blood: (95% CI: 95.77%~99.50%)Clinical Sensitivity99.02%Plasma:(95% CI: 96.50%~99.73%) Clinical Sensitivity98.53%Serum: (95% CI: 95.77%~99.50%) Clinical Specificity99.52%Plasma: (95% CI: 98.25%~99.87%). Clinical Specificity99.27%Whole blood: (95% CI:97.89%~99.75%)Clinical Specificity99.03%Serum: (95% CI:97.54%~99.62%) Type of antigenOther2045Novel Coronavirus (SARS-CoV-2) Neutralizing Antibody Detection Kit (Competitive ELISA)943Beijing Bohui Innovative Biotechnology Co. Ltd.Chinahttp://www.bohui-tech.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerumWhole blood1223B.1.525EtaWe have CE marking, registered in Spanien. The products was registered in Spanish MOH with number RPS/515/2021.2022-08-24 09:08:01 CET1723Immuno-AntibodyELISANeutralization Antibody (NAb)120LOD20AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2.4%Serum：5/208;False positives0.98%Plama:2/203False positives1.94%Whole blood:4/206False negatives0.49%Whole blood:2/411False negatives0.72%Plama:3/414False negatives0.24%Serum：1/409;PrecisionEvaluatedAccuracy98%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.51Serum:(95%CI：97.28%~99.91%) Clinical Sensitivity98.53Plasma:95%CI：95.77%~99.50%)Clinical Sensitivity99.02Whole blood:(95%CI：96.50%~99.73%)Clinical Specificity99.03Whole blood:(95%CI：97.54%~99.62%)Clinical Specificity99.52Plasma:(95%CI：98.25%~99.87%)Clinical Specificity98.79Serum: (95%CI：97.20%~99.48%)Type of antigenOther632019-nCoV IgG Antibody Determination Kit38Beijing Diagreat Biotechnologies Co. Ltd.Chinawww.diagreat.com/YesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET45Immuno-AntibodyYesYesImmunoassayQualitativeFluorescenceFluorescence15Analysis of cross reactivityEvaluated9602019-nCoV IgG/IgM Antibody Rapid Test Kit38Beijing Diagreat Biotechnologies Co. Ltd.Chinawww.diagreat.com/YesCommercialisedNoNoAutomatedManualAntibodyWhole blood2022-08-24 09:08:01 CET864Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15Manual or automated cassette Colloidal Gold Analysis of cross reactivityReported622019-nCoV IgM Antibody Determination Kit38Beijing Diagreat Biotechnologies Co. Ltd.Chinawww.diagreat.com/YesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET44Immuno-AntibodyYesYesImmunoassayQualitativeFluorescence15Analysis of cross reactivityReported519Coronavirus disease (COVID-19) Antibody Test (Colloidal Gold)328Beijing Hotgen Biotech Co. Ltd.Chinawww.hotgen.com.cn/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerum2022-08-24 09:08:01 CET437Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15521Coronavirus disease (COVID-19) Antibody Test (Up-converting Phosphor Technology)328Beijing Hotgen Biotech Co. Ltd.Chinawww.hotgen.com.cn/YesCommercialisedNoNoNear POC / POCAntibody2022-08-24 09:08:01 CET451Immuno-AntibodyYesYesImmunoassayQualitative15Rapid diagnostic test card 2808Novel Coronavirus (SARS-CoV-2) Neutralizing Antibodies Test (Colloidal Gold)1069Beijing Hotgen Biotech Co. Ltd.Chinawww.hotgen.com.cnYesCommercialisedNoNoNear POC / POCAntibodyPeripheral bloodSerumVenous whole bloodWhole blood with anti-coagulants689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1132B.1.427Epsilon1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu2041C.37LambdaThere are acolorimetric cards in the product, and the user can judge the semi-quantitative result based on the colorimetric card.2022-08-24 09:08:01 CET2513Immuno-AntibodyYesNoImmunochromatographySemiquantitativeSandwichColloidal gold15LOD0.25AUThe cut off Novel Coronavirus (SARS-CoV-2) Neutralizing Antibodies in serum samples detected by this kit was determined to be 0.250(OCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.69%869 samples have 6 false positivesFalse negatives1.47%339 samples have 5 false negativesPrecisionEvaluatedAccuracy99.09% IgGReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.53% IgGClinical Specificity99.31% IgG2809Novel Coronavirus(SARS-CoV-2) Neutralizing AntibodiesTest (Up-converting Phosphor Immunochromatographic Technology)1256Beijing Hotgen Biotech Co. Ltd.ChinaYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumVenous whole bloodWhole bloodWhole blood with anti-coagulants689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.32041C.37LambdaProducts need to pass UPT instrument testing to obtain results.2022-08-24 09:08:01 CET2514Immuno-AntibodyYesImmunochromatographyQuantitativeNeutralization Antibody (NAb)Phosphor technology15LOD0.25AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.57%869 negative samples have 5 false positives.False negatives1.17%339 positive samples have 4 false negatives.PrecisionEvaluatedAccuracy99.25% IgGReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.82% IgGClinical Specificity99.42% IgG2811SARS-CoV-2 (S-RBD & NP) Antibody Test (Colloidal Gold)1069Beijing Hotgen Biotech Co. Ltd.Chinawww.hotgen.com.cnYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumVenous whole bloodWhole blood with anti-coagulants689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1132B.1.427Epsilon1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.32041C.37LambdaTwo test results can be obtained through this product test: S-RBD antibody and NP antibody.2022-08-24 09:08:01 CET2516Immuno-AntibodyNoImmunochromatographySemiquantitativeSandwichColloidal gold20LOD15AU/mL15BAU/mLCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%408 negative samples have no false positives.False negatives0.43%230 positive samples have 1 false negative.PrecisionEvaluatedAccuracy99.84% IgGReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.57% IgGClinical Specificity100% IgG69Kewei COVID-19 IgG antibody ELISA Test Kit43Beijing Kewei Clinical Diagnostic Reagent Inc.Chinaen.keweidiagnostic.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET50Immuno-AntibodyNoYesELISAQualitativeMagnetic Electrochemical60Accuracy96% IgGClinical Sensitivity90.83% IgGClinical Specificity99.2% IgG71Kewei COVID-19 IgG/IgM antibody Rapid Test Kit (Colloidal Gold)43Beijing Kewei Clinical Diagnostic Reagent Inc.Chinaen.keweidiagnostic.com/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET1240Immuno-AntibodyYesNoImmunoassayQualitativeColloidal gold10Accuracy96%Clinical Sensitivity93.3%Clinical Specificity98.2%67Kewei COVID-19 IgM antibody ELISA Test Kit43Beijing Kewei Clinical Diagnostic Reagent Inc.Chinaen.keweidiagnostic.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET365Immuno-AntibodyNoYesELISAQualitativeCapture60Accuracy96% IgMClinical Sensitivity90.83% IgMClinical Specificity99.6% IgM1111Kewei COVID-19 total antibody ELISA Test Kit43Beijing Kewei Clinical Diagnostic Reagent Inc.Chinaen.keweidiagnostic.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum http://en.keweidiagnostic.com/index.php?m=content&c=index&a=show&catid=199&id=1752022-08-24 09:08:01 CET367Immuno-AntibodyNoYesELISAQualitativeSandwich, Double60Manual or automated microtiter plate Sandwich, Double Accuracy96%Clinical Sensitivity94.71%Clinical Specificity99.6%1112Kewei COVID-19 total antibody rapid test43Beijing Kewei Clinical Diagnostic Reagent Inc.Chinaen.keweidiagnostic.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerumWhole blood http://en.keweidiagnostic.com/uploadfile/2020/0704/20200704024137750.pdf2022-08-24 09:08:01 CET389Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry10Manual or automated Colloidal Gold Clinical Sensitivity93.33%Clinical Specificity99.6%523SARS-CoV-2 Antibody Test (colloidal gold immunochromatography)319Beijing Lepu Medical Technology Co. Ltd.Chinahttps://www.lepumedical.com/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerum2022-08-24 09:08:01 CET423Immuno-AntibodyYesImmunochromatographyColloidal goldLOD3.1U/ml77Tigsun COVID-19 Combo IgM/IgG Rapid Test (Lateral Flow Method)47Beijing Tigsun Diagnostics Co. Ltd.Chinawww.tigsun.com/YesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET54Immuno-AntibodyYesNoImmunoassayQualitative833SARS-CoV-2 Total Ab ELISA49Beijing Wantai Biological Pharmacy Enterprise Co. Ltd.Chinawww.ystwt.cnYesCommercialisedNoNoAutomatedManualAntibodySerum2022-08-24 09:08:01 CET684Immuno-AntibodyNoYesELISAQualitativeFluorescence75Manual or automated Fluorescence Clinical Sensitivity94.36%Clinical Specificity100%834Wantai SARS-CoV-2 IgM ELISA49Beijing Wantai Biological Pharmacy Enterprise Co. Ltd.Chinawww.ystwt.cnYesCommercialisedNoNoAutomatedManualAntibodySerum2022-08-24 09:08:01 CET1792Immuno-AntibodyELISA697SARS-CoV-2 IgG/igM Antibody Detection Kit425Beroni GroupAustraliawww.beronigroup.comYesCommercialisedNoNoLab-basedAntibody2022-08-24 09:08:01 CET581Immuno-AntibodyImmunoassay756Platelia SARS-CoV-2 Total Ab Assay332Bio-Rad Laboratories Inc.United Stateswww.bio-rad.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET612Immuno-AntibodyYesImmunoassayQualitativeSandwich, DoubleMAnalysis of cross reactivityEvaluatedPrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity86.5%(73-100)Clinical Specificity100%2703(COVID-19) IgM/IgG Antibody Rapid Test Kit1236Bioantibody Biotechnology Co. Ltd.Chinahttp://www.baikangbiotech.com/index.php/product/49.htmlYesCommercialisedNoNoManualAntibodyPlasmaSerumWhole bloodnucleocapsid protein(COVID-19) IgM/IgG Antibody Rapid Test Kit (Latex Chromatography) is based on the principle of capture immunoassay for determination of COVID-19 IgG/IgM antibodies in human whole blood, serum and plasma. When the sample is added to the test device, the sample will be absorbed into the device by capillary action, mixing with SARS- CoV-2 recombinant antigen-color latex conjugate and flowing through the pre-coated membrane. When the COVID-19 IgG antibody or IgM antibody level in the specimen is at or above the target cutoff (the detection limit of the test), the antibodies bound to the antigen- color latex conjugate are captured by anti-human IgG antibody immobilized on the Test Region (G)of the device or anti-human IgMantibody immobilized on the Test Region(M), and This produces one or two color teststrips indicating a positive result. When theCOVID-19 IgG/IgM antibodies level in thespecimen is zero or below the target cutoff,there is not a visible colored band in the TestRegion (G M) of the device. This indicates anegative result. To serve as a procedure control, a colored linewill appear at the Control Region (C), if the testhas been performed properly.2022-08-24 09:08:01 CET2408Immuno-AntibodyYesChromatographyQualitativeSandwich15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives%0False negatives%0PrecisionEvaluatedAccuracy100% IgGAccuracy100% IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100% IgGClinical Sensitivity100% IgMClinical Specificity100% IgGClinical Specificity100% IgMType of antigenNucleocapsid protein28952019-nCoV IgM/IgG Antibody Test Kit（Colloidal Gold）1272Biobase Biodustry（Shandong） Co. Ltd.Chinahttps://www.biobase.cc/YesCommercialisedNoNoLab-basedManualAntibodyOther689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1321B.1.617.2Delta678B.1.1.529Omicronenvelope proteinmembrane proteinnon-structural protein NSP1nucleocapsid proteinspike proteinThe SARS-COV-2 IgM/IgG Rapid Test Kit is used for the qualitative detection of IgM and IgG antibodies in human serum, plasma or whole blood.2022-08-24 09:08:01 CET2600Immuno-AntibodyYesYesImmunochromatographyQualitativeMembrane-basedColloidal gold15LOD5ng/mLIgG LOD25ng/mLIgMCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.67%False negatives1.85%PrecisionEvaluatedAccuracy98.33%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.15%Clinical Specificity98.44%Type of antigenNucleocapsid protein524Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Ab Test322Biocan Diagnostics Inc.Canadawww.rapidtest.caYesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET426Immuno-AntibodyYesNoImmunoassayQualitative15Rapid diagnostic test Lateral Flow 1099Anti-SARS-CoV-2 IgG590Biocheck GmbHGermanywww.polycheck.deYesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerumhttps://polycheck.de/wp-content/uploads/2020/07/Polycheck-Anti-SARS-CoV-2-IgG-Flyer.pdf2022-08-24 09:08:01 CET880Immuno-AntibodyNoNoImmunoassayQuantitativeMagnetic Electrochemical105Manual or automated microblot colorimetry LOD0.2KU/lAnalysis of cross reactivityEvaluatedReproducibilityEvaluatedClinical Sensitivity98.6% IgGClinical Specificity98.7% IgG1686Novel Coronavirus COVID-19 IgM/IgG Test Kit757Biocomma limitedChinawww.biocomma.comYesCommercialisedNoNoNear POC / POCAntibodyWhole bloodnucleocapsid protein2022-08-24 09:08:01 CET1365Immuno-AntibodyYesYesImmunoassayQualitativeColloidal gold15LOD312.5AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.35%False negatives0%PrecisionEvaluatedAccuracy99.26% IgGAccuracy99.26% IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100% IgGClinical Sensitivity100% IgMType of antigennucleoprotein2694BOH-180 Fluorescent Immunoassay Analyzer1037BIOHIT HealthCare (Hefei) Co. Ltd.Chinawww.biouhan.comYesCommercialisedNoNoNear POC / POCSemi-automatedAntibodyAnterior 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 protein87SARS-CoV-2 IgM/IgG antibody test kit (Colloidal Gold Method)53BIOHIT HealthCare (Hefei) Co. Ltd.Chinawww.biouhan.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWash aspirate689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1132B.1.427Epsilon1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta2041C.37Lambdanucleocapsid proteinThe SARS-CoV-2 IgM/IgG antibody test kit is based on the immunochromatographic method. The SARS-CoV-2 IgM/IgG is detected by SARS-CoV-2 recombinant N protein.2022-08-24 09:08:01 CET61Immuno-AntibodyYesNoImmunoassayQualitativeColloidal gold15LOD10μg/mLCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy99.1% IgMAccuracy99.4% IgGReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.66% IgMClinical Sensitivity99.46% IgGClinical Specificity98.46% IgMClinical Specificity100% IgGType of antigenNucleocapsid protein1829COVID-19 IgG/IgM Rapid Test Cassette835BIOLAN HEALTH S.L.Spainwww.biolanhealth.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole bloodDetection of neutralizing antibodies. IgG and IgM antibodies against RBD of spike protein.2022-08-24 09:08:01 CET1507Immuno-AntibodyYesImmunoassay4972019-nCoV IgG/IgM Antibody Detection Kit316BiolidicsSingaporewww.biolidics.com/YesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET418Immuno-AntibodyYesNoImmunoassayQualitativeColloidal gold10Accuracy95%Clinical Sensitivity91.54%Clinical Specificity97.02%2639SARS-CoV-2 Total Ab ELISA1206BioMARICBelgiumwww.biomaric.beYesCommercialisedNoNoManualSemi-automatedAntibodyPlasmaSerumnone2022-08-24 09:08:01 CET2344Immuno-AntibodyYesELISAQualitativeSandwich95LOD1.637IU/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%no false positive detected in 352 negative samplesFalse negatives0.8%1 false negative observed in 126 PCR-positive samplesPrecisionEvaluatedAccuracy99.79% (Total Ab)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.2%total AbClinical Specificity100% Total AbType of antigenSpike protein882019-nCoV IgG/IgM Rapid Test Cassette52BioMaxima SAPolandwww.biomaxima.com/YesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET60Immuno-AntibodyYesNoImmunoassayQualitative10Analysis of cross reactivityReportedClinical Sensitivity100% IgGClinical Sensitivity85% IgMClinical Specificity98% IgGClinical Specificity96% IgM881VIDAS SARS-COV-2 IgG56bioMérieux SAFrancehttps://www.biomerieux-diagnostics.com/covid-19-r-geneYesCommercialisedNoNoAutomatedManualAntibody2022-08-24 09:08:01 CET718Immuno-AntibodyYesImmunoassayQualitative30Clinical Sensitivity99.6%Clinical Specificity100%957VIDAS SARS-COV-2 IgM56bioMérieux SAFrancehttps://www.biomerieux-diagnostics.com/covid-19-r-geneYesCommercialisedNoNoAutomatedManualAntibody2022-08-24 09:08:01 CET771Immuno-AntibodyYesImmunoassayQualitative3090COVID-19 IgM/IgG Rapid Test55BioMedomics Inc.United Stateswww.biomedomics.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumVenous whole bloodWhole bloodWhole blood with anti-coagulantsTHis is an update to the BioMedomics COVID-19 IgM-IgG Rapid Test2022-08-24 09:08:01 CET64Immuno-AntibodyYesNoImmunochromatographyQualitativeSandwich, DoubleColorimetry10LODnot applicableCalibrationEvaluatedAnalysis of cross reactivityReported as not possibleAnalysis of cross reactivityEvaluatedFalse positives0.125%1 out of 80 samples produced a false positiveFalse negatives0%(0 out of 26 samples produced false negatives)PrecisionEvaluatedAccuracy99.1%combinedReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%combinedClinical Specificity98.75%combined1603Biomerica COVID-19 IgG/IgM Rapid Strip Test (1507B)708Biomerica Inc.United Statesbiomerica.com/index.aspYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole bloodnucleocapsid protein data available upon request2022-08-24 09:08:01 CET1284Immuno-AntibodyYesNoImmunoassayQualitative10LOD0AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives10AUFalse negatives2AUPrecisionEvaluatedAccuracy96.6%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.9%Type of antigennucleoprotein1601Biomerica COVID-19 IgG/IgM Rapid Test (1507A)708Biomerica Inc.United Statesbiomerica.com/index.aspYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole bloodnucleocapsid protein data available upon request (LOD=0) 2022-08-24 09:08:01 CET1282Immuno-AntibodyYesNoImmunoassayQualitative10Rapid diagnostic test lateral flow LOD0AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives4AUFalse negatives0AUPrecisionEvaluatedAccuracy96%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%Type of antigennucleoprotein2205COVID-19 Neutralizing Antibody Test Kit (Colloidal Gold)961Bioneovan Co. Ltd.Chinawww.bioneovan.comYesCommercialisedNoNoLab-basedNear POC / POCAntibodyPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351BetaOtherThis kit is used for in-vitro semi-quantitative determination of novel corona virus neutralizing antibodies in human serum, plasma, venous whole blood or peripheral whole blood.2022-08-24 09:08:01 CET1906Immuno-AntibodyYesNoImmunochromatographySemiquantitativeCaptureColloidal gold15LOD1.1AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.9%False negatives1.3%PrecisionNot evaluatedAccuracy98.9%(95% CI: 98.0%~99.4%)ReproducibilityNot evaluatedRobustnessNot evaluatedClinical Sensitivity98.7%（95% CI: 96.6%~99.5%）Clinical Specificity99.1%（95% CI: 97.9%~99.6%）Type of antigenOther1016COVID-19 Rapid Antibody Test538Biopanda ReagentsUnited Kingdomwww.biopanda.co.ukYesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET781Immuno-AntibodyYesNoImmunoassayQualitative10Clinical Sensitivity69.4%CI: 69.4 - 100Clinical Specificity98.3% IgGClinical Specificity96.7% IgM778SARS-COV-2 Antibody Test467Biosino Bio-Technology and Science Inc.Chinawww.sinobio.com.cn/YesCommercialisedNoNoLab-basedAntibody2022-08-24 09:08:01 CET646Immuno-AntibodyImmunoassay2865SARS-CoV-2 Neutralizing antibody Test KIT (Colloidal gold)467Biosino Bio-Technology and Science Inc.Chinawww.sinobio.com.cn/YesCommercialisedNoNoLab-basedManualNear POC / POCAntibodyPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1321B.1.617.2Delta1323B.1.621Mu2041C.37LambdaThis product with Colloidal Gold is used in the qualitative analysis of SARS-CoV-2 Neutralizing antibody in the samples about serum, plasma and whole blood. It is also used to monitor the process of different immune stages and evaluate the effect after vaccination. If there is a positive result, it indicates that there may be neutralizing antibody in the sample, but it cannot rule out the false positive caused by inhibitory peptides or small molecule inhibitors. If there is negative result, it indicates that the amount of neutralizing antibody is lower than the detection limit. The negative result can not rule out the possibility that there is neutral antibody in subjects.2022-08-24 09:08:01 CET2570Immuno-AntibodyNoImmunochromatographyQualitativeColloidal gold15LOD0.1ng/mLCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy95%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90%Clinical Specificity98%Type of antigenSpike protein2857SARS-CoV-2 Neutralizing antibody Test Kit (ELISA)467Biosino Bio-Technology and Science Inc.Chinawww.sinobio.com.cn/YesCommercialisedNoNoLab-basedManualSemi-automatedAntibodyPlasmaSerum689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1321B.1.617.2Delta1323B.1.621Mu2041C.37Lambda678B.1.1.529OmicronThe SARS-CoV-2 Neutralizing Antibody Test Kit (Enzyme-Linked Immunosorbent Assay，ELISA) is intended for in vitro concentration quantification of total neutralizing antibodies to SARS-CoV-2 in human serum or plasma. The kit is only intended for testing people who have received SARS-CoV-2 vaccine, cannot be used as the basis for the confirmation and exclusion of infectious SARS-CoV-2 pneumonia, and is not applicable for general population screening.2022-08-24 09:08:01 CET2562Immuno-AntibodyNoYesELISAQuantitativeNeutralization Antibody (NAb)120LOD0.1µg/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy98.75%serumReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity96.25%serumClinical Specificity100%serumType of antigenSpike protein779BIOSYNEX COVID-19 BSS651BIOSYNEX S.A.Switzerlandwww.biosynex.comYesCommercialisedNoNoLab-basedAntibodyWhole blood2022-08-24 09:08:01 CET821Immuno-AntibodyYesNoImmunoassayQualitative10Not found cassette Not found 14882019-nCoV IgM/IgG Antibody Test Kit (colloidal gold method)848Bioteke Taizhou Biotechnology Co. Ltd.Chinawww.bioteke.cn/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerumnucleocapsid protein2022-08-24 09:08:01 CET1231Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15LOD176AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1 for serum specimens, 2 for plasma specimensFalse negatives5 for serum specimens, 4 for plasma specimensPrecisionEvaluatedAccuracy98.35%serum specimensAccuracy98.3%plasma specimensReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.1%serum specimensClinical Sensitivity95.92%plasma specimensType of antigennucleoprotein1012Covid-19 IgG/IgM Rapid Test912Biozek MedicalNetherlandswww.biozek.comYesCommercialisedNoNoNear POC / POCAntibodyWhole blood this website redirects to another company (Biozek); http://biozek.com/corona-virus-covid-rapid-test/2022-08-24 09:08:01 CET780Immuno-AntibodyYesNoImmunoassayQualitative10Accuracy92.9%464COVID-19 IgG/IgM Rapid Test Cassette912Biozek MedicalNetherlandswww.biozek.comYesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET374Immuno-AntibodyYesNoImmunoassayQualitative10Rapid diagnostic test Lateral flow False positivesReportedFalse negativesReportedAccuracy98.6% IgGAccuracy92.9% IgMRobustnessReportedClinical Sensitivity100% IgGClinical Sensitivity85% IgMClinical Specificity98% IgGClinical Specificity96% IgM103ViroTrack Sero COVID-19 IgA+IgM/IgG Ab60BluSense Diagnostics ApSDenmarkhttps://www.blusense-diagnostics.com/YesNoNoAutomatedNear POC / POCAntibodyPlasmaSerumWhole bloodPatented IMA technology2022-08-24 09:08:01 CET73Immuno-AntibodyYesNoYesImmunoassaySemiquantitativeOther13Patented IMA technology CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.15%1 false positive in a cohort of 87 negative samplesFalse negatives17.14%6 false negatives in a cohort of 35 positive samplesPrecisionEvaluatedAccuracy93.4%IgA+IgMAccuracy93.4% IgGAccuracy93.4%IgA+IgM/IgGReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity80%IgA+IgMClinical Sensitivity77.1% IgGClinical Sensitivity82.9%IgA+IgM/IgG2906ViroTrack Sero COVID-19 Total Ab60BluSense Diagnostics ApSDenmarkhttps://www.blusense-diagnostics.com/YesCommercialisedNoNoAutomatedAntibodyPlasmaSerumVenous whole bloodWhole bloodWhole blood with anti-coagulants689B.1.1.7Alphaspike proteinViroTrack Sero COVID-19 Total Ab is an in vitro diagnostic (IVD) immunomagnetic (IMA) assay intended for the quantitative detection of anti-SARS-CoV-2 total human antibodies in human whole blood, serum or plasma as an aid at identifying individuals with an adaptive immune response to SARS-CoV-2 indicating recent or prior infection. The cartridge is single-use and intended to be used exclusively in combination with the BluBox reader (Ref.: 60BB01). The system is automated. The assay kit is intended to be used by Healthcare Professionals in a laboratory environment and by Healthcare Professionals in office-like near-patient testing environments, for example in hospitals, clinics, pharmacies, long-term care facilities, primary care settings, or General Practitioners offices with the purpose of testing patients of both genders in all age classes. Results must be confirmed by clinical assessment by an expert physician and/or using another marketed test method.2022-08-24 09:08:01 CET2611Immuno-AntibodyNoYesImmunoassayQuantitative7LOD9.1BAU/mLCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.28%2 FP out of 699 samplesFalse negatives0.55%1 FN out of 179 samples ( Detected as equivocal)PrecisionEvaluatedAccuracy99.7%(875/878) [99.0%;99.9%]ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.4%(178/179) [96.9%;100.0%]Clinical Specificity99.7%(697/699) [99.0%;100.0%]Type of antigenSpike protein1168Lab-On-Time 2019-nCoV IgG/IgM Rapid Test611BMT DiagnosticsIsraelwww.bmtdiagnostics.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerum2022-08-24 09:08:01 CET945Immuno-AntibodyYesNoImmunoassayQualitative10Rapid diagnostic test Lateral Flow Accuracy94.9%Clinical Sensitivity94.4%2194SARS-CoV-2 IgG/IgM Rapid Test834BN SantéFrancewww.biogyne.frYesCommercialisedNoNoNear POC / POCAntibodyWhole bloodNo additional information.2022-08-24 09:08:01 CET1895Immuno-AntibodyImmunoassay15LOD10AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives16AUFalse negatives4AUPrecisionEvaluatedAccuracy98% (97,38 % à 98,92 %)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98% (97,06 % à 99,67 %)Clinical Specificity98% (96,83 % à 98.82 %)Type of antigenOther836AFIAS COVID-19 Ab, IgM/IgG22Boditech Med Inc.South Koreahttps://www.boditech.co.kr/enYesCommercialisedNoNoAutomatedAntibodyWhole blood2022-08-24 09:08:01 CET686Immuno-AntibodyYesImmunoassayQualitativeFluorescence102399AFIAS COVID-19 nAb1104Boditech Med Inc.South Koreawww.boditech.co.kr/enYesCommercialisedNoNoAutomatedNear POC / POCAntibodyPlasmaSerumWhole bloodAFIAS COVID-19 nAb is a fluorescence Immunoassay (FIA) for the qualitative determination of neutralizing antibodies against SARS-CoV-2 that block the interaction between the receptor binding domain (RBD) of the viral spike glycoprotein with the ACE-2 cell surface receptor in human whole blood/serum/plasma. For in vitro diagnostic use only.2022-08-24 09:08:01 CET2101Immuno-AntibodyYesImmunoassayQualitativeSandwich20LOD10CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives2.7%PrecisionEvaluatedAccuracy98.8%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity97.3%Clinical Specificity100%Type of antigenOther2783AFIAS COVID-19 SP/NP IgG22Boditech Med Inc.South Koreahttps://www.boditech.co.kr/enYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole bloodAFIAS COVID-19 SP/NP IgG is a fluorescence Immunoassay (FIA) for the qualitative determination of SP/NP IgG antibodies against of novel corona virus (SARS-CoV-2) in human whole blood/serum/plasma. It is helpful as an aid in the screening of early mild, asymptomatic or acute patients for identification of 'Novel Coronavirus (eg. SARS-CoV-2)' infection. For in vitro diagnostic use only.2022-08-24 09:08:01 CET2488Immuno-AntibodyYesYesImmunoassayQualitativeSandwich10LOD37AU/mLBAU/mL (NP IgG)LOD26AU/mLBAU/mL (SP IgG)CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.7%SP IgGFalse positives1.4%NP IgGFalse negatives1.4%SP IgGFalse negatives1.4%NP IgGPrecisionEvaluatedAccuracy97.9%SP IgGAccuracy97.2%NP IgGReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity98.8%SP IgGClinical Sensitivity96.1%NP IgGClinical Specificity96.7%SP IgGClinical Specificity97.8%NP IgG2785Boditech Quick™ COVID-19 Neutralizing Ab22Boditech Med Inc.South Koreahttps://www.boditech.co.kr/enYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole bloodBoditech Quick™ COVID-19 Neutralizing Ab is a chromatographic Immunoassay for the qualitative detection of Neutralizing antibodies against SARS-CoV-2 that block the interaction between the receptor binding domain (RBD) of the viral spike glycoprotein with the ACE-2 cell surface receptor in human whole blood/serum/plasma. For in vitro diagnostic use only.2022-08-24 09:08:01 CET2490Immuno-AntibodyNoImmunoassayQualitativeMembrane-based20LODPRNT50 1:27CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives1.1%1 false positive out of 90 PRNT negative samplesFalse negatives6.5%5 false negative out of 77 PRNT positive samplesPrecisionEvaluatedAccuracy96.4%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity93.5%95% C.I. 85.68~97.19%Clinical Specificity98.9%95% C.I. 93.97~99.80%837Ichroma COVID-19 Ab, IgM/IgG22Boditech Med Inc.South Koreahttps://www.boditech.co.kr/enYesCommercialisedNoNoManualAntibodyWhole blood2022-08-24 09:08:01 CET687Immuno-AntibodyYesYesImmunoassayQualitativeFluorescence102398ichroma™ COVID-19 nAb1104Boditech Med Inc.South Koreawww.boditech.co.kr/enYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole bloodichroma™ COVID-19 nAb is a fluorescence Immunoassay (FIA) for the qualitative determination of neutralizing antibodies against SARS-CoV-2 that block the interaction between the receptor binding domain (RBD) of the viral spike glycoprotein with the ACE-2 cell surface receptor in human whole blood/serum/plasma. For in vitro diagnostic use only.2022-08-24 09:08:01 CET2100Immuno-AntibodyYesImmunoassayQualitativeSandwich15LOD10AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives1 (1 false positive out of 99 PRNT negative samples.)False negatives1(1 false negative out of 98 PRNT positive samples.)PrecisionEvaluatedAccuracy99 (Kappa = 0.97969)ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity99%(95% CI: 94.4 ~ 100%)Clinical Specificity99%(95% CI: 94.5 ~ 100%)Type of antigenOther2784ichroma™ COVID-19 SP/NP IgG22Boditech Med Inc.South Koreahttps://www.boditech.co.kr/enYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumichroma™ COVID-19 SP/NP IgG is a fluorescence Immunoassay (FIA) for the qualitative determination of SP/NP IgG antibodies against of novel corona virus (SARS-CoV-2) in human serum/plasma. It is helpful as an aid in the screening of early mild, asymptomatic or acute patients for identification of 'Novel Coronavirus (eg. SARS-CoV-2)' infection. For in vitro diagnostic use only.2022-08-24 09:08:01 CET2489Immuno-AntibodyYesImmunoassayQualitativeSandwichFluorescence10LOD37AU/mLBAU/mL (NP IgG)LOD26AU/mLBAU/mL (SP IgG)CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives4.3%SP IgGFalse positives8.3%NP IgGFalse negatives4%SP IgGFalse negatives0%NP IgGPrecisionEvaluatedAccuracy95.8%SP IgGAccuracy98.3%NP IgGReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity95.7%SP IgGClinical Sensitivity91.7%NP IgGClinical Specificity96%SP IgGClinical Specificity100%NP IgG2033Rapid Response COVID-19 IgG/IgM Rapid Test Device62BTNX Inc.Canadawww.btnx.com/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole bloodThe Rapid Response COVID-19 IgG/IgM Rapid Test Device has been CE marked since April of 2020. Since then various independent evaluations have been completed at various EU member state organizations. The "COVID-19 In Vitro Diagnostic Medical Devices" mentions that the product is not CE marked. The name of the product has been slightly changed since the first CE marking which could be the cause of this being missed. Could you please check and update the list during the next meeting of JRC? Thank you, Khasim Technical Operations Manager khasim@btnnx.com2022-08-24 09:08:01 CET1711Immuno-AntibodyNoImmunochromatographyQualitativeSandwich15LOD210CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2% IgMFalse positives3% IgGFalse negatives5% IgMFalse negatives1% IgGPrecisionEvaluatedAccuracy97.7% IgMAccuracy98.7% IgGReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.7% IgMClinical Sensitivity98.8% IgGClinical Specificity99.1% IgMClinical Specificity98.7% IgGType of antigenOther111Camtech COVID-19 Rapid Test Kit415CamtechSingaporecovid19-test.com/YesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET570Immuno-AntibodyYesNoImmunoassayQualitativeNot found10Analysis of cross reactivityReportedClinical Sensitivity87.5%Clinical Specificity100%2788SARS-CoV-2 Neutralizing Antibodies Test Kit1253CAS-EnvisionChinawww.cas-envision.comYesCommercialisedNoNoManualAntibodyWhole blood2022-08-24 09:08:01 CET2493Immuno-AntibodyImmunochromatographyQualitativeNeutralization Antibody (NAb)15LOD10ng/mLCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.37%1/269False negatives2.59%3/116PrecisionEvaluatedAccuracy99%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.4%Clinical Specificity99.6%Type of antigenSpike protein838Smart COVID-19 IgM/IgG RDT488Cell ID Pte Ltd.Singaporewww.cid.com.sg/YesCommercialisedNoNoAutomatedManualAntibody2022-08-24 09:08:01 CET688Immuno-AntibodyImmunoassayNot found116Cellex qSARS-CoV-2 IgGIgM Cassette Rapid Test416Cellex Inc.United Statescellex.us/YesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET571Immuno-AntibodyYesNoImmunoassayQualitativeNot found15Rapid diagnostic test cassette Not found Clinical Sensitivity93.75%Clinical Specificity96.4%460SARS-CoV-2 Antibody Test Strip498Changsha Sinocare Inc.Chinawww.sinocare.com/web/about/index_enYesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET708Immuno-AntibodyYesNoImmunoassayQualitativeColloidal gold20Precision90%Reproducibility100%Clinical Sensitivity95%Clinical Specificity98.3%1098CHiL COVID-19 IgG/IgM Rapid Test cassette589CHIL Medical Supplies Ltd.Turkeyhttps://www.chil.com.tr/YesCommercialisedNoNoNear POC / POCAntibody2022-08-24 09:08:01 CET879Immuno-AntibodyYesNoImmunoassayQualitative10CalibrationPerformed (QCRSARSCoV-2QC1 - Anti-SARS-CoV-2 Quality Control 1 NIBSC code: 20/B764 is used)Analysis of cross reactivity0% (anti-influenza A (IgG), anti-influenza B (IgG), anti-HCV (IgG and IgM), anti-HBV (IgG and IgM), anti-229E (alpha coronavirus), anti-NL63 (alpha coronavirus), anti-OC43 (beta coronavirus), anti-HKU1 (beta coronavirus) , anti-respiratory syncytial viruFalse positives0.1% IgGFalse positives0.8% IgMFalse negatives0.5% IgGFalse negatives8% IgMPrecision100%Accuracy99.7% IgGAccuracy98% IgMReproducibility100%Robustness99%Clinical Sensitivity100% IgGClinical Sensitivity92% IgM1939COVID-19 Antibody Rapid Test Kit886Chongqing iSIA BIO-Technology Co. Ltd.Chinawww.isiabio.com.cnYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole bloodOther2022-08-24 09:08:01 CET1615Immuno-AntibodyYesImmunoassay15LOD0.8AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy98%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98%Clinical Specificity97%Type of antigenOther1940COVID-19 Antibody Rapid Test Kit (QDs)886Chongqing iSIA BIO-Technology Co. Ltd.Chinawww.isiabio.com.cnYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blooduse instrument for test, quantum dots poct2022-08-24 09:08:01 CET1616Immuno-AntibodyImmunoassayImmunofluorescence15(Quantum Dots Immunofluorescence)LOD0.8AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy99%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99%Clinical Specificity99%Type of antigenOther1185Novegent COVID-19 Antibodies Rapid Test Kit620Chongqing Novegent Biotech Company LimitedChinawww.novegent.cnYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET969Immuno-AntibodyYesNoImmunoassayQuantitativeColorimetry15Rapid diagnostic test Colloidal Gold Analytical Sensitivity96% IgMAccuracy95.5% IgGAccuracy95.5% IgMClinical Sensitivity96% IgG13902019-nCoV IgG/IgM Rapid Test Cassette659CITEST DIAGNOSTICS Inc.Canadawww.citestdiagnostics.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET1156Immuno-AntibodyYesNoImmunoassayQualitative10LOD0CalibrationNot evaluatedFalse positives3.7%False negatives3.1%Accuracy96.4%Clinical Sensitivity96.9%24382019-nCoV IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)659CITEST DIAGNOSTICS Inc.Canadawww.citestdiagnostics.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThe 2019-nCoV IgG/IgM Rapid Test Cassette is a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to 2019-nCoV in human whole blood, serum or plasma specimen.2022-08-24 09:08:01 CET2141Immuno-AntibodyNoImmunoassayQualitativeSandwich10Ares(2021)4569376LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0% IgGFalse positives0.15% IgMFalse negatives0.02% IgGFalse negatives0.04% IgMPrecisionEvaluatedAccuracy98.6% IgGAccuracy92.9% IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100% IgGClinical Sensitivity85% IgMClinical Specificity98% IgGClinical Specificity96% IgMType of antigenNucleoprotein2435COVID-19 and M.pneumoniae IgG Combo Rapid Test (Whole Blood/Serum/Plasma)659CITEST DIAGNOSTICS Inc.Canadawww.citestdiagnostics.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.1B.1.526.11224B.1.526IotaB.1.526.21518P.2ZetaThe COVID-19 and M.pneumoniae IgG Combo Rapid Test (Whole Blood/ Serum/Plasma) is a lateral flow chromatographic immunoassay for the qualitative detection of IgG antibodies to SARS-COV-2 and Mycoplasma pneumoniae in human whole blood, serum or plasma specimen. The COVID-19 and M.pneumoniae IgG Combo Rapid Test is for professional use only and is intended to be used as an aid in the diagnosis of patients with suspected SARS-CoV-2/M.pneumoniae infection in conjunction with clinical presentation and the results of other laboratory tests. The product is intended to be used by trained laboratory personnel. Negative results will not preclude SARS-COV-2/M.pneumoniae infection and they cannot be used as the sole basis for treatment or other management decision. False positive results for IgG antibodies may occur due to cross-reactivity from pre-existing antibodies or other possible causes.2022-08-24 09:08:01 CET2138Immuno-AntibodyNoImmunoassayQualitativeSandwich10LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0AU(COVID-19 IgG)False positives0.078AU(Mycoplasma pneumoniae）False negatives0.02AU(COVID-19 IgG)False negatives0.054AU(Mycoplasma pneumoniae IgG）PrecisionEvaluatedAccuracy98.6% IgG(COVID-19)Accuracy93.7%（Mycoplasma pneumoniae IgG）ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100% IgG(COVID-19), Clinical Sensitivity92.2% IgG(Mycoplasma pneumoniae）Clinical Specificity98% IgG(COVID-19), Clinical Specificity94.6% IgG(Mycoplasma pneumoniae IgG）Type of antigenNucleoprotein2436COVID-19 and M.pneumoniae IgG/IgM Combo Rapid Test (Whole Blood/Serum/Plasma)659CITEST DIAGNOSTICS Inc.Canadawww.citestdiagnostics.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThe COVID-19 and M.pneumoniae IgG/IgM Combo Rapid Test (Whole Blood/Serum/Plasma) is a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to SARS-COV-2 and Mycoplasma pneumoniae in human whole blood, serum or plasma specimen. The COVID-19 and M.pneumoniae IgG/IgM Combo Rapid Test is for professional use only and is intended to be used as an aid in the diagnosis of patients with suspected SARS-CoV-2/M.pneumoniae infection in conjunction with clinical presentation and the results of other laboratory tests. The product is intended for use by trained laboratory personnel. The test provides preliminary test results. Negative results will not preclude SARS-COV-2/ M.pneumoniae infection and they cannot be used as the sole basis for treatment or other management decision. False positive results for IgM and IgG antibodies may occur due to cross- reactivity from pre-existing antibodies or other possible causes.2022-08-24 09:08:01 CET2139Immuno-AntibodyNoImmunoassayQualitativeSandwich10LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0AU(COVID19 IgG),False positives0.085AU(Mycoplasma pneumoniae IgM)False positives0.078AU(Mycoplasma pneumoniae IgG),False positives0.15AU(COVID19 IgM),False negatives0.02AU(COVID19 IgG),False negatives0.052AU(Mycoplasma pneumoniae IgM)False negatives0.054AU(Mycoplasma pneumoniae IgG),False negatives0.04(COVID19 IgM),PrecisionEvaluatedAccuracy93.7% IgG(Mycoplasma pneumoniae), Accuracy95% IgM(Mycoplasma pneumoniae)Accuracy98.6% IgG(COVID-19 )Accuracy92.9% IgM(COVID-19), ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100% IgG(COVID-19), Clinical Sensitivity85% IgM(COVID-19), Clinical Sensitivity92.2% IgG(Mycoplasma pneumoniae), Clinical Sensitivity91.5% IgM(Mycoplasma pneumoniae)Clinical Specificity98% IgG(COVID-19), Clinical Specificity96% IgM(COVID-19), Clinical Specificity94.6% IgG(Mycoplasma pneumoniae),Clinical Specificity94.8% IgM(Mycoplasma pneumoniae)Type of antigennucleoprotein1395COVID-19 IgG Rapid Test659CITEST DIAGNOSTICS Inc.Canadawww.citestdiagnostics.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET1161Immuno-AntibodyYesNoImmunoassayQualitative10LOD0CalibrationNot evaluatedFalse positives4.7%False negatives%5.70%Accuracy95% IgGClinical Sensitivity94.3% IgG2441COVID-19 IgG Rapid Test (Whole Blood/Serum/Plasma)659CITEST DIAGNOSTICS Inc.Canadawww.citestdiagnostics.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThe COVID-19 IgG Rapid Test (Whole Blood/Serum/Plasma) is a lateral flow chromatographic immunoassay for the qualitative detection of IgG antibodies to SARS-CoV-2 spike (S) protein receptor binding domain (RBD) and/or Nucleocapsid protein in human whole blood, serum or plasma specimen. The COVID-19 IgG Rapid Test (Whole Blood/Serum/Plasma) is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2. False positive results may occur due to cross-reactivity from pre-existing antibodies or other possible causes. Due to the risk of false positive results, confirmation of positive results should be considered using second, different IgG assay.2022-08-24 09:08:01 CET2144Immuno-AntibodyNoImmunoassayQualitativeSandwich10LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.038AU( SARS-CoV-2 infection), False positives0.043AU(vaccination)False negatives0.001AU( SARS-CoV-2 infection), False negatives0AU(vaccination)PrecisionEvaluatedAccuracy97.7%( SARS-CoV-2 infection), Accuracy97.9%(vaccination)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.3%( SARS-CoV-2 infection), Clinical Sensitivity95.7%(vaccination)Clinical Specificity99%( SARS-CoV-2 infection), Clinical Specificity100%(vaccination)Type of antigenOther1389COVID-19 IgG/IgM Rapid Test (cassette)659CITEST DIAGNOSTICS Inc.Canadawww.citestdiagnostics.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET1155Immuno-AntibodyYesNoImmunoassayQualitative10Rapid diagnostic test lateral flow LOD0AUCalibrationNot evaluatedFalse positives5%False negatives5.6%Accuracy94.4%Clinical Sensitivity94.4%1479COVID-19 IgG/IgM Rapid Test (For Reader)659CITEST DIAGNOSTICS Inc.Canadawww.citestdiagnostics.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood no info in company website2022-08-24 09:08:01 CET1228Immuno-AntibodyYesYesImmunoassayQualitative10LOD0IU/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives5%False negatives5.6%PrecisionEvaluatedAccuracy94.9%(IgG/IgM)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.9%94.4(IgG/IgM)1394COVID-19 IgG/IgM Rapid Test (Strip)659CITEST DIAGNOSTICS Inc.Canadawww.citestdiagnostics.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET1160Immuno-AntibodyYesNoImmunoassayQualitative10Rapid diagnostic test Strip LOD0CalibrationNot evaluatedFalse positives5%False negatives5.6%Accuracy94.9%Clinical Sensitivity94.4%2439COVID-19 IgG/IgM Rapid Test (Whole Blood/Serum/Plasma)659CITEST DIAGNOSTICS Inc.Canadawww.citestdiagnostics.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2Zetanucleocapsid proteinThe COVID-19 IgG/IgM Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to SARS-CoV-2 in human whole blood, serum or plasma specimen from patients suspected of COVID-19 infection by a healthcare provider. The COVID-19 IgG/IgM Rapid Test is an aid in the diagnosis of patients with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results from the COVID-19 IgG/IgM Rapid Test should not be used as the sole basis for diagnosis. Results are for the detection of SARS-CoV-2 antibodies. IgM antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, although levels over the course of infection are not well characterized. IgG antibodies to SARS-CoV-2 become detectable later following infection. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. IgM antibodies may not be detected in the first few days of infection; the sensitivity of the COVID-19 IgG/IgM Rapid Test early after infection is unknown. False positive results for IgM and IgG antibodies may occur due to cross-reactivity from preexisting antibodies or other possible causes.2022-08-24 09:08:01 CET2142Immuno-AntibodyYesNoImmunoassayQualitativeSandwich10LOD100CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.037% IgGFalse positives0.05% IgMFalse negatives0.014% IgGFalse negatives0.02% IgMPrecisionEvaluatedAccuracy98.1% IgGAccuracy97.4% IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.3% IgGClinical Sensitivity95% IgMClinical Specificity98.6% IgGClinical Specificity98% IgMType of antigenNucleoprotein1475COVID-19 IgG/IgM Test Cassette659CITEST DIAGNOSTICS Inc.Canadawww.citestdiagnostics.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET1224Immuno-AntibodyYesYesImmunoassayQualitative15LOD0CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives3.3%False negatives3.1%PrecisionEvaluatedAccuracy96.9%(IgG/IgM)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.7%(IgG/IgM)2393COVID-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma)659CITEST DIAGNOSTICS Inc.Canadawww.citestdiagnostics.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1223B.1.525Eta1495P.1Gamma1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThe COVID-19 IgG/IgM Test Cassette is a fluorescence immunoassay for the qualitative detection of IgG and IgM antibodies to SARS-CoV-2 in human whole blood, serum or plasma specimen.The COVID-19 IgG/IgM Test is an aid in the diagnosis of patients with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results from the COVID-19 IgG/IgM Test should not be used as the sole basis for diagnosis. Results are for the detection of SARS-CoV-2 antibodies. IgM antibodies to SARS-CoV- 2 are generally detectable in blood several days after initial infection, although levels over the course of infection are not well characterized. IgG antibodies to SARS-CoV-2 become detectable later following infection. Positive results for both IgG and IgM could occur after infection and can be indicative of acute or recent infection. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. IgM antibodies may not be detected in the first few days of infection; the sensitivity of the COVID-19 IgG/IgM Test early after infection is unknown. False positive results for IgM and IgG antibodies may occur due to cross-reactivity from pre-existing antibodies or other possible causes. At this time, it is unknown for how long IgM or IgG antibodies may persist following infection.2022-08-24 09:08:01 CET2095Immuno-AntibodyYesImmunoassayQualitativeSandwich15LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.033AUFalse negatives0.031AUPrecisionEvaluatedAccuracy96.9%(IgG/IgM)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.7%(IgG/IgM)Clinical Specificity96.9%(IgG/IgM)Type of antigenNucleoprotein2394SARS-CoV-2 Neutralization Antibody Rapid Test (Whole Blood/Serum/Plasma)659CITEST DIAGNOSTICS Inc.Canadawww.citestdiagnostics.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThe SARS-CoV-2 Neutralization Antibody Rapid Test (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay intended for the qualitative detection of neutralization antibodies against SARS-CoV-2 that block the interaction between the receptor binding domain of the viral spike glycoprotein (RBD) with the cell surface receptor ACE2 in human whole blood, serum or plasma. It is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2. Results are for the detection of SARS-CoV-2 neutralization antibodies. Positive results indicate the presence of neutralization antibodies to SARS-CoV-2.2022-08-24 09:08:01 CET2096Immuno-AntibodyNoImmunoassayQualitativeNeutralization Antibody (NAb)10LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.034AUFalse negatives0.015AUPrecisionEvaluatedAccuracy97.7%(Neturalization Antibody)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.6%(Neturalization Antibody)Clinical Specificity98.5%(Neturalization Antibody)Type of antigenNucleoprotein2395SARS-CoV-2 S-RBD Antibody Rapid Test (Whole Blood/Serum/Plasma)659CITEST DIAGNOSTICS Inc.Canadawww.citestdiagnostics.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThe SARS-CoV-2 S-RBD Antibody Rapid Test (Whole Blood/Serum/ Plasma) is a rapid chromatographic immunoassay intended for the qualitative detection of antibodies to SARS-CoV-2 spike (S) protein receptor binding domain (RBD) in human serum, plasma, or whole blood. It is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2. Results are for the detection of antibodies to SARS-CoV-2 spike (S) protein receptor binding domain (RBD). Positive results indicate the presence of antibodies to SARS-CoV-2 spike (S) protein receptor binding domain (RBD)2022-08-24 09:08:01 CET2097Immuno-AntibodyNoImmunoassayQualitativeSandwich10LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.022AUFalse negatives0.015AUPrecisionEvaluatedAccuracy98.2%(Antibody)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.8%(Antibody)Clinical Specificity98.5%(Antibody)Type of antigenOther2400SARS-CoV-2 S-RBD IgG Antibody Rapid Test (Whole Blood/Serum/Plasma)659CITEST DIAGNOSTICS Inc.Canadawww.citestdiagnostics.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThe SARS-CoV-2 S-RBD IgG Antibody Rapid Test (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay intended for the qualitative detection of IgG antibodies to SARS-CoV-2 spike (S) protein receptor binding domain (RBD) in human serum, plasma, or whole blood. It is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2. Results are for the detection of SARS-CoV-2 S-RBD IgG antibodies. Positive results indicate the presence of IgG antibodies to SARS-CoV-2.2022-08-24 09:08:01 CET2102Immuno-AntibodyNoImmunoassayQualitativeSandwich10LODAU100CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positivesAU0.022False negativesAU0.015PrecisionEvaluatedAccuracy98.2% IgG(IgG)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.8% IgG(IgG)Clinical Specificity98.5% IgG(IgG)Type of antigenOther3922CNAME1440CMANUItalyYesCommercialisedNoNoFully automated (robot)AntibodyBronchoalveolar lavage fluidAdenovirus20A.23.1angiotensin-converting enzyme 22022-08-24 09:08:01 CET3589Immuno-AntigenYesYesNoImmunoassayQualitativeSandwichColloidal gold12LOD12copies/sampleFalse positives12cpr/cpuFalse negatives12cpr/cpu131Instant COVID-19 “Coronavirus” Test418Confirm BioscienceUnited Stateswww.confirmbiosciences.com/YesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET573Immuno-AntibodyYesNoImmunoassayQualitative15Rapid diagnostic test cassette Not found 1923Coretests COVID-19 Neutralizing Ab Test420Core Technology Co. Ltd.YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole bloodCOVID-19 Neutralizing Ab Test is used for qualitative detection of the Neutralizing antibodies in patients who have recovered from Novel Coronavirus Pneumonia or those who have been vaccinated. The neutralizing antibody protects the host from infection by neutralizing the activity of the virus. It is a specific antibody that can block the virus from invading cells. The neutralizing antibody is produced by the immune response after a person is vaccinated or infected with a virus. Its titer will directly determine the body's ability to neutralize the virus, that is, the body's ability to avoid virus infection. Coretests® COVID-19 Neutralizing Ab Test can detect neutralizing antibodies faster, and the test only takes 10-15 minutes.2022-08-24 09:08:01 CET1599Immuno-AntibodyNoImmunoassayQualitativeSandwich15LODAU25CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives%0.7%False negatives%0.8%PrecisionEvaluatedAccuracy%99.3ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity%99.2Clinical Specificity%99.3Type of antigenOther132COVID-19 IgM/IgG Ab Test420Core Technology Co. Ltd.YesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET575Immuno-AntibodyYesNoImmunoassayQualitativeNot found15Rapid diagnostic test cassette Not found 2002COVID-19 Sero NP/RBD73Coris BioConceptBelgiumwww.corisbio.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumAssay evaluated with Anti-SARS-CoV-Verification Panel for Serology Assays (NIBSC code: 20/B770): 100% Accuracy. Test identifies antibodies against Nucleoprotein (NP Line) and against RBD domain of the spike protein (RBD line).2022-08-24 09:08:01 CET1679Immuno-AntibodyNoImmunochromatography15LOD10AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%No false positivity with seasonal coronaviruses HCoV-HKU1, -NL63, -OC43, and -229EFalse negatives1.47%(4 on 271 samples)PrecisionNot evaluatedAccuracy98.5%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity98.4%(combined NP and RBD)Clinical Specificity98.5%Type of antigenOther1074Cormay Rapid SARS-CoV-2 IgG/IgM Ab579CORMAYPolandcormay.pl/index.php?lang=_enYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET852Immuno-AntibodyYesNoChromatographyQualitative10Accuracy97.72% IgMAccuracy98.52% IgGClinical Sensitivity96.52% IgGClinical Sensitivity94.07% IgM902OnSite COVID-19 IgG/IgM Rapid Test79CTK Biotech Inc.United Stateshttps://ctkbiotech.com/YesCommercialisedNoNoAutomatedManualAntibodyWhole blood2022-08-24 09:08:01 CET857Immuno-AntibodyYesNoImmunoassayQualitativeNot found15Clinical Sensitivity98.2%Clinical Specificity97.8%1673COVID5GDIV-24749D-tek s.a.Belgiumwww.d-tek.beYesCommercialisedNoNoAutomatedManualAntibodySerum2022-08-24 09:08:01 CET1352Immuno-AntibodyNoNoImmunoassayQualitativeOther60 LOD5AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives5%False negatives5%PrecisionEvaluatedAccuracy100% IgGReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100% IgG1634DABLOOD COVID-19 IgM/IgG Rapid Antibody Test730Dablood pharmaceuticalChinawww.dabloodpharmaceutical.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET1314Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15rapid diagnostic test strip colloidal gold Accuracy98%1073Test Rapid IgG/IgM 2019-nCoV577DDS DIAGNOSTIC SRLRomaniawww.ddsdiagnostic.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood https://ddsdiagnostic.com/test-rapid-coronavirus-romania/2022-08-24 09:08:01 CET850Immuno-AntibodyYesNoImmunochromatographyQualitative10LOD0AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0AU0False negatives0AUPrecisionEvaluatedAccuracy98.82% IgGAccuracy98.88% IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100% IgGClinical Sensitivity100% IgMClinical Specificity98% IgGClinical Specificity97.96% IgM1007One check 2019-nCoV IgG/IgM536Delta Chemie Biotechnology SASItalywww.deltachemie.itYesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET779Immuno-AntibodyYesNoImmunoassayQualitative20Rapid diagnostic test card Analysis of cross reactivityReportedAccuracy92.9%Clinical Sensitivity99.9%Clinical Specificity98%840COVID-19 (SARS-CoV-2) IgA ELISA489Demeditec Diagnostics GmbHGermanywww.demeditec.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET689Immuno-AntibodyN.A.YesELISAQualitativeFluorescenceAnalysis of cross reactivityEvaluatedClinical Sensitivity100%7.69 - 100Clinical Specificity98.26%841COVID-19 (SARS-CoV-2) IgG ELISA489Demeditec Diagnostics GmbHGermanywww.demeditec.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET690Immuno-AntibodyNoYesELISAQualitativeFluorescenceAnalysis of cross reactivityEvaluatedClinical Sensitivity100% IgGRange: 7.69 - 100Clinical Specificity99.24% IgG842COVID-19 (SARS-CoV-2) IgM ELISA489Demeditec Diagnostics GmbHGermanywww.demeditec.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET691Immuno-AntibodyNoYesELISAQualitativeFluorescenceAnalysis of cross reactivityEvaluatedClinical Sensitivity57.14% IgMClinical Specificity100% IgM2193Dediatest IgG-Spike1021Devidia GmbHGermanywww.devidia.deYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaDediatest IgG-Spike erfasst sowohl die Immunreaktion auf SARS-CoV-2-Infektionen als auch auf SARS-CoV-2-Impfungen. Bei der Immunreaktion auf Impfung ist die Sensitivität 95,7% Spezifität 100% Genauigkeit 97,9%. Der Vergleich erfolgte hier mit einem CLIA.2022-08-24 09:08:01 CET1894Immuno-AntibodyYesImmunochromatographyQualitativeNeutralization Antibody (NAb)10LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2AUFalse negatives6AUPrecisionEvaluatedAccuracy97%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96%Clinical Specificity99%Type of antigenOther2279Covid-19 (2019-nCoV) Antigen Rapid Test Cassette1064Dewei Medical Equipment Co. Ltd.ChinaYesCommercialisedNoNoNear POC / POCAntibodyNasopharyngeal swabType of Antigen is N-Antigen LOD: See URL for additional information2022-08-24 09:08:01 CET1980Immuno-AntigenNoImmunochromatographyQualitativeSandwich, Double15LODAU0CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives2.94%(3 out of 102)False negatives2.58%(3 out of 116)PrecisionNot evaluatedAccuracy97.25% (Antigen)ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity97.06% (Antigen)Clinical Specificity97.41% (Antigen)Type of antigenNucleoprotein537COVID-19 IgG341DIA.PRO Diagnostic Bioprobes SrlItalywww.diapro.itYesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaMicroplates are coated with recombinant Nucleocapsid and Spike antigens specific to COVID-192022-08-24 09:08:01 CET453Immuno-AntibodyNoYesELISAQuantitativeFluorescence105CalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98%Clinical Specificity98%Type of antigenNucleocapside and Spike539COVID-19 IgG Confirmation341DIA.PRO Diagnostic Bioprobes SrlItalywww.diapro.itYesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum689B.1.1.7Alpha1495P.1Gamma1032B.1.351Beta1223B.1.525Eta1137B.1.429Epsilon1132B.1.427Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaModule-based Enzyme-Immuno-Assay (ELISA) for the confirmation of samples positive for IgG antibodies to COVID-19 in first screening. The test can be used in addition to identify the specificity of antibodies to the major immunodominant COVID-19 antigens2022-08-24 09:08:01 CET455Immuno-AntibodyNoYesELISAQuantitativeFluorescence105CalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%Clinical Specificity100%538COVID-19 IgM341DIA.PRO Diagnostic Bioprobes SrlItalywww.diapro.itYesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThe kit is intended for the monitoring of the immune response to COVID-19 in the early stage of the infection as an additional marker to PCR2022-08-24 09:08:01 CET454Immuno-AntibodyNoYesELISASemiquantitativeFluorescence105CalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedRobustnessEvaluatedClinical Sensitivity98%Clinical Specificity98%2463DIA.CHEMILUX SARS-CoV-2 NCP IgG341DIA.PRO Diagnostic Bioprobes SrlItalywww.diapro.itYesCommercialisedNoNoFully automated (robot)AntibodyPlasmaSerum689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaChemi-Luminescence ImmunoAssay (CLIA) for the semi-quantitative determination of IgG antibodies to SARS-CoV-2 Nucleocapsid protein (NCP) in human plasma and sera. The kit is intended for monitoring of infected patients. In addition the kit may be used when testing the population and health-care workers looking for potentially infective “pauci” or a-symptomatic individuals in the early phase of infection, in combination with SARS-COV-2 molecular tests. The device has been adapted for the use in exclusive combination with the Dia.Pro CLIA random access instrument named SARA2022-08-24 09:08:01 CET2166Immuno-AntibodyCLIAQuantitativeChemiluminescence35LOD2AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%Common autoantibodies in Autoimmune Diseases did not generate false positive resultsFalse negatives0%No false negative result was foundPrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98%Clinical Specificity99%Type of antigenOther1307Accudiag SCoV-2 IgG ELISA582Diagnostic Automation/Cortez Diagnostics Inc.United Stateswww.rapidtest.comYesCommercialisedNoNoAutomatedManualAntibodySerum2022-08-24 09:08:01 CET1079Immuno-AntibodyNoYesELISAQualitative150Clinical Sensitivity97.8% IgGClinical Specificity98.9% IgG1193Accudiag SCoV-2 IgM ELISA Kit582Diagnostic Automation/Cortez Diagnostics Inc.United Stateswww.rapidtest.comYesCommercialisedNoNoAutomatedManualAntibodySerum2022-08-24 09:08:01 CET975Immuno-AntibodyNoELISAQualitative150Manual or automated Accuracy98.95% IgMClinical Sensitivity92.5% IgM1078nCOV IgG/IgM Rapid Test582Diagnostic Automation/Cortez Diagnostics Inc.United Stateswww.rapidtest.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET858Immuno-AntibodyYesNoImmunoassayQualitative15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedReproducibilityEvaluatedClinical Sensitivity91.9%1055Diaquick Covid-19 IgG/IgM526DIALAB GmbHAustriawww.dialab.at/en/home/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET982Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry10Clinical Sensitivity87.9% IgMClinical Sensitivity97% IgGClinical Specificity100%986DIAQUICK COVID-19 IgG/IgM Cassette Rapid Test526DIALAB GmbHAustriawww.dialab.at/en/home/YesCommercialisedNoNoNear POC / POCAntibodyWhole bloodnucleocapsid protein2022-08-24 09:08:01 CET767Immuno-AntibodyYesNoImmunoassayQualitative10Type of antigennucleocapsid protein1053SARS-CoV-2 IgG526DIALAB GmbHAustriawww.dialab.at/en/home/YesCommercialisedNoNoLab-basedAntibodyPlasmaSerum2022-08-24 09:08:01 CET828Immuno-AntibodyYesImmunoassayQualitativeMagnetic Electrochemical70Analysis of cross reactivityNo cross reactivity observed with samples positive to RSV IgM/IgG/Antibodies and MP IgM/IgG/Antibodies.No interference with rheumatic factor up to 2000 U/mL, bilirubin 35 mg/dL or haemoglobin 0.9 g/dL observed.No cross specificity with similar pathogClinical Sensitivity100%(15/15)Clinical Specificity99.87%(3018/3022)1054SARS-CoV-2 IgM526DIALAB GmbHAustriawww.dialab.at/en/home/YesCommercialisedNoNoLab-basedAntibodyPlasmaSerum2022-08-24 09:08:01 CET833Immuno-AntibodyYesImmunoassayQualitativeMagnetic Electrochemical70Analysis of cross reactivityEvaluatedClinical Sensitivity96.49%(165/171)Clinical Specificity98.15%(742/756)1050SARS-CoV-2 Total Ab526DIALAB GmbHAustriawww.dialab.at/en/home/YesCommercialisedNoNoLab-basedAntibodyPlasmaSerum2022-08-24 09:08:01 CET822Immuno-AntibodyNoYesELISAQualitativeMagnetic Electrochemical70Analysis of cross reactivityEvaluatedClinical Sensitivity100%(15/15)Clinical Specificity99.52%(2927/2941)911LIAISON SARS-CoV-2 S1/S2 IgG511DiaSorin S.p.AItalywww.diasorin.com/YesCommercialisedNoNoAutomatedAntibodyPlasmaSerum2022-08-24 09:08:01 CET738Immuno-AntibodyYesImmunoassayQuantitativeChemiluminescence35Analysis of cross reactivityEvaluatedClinical Sensitivity97.4%Clinical Specificity98.9%980ENZY-WELL SARS-CoV-2 IgA543DIESSE Diagnostica Senese SPAItalywww.diesse.it/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET786Immuno-AntibodyYesImmunoassayQualitativeFluorescence135Analysis of cross reactivityEvaluatedClinical Sensitivity93.7%Clinical Specificity96.3%981ENZY-WELL SARS-CoV-2 IgG543DIESSE Diagnostica Senese SPAItalywww.diesse.it/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET787Immuno-AntibodyYesImmunoassayQualitativeFluorescence135Analysis of cross reactivityReportedClinical Sensitivity92.5%Clinical Specificity95.8%982ENZY-WELL SARS-CoV-2 IgM543DIESSE Diagnostica Senese SPAItalywww.diesse.it/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET788Immuno-AntibodyYesImmunoassayQualitativeFluorescence135Analysis of cross reactivityEvaluatedClinical Sensitivity87.7%Clinical Specificity97%2492Dixion SARS-CoV-2 Neutralizing antibody test kit1133Dixion Vertrieb medizinischer Geräte GmbH and Shenzhen Dymind Biotechnology Co. Ltd.Chinawww.dixion.deYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole bloodThe kit is used to detect the neutralizing antibody to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in human serum, plasma or whole blood sample qualitatively. It is mainly used to identify individuals with acquired immune response to the SARS-CoV-2, and to evaluate the effectiveness of the vaccine clinical trials and mass vaccination. The novel coronavirus (SARS-CoV-2) belongs to the β genus. Structural proteins include spike protein (S), envelope protein (E), membrane protein (M), and nucleocapsid protein (N). The spike protein is the most important surface membrane protein of the novel coronavirus, which undertakes the function of binding the virus to the host cell membrane receptor and membrane fusion, and is an important site for host neutralizing antibodies. The SARS-CoV-2 neutralizing antibody can prevent the receptor binding domain (RBD) protein from binding to ACE2, thereby blocking the virus from contacting the host cell, and ultimately preventing the virus infection. This reagent uses the principle of colloidal gold immunochromatography to detect SARS-CoV-2 neutralizing antibodies in samples. The kit does not need to be carried out in the biosafety level 3 laboratory (BSL-3). It has the advantages of simple operation, strong specificity, high safety and low cost, and can realize rapid detection2022-08-24 09:08:01 CET2195Immuno-AntibodyNoImmunochromatographyQualitativeNeutralization Antibody (NAb)15CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives9.3%False negatives1.36%PrecisionEvaluatedAccuracy95.74%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90.7%Clinical Specificity98.63%Type of antigenOther2955COVID-19 Neutralizing Antibody Testing Cassette(GICA)/COVID-19 Antigen Testing Cassette(GICA)1303DN Laboratory Co. Ltd.ChinaYesCommercialisedNoNoLab-basedManualSemi-automatedAntibodyNasal swabNasopharyngeal swabPlasmaSerumWhole bloodCOVID-19 Antigen Testing Cassette (GICA):The Reagent Kit can be used for a qualitative test of COVID-19 antigens in human nasopharyngeal swab and oropharyngeal swab samples in vitro, which is beneficial to the auxiliary examination of patients suffering from pneumonia caused by COVID-19 infection. COVID-19 neutralizing antibody testing cassette (GICA):The Reagent Kit can be used for a qualitative test of COVID-19 neutralizing antibodies in human serum, plasma or whole blood samples in vitro.2022-08-24 09:08:01 CET2661Immuno-AntibodyYesYesImmunochromatographySemiquantitativeSandwichColloidal gold15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positivesthe positive coincidence rate should be (+/+) 5/5False negativeshe negative coincidence rate should be (-/-) 10/10PrecisionEvaluatedAccuracy100% IgGReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100% IgGClinical Specificity100% IgG1719Epithod® SARS-CoV-2 IgG Test Kit763DxGen Corp.South Koreawww.dxgenco.comYesCommercialisedNoNoAutomatedManualAntibodySerumWhole bloodnucleocapsid protein2022-08-24 09:08:01 CET1399Immuno-AntibodyYesYesImmunoassay3LOD10000AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positivesPositive percent agreement (PPA) was determined by testing 97 positive samples with a clinical diagnosis of COVID-19 based on a positive PCR method. Overall, 88% of the positive samples yielded an IgG positive result with 0-7 days (35/46, 76%), 8-14 daysFalse negativesNegative percent agreement (NPA) was determined by testing 100 negative samples, including 2 negative conversion samples from recovered patients. Overall, 95% of the negative samples yielded an IgG negative result. PrecisionNot evaluatedAccuracy88% IgGReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity88% IgGType of antigennucleoprotein1720Epithod®616 IgG Test Kit763DxGen Corp.South Koreawww.dxgenco.comYesCommercialisedNoNoAutomatedManualAntibodySerumWhole bloodnucleocapsid protein2022-08-24 09:08:01 CET1400Immuno-AntibodyYesYesImmunoassayQuantitative3LOD10000AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives24Positive percent agreement (PPA) was determined by testing 97 positive samples with a clinical diagnosis of COVID-19 based on a positive PCR method. Overall, 88% of the positive samples yielded an IgG positive result with 0-7 days (35/46, 76%), 8-14 daysFalse negatives5Negative percent agreement (NPA) was determined by testing 100 negative samples, including 2 negative conversion samples from recovered patients. Overall, 95% of the negative samples yielded an IgG negative result. PrecisionNot evaluatedAccuracy88% IgGReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity88% IgGType of antigennucleoprotein1522019 nCOV IgG/IgM Rapid Test86Dynamiker Biotechnology (Tianjin) Co. Ltd.Chinahttps://en.dynamiker.com/YesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET116Immuno-AntibodyYesNoImmunoassayQualitative10Accuracy92%8442019-nCOV IgG Antibody kit (ELISA)86Dynamiker Biotechnology (Tianjin) Co. Ltd.Chinahttps://en.dynamiker.com/YesCommercialisedNoNoAutomatedManualAntibody2022-08-24 09:08:01 CET693Immuno-AntibodyELISANot foundManual or automated Not found Not found 8452019-nCOV IgM Antibody kit (ELISA)86Dynamiker Biotechnology (Tianjin) Co. Ltd.Chinahttps://en.dynamiker.com/YesCommercialisedNoNoAutomatedManualAntibody2022-08-24 09:08:01 CET694Immuno-AntibodyELISANot found991DyonCovid19 - SARS-CoV-2 IgM/IgG Antibody Rapid Test Device.529DyonMed SAGreecewww.dyonmedical.comYesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET770Immuno-AntibodyYesNoImmunoassayQualitative151562019 nCoV novel coronavirus antibody detection reagent (Colloidal gold)88Edinburgh Genetics LimitedUnited Kingdomeggenetics.comYesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET120Immuno-AntibodyYesNoImmunoassayQualitativeColloidal gold10Clinical Sensitivity98% IgMClinical Sensitivity99% IgG662Edinburgh Genetics COVID-19 Colloidal Gold Immunoassay Testing Kit, IgG/IgM Combined88Edinburgh Genetics LimitedUnited Kingdomeggenetics.comYesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET555Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry10Clinical Sensitivity98.43%Clinical Specificity99.31%1044SeroFlash SARS-CoV-2 IgG/IgM ELISA Fast Kit570Epigentek Group Inc.United Stateswww.epigentek.comYesCommercialisedNoNoLab-basedAntibodyPlasmaSerum2022-08-24 09:08:01 CET837Immuno-AntibodyNoYesELISAQualitativeFluorescence45LOD0.002µg/mlAnalysis of cross reactivityEvaluatedPrecisionInter-assay 8%; Intra assay: 12%.157EDI Novel Coronavirus COVID-19 IgG ELISA Kit94Epitope Diagnostics Inc.United Stateswww.epitopediagnostics.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET121Immuno-AntibodyNoYesELISAQuantitativeFluorescence120Clinical Sensitivity100% IgGClinical Specificity100% IgG158EDI Novel Coronavirus COVID-19 IgM ELISA Kit94Epitope Diagnostics Inc.United Stateswww.epitopediagnostics.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET122Immuno-AntibodyNoYesELISAQuantitativeFluorescence120Clinical Sensitivity100% IgMClinical Specificity100% IgM533ErbaLisa COVID-19 IgG ELISA327Erba MannheimUnited Kingdomwww.erbamannheim.comYesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET436Immuno-AntibodyYesELISASemiquantitativeSandwich, Double50Analysis of cross reactivityEvaluatedPrecision6.37% IgG5.29% - 6.37%Clinical Sensitivity98.3% IgGClinical Specificity98.1% IgG1066COVIDual COVID-19 IgM/IgG Rapid Test573Eternal Materials Co. Ltd.Taiwan ROCwww.eternal-group.com/Home/EngIndexYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET844Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15CalibrationNot evaluatedAnalysis of cross reactivityNot evaluatedPrecisionEvaluatedAccuracy98.76%ReproducibilityNot evaluatedRobustnessNot evaluatedClinical Sensitivity93.94%Clinical Specificity99.311682INGEZIM Covid 19 CROM445EurofinsSpainhttps://ingenasa.eurofins-technologies.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole bloodnucleocapsid protein2022-08-24 09:08:01 CET1361Immuno-AntibodyYesNoImmunoassayQualitative15LOD0AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1%False negatives5%PrecisionEvaluatedAccuracy96%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.5%Type of antigennucleoprotein1683INGEZIM COVID 19 DR445EurofinsSpainhttps://ingenasa.eurofins-technologies.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET1362Immuno-AntibodyNoYesELISAQualitativeOther75LOD0AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1%False negatives1%PrecisionEvaluatedAccuracy97%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.3%Clinical Specificity99.2%Type of antigennucleoprotein725NovaLisa SARS-CoV-2 IgG assay445EurofinsSpainhttps://ingenasa.eurofins-technologies.comYesCommercialisedNoNoAutomatedManualAntibodySerum2022-08-24 09:08:01 CET605Immuno-AntibodyImmunoassayQualitativeFluorescenceManual or automated Fluorescence 880VIROTECH SARS-CoV-2 IgG445EurofinsSpainhttps://ingenasa.eurofins-technologies.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerum2022-08-24 09:08:01 CET717Immuno-AntibodyNoYesImmunoassayQualitativeFluorescence1202458INGEZIM COVID 19 SPIKE CROM1121EUROFINS INGENASASpainhttps://ingenasa.eurofins-technologies.comYesCommercialisedNoNoNear POC / POCAntibodySerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2Zetadetection of antibodies specific of protein S of SARS-CoV-22022-08-24 09:08:01 CET2161Immuno-AntibodyNoImmunochromatographyQualitativeEnzyme-linked15CalibrationEvaluatedAnalysis of cross reactivityEvalautedFalse positives3.7%False negatives2.78%PrecisionEvalautedAccuracy96%ReproducibilityEvaluatedRobustnessEvalautedClinical Sensitivity97.22%(day 15 after vaccination)Clinical Specificity96.3%2552INGEZIM COVID RBD-DR1121EUROFINS INGENASASpainhttps://ingenasa.eurofins-technologies.comYesCommercialisedNoNoNear POC / POCAntibodySerumTHE PRODUCT IS UNDER CE MARKING2022-08-24 09:08:01 CET2257Immuno-AntibodyYesELISAQualitative75CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1%False negatives0.1%<0.1% Fifteen days after finishing the vaccination protocolPrecisionEvaluatedAccuracy97%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.9% Fifteen days after finishing the vaccination protocolClinical Specificity99%Type of antigenSpike protein160Anti-SARS-CoV-2 ELISA (IgA)90EUROIMMUN AGGermanywww.coronavirus-diagnostics.comYesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET124Immuno-AntibodyYesELISAQualitativeFluorescenceClinical Sensitivity100%Range:91.7 - 100Clinical Specificity92.4%Range:88.2- 92.4883Anti-SARS-CoV-2 ELISA (IgG)90EUROIMMUN AGGermanywww.coronavirus-diagnostics.comYesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET720Immuno-AntibodyYesELISAQualitativeFluorescenceClinical Sensitivity93.8% IgG(75 - 93.8)Clinical Specificity99.6% IgG2743Anti-SARS-CoV-2 QuantiVac ELISA (IgG)90EUROIMMUN AGGermanywww.coronavirus-diagnostics.comYesCommercialisedNoNoAutomatedFully automated (robot)Lab-basedManualSemi-automatedAntibodyOtherPlasmaSerum689B.1.1.7Alpha1032B.1.351BetaThe EUROIMMUN Anti-SARS-CoV-2-QuantiVac-ELISA IgG (order no. EI 2606-9601-10 G) is suitable for the quantitative detection of antibodies against the S1 antigen of SARS-CoV-2 and enables the results to be given in standardized units (BAU / ml).2022-08-24 09:08:01 CET2448Immuno-AntibodyYesELISAQuantitative120CalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.2% IgG90.3-93.2Clinical Specificity99.8% IgG849Anti-SARS-CoV-2-NCP ELISA (IgG)90EUROIMMUN AGGermanywww.coronavirus-diagnostics.comYesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET1845Immuno-AntibodyELISA2751SARS-CoV-2 NeutraLISA90EUROIMMUN AGGermanywww.coronavirus-diagnostics.comYesCommercialisedNoNoAutomatedFully automated (robot)Lab-basedManualSemi-automatedAntibodyPlasmaSerum689B.1.1.7Alpha1032B.1.351BetaThe EUROIMMUN SARS-CoV-2-NeutraLISA is a surrogate neutralisation test for the detection of neutralising antibodies, which inhibit binding if the receptor binding domain (RBD) of SARS-CoV-2 to ACE2 receptors of human cells. The SARS-CoV-2-NeutraLISA can be processed in a standardized and automated manner in every routine laboratory.2022-08-24 09:08:01 CET2456Immuno-AntibodyYesELISASemiquantitativeNeutralization Antibody (NAb)105CalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.9%Clinical Specificity99.7%2175FAMEX SARS-CoV-2 RAPID ANTIBODY TEST1012fago medikal san. tic. Ltd. ÅŸti.Turkeyhttp://famextestkit.com/YesCommercialisedNoNoNear POC / POCAntibodyWhole bloodWhole blood with anti-coagulants689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.1B.1.526.1B.1.526.21224B.1.526Iota1518P.2Zetasars-cov 2 antikörper rapid test2022-08-24 09:08:01 CET1876Immuno-AntibodyNoImmunoassayQualitative10LOD100AUCalibrationEvaluatedAnalytical Sensitivity85% IgMAnalysis of cross reactivityEvaluatedFalse positives10AUFalse negatives8AUPrecisionEvaluatedAccuracy98.6% IgGAccuracy92.8% IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100% IgGClinical Specificity98% IgGClinical Specificity96% IgMType of antigenNucleoprotein2598SARS-CoV-2 Neutralizing Antibody Detection Kit1183FENG CHUN YUAN MEDICAL EQUIPMENT(SHENZHEN) Co. Ltd.Chinawww.fcy-medical.comYesIn developmentNoNoNear POC / POCAntibodyPlasmaSerumWhole blood689B.1.1.7Alpha1320B.1.617.1KappaOtherThe SARS-CoV-2 Neutralizing Antibody Test Kit can be used for in-vitro semi-quantitative detection of SARS-CoV-2 neutralizing antibody in human serum, plasma or whole blood samples, which is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. The SARS-CoV-2 Neutralizing Antibody Test Kit should not be used to diagnose or exclude acute SARS-CoV-2 infection. For professional use only.2022-08-24 09:08:01 CET2303Immuno-AntibodyYesNoImmunochromatographySemiquantitativeSandwich15LOD20IU/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%0 out of 27False negatives0%0 out of 28PrecisionEvaluatedAccuracy95%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%28/28,, (95% CI 87.94%~100%)Clinical Specificity100%27/27, (95% CI 87.54%~100%)Type of antigenOther2730Fosun SARS-CoV-2 Neutralization Antibody Detection Kit1239Fosun Diagnostics (Shanghai) Co. Ltd.Chinahttps://www.fosunpharma.com/en/product/medical-list.aspx?type=8YesCommercialisedNoNoAntibodyNothing2022-08-24 09:08:01 CET2435Immuno-AntibodyNeutralization Antibody (NAb)2726Fosun SARS-CoV-2 Neutralization Antibody Rapid1239Fosun Diagnostics (Shanghai) Co. Ltd.Chinahttps://www.fosunpharma.com/en/product/medical-list.aspx?type=8YesCommercialisedNoNoAntibodyNothing2022-08-24 09:08:01 CET2431Unknown2727Fosun SARS-CoV-2 Neutralization Antibody Rapid (Immunofluorescence)1239Fosun Diagnostics (Shanghai) Co. Ltd.Chinahttps://www.fosunpharma.com/en/product/medical-list.aspx?type=8YesCommercialisedNoNoAntibody2022-08-24 09:08:01 CET2432Immuno-AntibodyImmunoassayFluorescence554GA CoV-2 IgG/IgM/IgG+351GA Generic Assays GmbHGermanywww.genericassays.comYesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET469Immuno-AntibodyNoYesELISAQualitativeFluorescence105Manual or automated Fluorescence Clinical Sensitivity98%Clinical Specificity98% 1576SARS-CoV-2 IgM/IgG (GICA) Test698GenaBio Diagnostics Inc.United Stateswww.genabio.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole bloodnucleocapsid protein2022-08-24 09:08:01 CET1255Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry10Rapid diagnostic test cassette colloidal gold LOD1CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0False negatives1.65%PrecisionEvaluatedAccuracy100% IgGAccuracy100% IgMReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity100% IgMClinical Sensitivity100% IgGClinical Specificity99.2%combinedType of antigennucleoprotein169GenBody COVID-19 IgM/IgG97GenBody Inc.South Koreawww.genbody.co.krYesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET127Immuno-AntibodyYesNoImmunoassayQualitative15Rapid diagnostic test cassette Analysis of cross reactivityReportedAccuracy96.5%Clinical Sensitivity91.7%Clinical Specificity97.5%850Genelogic COVID-19 IgM/IgG Antibody Test Kit484Genelogic Research LimitedHong Kong S.A.Rwww.genelogic.com.hk/YesCommercialisedNoNoAutomatedManualAntibodyWhole blood2022-08-24 09:08:01 CET671Immuno-AntibodyYesNoImmunoassayQualitative15Clinical Sensitivity94.8%Clinical Specificity91.7%Type of antigenSARS-CoV-21586GB SARS-CoV-2 Ab ELISA104General Biologicals CorporationTaiwan ROCwww.gbc.com.tw/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET1266Immuno-AntibodyNoYesELISAQualitative120LOD0.089AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives1.92%PrecisionEvaluatedAccuracy98.75%(Total antibody)ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity100%(Total antibody)Type of antigennucleoprotein1609Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV- 2704Genesprint Group LimitedYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET1289Immuno-AntibodyYesNoImmunoassayQualitativeColloidal gold10LOD170CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.64%False negatives1.52%PrecisionEvaluatedAccuracy87.06% IgGAccuracy86.57% IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity87.06% IgGClinical Sensitivity86.57% IgM563COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)524Genitech NSAN Pharmaceutical Pvt. Ltd.Indiawww.linkedin.com/in/genitech-nsan-pharmaceutical-pvt-ltd-3739061a0/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET763Immuno-AntibodyYesNoImmunoassayQualitative10Rapid diagnostic test cassette Not found Accuracy92.9%786Novel Coronavirus (2019-nCoV) IgG/IgM Test Kit (Colloidal Gold)472Genrui Biotech Inc.Chinawww.genrui-bio.comYesCommercialisedNoNoLab-basedAntibody2022-08-24 09:08:01 CET653Immuno-AntibodyImmunoassay www.genrui-bio.com/products-detail.php?ProId=572860cPass™ SARS-CoV-2 Neutralization Antibody Detection Kit1270GenScript Biotech CorporationChinahttps://www.genscript.com/YesCommercialisedNoNoManualAntibodyPlasmaSerumcPass™ SARS-CoV-2 Neutralization Antibody Detection Kit is authorized with FDA EUA authorization. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/eua-authorized-serology-test-performance.2022-08-24 09:08:01 CET2565Immuno-AntibodyELISAQuantitative90CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%Compared to PRNT50 and PRNT90, out of 88 negative samples, 0 is positiveFalse negatives0%Compared to PRNT50 and PRNT90, out of 26 positive samples, 0 is negativePrecisionEvaluatedAccuracy100%Neutralizing antibodyReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%Neutralizing antibodyClinical Specificity100%Neutralizing antibodyType of antigenSpike protein565GenSure COVID-19 IgG/IgM Rapid Test (REF: P2002)340GenSure Biotech Inc.Chinawww.gensbio.com/YesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET450Immuno-AntibodyYesNoImmunoassayQualitative15566GenSure COVID-19 IgM Rapid Test (REF: P2001)340GenSure Biotech Inc.Chinawww.gensbio.com/YesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET452Immuno-AntibodyYesNoImmunoassayQualitative15Clinical Sensitivity95%Clinical Specificity95%1826GenSure COVID-19 Neutralizing Antibody Test (Fluorescence)340GenSure Biotech Inc.Chinawww.gensbio.com/YesCommercialisedNoNoManualAntibody2022-08-24 09:08:01 CET1503Immuno-AntibodyImmunoassayNeutralization Antibody (NAb)15LODEvaluatedCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedReproducibilityNot evaluatedRobustnessNot evaluated2112GenSure COVID-19 Neutralizing Antibody Test (Latex)979GenSure Biotech Inc.Chinahttp://www.gensbio.comYesCommercialisedNoNoAntibody689B.1.1.7Alpha1032B.1.351Beta2022-08-24 09:08:01 CET1802Immuno-AntibodyImmunoassayNeutralization Antibody (NAb)15LOD0AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positivesThere is a very small possibility of false positives.False negativesThere is a very small possibility of false negatives.PrecisionEvaluatedAccuracy98.1%ReproducibilityNot evaluatedRobustnessNot evaluatedClinical Sensitivity94.6%Clinical Specificity100%190One Step Test for Novel Coronavirus(2019-nCoV) IgM/IgG antibody (Colloidal Gold)112Getein Biotech Inc.Chinaen.bio-gp.com.cnYesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET578Immuno-AntibodyYesImmunoassayQualitativeColloidal gold15Rapid diagnostic test cassette Colloidal Gold 2592SARS-CoV-2 Neutralizing Antibody Fast Test Kit (Immunofluorescence Assay)112Getein Biotech Inc.Chinaen.bio-gp.com.cnYesCommercialisedNoNoSemi-automatedAntibodyPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351BetaSARS-CoV-2 Neutralizing Antibody Fast Test Kit (Immunofluorescence Assay) is intended for in vitro qualitative detection of SARS-CoV-2 neutralizing antibody in serum, plasma or whole blood samples. The test is only used for professional and laboratory use, not for home testing.2022-08-24 09:08:01 CET2297Immuno-AntibodyYesImmunoassayQualitativeCaptureImmunofluorescence15LOD0.50 BAU/mLCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.38%1 of 257False negatives0.65%1 of 152PrecisionEvaluatedAccuracy99.51%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.34%Clinical Specificity99.61%Type of antigenOther2707Novel Coronavirus (2019-nCoV) Neutralization Antibody Test Kit (Colloidal Gold Immunochromatography)1237Glallergen Co. Ltd.Chinawww.glallergen.comYesCommercialisedNoNoManualAntibodyWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2Zetanon-structural protein NSP6ORF1a polyproteinORF1ab polyproteinNovel coronavirus (2019-nCoV) neutralization antibody test kit is a solid phase immunochromatographic assay for the in vitro qualitative detection of neutralization antibodies in human serum, plasma and whole blood after vaccination against 2019-nCoV.2022-08-24 09:08:01 CET2412Immuno-AntibodyYesYesImmunochromatographyQualitativeSandwich, DoubleColloidal gold20LOD9.65TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positivesFalse positive is not allowedFalse negativesImproper operation procedures, below limits detection, mutant strains, disease stagePrecisionEvaluatedAccuracy96.67%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.44%Clinical Specificity99.02%Type of antigenNonstructural protein NS6192SARS-CoV-2 IgG/IgM Kit (manual)117Goldsite Diagnostics Inc.Chinaen.goldsite.com.cn/YesCommercialisedNoNoAutomatedManualAntibodyWhole blood2022-08-24 09:08:01 CET154Immuno-AntibodyYesNoImmunoassayQualitativeFluorescence121145GENEDIA W ONE COVID 19 IgM&IgG600Green Cross Medical Science Corp.South Koreawww.greencrossms.com/eng/main.do?lang=ENYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET922Immuno-AntibodyYesNoImmunoassayQualitative15Accuracy98%Clinical Sensitivity95.6%18072019-nCoV IgM/IgG Antibody Test Kit (colloidal gold method)779Guangdong Hecin Scientific Inc.Chinahttps://www.hecin-scientific.cn/YesCommercialisedNoNoNear POC / POCAntibody/2022-08-24 09:08:01 CET1484Immuno-AntibodyYesImmunoassayQualitativeColloidal gold15LOD1AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2AUFalse negatives3AUPrecisionEvaluatedAccuracy98.02%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.17%Clinical Specificity98.63%18112019-nCoV Neutralizing Antibody Test Kit (colloidal gold method)779Guangdong Hecin Scientific Inc.Chinahttps://www.hecin-scientific.cn/YesCommercialisedNoNoLab-basedAntibodyOther2022-08-24 09:08:01 CET1490Immuno-AntibodyYesImmunoassayQualitativeNeutralization Antibody (NAb)15LOD1AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives16AU16False negatives8AU8PrecisionEvaluatedAccuracy91.97%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity91.3%Clinical Specificity92.27%Type of antigenother18122019-nCoV Neutralizing Antibody Test Kit (Fluorescent immunochromatography)779Guangdong Hecin Scientific Inc.Chinahttps://www.hecin-scientific.cn/YesCommercialisedNoNoLab-basedAntibody2022-08-24 09:08:01 CET1491Immuno-AntibodyImmunochromatographyQualitativeNeutralization Antibody (NAb)15fluorescence detectionLOD1AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives5False negatives3PrecisionEvaluatedAccuracy97.32%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.74%Clinical Specificity97.58%1440Coronavirus COVID-19 IgM/IgG Test Kit655Guangdong Wesail Biotech Co. Ltd.Chinahttp://en.wesailbio.com/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET1191Immuno-AntibodyYesNoImmunoassayQualitativeColloidal gold6LOD3.125CalibrationNot evaluatedAnalysis of cross reactivityNot evaluatedPrecisionNot evaluatedAccuracy93%ReproducibilityNot evaluatedRobustnessNot evaluatedClinical Sensitivity93%1428Coronavirus COVID-19 lgM/IgG Test Kit (colloidal)655Guangdong Wesail Biotech Co. Ltd.Chinahttp://en.wesailbio.com/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood http://en.wesailbio.com/product/82.html2022-08-24 09:08:01 CET1187Immuno-AntibodyYesNoImmunoassayQualitativeColloidal gold6Accuracy97.93%Clinical Sensitivity92.86%Clinical Specificity99%1668COVID-19 Neutralizing Antibody Test Kit655Guangdong Wesail Biotech Co. Ltd.Chinahttp://en.wesailbio.com/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET1347OtherYesYesImmunoassayQualitativeColloidal gold15LOD0CalibrationNot evaluatedAnalysis of cross reactivityNot evaluatedFalse positives1.6%False negatives4.6%PrecisionEvaluatedAccuracy97.9%ReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity95.4%206Finecare SARS-CoV-2 Antibody Test124Guangzhou Wondfo Biotech Co. Ltd.Chinahttps://en.wondfo.com.cn/YesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET163Immuno-AntibodyYesYesImmunoassayQualitativeFluorescenceRapid diagnostic test chip fluorescence 1191Finecare SARS-CoV-2 IgG Test124Guangzhou Wondfo Biotech Co. Ltd.Chinahttps://en.wondfo.com.cn/YesCommercialisedNoNoNear POC / POCAntibody2022-08-24 09:08:01 CET976Immuno-AntibodyYesYesImmunoassayFluorescenceRapid diagnostic test Fluorescence 977Immuno-AntibodyYesImmunoassayRapid diagnostic test 1211Finecare SARS-CoV-2 IgM/IgG Test124Guangzhou Wondfo Biotech Co. Ltd.Chinahttps://en.wondfo.com.cn/YesCommercialisedNoNoNear POC / POCAntibody2022-08-24 09:08:01 CET994Immuno-AntibodyYesImmunoassay2925Finecare™ 2019-nCoV RBD Antibody Test1285Guangzhou Wondfo Biotech Co. Ltd.Chinahttps://en.wondfo.com.cn/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumVenous whole bloodWhole bloodnucleocapsid proteinFinecare™ 2019-nCoV RBD Antibody Test is a fluorescence immunoassay used along with Finecare™ FIA Meters (Model No.: FS-113, FS-114, FS-205) for qualitative detection of spike receptor-binding domain (RBD) antibodies of novel coronaviruses (2019-nCoV) in human fingerstick whole blood, venipuncture whole blood, serum or plasma specimen.2022-08-24 09:08:01 CET2631Immuno-AntibodyNoYesImmunoassayQualitativeNeutralization Antibody (NAb)Fluorescence15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2AUFalse negatives1AUPrecisionEvaluatedAccuracy98.99%RBD AntibodyReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.83%RBD AntibodyClinical Specificity99.57%RBD Antibody461Wondfo SARS-CoV-2 Antibody Test (lateral flow method)124Guangzhou Wondfo Biotech Co. Ltd.Chinahttps://en.wondfo.com.cn/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaWhole blood2022-08-24 09:08:01 CET372Immuno-AntibodyYesNoImmunoassayQualitative15Analysis of cross reactivityEvaluatedReproducibilityEvaluatedClinical Sensitivity85.8%IgM+IgG1212Wondof SARS-CoV-2 IgG Antibody Test (Lateral Flow Method)124Guangzhou Wondfo Biotech Co. Ltd.Chinahttps://en.wondfo.com.cn/YesCommercialisedNoNoNear POC / POCAntibody2022-08-24 09:08:01 CET996Immuno-AntibodyYesImmunoassayColloidal gold1306Wondof SARS-CoV-2 IgM Antibody Test124Guangzhou Wondfo Biotech Co. Ltd.Chinahttps://en.wondfo.com.cn/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET1078Immuno-AntibodyYesNoImmunoassayQualitativeColorimetryRapid diagnostic test lateral flow colloidal gold 1213Wondof SARS-CoV-2 IgM Antibody Test (Lateral Flow Method)124Guangzhou Wondfo Biotech Co. Ltd.Chinahttps://en.wondfo.com.cn/YesCommercialisedNoNoNear POC / POCAntibody2022-08-24 09:08:01 CET997Immuno-AntibodyYesImmunoassayQualitative673SARS-CoV-2 IgM/IgG Combo Rapid Test Kit392Guanxhow Fenghua Bioengineering Co. Ltd.Chinawww.bio-fenghua.com/YesCommercialisedNoNoNear POC / POCAntibodyWhole bloodnucleocapsid proteinspike protein2022-08-24 09:08:01 CET540Immuno-AntibodyYesNoImmunoassayQualitativeType of antigenSARS-CoV-2 N-, S1- and S2-Proteine1172Anti-COVID-19 virus IgM/IgG Test Kit (lateral flow assay)616H&Z Life Science Co. Ltd.South Koreawww.hzlifescience.comYesCommercialisedNoNoNear POC / POCAntibodyOtherSerumWhole blood2022-08-24 09:08:01 CET953Immuno-AntibodyYesImmunoassayQualitative104158SARS-CoV-2 Rapid Antigen Test Kit (RAT-01)1234HA TECH PTY Ltd.Australiahttps://ha-tech-ltd.com/YesCommercialisedNoNoManualNear POC / POCAntibodyNasal swabSARS-CoV-2678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1321B.1.617.2Deltanucleocapsid protein2022-10-14 09:36:48 CET4012Immuno-AntibodyYesYesNoImmunochromatographyQualitativeN.A.Colorimetry15LOD130TCID50/mlCalibrationNot evaluatedAnalytical Sensitivity96.97%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives5samplesThe RAT-01 Kit correctly identified 103/108 RT-PCR positive samples False negatives1samplesThe RAT-01 Kit correctly identified 300/301 RT-PCR negative samplesPrecisionEvaluatedAccuracy98.53%RobustnessEvaluatedClinical Sensitivity95.58%Clinical Specificity99.67%4160SARS-CoV-2 Rapid Antigen Test Kit (RAT-01)1234HA TECH PTY Ltd.Australiahttps://ha-tech-ltd.com/YesCommercialisedNoNoManualNear POC / POCAntibodyNasal swabSARS-CoV-2678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1321B.1.617.2Deltanucleocapsid protein2022-10-14 10:52:17 CET5193Immuno-AntibodyYesNoNoImmunochromatographyQualitativeN.A.Colorimetry15LOD130TCID50/mlN/ACalibrationNot evaluatedAnalytical Sensitivity96.97%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives5samplesThe RAT-01 Kit correctly identified 103/108 RT-PCR positive samples False negatives1samplesThe RAT-01 Kit correctly identified 300/301 RT-PCR negative samplesPrecisionEvaluatedAccuracy98.53%RobustnessEvaluatedClinical Sensitivity95.58%Clinical Specificity99.67%2082019-nCoV IgG/IgM Rapid Test Cassette126Hangzhou AllTest Biotech Co. Ltd.Chinawww.alltests.com.cnYesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET165Immuno-AntibodyYesImmunoassayQualitative1386COVID-19 and M.pneumoniae IgG Combo Rapid Test126Hangzhou AllTest Biotech Co. Ltd.Chinawww.alltests.com.cnYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood http://www.alltests.com.cn/EN/Prodetail.asp?newsid=1788&cclassid=2&classid=512022-08-24 09:08:01 CET1152Immuno-AntibodyYesNoImmunoassayQualitative10CalibrationNot evaluatedFalse positives2% IgG5.4% IgG (M.pneumoniae)False negatives0%7.8% IgG (M.pneumoniae)RobustnessNot evaluatedClinical Sensitivity100% IgG+ (Mycoplasma pneumoniae= 92.2% IgG )Clinical Specificity98.6% IgG+ (Mycoplasma pneumoniae = 93.7% IgG )1385COVID-19 and M.pneumoniae IgG/IgM Combo126Hangzhou AllTest Biotech Co. Ltd.Chinawww.alltests.com.cnYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET1151Immuno-AntibodyYesNoImmunoassayQualitative10Rapid diagnostic test lateral flow LOD0AU0CalibrationNot evaluatedFalse positives2% IgG+ M.pneumoniae IgG: 5.4%; M.pneumoniae IgM: 5.2%False positives4% IgMFalse negatives0% IgG+ M.pneumoniae IgG: 7.8%; M.pneumoniae IgM: 8.5%False negatives15% IgMRobustnessNot evaluatedClinical Sensitivity100% IgG+92.2(Mycoplasma pneumoniae IgG); 91.5(Mycoplasma pneumoniae IgM)Clinical Sensitivity85% IgMClinical Specificity98.6% IgG+ 93.7(Mycoplasma pneumoniae IgG); 93.7(Mycoplasma pneumoniae IgM)Clinical Specificity92.9% IgM1383COVID-19 IgG Rapid Test (cassette)126Hangzhou AllTest Biotech Co. Ltd.Chinawww.alltests.com.cnYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET1149Immuno-AntibodyYesNoImmunoassayQualitative10Rapid diagnostic test lateral flow LOD0AUCalibrationNot evaluatedFalse positives4.7%False negatives5.7%Accuracy95% IgGRobustnessNot evaluatedClinical Sensitivity94.3% IgG1384COVID-19 IgG Rapid Test (strip)126Hangzhou AllTest Biotech Co. Ltd.Chinawww.alltests.com.cnYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET1150Immuno-AntibodyYesNoImmunoassayQualitative10LOD0CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives4.7%False negatives5.7%Accuracy96% IgGRobustnessNot evaluatedClinical Sensitivity94.3% IgG1381COVID-19 IgG/IgM Rapid Test126Hangzhou AllTest Biotech Co. Ltd.Chinawww.alltests.com.cnYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET1147Immuno-AntibodyYesNoImmunoassayQualitative10Rapid diagnostic test Strip LOD0False positives5%False negatives5.6%Accuracy94.9%Clinical Sensitivity94.4%1377COVID-19 IgG/IgM Rapid Test Cassette126Hangzhou AllTest Biotech Co. Ltd.Chinawww.alltests.com.cnYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood similar to 208 (name a bit different but in website : 2019-nCoV IgG/IgM Rapid Test Cassette)2022-08-24 09:08:01 CET1142Immuno-AntibodyYesNoImmunoassayQualitative10Rapid diagnostic test lateral flow LOD0CalibrationNot evaluatedFalse positives5%False negatives5.6%Accuracy94.9%Clinical Sensitivity94.4%1382COVID-19 IgG/IgM Rapid Test Dipstick126Hangzhou AllTest Biotech Co. Ltd.Chinawww.alltests.com.cnYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood similar to 674 but name a bit different (on website same as 674: 2019-nCoV IgG/IgM Rapid Test Dipstick)2022-08-24 09:08:01 CET1148Immuno-AntibodyYesNoImmunoassayQualitative10LOD0AUFalse positives2% IgGFalse positives3% IgMFalse negatives0.1% IgG<0.1% False negatives9.1% IgMAccuracy98.4% IgGAccuracy95.9% IgMClinical Sensitivity99.9% IgG>99.9Clinical Sensitivity90.9% IgM2416COVID-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma)1003Hangzhou AllTest Biotech Co. Ltd.Chinawww.alltests.com.cnYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThe COVID-19 IgG/IgM Test Cassette is a fluorescence immunoassay for the qualitative detection of IgG and IgM antibodies to SARS-CoV-2 in human whole blood, serum or plasma specimen.The COVID-19 IgG/IgM Test is an aid in the diagnosis of patients with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results from the COVID-19 IgG/IgM Test should not be used as the sole basis for diagnosis. Results are for the detection of SARS-CoV-2 antibodies. IgM antibodies to SARS-CoV- 2 are generally detectable in blood several days after initial infection, although levels over the course of infection are not well characterized. IgG antibodies to SARS-CoV-2 become detectable later following infection. Positive results for both IgG and IgM could occur after infection and can be indicative of acute or recent infection. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. IgM antibodies may not be detected in the first few days of infection; the sensitivity of the COVID-19 IgG/IgM Test early after infection is unknown. False positive results for IgM and IgG antibodies may occur due to cross-reactivity from pre-existing antibodies or other possible causes. At this time, it is unknown for how long IgM or IgG antibodies may persist following infection.2022-08-24 09:08:01 CET2118Immuno-AntibodyYesImmunoassayQualitativeSandwich15LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.033AUFalse negatives0.031AUPrecisionEvaluatedAccuracy96.9%(IgG/IgM)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.7%(IgG/IgM)Clinical Specificity96.9%(IgG/IgM)Type of antigenNucleoprotein2327COVID-19 S-RBD IgG Antibody Test Cassette (Whole Blood/Serum/Plasma)1003Hangzhou AllTest Biotech Co. Ltd.Chinawww.alltests.com.cnYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1223B.1.525Eta1495P.1Gamma1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThe COVID-19 S-RBD IgG Antibody Test Cassette is a fluorescence immunoassay for the qualitative detection of IgG antibodies to SARS-CoV-2 spike(S) protein receptor binding domain(RBD) in human whole blood, serum or plasma specimen.It is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2.2022-08-24 09:08:01 CET2028Immuno-AntibodyYesImmunoassayQualitativeMembrane-based15LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.048AUFalse negatives0.011AUPrecisionEvaluatedAccuracy98.2%（Antibody）ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.2%（Antibody）Clinical Specificity98.9%（Antibody）Type of antigenNucleoprotein2403SARS-CoV-2 S-RBD Antibody Rapid Test (Whole Blood/Serum/Plasma)1003Hangzhou AllTest Biotech Co. Ltd.Chinawww.alltests.com.cnYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThe SARS-CoV-2 S-RBD Antibody Rapid Test (Whole Blood/Serum/ Plasma) is a rapid chromatographic immunoassay intended for the qualitative detection of antibodies to SARS-CoV-2 spike (S) protein receptor binding domain (RBD) in human serum, plasma, or whole blood. It is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2. Results are for the detection of antibodies to SARS-CoV-2 spike (S) protein receptor binding domain (RBD). Positive results indicate the presence of antibodies to SARS-CoV-2 spike (S) protein receptor binding domain (RBD).2022-08-24 09:08:01 CET2105Immuno-AntibodyNoImmunoassayQualitativeSandwich10LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.022AUFalse negatives0.015AUPrecisionEvaluatedAccuracy98.2%(Antibody)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.8%(Antibody)Clinical Specificity98.5%(Antibody)Type of antigenOther2404SARS-CoV-2 S-RBD IgG Antibody Rapid Test (Whole Blood/Serum/Plasma)1003Hangzhou AllTest Biotech Co. Ltd.Chinawww.alltests.com.cnYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThe SARS-CoV-2 S-RBD IgG Antibody Rapid Test (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay intended for the qualitative detection of IgG antibodies to SARS-CoV-2 spike (S) protein receptor binding domain (RBD) in human serum, plasma, or whole blood. It is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2. Results are for the detection of SARS-CoV-2 S-RBD IgG antibodies. Positive results indicate the presence of IgG antibodies to SARS-CoV-2.2022-08-24 09:08:01 CET2106Immuno-AntibodyNoImmunoassayQualitativeSandwich10LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.022AUFalse negatives0.015AUPrecisionEvaluatedAccuracy98.2% IgGReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.8% IgGClinical Specificity98.5% IgGType of antigenOther2059SARS-CoV-2 IgM/IgG Antibody Test Kit (colloidal gold method)949Hangzhou Bioer Technology Co. Ltd.Chinahttp://www.bioer.com.cn/en/YesCommercialisedNoNoManualAntibodyPlasmaSerum689B.1.1.7Alphahttp://www.bioer.com.cn/en/ LoD: 250U/mL2022-08-24 09:08:01 CET1739Immuno-AntibodyNoImmunochromatographyQualitativeSandwichColloidal gold15LOD250CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.3%False negatives4.9%PrecisionEvaluatedAccuracy98.3%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity95.1%Clinical Specificity99.6%Type of antigenOther4123COVID-19 IgG/IgM Rapid Test Cassette (Protective Antibodies)128Hangzhou Biotest Biotech Co. Ltd.Chinaen.biotests.com.cnYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole bloodSARS-CoV-2689B.1.1.7Alpha1032B.1.351Beta1320B.1.617.1Kappa1321B.1.617.2DeltaOther2022-10-31 09:34:00 CET5267Immuno-AntibodyYesNoNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold10LODAUCalibrationNot evaluatedAnalytical Sensitivity83.04%Analytical Specificity98.91%Analysis of cross reactivityEvaluatedFalse positives58%False negatives4%PrecisionEvaluatedAccuracy89.45%RobustnessEvaluatedClinical Sensitivity83.04%Clinical Specificity98.91%212COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)128Hangzhou Biotest Biotech Co. Ltd.Chinaen.biotests.com.cnYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET168Immuno-AntibodyYesNoImmunoassayQualitative151921SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette (Whole Blood/Serum/Plasma)128Hangzhou Biotest Biotech Co. Ltd.Chinaen.biotests.com.cnYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumVenous whole bloodWhole bloodWhole blood with anti-coagulantsA rapid test for the qualitative detection of neutralizing antibodies to SARS-CoV-2 in whole blood, serum, or plasma. Indirect method.2022-08-24 09:08:01 CET1597Immuno-AntibodyNoImmunoassayQualitativeNeutralization Antibody (NAb)10LOD0AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives1.92%2 false positive results are observed in 104 negative samplesFalse negatives0%No false negative result is observed in 152 positive samplesPrecisionEvaluatedAccuracy99%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%Clinical Specificity98%Type of antigenOther4114SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette(Combo)128Hangzhou Biotest Biotech Co. Ltd.Chinaen.biotests.com.cnYesCommercialisedNoNoNear POC / POCOtherAntibodyPlasmaSerumWhole bloodSARS-CoV-2678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1320B.1.617.1Kappa1321B.1.617.2Delta1495P.1Gammanucleocapsid proteinspike protein2022-10-31 09:32:15 CET5262Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold10LODAUCalibrationNot evaluatedAnalytical Sensitivity100%Analytical Specificity99.5%Analysis of cross reactivityEvaluatedFalse positives%0 false positive results are observed in 60 positive samples confirmed by RT-PCRFalse negatives1%3 false negative results are observed in 208 negative samples confirmed by RT-PCRPrecisionEvaluatedAccuracy99.6%RobustnessEvaluatedClinical Sensitivity100%Clinical Specificity99.5%1922SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette(Whole Blood/Serum/Plasma)128Hangzhou Biotest Biotech Co. Ltd.Chinaen.biotests.com.cnYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumVenous whole bloodWhole bloodWhole blood with anti-coagulantsA rapid test for the qualitative detection of neutralizing antibodies to SARSCoV-2 in whole blood, serum, or plasma. Competition method.2022-08-24 09:08:01 CET1598Immuno-AntibodyNoImmunoassayQualitativeNeutralization Antibody (NAb)15LOD0AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%No false positive result is observed in 130 negative samplesFalse negatives1.53%2 false negative results are observed in 130 positive samplesPrecisionEvaluatedAccuracy99%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98%Clinical Specificity100%Type of antigenOther5682019-nCoV IgG/IgM Rapid Test413Hangzhou Clongene Biotech Co. Ltd.Chinahttp://en.clongene.com/YesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET778Immuno-AntibodyYesImmunoassayQualitative675Clungene COVID-19 IgM/IgG Rapid Test Cassette413Hangzhou Clongene Biotech Co. Ltd.Chinahttp://en.clongene.com/YesCommercialisedNoNoNear POC / POCAntibody Product information is being updated...2022-08-24 09:08:01 CET568Immuno-AntibodyYesImmunoassay477LYHER Novel Coronavirus(2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold)302Hangzhou Laihe Biotech Co. Ltd.Chinawww.lyherbio.com/YesCommercialisedNoNoNear POC / POCAntibody2022-08-24 09:08:01 CET399Immuno-AntibodyYesImmunoassayColloidal gold2142COVID-19 Neutralizing Antibody Rapid Test Device（Colloidal Gold）990HANGZHOU LYSUN BIOTECHNOLOGY Co. Ltd.Chinahttp://www.lysunbio.com/YesIn developmentNoNoManualNear POC / POCAntibodyPlasmaSerumWhole blood689B.1.1.7AlphaOtherNone2022-08-24 09:08:01 CET1832Immuno-AntibodyYesYesImmunochromatographyQualitativeCaptureColloidal gold10LOD0AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%(0 of 413）False negatives0.42%(1 of 239）PrecisionEvaluatedAccuracy99.85%(95%CI: 99.15%~100%)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.58%(95%CI: 97.69%~99.99%)Clinical Specificity100%(95%CI: 99.28%~100%)Type of antigenOther2141nCoV-19 IgG/IgM Rapid Test Device (Whole Blood/Plasma/Serum)990HANGZHOU LYSUN BIOTECHNOLOGY Co. Ltd.Chinahttp://www.lysunbio.com/YesIn developmentNoNoManualNear POC / POCAntibodyPlasmaSerumWhole blood689B.1.1.7AlphaOtherNone2022-08-24 09:08:01 CET1831Immuno-AntibodyYesYesImmunochromatographyQualitativeCapture15LOD0AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0% IgM(0 of 102)False positives1.96% IgG(2 of 102)False negatives4.55% IgM(2 of 44)False negatives0% IgG (0 of 102)PrecisionEvaluatedAccuracy98.6% IgM(95%CI:96.7%~100%)Accuracy98.7% IgG(95%CI:97.0%~100%)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.5% IgM(95%CI:89.3%~100%)Clinical Sensitivity100% IgG(95%CI:99.7%~100%)Clinical Specificity100% IgM(95%CI:99.8%~100%)Clinical Specificity98% IgG(95%CI:95.4%~100%)Type of antigenOther5702019-nCOV IgG/LgM Rapid Test Device344Hangzhou Realy Tech Co. Ltd.Chinawww.realytech.comYesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET458Immuno-AntibodyYesNoImmunoassayQualitativeRapid diagnostic test cassette 17932019-nCoV-IgG Assay Reagent Kit (CMIA)344Hangzhou Realy Tech Co. Ltd.Chinawww.realytech.comYesCommercialisedNoNoNear POC / POCAntibodySerum2022-08-24 09:08:01 CET1472Immuno-AntibodyYesImmunoassayQualitativeChemiluminescence40False positives0.48%False negatives1.11%Accuracy99%Clinical Sensitivity98.89%1802Novel Coronavirus Neutralizing Antibody Assay Reagent Kit344Hangzhou Realy Tech Co. Ltd.Chinawww.realytech.comYesCommercialisedNoNoNear POC / POCAntibody2022-08-24 09:08:01 CET1481Immuno-AntibodyNoYesImmunoassayQualitativeNeutralization Antibody (NAb)40LOD0AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.44%228 samples are proven negative of 229 negative specimens.False negatives0%120 samples are proven negative of 120 positive specimens.PrecisionEvaluatedAccuracy99.71%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.9%Clinical Specificity99.56%1896Novel coronavirus neutralizing antibody Rapid Test Device344Hangzhou Realy Tech Co. Ltd.Chinawww.realytech.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole bloodThe Novel coronavirus neutralizing antibody Rapid Test Device is a qualitative product, not applicable to LOD.2022-08-24 09:08:01 CET1573Immuno-AntibodyNoImmunoassayQualitativeColorimetry10LOD0AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%371 samples are proven negative of 371 negative specimens，so the false positive percentage is 0%.False negatives5.27%144 samples are proven negative of 152 positive specimens，so the false negative percentage is 5.26%.PrecisionEvaluatedAccuracy98.47%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.73%Clinical Specificity99.9%(>99.9)1970COVID-19 IgG/IgM Rapid Test Cassette887Hangzhou Sejoy Electronics & Instruments Co. Ltd.Chinasejoy.com/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood with anti-coagulantsWe have evulated the relative interference substances.2022-08-24 09:08:01 CET1646Immuno-AntibodyNoImmunoassayQualitativeSandwich15LOD40AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0% IgGFalse positives2% IgMFalse negatives0AUFalse negatives9% IgMPrecisionEvaluatedAccuracy100% IgGAccuracy93.33% IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100% IgGClinical Sensitivity88.61% IgMClinical Specificity100% IgGClinical Specificity97.67% IgMType of antigenOther2062SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette952Hangzhou Sejoy Electronics & Instruments Co. Ltd.Chinahttp://www.sejoy.com.cn/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood1518P.2ZetaWe have also evaluated the cross reactivity and interference substances.2022-08-24 09:08:01 CET1742Immuno-AntibodyNoImmunoassayQualitativeSandwich15neutralizing antibodyLOD5050AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives3AUFalse negatives2AUPrecisionEvaluatedAccuracy98.97%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.4%Clinical Specificity99.2%Type of antigenOther10002019-nCoV Ab Test (Colloidal Gold)1191Hangzhou Singclean Medical Products Co. Ltd.Chinawww.singclean.netYesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET907Immuno-AntibodyYesNoImmunoassayQualitativeColloidal gold15Analysis of cross reactivityReportedClinical Sensitivity87.3%Clinical Specificity100%1001Covid-19 IgG/IgM test kit (Colloidal Gold Method)1191Hangzhou Singclean Medical Products Co. Ltd.Chinawww.singclean.netYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET775Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry151632COVID-19 IgG/IgM Antibody Test(Colloidal Gold)131Hangzhou Testsea Biotechnology Co. Ltd.Chinawww.testsealabs.com/YesCommercialisedNoNoLab-basedAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET1312Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15857COVID-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma)131Hangzhou Testsea Biotechnology Co. Ltd.Chinawww.testsealabs.com/YesCommercialisedNoNoAutomatedManualAntibodyWhole blood2022-08-24 09:08:01 CET831Immuno-AntibodyYesNoImmunoassayQualitativeColloidal gold5Accuracy94%Clinical Sensitivity88%677COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)554Healgen ScientificUnited Stateshttps://www.healgen.com/YesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET806Immuno-AntibodyYesNoImmunoassayQualitative10478COVID-19 IgM Antibody Rapid Test Kit303Hecin Scientific Inc.Chinawww.hecin-scientific.cn/YesCommercialisedNoNoNear POC / POCAntibody2022-08-24 09:08:01 CET400Immuno-AntibodyYesImmunoassay1637SARS-CoV-2 IgM/IgG Antibody Test Kit (Colloidal Gold Method)733Hefei Biohit HealthcareChinawww.biouhan.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole bloodAnti-Nuclear AntibodyHemophilus InfluenzaeHepatitis B Virus (HBV)Hepatitis C Virus (HCV)Influenza AInfluenza BRespiratory Syncytial V (RSV)689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1132B.1.427Epsilon1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta2041C.37Lambda678B.1.1.529Omicronnucleocapsid proteinspike proteinThe SARS-CoV-2 IgM/IgG Antibody Test Kit is a single-use rapid immunochromatographic test for the qualitative detection and differentiation of Immunoglobulin M(IgM) and Immunoglobulin G(IgG) antibodies to SARS-CoV-2 in human serum, plasma (heparin, K2-EDTA, and sodium citrate), and whole blood (heparin, K2-EDTA, sodium citrate, and no anticoagulant).2022-08-24 09:08:01 CET1317Immuno-AntibodyYesNoNoImmunochromatographyQualitativeSandwichColloidal gold14LOD10AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy99.4% IgGAccuracy99.1% IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.66% IgMClinical Sensitivity99.46% IgGClinical Specificity98.66% IgMClinical Specificity100% IgGType of antigenNucleocapsid protein1930Corona Virus (COVID-19) Combined (IgM/IgG/Neutralizing antibody) Rapid Test (Colloidal gold)883Hoyotek Biomedical Co. Ltd.Chinahttp://hoyotek.cn/YesCommercialisedNoNoManualAntibodyWhole bloodThis kit consists of test card 1 and test card 2. Test card 1 adopts the principle of colloidal gold immunochromatographic sandwich method to detect the novel Corona Virus (COVID-19) IgM / IgG antibody. When a positive sample is added to the sample well，COVID-19 Antibodies (IgM/IgG) in the sample will be combined with colloidal gold labeled COVID-19 RBD recombinant protein and form into immune complexes。When reaching Test Zone, the complexes will be combined with mouse anti-human IgM monoclonal antibody and mouse anti-human IgG monoclonal antibody. M line and G line occur red color. When testing negative samples, there’s no COVID-19 IgM or IgG in the samples, no immune complexes will be formed and color only appears in the Control line. Test card 2 adopts the principle of colloidal gold immunochromatographic competition method to detect Neutralizing antibody. When testing negative samples, colloidal gold labeled ACE2 protein will be combined with COVID-19 RBD recombinant protein which coated on test line and the detection line develops color. When a positive sample is added to the sample well, COVID-19 Neutralizing antibody in the sample mix with colloidal gold labeled ACE2 protein, and does not bind to COVID-19 RBD recombinant protein. The intensity of T line color is) less than C line.2022-08-24 09:08:01 CET1606Immuno-AntibodyNoImmunoassayQualitativeCaptureColloidal gold15Neutralizing antibodyLOD0.5AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives3%False negatives1%PrecisionEvaluatedAccuracy98%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity99%Clinical Specificity97%Type of antigenOther2527COVID-19 lgM/lgG Antibody Diagnostic Kit(Colloidal Gold)780Huachenyang (Shenzhen) Technology Co. Ltd.Chinahttps://www.chenyanglobal.comYesCommercialisedNoNoManualAntibodyAnterior nasal swabNasal swabNasopharyngeal swabOropharyngeal swabSalivaThroat swab689B.1.1.7Alpha1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.320A.23.1for Covid-19 antibody IgG/IGM rapid test kit, in 10-15 minutes2022-08-24 09:08:01 CET2231Immuno-AntibodyNoImmunochromatographyQualitativeNeutralization Antibody (NAb)Colloidal gold10CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy97.3%ReproducibilityNot evaluatedRobustnessNot evaluatedClinical Sensitivity90%Clinical SpecificityshenzhenType of antigenEnvelop protein5719Celltrion DiaTrust™ COVID-19 IgG/IgM Rapid Test1062Humasis Co. Ltd.South Koreahttp://www.humasis.com/en/YesCommercialisedNoNoManualAntibodyPlasmaSerumWhole bloodOtherOtherOther2022-10-18 08:52:01 CET5210Immuno-AntibodyYesNoNoImmunochromatographyQualitativeCaptureColloidal gold15LOD0%CalibrationEvaluatedAnalytical Sensitivity100%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy100%RobustnessEvaluatedClinical Sensitivity96%% IgMClinical Sensitivity92% IgGClinical Specificity98.7%% IgMClinical Specificity100% IgG219Humasis COVID-19 IgG/IgM Test1062Humasis Co. Ltd.South Koreahttp://www.humasis.com/en/YesCommercialisedNoNoManualAntibodyPlasmaSerumWhole bloodNA2022-08-24 09:08:01 CET180Immuno-AntigenYesNoImmunochromatographyQualitativeCapture15LOD0%CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives4% IgMFalse positives8% IgGFalse negatives1.3% IgMFalse negatives0% IgGPrecisionEvaluatedAccuracy99ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity96% IgMClinical Sensitivity92% IgGClinical Specificity98.7% IgMClinical Specificity100% IgG220COVID-19 IgG/IgM Detection Kit (Colloidal Gold)135Hunan Lituo Biotechnology Co. Ltd.Chinawww.lituo.com.cn/en/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET175Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry153045OJABIO SARS-CoV-2 Neutralizing Antibody Detection Kit (Colloidal Gold Method)1348Hunan Zhongke Lanhai Biotechnology Co. Ltd.Chinawww.ojabio.comYesCommercialisedNoNoManualAntibodyPlasmaSerumWhole bloodOthersend email to us2022-08-24 09:08:01 CET2751Immuno-AntibodyYesNoImmunoassayQualitativeNeutralization Antibody (NAb)Colloidal gold15LOD0.25AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives10%False negatives5.5%PrecisionEvaluatedAccuracy92%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90%Clinical Specificity94.5%3046SARS-CoV-2 Neutralizing Antibody Detection Kit (Colloidal Gold Method)1342Hunan Zhongke Lanhai Biotechnology Co. Ltd.Chinawww.zoonkr.netYesCommercialisedNoNoManualAntibodyPlasmaSerumWhole bloodOther2022-08-24 09:08:01 CET2752Immuno-AntibodyYesYesNoImmunoassayQualitativeNeutralization Antibody (NAb)Colloidal gold15LOD0.25AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives10%False negatives5.5%PrecisionEvaluatedAccuracy92%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90%Clinical Specificity94.5%859ID Screen SARS-CoV-2-N IgG Indirect ELISA Kit (manual, automated)41ID.vetFrancewww.id-vet.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET48Immuno-AntibodyYesELISASemiquantitativeFluorescence95Clinical Sensitivity99.9% IgGClinical Specificity99.9% IgG571SARS-CoV-2 IgG ELISA Kit360Ideal Tashkhis Atieh Co.Iranwww.idealdiag.com/en/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET485Immuno-AntibodyYesELISAQualitativeFluorescence75Clinical Sensitivity94.1% IgGClinical Specificity98.3% IgGType of antigennucleocapsid659SARS-CoV-2 IgM ELISA Kit360Ideal Tashkhis Atieh Co.Iranwww.idealdiag.com/en/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET552Immuno-AntibodyYesELISAQualitativeFluorescence75Clinical Sensitivity97.3% IgMClinical Specificity79.4% IgMType of antigennucleocapsid1904Rapid New Coronavirus (COVID19) Neutralizing Antibody Test806Immunospark s.r.l.Italywww.immunospark.comYesCommercialisedNoNoManualNear POC / POCAntibodyPeripheral bloodPlasmaSerumWhole bloodcompetitive assay that provide a multiple interpretatino of the protection level2022-08-24 09:08:01 CET1580Immuno-AntibodyNoImmunochromatographyQualitativeNeutralization Antibody (NAb)10Colloidal Gold detectionLOD40AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positivesA smal amount of results did not correltaed with the reference but correlated with rapid testFalse negativesA smal amount of results did not correltaed with the reference but correlated with rapid testPrecisionEvaluatedAccuracy99%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93%Clinical Specificity99%Type of antigenOther1656Anti-SARS-Cov-2 ELISA IgA742Immunostep S.LSpainwww.immunostep.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET1335Immuno-AntibodyYesELISAQualitativeFluorescence120LOD0AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluated1657Anti-SARS-Cov-2 ELISA IgG742Immunostep S.LSpainwww.immunostep.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET1336Immuno-AntibodyNoYesELISAQualitativeFluorescence120Manual or automated fluorescence LOD0CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positivesSee technical Data SheetFalse negativesSee technical Data SheetPrecisionEvaluatedAccuracySee technical Data SheetReproducibilityEvaluatedRobustnessEvaluatedClinical SensitivitySee technical Data Sheet660SARS-CoV-2 Total Antibody EIA403ImmyUnited Stateswww.immy.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET553Immuno-AntibodyYesImmunoassayQualitativeFluorescence60Accuracy98%Clinical Sensitivity92%Clinical Specificity100%1409SCoV-2 Detect IgG ELISA139InBios InternationalUnited Statesinbios.com/YesCommercialisedNoNoLab-basedAntibodySerum https://inbios.com/scov-2-detect-igg-elisa-kit-2/2022-08-24 09:08:01 CET1172Immuno-AntibodyNoYesELISAQualitativeMagnetic Electrochemical150Analysis of cross reactivity0% IgGfor tested agentsClinical Sensitivity97.8% IgGClinical Specificity98.95% IgG1410SCoV-2 Detect IgM ELISA139InBios InternationalUnited Statesinbios.com/YesCommercialisedNoNoLab-basedAntibodySerum https://inbios.com/scov-2-detect-igm-elisa-kit/2022-08-24 09:08:01 CET1173Immuno-AntibodyYesELISAQualitativeMagnetic Electrochemical150Analysis of cross reactivity0% IgMfor tested agentsClinical Sensitivity92.5% IgMClinical Specificity98.95% IgM2287COVID-19 Neutralizing Antibody Rapid Test Device1066Innovation Biotech(Beijing) Co. Ltd.Chinawww.invbio.comYesCommercialisedNoNoNear POC / POCAntibodyWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1GammaThe COVID-19 Neutralizing Antibody Rapid Test is a lateral flow chromatographic immunoassay for qualitative detection of neutralizing antibody to SARS-CoV-2 in human whole blood,serum,or plasma as an aid in the evaluation of human anti-SARS-CoV-2 neutralizing antibody titer.2022-08-24 09:08:01 CET1988Immuno-Antibody15LOD1AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives4.61%False negatives0.01%PrecisionEvaluatedAccuracy93.36%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.39%Clinical Specificity99.9%Type of antigenNucleoprotein2286RAPID 2019-NCOV IGG/IGM COMBO TEST CARD1066Innovation Biotech(Beijing) Co. Ltd.Chinawww.invbio.comYesCommercialisedNoNoNear POC / POCAntibodyWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1GammaThe Coronavirus COVID-19 IgG/IgM Rapid Test Device is a rapid chromatographic immunoassay for the qualitative detection of IgG&IgM antibody of Coronavirus Disease 2019 in human whole blood,serum,or plasma as an aid in the diagnosis of COVID-19 infections.2022-08-24 09:08:01 CET1987Immuno-Antibody15LOD1AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives13.06%False negatives0.69%PrecisionEvaluatedAccuracy93.36%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity86.94%Clinical Specificity99.31%Type of antigenNucleoprotein1726ID Screen® SARS-CoV-2-N IgG Indirect766Innovative DiagnosticsFrancewww.innovative-diagnostics.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET1406Immuno-AntibodyNoYesELISAQualitative95LOD0AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.4% IgG5 false positive on 1242 samples tested negative by PCRFalse negatives4.8% IgG4 false negative on 84 samples tested positive by PCRPrecisionEvaluatedAccuracy99.6ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.2% IgGType of antigennucleoprotein2272019-nCoV Ab Test (Colloidal Gold) (IgM/IgG Whole Blood/Serum/Plasma Combo)1144INNOVITA (Tangshan) Biological Technology Co. Ltd.Chinawww.innovita.com.cnYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole bloodWe want to correct our company name. Innovita Biological Technology is wrong. The correct name is INNOVITA (Tangshan) Biological Technology Co., Ltd.2022-08-24 09:08:01 CET188Immuno-AntibodyYesImmunoassayQualitativeColorimetry1525312019-nCoV Neutralizing Antibody Test (Quantum Dot Immunofluorescence Chromatography)1144INNOVITA (Tangshan) Biological Technology Co. Ltd.Chinawww.innovita.com.cnYesCommercialisedNoNoManualNear POC / POCAntibodyPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaNone.2022-08-24 09:08:01 CET2235Immuno-AntibodyYesImmunochromatographyQuantitative15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives3.3%False negatives8.4%PrecisionEvaluatedAccuracy94.8%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity91.6%Clinical Specificity96.7%Type of antigenSpike protein229Rapid SARS-CoV-2 Antibody (IgM/IgG)147InTec Products Inc.Chinahttp://www.intecasi.comYesCommercialisedNoNoNear POC / POCAntibody2022-08-24 09:08:01 CET190Immuno-AntibodyYesImmunoassay228Rapid SARS-CoV-2 Antibody Test147InTec Products Inc.Chinahttp://www.intecasi.comYesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET189Immuno-AntibodyYesNoImmunoassayQualitativeRapid diagnostic test Fingertip Not found 1018SARS-CoV-2 Antibody147InTec Products Inc.Chinahttp://www.intecasi.comYesCommercialisedNoNoNear POC / POCAntibody2022-08-24 09:08:01 CET813Immuno-AntibodyYesImmunoassay1017SARS-CoV-2 Antibody (IgM/IgG)147InTec Products Inc.Chinahttp://www.intecasi.comYesCommercialisedNoNoNear POC / POCAntibody2022-08-24 09:08:01 CET812Immuno-AntibodyYesImmunoassay2833SARS-CoV-2 IgG/IgM rapid test kits（Golloidal Gold)1260Jiangsu Baozhilin Medical Technology Co. Ltd.ChinaYesCommercialisedNoNoManualNear POC / POCAntibodyPeripheral bloodPlasmaSerumVenous whole bloodWhole bloodThis product is used for the qualitative detection of SARS-CoV-2 (COVID-19) IgM and IgG Antibodies in human serum, plasma, whole blood or fingertip blood.2022-08-24 09:08:01 CET2538Immuno-AntibodyYesImmunochromatographyQualitativeN.A.Colloidal gold152832SARS-CoV-2 Neutralizing Antibodies Test kits (Colloidal Gold)1260Jiangsu Baozhilin Medical Technology Co. Ltd.ChinaYesCommercialisedNoNoManualNear POC / POCAntibodyPeripheral bloodPlasmaSerumVenous whole bloodWhole bloodThis kit is used for in-vitro a lateral flow immunoassay for the simultaneous detection and differentiation of novel coronavirus neutralizing antibodies in human serum, plasma, venous whole blood or peripheral whole blood.The novel coronavirus neutralizing antibodies are protective antibody produced by the human body after inoculation with novel coronavirus vaccine or infection with novel coronavirus. The kit is used to monitor the presence of neutralizing antibodies in subjects vaccinated with the novel coronavirus vaccine or in people infected with the novel coronavirus, it can be used to evaluate the immune effect after vaccination or whether neutralizing antibodies are produced in human body after infection with novel coronavirus.2022-08-24 09:08:01 CET2537UnknownYesImmunochromatographyQualitativeNeutralization Antibody (NAb)Colloidal gold15236Novel Corona Virus (SARS-CoV-2) IgM/IgG Rapid Test Kit145Jiangsu Bioperfectus Technologies Co. Ltd.Chinawww.bioperfectus.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET194Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry101043Rapid test for IgM/IgG Antibody to SARS-CoV-2553Jiangsu Dabo Pharmaceutical Co. Ltd.Chinawww.dabloodpharmaceutical.com/YesCommercialisedNoNoNear POC / POCAntibody Data provided by the Manufacturer2022-08-24 09:08:01 CET804Immuno-AntibodyYesNoImmunoassayQualitative15Analysis of cross reactivityEvaluatedAccuracy98%RobustnessEvaluated2889SARS-CoV-2 Neutralizing Antibody Detection Kit (Colloidal gold method)1179Jiangsu Macro & Micro-Test Med-Tech Co. Ltd.Chinahttps://www.hongweitest.com/YesCommercialisedNoNoLab-basedManualNear POC / POCAntibodyPeripheral bloodPlasmaSerumVenous whole bloodWhole bloodWhole blood with anti-coagulants689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.3678B.1.1.529Omicronnucleocapsid proteinOur SARS-CoV-2 Neutralizing Antibody Detection Kit (Colloidal gold method) have passed CE certification.2022-08-24 09:08:01 CET2594Immuno-AntibodyImmunoassayColloidal gold15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.7%False negatives0.8%PrecisionEvaluatedAccuracy99.3%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.2%Clinical Specificity99.3%Type of antigenNucleocapsid protein500SARS-CoV-2 rapid combined IgM/IgG antibody test kit317Jiangsu Medomics Medical TechnologiesChinawww.cn-hos.com/YesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET419Immuno-AntibodyYesNoImmunoassayQualitative15Clinical Sensitivity88.66%Clinical Specificity90.63%1680A Rapid IgM-IgG Combined Antibody Test Kit for SARS-Cov-2 (ICA)753Jiangsu Mole Bioscience Co. Ltd.Chinaen.molechina.com/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET1359Immuno-AntibodyYesNoImmunoassayQualitative15LOD5AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2.1%False negatives1.6%PrecisionEvaluatedAccuracy98% IgGAccuracy98% IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.96% IgGClinical Sensitivity97.98% IgM1645A Rapid IgM-IgG Combined Antibody Test Kit for SARS-Cov-2-(ICA)753Jiangsu Mole Bioscience Co. Ltd.Chinaen.molechina.com/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET1326Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15LOD0.1AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2.1%False negatives1.6%PrecisionEvaluatedAccuracy98% IgGAccuracy98% IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.96% IgGClinical Sensitivity97.98% IgM2329SARS-CoV-2 IgM-IgG-IgA Combined Antibody Rapid Test Kit1083Jiangsu Mole Bioscience Co. Ltd.Chinahttp://en.molechina.com/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole bloodWhole blood with anti-coagulantsOtherSARS-CoV-2 IgM-IgG-IgA Combined Antibody Rapid Test Kit is a lateral flow chromatographic immunoassay for the qualitative detection of IgG, IgM and IgA antibodies to SARS-CoV-2 in human whole blood, serum or plasma specimen.2022-08-24 09:08:01 CET2030Immuno-AntibodyYesNoImmunochromatographyQualitativeMembrane-based15LOD5AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2.88% IgAFalse positives2.02% IgMFalse positives2.04% IgGFalse negatives3.96% IgAFalse negatives8.41% IgGFalse negatives7.55% IgMPrecisionEvaluatedAccuracy98% IgGAccuracy98% IgMAccuracy97% IgAReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.12% IgAClinical Sensitivity97.98% IgMClinical Sensitivity97.96% IgGClinical Specificity91.58% IgGClinical Specificity92.45% IgMClinical Specificity96.04% IgAType of antigenOther2341SARS-CoV-2 Neutralization Antibody Rapid Test Kit1083Jiangsu Mole Bioscience Co. Ltd.Chinahttp://en.molechina.com/YesCommercialisedNoNoManualNear POC / POCAntibodyPlasmaSerumWhole bloodWhole blood with anti-coagulantsThe SARS-CoV-2 Neutralization Antibody Rapid Test Kit is a lateral flow chromatographic immunoassay for the qualitative detection of neutralization antibody to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in human whole blood, serum or plasma specimen. The test is intended for detection of neutralization antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in whole blood, serum or plasma specimen from the population vaccinated with SARS-CoV-2 vaccine.2022-08-24 09:08:01 CET2042Immuno-AntibodyNoImmunochromatographyQualitativeNeutralization Antibody (NAb)15LOD1AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.69%False negatives0.87%PrecisionEvaluatedAccuracy98%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.31%Clinical Specificity99.13%Type of antigenOther2338SARS-CoV-2 Neutralization Antibody Test Kit (ELISA)1083Jiangsu Mole Bioscience Co. Ltd.Chinahttp://en.molechina.com/YesCommercialisedNoNoManualSemi-automatedAntibodyPlasmaSerumSARS-CoV-2 Neutralization Antibody Test Kit (ELISA) is an Enzyme-Linked Immunosorbent Assay (ELISA) intended for the qualitative detection of neutralization antibodies to SARS-CoV-2 in human serum or plasma specimen (dipotassium EDTA, lithium heparin and sodium citrate).2022-08-24 09:08:01 CET2039Immuno-AntibodyYesELISAQualitativeEnzyme-linked120LOD5AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.47%False negatives2.39%PrecisionEvaluatedAccuracy98.39%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.53%Clinical Specificity97.61%Type of antigenOther2339SARS-CoV-2 Total Antibody Rapid Test Kit1083Jiangsu Mole Bioscience Co. Ltd.Chinahttp://en.molechina.com/YesCommercialisedNoNoManualNear POC / POCAntibodyPlasmaSerumWhole bloodWhole blood with anti-coagulantsSARS-CoV-2 Total Antibody Rapid Test Kit is a lateral flow chromatographic immunoassay for the qualitative detection of total antibodies to SARS-CoV-2 in human whole blood, serum or plasma specimen.2022-08-24 09:08:01 CET2040Immuno-AntibodyNoImmunochromatographyQualitativeMembrane-based15LOD10AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives6.31%False negatives1.06%PrecisionEvaluatedAccuracy94%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.69%Clinical Specificity98.94%Type of antigenOther2337SARS-CoV-2 Total Antibody Test Kit (ELISA)1083Jiangsu Mole Bioscience Co. Ltd.Chinahttp://en.molechina.com/YesCommercialisedNoNoManualSemi-automatedAntibodyPlasmaSerumSARS-CoV-2 Total Antibody Test Kit (ELISA) is an Enzyme-Linked Immunosorbent Assay (ELISA) intended for the qualitative detection of IgG, IgM and IgA antibodies to SARS-CoV-2 in human serum or plasma specimen (dipotassium EDTA, lithium heparin and sodium citrate).2022-08-24 09:08:01 CET2038Immuno-AntibodyYesELISAQualitativeEnzyme-linked120LOD5AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2.6%False negatives1.21%PrecisionEvaluatedAccuracy99.21%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.4%Clinical Specificity98.79%Type of antigenOther2496OraWell COVID-19 NEUTRALIZING ANTIBODY Rapid Test Device - CO_04 (Check vaccination coverage)1131Jiangsu Well Biotech Co. Ltd.Chinahttps://www.wellbioscience.com/YesCommercialisedNoNoManualNear POC / POCOtherSemi-automatedAntibodyPeripheral bloodPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1132B.1.427Epsilon3939B.1.6161320B.1.617.1Kappa20A.23.1COVID-19 neutralizing antibody Test is a chromatographic immunoassay for the detection of neutralizing antibodies to COVID-19 in human whole blood, serum and plasma. The test device contains: 1) Colloidal gold-labeled recombinant SARS-CoV-2 RBD antigen; 2) Detection line (T line) immobilized with SARS-CoV-2 RBD antigen for detecting COVID-19 neutralizing antibody and Control line(C line) immobilized with quality contro! antibody on nitrocellulose membrane. Ifthe sample contains COVID-19 neutralizing antibody, it will bind to antigens coated on colloidal gold, and a pink colored band will develop in the test region (T) on the membrane.If there is no COVID-19 neutralizing antibody in the sample, the pink colored band in the test region (T) will not appears and that suggests a negative result.2022-08-24 09:08:01 CET2199Immuno-AntibodyNoImmunochromatographyQualitativeNeutralization Antibody (NAb)15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives4.6%7 on 152False negatives0%0 on 371PrecisionEvaluatedAccuracy97.65%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.39%Clinical Specificity99.9%Type of antigenOther2528ABtex AG1153JIAXING WISETEST BIO-TECH Co. Ltd.Chinahttp://www.biotech-crm.com/YesCommercialisedNoNoManualAntibodySalivaThe company would like to work with us to sell their products in Switzerland. One requirement from Switzerland is to be listed on your list. More information about the Product: At present, the main detection method for the new coronavirus virus is nucleic acid detection, which has strict requirements on detection equipment and personnel. Therefore, the establishment of a detection method with faster detection time, easier operation, and lower cost is of great significance to the control of the epidemic. The saliva novel coronavirus antigen detection kit independently developed by JIAXING WISETEST BIO-TECH CO., LTD. is used for people who have symptoms in the early stage of infection (window period). Highly sensitive, convenient saliva collection, 15 minutes on-site results. The tested person can operate and interpret by himself, which is convenient and quick. There is no need for sample collection, storage, transportation and testing equipment.2022-08-24 09:08:01 CET2232Immuno-AntigenYesNoImmunoassayQualitativeSandwich15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0noneFalse negatives11AUPrecisionEvaluatedAccuracy95%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99%Highly sensitivClinical Specificity95%575(COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold)545JinHuan Medical Instrument Co. Ltd.Chinawww.jinhuan123.comYesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET791Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry151204SARS-CoV-2 IgM/IgG Antibody Test (Colloidal Gold)44Joinstar Biomedical Technology Co. Ltd.Chinawww.joinstar.cnYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET51Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry10LOD0AUFalse positives0%No false positives in 112 samples vs PCR False negatives8.93%10 False negatives in 112 samples vs PCRAccuracy91.07%IgG+IgMClinical Sensitivity89%90 samples which were PCR positive933COVID-9 IgG/IgM Rapid Test Kit (Colloidal Gold)516JOYSBIO (Tianjin) Biotechnology Co. Ltd.Chinaen.joysbio.com/YesCommercialisedNoNoNear POC / POCAntibody2022-08-24 09:08:01 CET753Immuno-AntibodyYesImmunoassayColorimetry248Human Anti-SARS-CoV-2 (Covid-19) IgG/IgM Rapid Test153KRISHGEN BioSystemsUnited Stateswww.krishgen.com/YesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET200Immuno-AntibodyYesNoImmunoassayQualitative15577COVID-19 (SARS-CoV-2) IgM/IgG Antibody Test Kit346Labnovation Technologies Inc.Chinawww.labnovation.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerum2022-08-24 09:08:01 CET464Immuno-AntibodyYesNoImmunoassayQualitative201649(COVID-19) IgM/IgG Test Kit (Dry Fluorescence Immunoassay)739Lansion Biotechnology Co. Ltd.Chinaen.lansionbio.comYesCommercialisedNoNoAutomatedLab-basedNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET1330Immuno-AntibodyYesYesImmunoassayQuantitativeFluorescenceFluorescence15LOD1AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives5%False negatives3%PrecisionEvaluatedAccuracy96%(IgM, IgG)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.14%(IgM, IgG)264COVID-19 IgG/IgM Combo Rapid Test Device160Liming Bio-Products Co. Ltd.Chinawww.limingbio.com/YesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET219Immuno-AntibodyYesNoImmunoassayQualitative15Clinical Sensitivity82.2% IgGClinical Sensitivity64.7% IgMClinical Specificity100% IgGClinical Specificity100% IgM265SARS-CoV-2(COVID19)IgM/IgG Antibody Fast Detection Kit166LOMINA AGSwitzerlandwww.lomina.ch/YesCommercialisedNoNoAutomatedManualAntibodyWhole blood2022-08-24 09:08:01 CET220Immuno-AntibodyNoImmunoassayQualitativeColorimetry5268QuickProfile 2019-nCoV IgG/IgM Combo Test Card167LumiQuick Diagnostics Inc.United Stateslumiquick.co/YesCommercialisedNoNoNear POC / POCAntibody2022-08-24 09:08:01 CET223Immuno-AntibodyYesImmunoassayQualitative15Type of antigenSpike and Nucleocapsid1147SARS-CoV-2 Antibody Test252LumiraDx UK Ltd.United Kingdomwww.lumiradx.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood https://www.lumiradx.com/uk-en/what-we-do/diagnostics/test-technology/antibody-test; https://www.lumiradx.com/assets/pdfs/covid-19-antibody-test/s-com-art-00532_r2_sars_cov-2_ab_test_strip_product_insert_ce.pdf2022-08-24 09:08:01 CET338Immuno-AntibodyYesYesImmunoassayQualitativeImmunofluorescence11Analysis of cross reactivity not cross reactivity with samples positive for antibody to Influenza A, Influenza B, Hepatitis C Virus, Hepatitis B Virus (Genotype D) Hemophilus influenzae, human coronaviruses (HKU1, NL63, OC43 and 229E), Anti-Nuclear Antibody, Respiratory Syncytial VClinical Sensitivity97.2%Clinical Specificity100%1034Maccura SARS-CoV-2 IgG168Maccura Biotechnology Co. Ltd.Chinawww.maccura.com/enYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerum2022-08-24 09:08:01 CET792Immuno-AntibodyYesImmunoassayQualitativeChemiluminescence20Clinical Sensitivity98.13%Clinical Specificity97.15%1033Maccura SARS-CoV-2 IgM168Maccura Biotechnology Co. Ltd.Chinawww.maccura.com/enYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerum2022-08-24 09:08:01 CET789Immuno-AntibodyYesYesImmunoassayQualitativeChemiluminescence20Clinical Sensitivity86.99%Clinical Specificity100%989SARS-CoV-2 IgG (CLIA)168Maccura Biotechnology Co. Ltd.Chinawww.maccura.com/enYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerum2022-08-24 09:08:01 CET888Immuno-AntibodyYesYesImmunoassayQualitativeChemiluminescence20Clinical Sensitivity96.24%Clinical Specificity98.13%988SARS-CoV-2 IgM (CLIA)168Maccura Biotechnology Co. Ltd.Chinawww.maccura.com/enYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerum2022-08-24 09:08:01 CET876Immuno-AntibodyYesYesImmunoassayQualitativeChemiluminescence20Clinical Sensitivity86.99%Clinical Specificity100%1953SARS-CoV-2 Neutralizing Antibody Kit (CLIA)168Maccura Biotechnology Co. Ltd.Chinawww.maccura.com/enYesCommercialisedNoNoAutomatedAntibodyPlasmaSerummembrane proteinFor in vitro detection of neutralizing antibodies against SARS-CoV-2 in human serum or plasma.2022-08-24 09:08:01 CET1629Immuno-AntibodyImmunoassayNeutralization Antibody (NAb)20LOD2AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2.7AUFalse negatives2.2AUPrecisionEvaluatedAccuracy97.8%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.3%Clinical Specificity98.2%Type of antigenOther1918Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV-2) IgM/IgG Antibody Assay Kit by Colloidal Gold Method168Maccura Biotechnology Co. Ltd.Chinawww.maccura.com/enYesCommercialisedNoNoManualNear POC / POCAntibodyPlasmaSerumWhole blood/2022-08-24 09:08:01 CET1594Immuno-AntibodyNoImmunochromatographyQualitativeColorimetry10LOD0AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positivesNoneFalse negativesNonePrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.39%Clinical Specificity97.01%Type of antigenOther2126AxenTM COVID-19 IgM/IgG RAPID985MacrogenSouth Koreawww.macrogen.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumAR Qarad BV Pas 257 2440 Geel, Belgium Tel: + 32 14 49 04 222022-08-24 09:08:01 CET1816Immuno-AntibodyNoImmunoassayQualitative15ReproducibilityEvaluatedClinical Sensitivity97.7%Clinical Specificity97.3%997mö-screen 2019-NCOV Corona Virus Test532möLabGermanywww.moelab.de/startseite.htmlYesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET774Immuno-AntibodyYesNoImmunoassayQualitative10Analysis of cross reactivityEvaluatedAccuracy99.4% IgGAccuracy97.6% IgMClinical Sensitivity99.9% IgGClinical Sensitivity91.8% IgMClinical Specificity99.5% IgGClinical Specificity99.2% IgM1709SARS-CoV-2 IgG (CLIA)761MEDCAPTAIN MEDICAL TECHNOLOGY Co. Ltd.Chinawww.medcaptain.comYesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET1389Immuno-AntibodyYesCLIAQualitativeChemiluminescence25Manual or automated cassette chemiluminiscence LOD2AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives3.7% IgGFalse negatives3.1% IgGPrecisionEvaluatedAccuracy96.5% IgGReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.9% IgG1712SARS-CoV-2 IgG/IgM (GICA)761MEDCAPTAIN MEDICAL TECHNOLOGY Co. Ltd.Chinawww.medcaptain.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaWhole blood2022-08-24 09:08:01 CET1392Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15LOD0AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives3.7%False negatives0%PrecisionEvaluatedAccuracy96.3%(IgG, IgM)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%(IgG, IgM)1710SARS-CoV-2 IgM (CLIA)761MEDCAPTAIN MEDICAL TECHNOLOGY Co. Ltd.Chinawww.medcaptain.comYesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET1390Immuno-AntibodyYesCLIAQualitativeChemiluminescence25LOD0AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.2% IgMFalse negatives6.2% IgMPrecisionEvaluatedAccuracy97.4% IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.8% IgM1708SARS-CoV-2 NAbs (CLIA)761MEDCAPTAIN MEDICAL TECHNOLOGY Co. Ltd.Chinawww.medcaptain.comYesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET1388Immuno-AntibodyYesCLIAQuantitativeChemiluminescence25LOD3AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2.9%False negatives0%PrecisionEvaluatedAccuracy97.9%(Neutralizing Antibodies)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%(Neutralizing Antibodies)1625Anti-SARS-CoV-2 IgG ELISA723MediagnostGermanymediagnost.deYesCommercialisedNoNoLab-basedAntibodyPlasmaSerum2022-08-24 09:08:01 CET1552Immuno-AntibodyELISAAnalytical Specificity98.6Analysis of cross reactivityBeta Corona HKU1, SARS-CoV, VZV, HCV, HAV, HBV, EBV, CMV, HSVAccuracy96.99Clinical Sensitivity95.3(69.4-95.3)%2050Coronavirus Disease 2019 Antibody (IgM/IgG) Combined Test Kit944MedicalSystem Biotechnology Co. Ltd.Chinahttps://en.nbmedicalsystem.com/en/YesCommercialisedNoNoLab-basedAntibodyOther biological fluidsPeripheral bloodPlasmaSalivaSerumSputumStoolThroat secretionThroat swabTissue homogenatesWhole bloodWhole blood with anti-coagulants689B.1.1.7Alpha20A.23.1N.A.2022-08-24 09:08:01 CET1728Immuno-AntibodyNoImmunochromatographyQualitativeOther10LOD180AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives8.23%False negatives2.1%PrecisionEvaluatedAccuracy90% IgGAccuracy90% IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.9% IgGClinical Sensitivity97.9% IgMClinical Specificity91.77% IgGClinical Specificity91.77% IgMType of antigenNucleoprotein276COVID-19 IgM/IgG Rapid Test Cassette449MedicalSystem Biotechnology Co. Ltd.Chinaen.nbmedicalsystem.com/en/YesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET647Immuno-AntibodyYesNoImmunoassayQualitative10796MediKit Covid-19 Antibody Test (IgM/IgG Lateral flow Immunoassay)463MedikitIndiawww.medikitglobal.com/YesCommercialisedNoNoNear POC / POCAntibodyWhole blood the kit's name is slighlty different 2022-08-24 09:08:01 CET640Immuno-AntibodyYesNoImmunoassayQualitative15Clinical Sensitivity88.66%Clinical Specificity90.63%2383REVEALCOVID-19(TM) Total Antibody Test1103MedMira Laboratories Inc.Canadawww.medmira.comYesCommercialisedNoNoManualNear POC / POCAntibodyOtherPlasmaSerumWhole bloodINTENDED USE: REVEALCOVID-19TM Total Antibody Test is an in vitro diagnostic test for the qualitative detection of total antibodies to the specific SARS-CoV-2 antigens in human serum, plasma and whole blood samples collected in certified laboratories and/or by the healthcare workers at the point-of-care. DEVICE DESCRIPTION: REVEALCOVID-19TM Total Antibody Test is a manually performed, visually interpreted Rapid Vertical Flow® (RVF) immunoassay that detects total antibodies to SARS-CoV-2, the causative agent of COVID-19 disease, in human serum, plasma and venipuncture whole blood. REVEALCOVID-19TM Total Antibody Test consists of a Test Cartridge, an InstantGold Cap, and two (2) vials of pre-aliquoted universal buffer solutions. Test Cartridge consists of two plastic casings (top and bottom) that snap together to securely hold the reactive nitrocellulose membrane overlaid on top of the absorbent pad. The Test Zone of the membrane is coated with a combination of synthetic proteins that correspond to the conserved regions of the SARS-CoV-2 nucleocapsid protein (N), thus, allowing the capture of SARS-CoV-2 antibodies. As a procedural/reagent control, Protein A is immobilized in a designated area (Control Zone) on the nitrocellulose membrane to allow a non-specific capture of Ig antibodies. InstantGold cap, which contains proprietary Protein A/L colloidal gold conjugates, enables the visualization of the aforementioned antigen – antibody immunocomplexes formed on the reactive membrane. Universal buffer solutions are proprietary formulations of ionic and non-ionic detergents in Tris-buffered saline that serve four main functions: a) lysis of blood cells in whole blood specimens; b) optimization of the interactions between capture antigens on the test membrane and antibodies present in the specimen; c) reduction of non-specific binding to the membrane; d) reconstitution of the colorimetric detection agent in the InstantGold Cap.2022-08-24 09:08:01 CET2085Immuno-AntibodyNoImmunoassayQualitativeCapture3LOD20AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives3.22%Plasma: 1/37 (PPA = 97.1%)False positives0%Serum: 0/31 (PPA = 100%)False positives3.22%Whole Blood: 1/37 (PPA = 97.1%)False negatives1.61%Plasma: 2/124 (NPA = 98.1)False negatives0.91%Serum: 1/110 (NPA = 99.0%), False negatives0%Whole Blood: 0/37 (NPA = 100%)PrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.5%Clinical Specificity98.7%Type of antigenOther1068MEDsan COVID-19 IgM/IgG Rapid Test Hybrid617MEDsan GmbHhttps://www.medsan.eu/en/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood https://www.medsan.eu/en/detection/2022-08-24 09:08:01 CET995Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry101063Rapid COVID-19 IgM/IgG Combo Test Kit (Antibody)77Megna Health Inc.United Stateswww.megnahealth.comYesCommercialisedNoNoNear POC / POCAntibodyACD plasmaSerumThe Megna Rapid COVID-19 IgM/IgG Combo Test Kit has been exhaustively tested - by Megna Health and by independent testing conducted by National Institute of Health and National Cancer Society - as required by FDA prior to issuing an Emergency Use Authorization letter on July 17, 2020.; https://www.megnahealth.com/wp-content/uploads/2020/07/MegnaHealth-Test-Kit_-IFU.pdf2022-08-24 09:08:01 CET97Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedRobustnessEvaluatedClinical Sensitivity100%Clinical Sensitivity83.3% IgMClinical Sensitivity100% IgGClinical Specificity95%Clinical Specificity97.5% IgMClinical Specificity97.5% IgM2596SARS-CoV-2 Antigen Rapid Test Cassette1182Merlin Biomedical (Xiamen) Co. Ltd.Chinahttp://www.merlinbio.com.cn/en/YesCommercialisedNoNoManualAntibodySaliva689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2Zetanucleocapsid proteinThis cassette belongs to in vitro diagnostic reagents, and is suitable for the qualitative cietection cf SARS-CoV-2's Nucleocapsid protein in human saliva specimen. It cannot be served as the basis of the confirmation or exclusion for coronavirus pneumonia. This product is used only far medicai institutions. The positive test result requires further confirmation. A negative test cannot rule out the possibility of infection. The test results of this cassette are only for clinica! reference. It is recommended to conduct a comprehensive analysis of the patient's condition in combination with clinical manifestations and other laboratory tests. A total of 443 clinical samples were tested in this clinical study. The clear diagnosis and exclusion criteria of the "SARS-CoV-2 diagnosis and treatment protocol" were taken as a reference. Clinical trials were conducted at Fujian's Fuzhou Lung Hospital and Zhangzliou Hospital. The positive coincidence rate of the SARS-CoV-2 Antigen Rapid Test Cassette, developed by Merlin was 95.5% and the negative coincidence rate of the cassette was 99.7%, the total coincidence rate of the cassette was 98 , 4% compared to the reference method (RT-PCR) which indicates a high consistency.2022-08-24 09:08:01 CET2301Immuno-AntigenYesImmunochromatography15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives4.5%Positive coincidence rate = 127/ (127+6) x100%=95.5%, (95% Cl: 90.5%-98.0%)False negatives0.3%Negative coincidence rate = 299/ (299+1) x100%=99.7%, (95% Cl: 98.1%-99.9%);PrecisionEvaluatedAccuracy98% (Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95% (Antigen)Clinical Specificity99% (Antigen)Type of antigenNucleocapsid protein2793COVID-19 Biokit IgG/IgM174MiCo Biomed Co. Ltd.South Koreawww.micobiomed.com/YesCommercialisedNoNoManualAntibodyPlasmaSerumWhole bloodThe COVID-19 Biokit IgG/IgM is a single use lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 present in human capillary whole boold from patients suspected of COVID-19 infection. The COVID-19 Biokit IgG/IgM is suitable for professional use. The COVID-19 Biokit IgG/IgM is for in vitro diagnosis use only. The COVID-19 Biokit IgG/IgM is an aid in the diagnosis of patients with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results from the COVID-19 Biokit IgG/IgM should not be used as the sole basis for diagnosis. This assay only provides a preliminary result. A positive result does not necessarily mean a current infection but represents a different stage of the disease after infection. IgM positive or IgG/IgM both positive suggest recent exposure, while IgG positive suggests previous infection, or latent infection. Current infection should be confirmed by Real-Time Reverse Transcriptase (RT-PCR) or viral gene sequencing.2022-08-24 09:08:01 CET2498Immuno-AntibodyYesNoImmunochromatographyQualitativeSandwich20LODPRNT50: 20CalibrationNot evaluatedAnalysis of cross reactivityNot evaluatedFalse positives9.91%False negatives0.25%PrecisionEvaluatedAccuracy97.74%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity90.09%95% CI, 85.33% - 93.43%Clinical Specificity99.75%95% CI, 99.1% - 99.93%Type of antigenSpike protein2827MiCo BioMed Co., Ltd.1254MiCo Biomed Co. Ltd.South Koreawww.micobiomed.com/YesCommercialisedNoNoManualAntibodyPlasmaSerumWhole bloodThe COVID-19 Biokit IgG/IgM is a single use lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 present in human capillary whole boold from patients suspected of COVID-19 infection. The COVID-19 Biokit IgG/IgM is suitable for professional use. The COVID-19 Biokit IgG/IgM is for in vitro diagnosis use only. The COVID-19 Biokit IgG/IgM is an aid in the diagnosis of patients with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results from the COVID-19 Biokit IgG/IgM should not be used as the sole basis for diagnosis. This assay only provides a preliminary result. A positive result does not necessarily mean a current infection but represents a different stage of the disease after infection. IgM positive or IgG/IgM both positive suggest recent exposure, while IgG positive suggests previous infection, or latent infection. Current infection should be confirmed by Real-Time Reverse Transcriptase (RT-PCR) or viral gene sequencing.2022-08-24 09:08:01 CET2532Immuno-AntibodyNoImmunochromatographyQualitativeSandwich20LODPRNT50: 20CalibrationNot evaluatedAnalysis of cross reactivityNot evaluatedFalse positives9.91%False negatives0.25%PrecisionEvaluatedAccuracy97.74%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity90.09%95% CI, 85.33% - 93.43%Clinical Specificity99.75%95% CI, 99.1% - 99.93%Type of antigenSpike protein2790Veri-Q COVID-19 SARS-CoV-2 Neutralizing Antibody Detection ELISA Kit174MiCo Biomed Co. Ltd.South Koreawww.micobiomed.com/YesCommercialisedNoNoLab-basedAntibodyPlasmaSerumThe VERI-Q SARS-CoV-2 Neutralizing Antibody Detection ELISA Kit is in vitro diagnostic test intended for the qualitative detection of neutralization antibody to SARS-CoV-2 in human serum or plasma (EDTA, heparin, citrate). The VERI-Q SARS-CoV-2 Neutralizing Antibody Detection ELISA Kit is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The VERI-Q SARS-CoV-2 Neutralizing Antibody Detection ELISA Kit should not be used to diagnose acute SARS-CoV-2 infection.2022-08-24 09:08:01 CET2495Immuno-AntibodyYesELISAQualitativeNeutralization Antibody (NAb)70CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positivesO.D. > 0.1False negativesO.D < 1.0PrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity94.4%Clinical Specificity100%2791Veri-Q SARS-CoV-2 Neutralizing Antibody Rapid Test Kit174MiCo Biomed Co. Ltd.South Koreawww.micobiomed.com/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole bloodThe Veri-Q SARS-CoV-2 Neutralizing Antibody Detection Rapid Test is a lateral flow immunoassay intended for the qualitative detection of neutralizing antibodies to SARS-CoV-2 in human plasma from anticoagulated blood, serum, finger-stick whole blood or venous whole blood samples. The Veri-Q SARS-CoV-2 Neutralizing Antibody Detection Rapid Test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. The Veri-Q SARS-CoV-2 Neutralizing Antibody Detection Rapid Test should not be used to diagnose or exclude acute SARS-CoV-2 infection.2022-08-24 09:08:01 CET2496Immuno-AntibodyImmunochromatographyNeutralization Antibody (NAb)20CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedReproducibilityEvaluatedRobustnessNot evaluatedClinical Specificity95.6%1629recomWell SARS-CoV-2 IgG725Mikrogen DiagnostikGermanywww.mikrogen.deYesCommercialisedNoNoLab-basedAntibody2022-08-24 09:08:01 CET1309Immuno-AntibodyImmunoassay390Analysis of cross reactivitySeasonal coronaviruses (HCoV), Influenza A virus, Influenza B virus, Respiratory syncytial virus (RSV), Adenoviruses, Mycoplasma pneumoniae, Chlamydia pneumoniae, Epstein-Barr virus (EBV), Cytomegalovirus (CMV), Autoantibodies positive, Pregnant women, RClinical Sensitivity98% IgGClinical Sensitivity73% IgAClinical Specificity98.7% IgGClinical Specificity99.3% IgA285SARS-CoV-2 IgM & IgG Quantum Dot Immunoassay477Mokobio Biotechnology R&D CenterUnited Stateswww.mokobious.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET660Immuno-AntibodyYesImmunoassayQualitativeFluorescence60Clinical Sensitivity89.52%Clinical Specificity99.36%1329COVID-19 IgA ELISA410Monocent Inc.United Stateswww.monocent.comYesCommercialisedNoNoAutomatedManualAntibody2022-08-24 09:08:01 CET1098Immuno-AntibodyYesELISAQualitative85Manual or automated Accuracy99.59% IgAClinical Sensitivity98.7% IgAType of antigennucleoprotein1327COVID-19 IgG ELISA410Monocent Inc.United Stateswww.monocent.comYesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET1096Immuno-AntibodyYesELISAQualitative70Manual or automated Accuracy97% IgGClinical Sensitivity95% IgGType of antigennucleoprotein1321COVID-19 IgG/IgM Rapid Test410Monocent Inc.United Stateswww.monocent.comYesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET1087Immuno-AntibodyNoImmunoassayQualitative15False positives0AUFalse negatives0AUAccuracy100%Clinical Sensitivity100%1328COVID-19 IgM ELISA410Monocent Inc.United Stateswww.monocent.comYesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET1097Immuno-AntibodyYesELISAQualitative85Accuracy99.44% IgMClinical Sensitivity96% IgMType of antigennucleoprotein937ASSURE SARS-CoV-2 IgG/IgM Rapid Test367MP BiomedicalsGermanyhttps://www.mpbio.com/eu/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood with anti-coagulants2022-08-24 09:08:01 CET737Immuno-AntibodyYesNoImmunoassayQualitative15Analysis of cross reactivityEvaluatedAccuracy99.43%Clinical Sensitivity100%Clinical Specificity99.41%1125Human anti-SARS-CoV-2 IgG ELISA Kit367MP BiomedicalsGermanyhttps://www.mpbio.com/eu/YesCommercialisedNoNoAutomatedManualAntibodyOther biological fluidsPlasmaTissue homogenateshttps://www.mpbio.com/us/human-anti-sars-cov-2-igg-elisa-kit2022-08-24 09:08:01 CET908Immuno-AntibodyYesELISAQuantitativeClinical Sensitivity2.34ng/mL1124Human anti-SARS-CoV-2 IgM ELISA367MP BiomedicalsGermanyhttps://www.mpbio.com/eu/YesCommercialisedNoNoAutomatedManualAntibodyOther biological fluidsPlasmaTissue homogenates https://www.mpbio.com/us/human-anti-sars-cov-2-igm-elisa-kit2022-08-24 09:08:01 CET906Immuno-AntibodyYesELISAQuantitative584MP Rapid 2019-nCoV IgG/IgM367MP BiomedicalsGermanyhttps://www.mpbio.com/eu/YesCommercialisedNoNoNear POC / POCAntibody2022-08-24 09:08:01 CET494Immuno-AntibodyYesImmunoassay1126Rapid 2019-nCoV IgG/IgM Combo Test367MP BiomedicalsGermanyhttps://www.mpbio.com/eu/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood with anti-coagulants https://www.mpbio.com/eu/2019-ncov-igg-igm-combo-test2022-08-24 09:08:01 CET909Immuno-AntibodyYesNoImmunoassayQualitative10Analysis of cross reactivitynone for tested diseases; (HBsAb, TP antibody, HCV antibody, HIV antibody,Influenza Avirus antibody, Influenza Bvirus antibody, Respiratory syncytial virus antibody,Mycoplasmapneumoniae antibody, Chlamydia pneumonia antibody, Respiratory adenovirus antibPrecision100%Accuracy95.87%Clinical Sensitivity94.74%Clinical Sensitivity70.59% IgMClinical Sensitivity90.4% IgGClinical Specificity97.06%Clinical Specificity99.67% IgMClinical Specificity97.39% IgG1051MEDsan COVID-19 IgM/IgG Rapid Test621MPC International S.A.Germanywww.medsan.eu/en/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole bloodnucleocapsid protein2022-08-24 09:08:01 CET973Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry10Analysis of cross reactivityEvaluatedType of antigenNucleoprotein1021Novel Coronavirus(COVID-19) Test607MR HealthcareHong Kong S.A.Rwww.mr-healthcare.com/YesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET933Immuno-AntibodyYesNoImmunoassayQualitative152262Covid19Check-MG1052Multi-G bvbaBelgiumwww.covid19check-mg.comYesCommercialisedNoNoManualAntibodyPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaAll additional data is available on demand. This test is validated by the French Health agency : https://covid-19.sante.gouv.fr/tests#e786994f-fc19-4c68-a3f5-74ce44fc3bb72022-08-24 09:08:01 CET1963Immuno-AntibodyNoImmunochromatographyQualitativeCapture15LOD22.5AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives3%(NPA 97%)False negatives7%(PPA 93%)PrecisionEvaluatedAccuracy96.5%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93%Clinical Specificity97%Type of antigenOther2424PathoCatch COVID-19 Neutralizing Antibody ELISA Kit1081Mylab Discovery Solutions Pvt. Ltd.Indiahttps://mylabdiscoverysolutions.com/YesCommercialisedNoNoLab-basedSemi-automatedAntibodyPlasmaSerum689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2Zeta2022-08-24 09:08:01 CET2126Immuno-AntibodyYesELISAQualitativeNeutralization Antibody (NAb)120LOD21AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives5%PrecisionEvaluatedAccuracy95%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95%Clinical Specificity93%Type of antigenNucleoprotein2425PathoCatch COVID-19 Neutralizing Antibody Lateral Flow Test Kit1081Mylab Discovery Solutions Pvt. Ltd.Indiahttps://mylabdiscoverysolutions.com/YesCommercialisedNoNoLab-basedManualNear POC / POCAntibodyPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaN/A2022-08-24 09:08:01 CET2127Immuno-AntibodyImmunoassayQualitativeNeutralization Antibody (NAb)20LOD21AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives5%PrecisionEvaluatedAccuracy95%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97%Clinical Specificity100%Type of antigenOther2128Unknown289NADAL COVID-19 IgG/IgM Test (243003N-25 and 243001N-10)182Nal von minden GmbHGermanyhttps://www.nal-vonminden.com/YesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET239Immuno-AntibodyYesNoImmunoassayQualitative10CalibrationNot evaluatedAnalysis of cross reactivityReported as possiblePrecisionNot evaluatedRobustnessNot evaluatedClinical Sensitivity94.1%Clinical Specificity98.2%2515Novel Coronavirus (2019-nCoV) IgG / IgM Antibody Testing Kit (Colloidal Gold)1143Nanjing Norman Biological Technology Co. Ltd.Chinahttps://www.normanbio.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood/2022-08-24 09:08:01 CET2219Immuno-AntibodyNoImmunoassayQualitativeColloidal gold15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0% IgG(whole blood)False positives0% IgM(whole blood)False negatives14.13% IgG(whole blood)False negatives4.35% IgM(whole blood)PrecisionEvaluatedAccuracy95.55% IgGAccuracy98.63% IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity85.87% IgGClinical Sensitivity95.65% IgMClinical Specificity100% IgGClinical Specificity100% IgMType of antigenOther2514Novel Coronavirus (COVID-19) Neutralizing Antibody Testing Kit (Colloidal Gold)1143Nanjing Norman Biological Technology Co. Ltd.Chinahttps://www.normanbio.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET2218Immuno-AntibodyNoImmunoassayQualitativeNeutralization Antibody (NAb)Colloidal gold15LODAU0CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives1.69%(serum)False negatives4.96%(serum)PrecisionEvaluatedAccuracy97.2%(serum)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.04%(serum)Clinical Specificity98.31%(serum)Type of antigenOther2822SARS-CoV-2 Virus Neutralization Test Kit (Colloidal gold method)1007Nanjing Synthgene Medical Technology Co. Ltd.Chinahttp://www.syngenemed.com/YesCommercialisedNoNoManualNear POC / POCAntibodyPlasmaSerumWhole bloodWhole blood with anti-coagulants689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThis product does not require any equipment, and is used to qualitatively detect the neutralizing antibody of the new coronavirus (SARS-CoV-2) in the human body. The entire detection process only takes 10-15 minutes. It is easy to operate and has high sensitivity. It is convenient for the screening of people vaccinated with the new coronavirus vaccine and the judgment of the effect after vaccination2022-08-24 09:08:01 CET2527Immuno-AntibodyYesYesImmunoassayQualitativeNeutralization Antibody (NAb)Colloidal gold10LOD100TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.67%False negatives0.5%PrecisionEvaluatedAccuracy99.45%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.33%Clinical Specificity99.5%Type of antigenSpike protein1864Anti-SARS-CoV-2 Neutralizing Antibody ELISA Kit184Nanjing Vazyme Medical Technology Co. Ltd.Chinawww.vazyme.comYesCommercialisedNoNoLatexManualAntibodyPlasmaSerumhttp://www.vazymebiotech.com/COVID.html2022-08-24 09:08:01 CET1541Immuno-AntibodyYesELISAQualitativeEnzyme-linked120LOD92.5AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives1%PrecisionEvaluatedAccuracy99.27%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.5%Clinical Specificity99.3%Type of antigenOther938Nano-Check COVID-9 IgG/IgM Antibody Test583Nano-Ditech CorporationUnited Stateswww.nanoditech.com/YesCommercialisedNoNoAutomatedManualAntibodyWhole blood2022-08-24 09:08:01 CET859Immuno-AntibodyNoImmunoassayQualitativeChemiluminescence10Analysis of cross reactivityEvaluated585FREND COVID-19 IgG/IgM Duo354NanoEntekSouth Koreawww.nanoentek.comYesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET478Immuno-AntibodyYesImmunoassayQuantitativeFluorescence3Analysis of cross reactivityEvaluatedFalse positivesEvaluatedFalse negativesEvaluatedClinical Sensitivity93%Clinical Specificity97%1411FREND COVID-19 SP354NanoEntekSouth Koreawww.nanoentek.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumspike protein http://www.nanoentek.com/theme/nanont2_en/shop/02/product01_view.php?it_id=15996404982022-08-24 09:08:01 CET1174Immuno-AntibodyYesImmunoassayQualitativeFluorescence3Analysis of cross reactivity0%for tested agentsClinical Sensitivity97.06%Clinical Specificity96.3%Type of antigenspike protein1355(2019-nCoV) New coronavirus Antibody Test (Colloidal Gold)851Nantong Diagnos Biotechnology Co. Ltd.Spainlinkcarebio.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET1115Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15LOD0AUAnalytical Sensitivity87.04% IgGAccuracy93.33% IgMAccuracy92.38% IgGClinical Sensitivity88.89% IgM1019(COVID-19) IgG/IgM Rapid Test558NatejahSaudi Arabianatejah.com/YesCommercialisedNoNoNear POC / POCAntibody2022-08-24 09:08:01 CET814Immuno-AntibodyYesImmunoassay1303Chexel COVID-19 IgM/IgG645NB POSTECHSouth Koreawww.nbpostech.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET1074Immuno-AntibodyYesNoImmunoassayQualitative15Clinical Sensitivity75% IgGClinical Sensitivity96.8% IgM10222019-nCoV(COVID-19) IgG&IgM Rapid Test Kit539Neo Nostics (Suzhou) Bioingeneering Co. Ltd.Chinawww.neo-nostics.com/en/YesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET782Immuno-AntibodyYesNoImmunoassayQualitative1134NAISSA SARS-COV-2 IgA585Neomedica d.o.o.Serbiawww.neomedica.rsYesCommercialisedNoNoAutomatedAntibodyPlasmaSerum https://neomedica.rs/products/immunodiagnostics/monotest-immunoanalyzer-naissa/naissa-new/2022-08-24 09:08:01 CET916Immuno-AntibodyYesImmunoassayQualitativeSandwich, Double150CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1AUFalse negatives0AUPrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity93.4%1087NAISSA SARS-COV-2 IgG585Neomedica d.o.o.Serbiawww.neomedica.rsYesCommercialisedNoNoAutomatedAntibodyPlasmaSerum https://neomedica.rs/products/immunodiagnostics/monotest-immunoanalyzer-naissa/naissa-new/2022-08-24 09:08:01 CET870Immuno-AntibodyYesImmunoassayQualitativeSandwich, Double150CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1AUFalse negatives0AUPrecisionEvaluatedAccuracy99%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity97.5%1133NAISSA SARS-COV-2 IgM585Neomedica d.o.o.Serbiawww.neomedica.rsYesCommercialisedNoNoAutomatedAntibodyPlasmaSerum https://neomedica.rs/products/immunodiagnostics/monotest-immunoanalyzer-naissa/naissa-new/2022-08-24 09:08:01 CET915Immuno-AntibodyYesImmunoassayQualitativeSandwich, Double150CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1AUFalse negatives0AUPrecisionEvaluatedAccuracy98%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity92.6%2377NAISSA SARS-COV-2 S1/S2/RBD Neutralizing antibodies585Neomedica d.o.o.Serbiawww.neomedica.rsYesCommercialisedNoNoAutomatedAntibodyPlasmaSerumEnzyme-linked immunosorbent assay for quantitative determination of neutralizing IgG antibodies to S1/S2/RBD antigens of SARS-CoV-2 virus2022-08-24 09:08:01 CET2079Immuno-AntibodyYesELISAQuantitativeEnzyme-linked105LOD0AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%There are no false positivesFalse negatives0%There are no false negativesPrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.4%Clinical Specificity100%Type of antigenOther2306COVID-19 Antibody Detection Kit1074New Gene (Hangzhou) Bioengineering Co. Ltd.Chinawww.new-gene.net/YesCommercialisedNoNoManualNear POC / POCAntibodyACD plasmaPeripheral bloodPlasmaSerum689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1132B.1.427Epsilon1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.3This product is intended for the qualitative detection of COVID-19 antibodies (IgM and IgG). It provides an aid in the diagnosis of infection with novel coronavirus.2022-08-24 09:08:01 CET2007Immuno-AntibodyNoImmunoassayQuantitativeSandwich20LOD1CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.95% IgM1 out of 105False positives0.95%1 out of 105False negatives2.04%2 out of 98 False negatives5.1% IgM5 out of 98PrecisionEvaluatedAccuracy97% IgMAccuracy98.5% IgGReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.9% IgGClinical Sensitivity94.9% IgMClinical Specificity99% IgGClinical Specificity99% IgMType of antigenOther2305COVID-19 Neutralizing Antibody Detection Kit1074New Gene (Hangzhou) Bioengineering Co. Ltd.Chinawww.new-gene.net/YesCommercialisedNoNoManualNear POC / POCAntibodyACD plasmaPeripheral bloodPlasmaSerum689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1132B.1.427Epsilon1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.3This product is intended for the qualitative detection of neutralizing antibodies for SARS-CoV-2 spike glycoproteins. The test results can help to identify individuals with an adaptive immune response to SARS-CoV-2, which is acquired from recent or prior infection or vaccination. The COVID-19 Neutralization Antibody Detection Kit should not be used to diagnose acute SARS-CoV-2 infection.2022-08-24 09:08:01 CET2006Immuno-AntibodyNoImmunoassayQuantitativeNeutralization Antibody (NAb)20LOD1AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.84%1 out of 118False negatives1.63%2 out of 122PrecisionEvaluatedAccuracy98.8% (Antibody)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.4% (Antibody)Clinical Specificity99.2% (Antibody)Type of antigenOther1029COVID-19 Coronavirus Rapid Test Kit613Newbury Pharmaceuticals S.ASwedenwww.newburypharma.ch/YesCommercialisedNoNoNear POC / POCAntibodyWhole bloodhttps://www.newburypharma.ch/pages/covid-19-instant-antibody-test-kit-15-min2022-08-24 09:08:01 CET947Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry865NG-Test IgG-IgM COVID-19572NG BiotechFrancehttps://ngbiotech.com/YesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET841Immuno-AntibodyYesNoImmunoassayQualitative15587NovaLisa COVID-19 (SARS-CoV-2) IgA368NovaTec Immundiagnostica GmbHGermanyhttps://www.goldstandarddiagnostics.com/home/products/covid-19-elisa-assays/gsd-sars-cov-2-elisa/gsd-sars-cov-2-elisa-igg/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET496Immuno-AntibodyYesELISAQualitativeFluorescenceType of antigenspike (S1) and nucleocapsid (N)588NovaLisa COVID-19 (SARS-CoV-2) IgG368NovaTec Immundiagnostica GmbHGermanyhttps://www.goldstandarddiagnostics.com/home/products/covid-19-elisa-assays/gsd-sars-cov-2-elisa/gsd-sars-cov-2-elisa-igg/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET497Immuno-AntibodyYesImmunoassayQualitativeFluorescence589NovaLisa COVID-19 (SARS-CoV-2) IgM368NovaTec Immundiagnostica GmbHGermanyhttps://www.goldstandarddiagnostics.com/home/products/covid-19-elisa-assays/gsd-sars-cov-2-elisa/gsd-sars-cov-2-elisa-igg/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET498Immuno-AntibodyYesImmunoassayQualitativeFluorescence819NovaLisa SARS-CoV-2 (COVID-19)368NovaTec Immundiagnostica GmbHGermanyhttps://www.goldstandarddiagnostics.com/home/products/covid-19-elisa-assays/gsd-sars-cov-2-elisa/gsd-sars-cov-2-elisa-igg/YesCommercialisedNoNoAutomatedManualAntibodySerum2022-08-24 09:08:01 CET675Immuno-AntibodyYesImmunoassayQualitativeFluorescence105Clinical Sensitivity88.9%Clinical Specificity98.3%Type of antigenRecombinant angen1582Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV-2661NovatechTurkeywww.novadiag.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET1262Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15LOD95AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives97%False negatives98%PrecisionEvaluatedAccuracy98.6% IgGAccuracy88.4% IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.4% IgGClinical Sensitivity71.4% IgM1393NOVACHECK Diagnostic kit (collodial gold) for IgG/IgM Antibody to SARS-CoV-2661NovatechTurkeywww.novadiag.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole bloodnucleocapsid protein https://www.novadiag.com/files/novadiag-katalog-english.pdf2022-08-24 09:08:01 CET1159Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15LOD0AUCalibrationNot evaluatedFalse positives7.92%16 fake POSITIVE NUMBER OF PATIENTS / 202 TOTAL NUMBER OF PATIENTS) * 100: 7.92%False negatives2.1%8 fake NEGATIVE NUMBER OF PATIENTS / 380 TOTAL NUMBER OF PATIENTS) *100: %2.10Accuracy95.88%95 CI:%93.44-%97.2Clinical Sensitivity92.08%95 CI:%87.52-%95.07Clinical Specificity97.89%Type of antigennucleoprotein661COVID-19 IgG/IgM Antibody Test Cassette550NTBio Diagnostics Inc.Canadantbio.ca/YesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET798Immuno-AntibodyYesNoImmunoassayQualitativeNot found15Accuracy97.2% IgGAccuracy87.9% IgM1163CRT (COVID 19 RAPID TEST)610Oncosem Onkolojik Sistemler San. ve Tic. A.S.Turkeywww.oncosem.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood https://oncosem.com/en/crt-2/2022-08-24 09:08:01 CET944Immuno-AntibodyYesNoImmunoassayQualitative15False positives1%False negatives5.14%Accuracy97.3%Clinical Sensitivity94.85%2171SIMPLE IgA/IgM/IgG SARS-CoV-2776OPERON S.A.Spainhttps://operondx.com/molecular-diagnostics/YesCommercialisedNoNoManualNear POC / POCSemi-automatedAntibodyOtherSerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1519P.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.2ZetaInterpretación de resultados: visual ó automática con el LF OPERON reader. SENSIBILIDAD Y ESPECIFICIDAD DIAGNÓSTICA > 6 días Sensibilidad: 96,3% (Ig tot); 92,5% (IgA), 91,3% (IgG), 91,3% (IgM) Especificidad: 96,7% (Ig tot); 98,4% (IgA), 100% (IgG), 98,3% (IgM) Precisión: 96,5% (Ig tot); 95% (IgA), 95% (IgG), 94,3% (IgM) >15 días Sensibilidad: 96,9% (Ig tot); 93,8% (IgA), 96,9% (IgG), 92,3% (IgM) Especificidad: 96,7% (Ig tot); 98,4% (IgA), 100% (IgG), 98,3% (IgM) Precisión: 96,8% (Ig tot); 96% (IgA), 98,4% (IgG), 95,2% (IgM)2022-08-24 09:08:01 CET1872Immuno-AntibodyNoImmunochromatographyQualitativeSandwich15LOD0.04AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives3%(Ig tot)False positives1.7% IgMFalse positives0% IgGFalse positives1% IgAFalse negatives3% (Ig tot)False negatives7% IgMFalse negatives3% IgGFalse negatives6% IgAPrecisionEvaluatedAccuracy95% IgMAccuracy96%(Ig tot)Accuracy98% IgGAccuracy96% IgAReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96% (Ig tot)Clinical Sensitivity93Clinical Sensitivity96Clinical Sensitivity92Clinical Specificity96% (Ig tot)Clinical Specificity98% IgAClinical Specificity100% IgGClinical Specificity98% IgMType of antigenOther1422OPTI SARS-CoV-2 Total Antibody Test Kit668OPTI Medical SystemsUnited Stateswww.optimedical.comYesCommercialisedNoNoLab-basedAntibodyPlasmaSerum2022-08-24 09:08:01 CET1182Immuno-AntibodyYesImmunoassayQualitativeMagnetic Electrochemical90Clinical Sensitivity96.1%Clinical Specificity98%795VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG356Ortho Clinical DiagnosticsUnited Kingdomwww.orthoclinicaldiagnostics.com/YesCommercialisedNoNoAutomatedLab-basedAntibodySerumhttps://www.orthoclinicaldiagnostics.com/en-us/home/technical-documents2022-08-24 09:08:01 CET639Immuno-AntibodyNoYesCLIAQualitativeSandwich, Double37CalibrationEvaluatedAnalysis of cross reactivityEvaluatedAccuracy100%95% CI: 99,1–100,0%ReproducibilityEvaluatedClinical Specificity90%95% CI: 76,3–97,2%Type of antigenSpike protein590VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total356Ortho Clinical DiagnosticsUnited Kingdomwww.orthoclinicaldiagnostics.com/YesCommercialisedNoNoAutomatedLab-basedAntibodyPlasmaSerumhttps://www.orthoclinicaldiagnostics.com/en-us/home/technical-documents2022-08-24 09:08:01 CET480Immuno-AntibodyNoCLIAQualitativeSandwich, Double37CalibrationEvaluatedAnalysis of cross reactivityEvaluatedReproducibilityEvaluatedClinical Sensitivity100%95% CI: 92,7–100,0%Clinical Specificity100%95% CI: 99,1–100,0%Type of antigenSpike protein3102GeneFinder™ COVID-19 IgG/IgM Rapid Test702OSANG Healthcare Co. Ltd.South Koreahttp://www.osanghc.com/enYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumVenous whole bloodWhole bloodSARS-CoV689B.1.1.7Alpha1032B.1.351Beta1321B.1.617.2Delta1495P.1Gamma678B.1.1.529OmicronOtherspike proteinPublished article : Positivity of SARS-CoV-2 Antibodies among Korean Healthy Healthcare Workers 1 and 2 Weeks after Second Dose of Pfizer-BioNTech Vaccination2022-08-24 09:08:01 CET2817Immuno-AntibodyYesNoNoImmunoassayQualitativeCapture15Tested total 20 pathogens (No cross-reactivity : 20, Detected : only SARS-CoV). LODSerum IgG 1/128 (Dilution rate), IgM 1/4 (Dilution rate)CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives3.06%Predict Postivie Value : 96.94% (95% CI : 91.38 - 98.95)False negatives3.29%Predict Negative Value : 96.71% (95% CI : 92.53 - 98.59)PrecisionEvaluatedAccuracy96.8%95% CI: 93.81 - 98.37ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95%95% CI: 88.82 - 97.85Clinical Specificity98%95% CI: 94.29 - 99.32Type of antigenSpike protein474OZO Diamond - OZO SARS-CoV-2 IgM + IgG Method226OZO LifeUnited Kingdomwww.ozo.life/YesCommercialisedNoNoAutomatedManualAntibodyWhole blood2022-08-24 09:08:01 CET289Immuno-AntibodyNoImmunoassayQualitativeNot found15Accuracy99.3%Type of antigenRecombinant SARS-CoV-2 antigens475OZO Gold - OZO SARS-CoV-2 IgG Method226OZO LifeUnited Kingdomwww.ozo.life/YesCommercialisedNoNoAutomatedManualAntibodyWhole blood OZO INDIA SARS-COV-2 IGM/IGG RAPID TEST Kit and OZO Diamond - OZO SARS-CoV-2 IgM + IgG Method are the only two kits available in the company's website2022-08-24 09:08:01 CET397Immuno-AntibodyNoImmunoassayQualitativeColorimetry15Accuracy98%Type of antigenRecombinant SARS-CoV-2 IgM antigens476OZO Silver - OZO SARS-CoV-2 IgM Method226OZO LifeUnited Kingdomwww.ozo.life/YesCommercialisedNoNoAutomatedManualAntibody OZO INDIA SARS-COV-2 IGM/IGG RAPID TEST Kit and OZO Diamond - OZO SARS-CoV-2 IgM + IgG Method are the only two kits available in the company's website2022-08-24 09:08:01 CET398Immuno-AntibodyImmunoassay1003Pantest de Coronavirus IgM/IgG 2019-n-CoV599Pantest SAPortugalwww.pantest.ptYesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET917Immuno-AntibodyYesNoImmunoassayQualitative20Precision98.6% IgGPrecision92.9% IgMClinical Sensitivity100% IgGClinical Sensitivity85% IgMClinical Specificity98% IgGClinical Specificity96% IgM307PCL COVID19 IgG/IgM Rapid Gold202PCL Inc.South Koreawww.pclchip.com/YesCommercialisedNoNoNear POC / POCAntibody2022-08-24 09:08:01 CET259Immuno-AntibodyYesImmunoassay310SARS-CoV-2 Antibody Detection Kit (Colloidal Gold Immunochromatographic assay)204PerGrande BioTech Development Co. Ltd.Chinawww.pergrande.com.cn/YesCommercialisedNoNoNear POC / POCAntibody2022-08-24 09:08:01 CET262Immuno-AntibodyYesImmunochromatographyColorimetry485SARS-CoV-2 Rapid TesIgM/IgG318Pharmact (Berlin)Germanypharmact-health.comYesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET716Immuno-AntibodyYesNoImmunoassayQualitative20Precision99% IgMPrecision99.2% IgGClinical Sensitivity98.1% IgMClinical Sensitivity99.5% IgGClinical Specificity99.5% IgMClinical Specificity99.7% IgG501SARS-COV-2 Rapid Test318Pharmact (Berlin)Germanypharmact-health.comYesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET420Immuno-AntibodyYesNoImmunoassayQualitative20FingertipAccuracy99% IgMAccuracy99.2% IgGClinical Sensitivity98.1% IgMClinical Sensitivity98.2% IgGClinical Specificity99.5% IgMClinical Specificity99.7% IgG421Immuno-AntibodyYesNoImmunoassayQualitative20Card Precision99% IgMPrecision99.2% IgGClinical Sensitivity98% IgMClinical Sensitivity98.2% IgGClinical Specificity99.5% IgMClinical Specificity99.7% IgG2861Gmate COVID-19 Neutralizing antibody715PhilosysSouth Koreahttp://www.philosys.com/YesCommercialisedNoNoManualAntibodyPlasmaSerumWhole bloodSee more information via http://www.philosys.com/2022-08-24 09:08:01 CET2566Immuno-AntibodyYesNoImmunochromatographyQualitativeNeutralization Antibody (NAb)15LOD10AU/mLneutralizing antibodyLOD2.7ng/mLtotal antibodyCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives2.38%total antibodyFalse positives4.76%neutralizing antibodyFalse negatives1.47%total antibodyFalse negatives0.74%neutralizing antibodyPrecisionEvaluatedAccuracy98.31%total antibodyAccuracy98.31%neutralizing antibodyReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.62%total antibodyClinical Sensitivity95.24%neutralizing antibodyClinical Specificity98.53%total antibodyClinical Specificity99.26%neutralizing antibody2916SoluM COVID-19 Ag Neutralizing Antibody715PhilosysSouth Koreahttp://www.philosys.com/YesCommercialisedNoNoManualAntibodyPlasmaSerumWhole blood678B.1.1.529Omicronnucleocapsid proteinThe kit is used to detect the total antibody and neutralizing antibody to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in human serum, plasma or whole blood sample qualitatively. It is mainly used to identify individuals with acquired immune response to the SARS-CoV-2, and to evaluate the effectiveness of the vaccine clinical trials and mass vaccination.2022-08-24 09:08:01 CET2621Immuno-AntibodyNoNoImmunochromatographyQualitativeNeutralization Antibody (NAb)15LOD98.31%Neutralizing antibodyLOD98.31%Total AntibodyCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives2.38%Total AntibodyFalse positives4.76%Neutralizing AntibodyFalse negatives1.47%Total antibodyFalse negatives0.74%Neutralizing antibodyPrecisionEvaluatedAccuracy98.31Total antibodyAccuracy98.31%Neutralizing antibodyReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.62Total antibodyClinical Sensitivity95.24%Neutralizing antibodyClinical Specificity98.53Total antibodyClinical Specificity99.26%Neutralizing antibody596SARS-CoV-2 IgG ELISA358Pishtaz Teb DiagnosticsIranwww.pishtazteb.com/enYesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET503Immuno-AntibodyYesELISAQualitativeFluorescence75Analysis of cross reactivityEvalaueatedClinical Sensitivity94.1% IgGClinical Specificity98.3% IgG597SARS-CoV-2 IgM ELISA Kit358Pishtaz Teb DiagnosticsIranwww.pishtazteb.com/enYesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET504Immuno-AntibodyNoYesELISAQualitativeFluorescence75 Analysis of cross reactivityEvaluatedClinical Sensitivity79.4% IgMClinical Specificity97.3% IgM2005ACCEL ELISA COVID-19 kit922Plexense Inc.South Koreawww.plexense.comYesCommercialisedNoNoManualSemi-automatedAntibodyPlasmaCalculate positive and negative results by dividing each sample’s or control’s reaction value at OD 650 nm by the cutoff value determined during the assay procedure. The cut-off value is determined by + 3 SD from the average OD of triplicated negative controls.2022-08-24 09:08:01 CET1683Immuno-AntibodyYesELISAQualitativeEnzyme-linked45LOD4.3AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives2AUFalse negatives1AUPrecisionEvaluatedAccuracy98.5%(IgG,IgM,IgA)ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity98%(IgG,IgM,IgA)Clinical Specificity99%(IgG,IgM,IgA)Type of antigenNucleoprotein10702019-nCoV IgG/IgM Rapid Test575Prestige Diagnostics UK Ltd.United Kingdomwww.prestigediagnostics.co.ukYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET846Immuno-AntibodyYesNoImmunochromatographyQualitative10LOD0AU0CalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracy95% IgGAccuracy96.7% IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity91.8% IgGClinical Sensitivity95.7% IgMClinical Specificity96.4% IgGClinical Specificity97.3% IgM22272019-nCoV Neutralising Antibody1035Prestige Diagnostics UK Ltd.United Kingdomhttps://www.prestigediagnostics.co.uk/YesCommercialisedNoNoLab-basedManualNear POC / POCAntibodyPeripheral bloodPlasmaSerumVenous whole bloodWhole bloodWhole blood with anti-coagulantsThe 2019-nCoV Neutralization Antibody device is a rapid chromatographic immunoassay intended for the qualitative detection of neutralization antibodies against viral spike glycoprotein2022-08-24 09:08:01 CET1928Immuno-AntibodyNoImmunochromatographyQualitativeNeutralization Antibody (NAb)15LOD500AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2.29%(3/131)False negatives2.27%(2/88)PrecisionEvaluatedAccuracy97.7%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.6%Clinical Specificity98.5%Type of antigenOther318PRIMA COVID-19 IgG/IgM Rapid Test (For Professional Use)808PRIMA Lab SASwitzerlandprimahometest.com/en/YesCommercialisedNoNoNear POC / POCAntibodyWhole bloodnucleocapsid protein2022-08-24 09:08:01 CET266Immuno-AntibodyYesNoImmunoassayQualitative10Type of antigenNucleocapsid (N) antigen 2486COVID-19 IgM/IgG Antibody Rapid Detection Kit（Colloidal Gold）1127Pro-med (Beijing) Technology Co. Ltd.Chinawww.pmdt.com.cnYesCommercialisedNoNoManualAntibodyPeripheral bloodPlasmaSerumVenous whole bloodWhole bloodWhole blood with anti-coagulantsNone2022-08-24 09:08:01 CET2189Immuno-AntibodyImmunochromatographyQualitativeOtherColloidal gold15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2.01%False negatives11.38%PrecisionEvaluatedAccuracy93.75%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity88.62%Clinical Specificity97.99%Type of antigenNucleoprotein2485COVID-19 Neutralizing Antibody Rapid Detection Kit（Colloidal Gold）1127Pro-med (Beijing) Technology Co. Ltd.Chinawww.pmdt.com.cnYesCommercialisedNoNoManualAntibodyPeripheral bloodPlasmaSerumVenous whole bloodWhole bloodWhole blood with anti-coagulantsNone2022-08-24 09:08:01 CET2188Immuno-AntibodyImmunochromatographyQualitativeNeutralization Antibody (NAb)Colloidal gold15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.33%False negatives4.9%PrecisionEvaluatedAccuracy97.22%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.1%Clinical Specificity98.67%Type of antigenNucleoprotein1482SARS-CoV-2 IgG antibody detection kit (ELISA)686Proel Biotech Ltd.Romaniahttps://proelbiotech.com/YesCommercialisedNoNoAutomatedLab-basedManualSemi-automatedAntibodyPlasmaSerumThe kit detects anti-spike 1 and anti-nucleocapsid IgG antibodies (combined), and each lot is calibrated against the first WHO international standard. Measured values can be specified in IU/ml (BAU/ml) based on a conversion spreadsheet.2022-08-24 09:08:01 CET1233Immuno-AntibodyNoYesELISAQuantitativeSandwich110manual or automated LOD0.7AU/mL30 IU/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%as determined by testing 88 samples collected prior February 2019False negatives0%as determined by testing 30 samples of recovered COVID-19 patientsPrecisionEvaluatedAccuracy100% IgGReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity100% IgGClinical Specificity100% IgG1499Bio-Shield 2019-nCoV IgG688Prognosis BiotechGreecehttps://www.prognosis-biotech.comYesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET1249Immuno-AntibodyYesImmunoassayQualitativeOther90LOD1AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1%False negatives2%PrecisionEvaluatedAccuracy99.59%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.85%1500Bio-Shield 2019-nCov IgM688Prognosis BiotechGreecehttps://www.prognosis-biotech.comYesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET1250Immuno-AntibodyYesImmunoassayQualitativeOther90LOD1AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1%False negatives6%PrecisionEvaluatedAccuracy99.06%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.31%1498Bio-Shield 2019-nCov Total Ig688Prognosis BiotechGreecehttps://www.prognosis-biotech.comYesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET1248Immuno-AntibodyYesImmunoassayQualitativeSandwich, Double120LOD1AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives1%PrecisionEvaluatedAccuracy99.86%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%1496Rapid test 2019-nCoV Total Ig688Prognosis BiotechGreecehttps://www.prognosis-biotech.comYesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET1246Immuno-AntibodyYesNoImmunoassayQualitative10LOD1AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1%False negatives4%PrecisionEvaluatedAccuracy99.15%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.72%8682019-nCOV IgG/IgM Test Cassette (Whole blood/Serum/Plasma)487Prometheus Bio Inc.Chinawww.prometheusbio.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET683Immuno-AntibodyNoImmunoassayQualitative10Clinical Sensitivity88.9%Clinical Specificity94%1452COVIDTECH One Step SARS-CoV-2 IgM/IgG Antibody Rapid Test286Qingdao Hightop Biotech Co. Ltd.Chinawww.hightopbio.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole bloodnucleocapsid protein2022-08-24 09:08:01 CET1201Immuno-AntibodyYesNoImmunoassayQualitative15LOD200IU/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives18% IgM54/300 False positives7% IgG21/300False negatives4% IgM40/1000 False negatives25% IgG25/100PrecisionNot evaluatedAccuracy97%ReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity92% IgMClinical Sensitivity96% IgGType of antigennucleoprotein463Hightop SARS-CoV-2 IgM/IgG Antibody Rapid Test286Qingdao Hightop Biotech Co. Ltd.Chinawww.hightopbio.comYesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET373Immuno-AntibodyYesNoImmunoassayQualitative10Analysis of cross reactivityReported as not possibleFalse positivesEvaluatedFalse negativesEvaluatedPrecisionNot evaluatedAccuracy92.8% IgMAccuracy96% IgGReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity82% IgMClinical Sensitivity93% IgGClinical Specificity96% IgMClinical Specificity97% IgG1340SARS-COV-2 IGM/IGG ANTIBODY RAPID TEST286Qingdao Hightop Biotech Co. Ltd.Chinawww.hightopbio.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET1116Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15Accuracy93% IgGAccuracy82% IgMClinical Sensitivity93% IgGClinical Sensitivity82% IgM600MosaiQ COVID-19 Antibody Microarray369Quotient Limited SAUnited Kingdomquotientbd.com/covid-19YesCommercialisedNoNoAutomatedManualAntibodyWhole blood Data provided by the Manufacturer 2022-08-24 09:08:01 CET508Immuno-AntibodyYesImmunoassayQualitativeMicroarray35Clinical Sensitivity100%Clinical Specificity99.8%Type of antigenS1 and S2 proteins336BIOCREDIT COVID-19 IgG+IgM Duo220RapiGEN Inc.South Koreawww.rapigen-inc.com/engYesCommercialisedNoNoNear POC / POCAntibodyWhole blood these are two separated strips2022-08-24 09:08:01 CET282Immuno-AntibodyYesNoImmunoassayQualitative101716BIOCREDIT COVID-19 IgG/IgM Combo220RapiGEN Inc.South Koreawww.rapigen-inc.com/engYesCommercialisedNoNoNear POC / POCAntibody2022-08-24 09:08:01 CET1396Immuno-AntibodyYesNoImmunoassayQualitative15LOD0AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2.67%4/150False negatives0%0/52PrecisionEvaluatedAccuracy98%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%337Coronavirus (SARS-CoV-2) IgM/IgG Test Kit (Colloidal Gold)154RayBiotechUnited Stateswww.raybiotech.com/YesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET205Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry10Accuracy97.41%Clinical Sensitivity90.44%Clinical Specificity98.31%603COVID-19 IgM/IgG Rapid Test Kit364Ring Biotechnology Co. Ltd.Chinawww.ringbio.com/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerum2022-08-24 09:08:01 CET490Immuno-AntibodyYesNoImmunoassayQualitative10Analysis of cross reactivityEvaluatedFalse positivesEvaluatedFalse negativesEvaluatedAccuracy95.12%Clinical Sensitivity85%Clinical Specificity98.39%882Elecsys® Anti-SARS-CoV-2221ROCHE DiagnosticsGermanyhttps://diagnostics.roche.com/YesCommercialisedNoNoAutomatedLab-basedAntibodyPlasmaSerum689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThe Elecsys Anti SARS CoV 2 assay uses a recombinant antigen representing the nucleocapsid (N) protein in a double-antigen sandwich assay format. OTher pathogens tested for cross-linking Borrelia burgdorferi; E. coli; Neisseria gonorrhoeae; HEV; HTLV; Listeria; Measles; Parvovirus B19; Plasmodium falciparum; Rubella;; Toxoplasma gondii; 2022-08-24 09:08:01 CET696Immuno-AntibodyNoYesImmunoassayQualitativeSandwich, DoubleChemiluminescence18Preliminary assessment indicates that the mutations within the described variants are not expected to affect the clinical interpretation of samples measured with the Elecsys® Anti-SARS-CoV-2 S assay.LOD0CalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.5% (95% CI: 97-100%) (≥14 days after PCR confirmation)Clinical Specificity99.8%(95% CI: 99.69-99.88%)Type of antigenNucleocapsid N-protein2160Elecsys® Anti-SARS-CoV-2 S221ROCHE DiagnosticsGermanyhttps://diagnostics.roche.com/YesCommercialisedNoNoAutomatedLab-basedAntibodyPlasmaSerum689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaThe Elecsys Anti SARS CoV 2 S assay uses a recombinant antigen representing the receptor-binding domain (RBD) of the Spike protein in a double-antigen sandwich assay format. Other pathogens tested for cross-reactivity are: Borrelia burgdorferi; E. coli; Neisseria gonorrhoeae; HEV; HTLV; Listeria; Measles; Parvovirus B19; Plasmodium falciparum; Rubella;; Toxoplasma gondii; Enterovirus; Haemophilus influenza B; Candida albicans; Chlamydia trachomatis; Legionella; 2022-08-24 09:08:01 CET1861Immuno-AntibodyYesImmunoassayQuantitativeSandwich, Double18LOD0.4AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.8% (95% CI: 98.1 99.3)Clinical Specificity99.98% (95% CI: 99.91 100)Type of antigenreceptor-binding domain (RBD) of the Spike protein1035COVID-19 IgG/IgM Rapid Test Device (Whole Blood/Plasma/Serum)546Safecare Biotech (Hangzhou) Co. Ltd.Chinawww.safecare.com.cnYesCommercialisedNoNoLab-basedNear POC / POCAntibodyPlasmaSerumWhole bloodWhole blood with anti-coagulants689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaLOD: 10-time diluted of internal reference material2022-08-24 09:08:01 CET793Immuno-AntibodyYesNoImmunochromatographyQualitativeSandwich15LOD10AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives%9.19%False negatives%15.09%PrecisionEvaluatedAccuracy90.19%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity84.91%Clinical Specificity91.81%2199COVID-19 Neutralizing Antibody Rapid Test Kit( Whole blood/Serum/Plasma)1026Safecare Biotech (Hangzhou) Co. Ltd.Chinawww.safecare.com.cnre.com.cnYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumVenous whole bloodWhole bloodWhole blood with anti-coagulants689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2ZetaLoD:Internal positive control- 5 times diluted2022-08-24 09:08:01 CET1900Immuno-AntibodyImmunochromatographyNeutralization Antibody (NAb)15LOD5AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.24%False negatives0.71%PrecisionEvaluatedAccuracy99.52%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.29%Clinical Specificity99.76%Type of antigenNucleoprotein1047Salocor COVID-19 IgG/IgM Rapid Test Cassette567Salofa OyFinlandhttps://www.salofa.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET840Immuno-AntibodyYesImmunoassayQualitative15Analysis of cross reactivityEvaluatedClinical Sensitivity93.7% IgGClinical Sensitivity94.9% IgM1039Sienna COVID-19 IgG/IgM Rapid Test Cassette567Salofa OyFinlandhttps://www.salofa.comYesCommercialisedNoNoNear POC / POCAntibody2022-08-24 09:08:01 CET832Immuno-AntibodyYesImmunoassay798ScheBo SARS-CoV-2 Quick359ScheBo BiotechGermanywww.schebo.de/YesCommercialisedNoNoAutomatedManualAntibodyWhole blood2022-08-24 09:08:01 CET484Immuno-AntibodyNoImmunoassayQualitativeColorimetry15Clinical Sensitivity97.5% IgGClinical Sensitivity97.5% IgMClinical Specificity99.5% IgGClinical Specificity100% IgM992Screen Test Covid-19 - 2019-NCoV IgG/IgM Rapid Test Cassette701SCREEN ITALIA S.r.l.Italywww.screenitalia.itYesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET772Immuno-AntibodyYesNoImmunoassayQualitative10Analysis of cross reactivityEvaluatedPrecision99%Accuracy98.6% IgGAccuracy92.9% IgMClinical Sensitivity100% IgGClinical Sensitivity85% IgMClinical Specificity98% IgGClinical Specificity96% IgM346STANDARD Q COVID-19 IgM/IgG Duo Test224SD BIOSENSOR Inc.South Koreahttp://sdbiosensor.com/xe/YesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET288Immuno-AntibodyYesNoImmunoassayQualitative10LOD20µg/ml(IgM, IgG)CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedPrecisionNot evaluatedAccuracyNot evaluatedRobustnessNot evaluatedClinical Sensitivity99.1%Clinical Specificity95.09%1152SETRO602Secutronic Technology Co. Ltd.Chinasecutronic.en.made-in-china.com/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood https://secutronic.en.made-in-china.com/product-group/SqEneLFCnzVu/Rapid-Test-Kit-catalog-1.html2022-08-24 09:08:01 CET924Immuno-AntibodyYesYesImmunoassayQualitative10False positives0%False negatives3.12%Accuracy99%Clinical Sensitivity96.88%870COVID-19 Rapid IgG/IgM Combined Antigen Assay Pre-screening Test Kit (Model ERCSS05401)687Sensing Self Pte. Ltd.Singaporewww.sensingself.meYesCommercialisedNoNoAutomatedManualAntibodyWhole blood2022-08-24 09:08:01 CET711Immuno-AntibodyImmunoassay10351EDR COVID 19 Rapid Test Kit (IgM/IgG)687Sensing Self Pte. Ltd.Singaporewww.sensingself.meYesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET218Immuno-AntibodyYesNoImmunoassayQualitativeColorimetryAnalysis of cross reactivityReported as not possibleAccuracy92.8% IgMAccuracy96.5% IgGClinical Sensitivity82% IgMClinical Sensitivity93% IgGClinical Specificity96% IgMClinical Specificity97% IgG2040Novel Coronavirus Neutralizing Antibody Rapid Test Kit940Sensing Self Pte. Ltd.Singaporewww.sensingself.meYesCommercialisedNoNoManualAntibodyPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.3The Novel Coronavirus Neutralizing Antibody Rapid Test Kit is a qualitative product, not applicable to LOD2022-08-24 09:08:01 CET1718Immuno-AntibodyNoImmunochromatographyQualitativeNeutralization Antibody (NAb)10LOD0AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%(377 samples are proven negative of 377 negative specimens)False negatives1.37%(2 samples are proven negative of 144 positive specimens.PrecisionEvaluatedAccuracy99.62%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.63%Clinical Specificity99.99%Type of antigenOther354Cleartest Corona, Covid-19242servoprax GmbHGermanywww.servoprax.de/YesCommercialisedNoNoNear POC / POCAntibody2022-08-24 09:08:01 CET305Immuno-AntibodyYesImmunoassay2028SG Diagnostics COVID-19 Immunity Strength Rapid Test Kit (RBD Neutralizing Antibody)932SG DiagnosticsSingaporewww.sgdiagnostics.comYesCommercialisedNoNoManualAntibodyPlasmaSerumWhole bloodNone2022-08-24 09:08:01 CET1706Immuno-AntibodyNoImmunochromatographyQualitativeMembrane-based10Neutralizing antibodyLOD0AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2AUFalse negatives4AUPrecisionEvaluatedAccuracy97.07%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.19%Clinical Specificity98%Type of antigenOther94509-nCOV IgM/IgG antibody test kits (Colloidal-gold Assay)523Shandong ThinkLab Biotechnology Co. Ltd.Chinayq.yyigou.com/foreign_trade.htmlYesCommercialisedNoNoAutomatedManualAntibody2022-08-24 09:08:01 CET762Immuno-AntibodyImmunoassayColorimetry1015SARTS-CoV2 IgM/IgG antibody test605Shanghai B&C Biological TechnologyChinawww.beixi.com/YesCommercialisedNoNoNear POC / POCAntibodyWhole blood https://www.medicalexpo.es/prod/shanghai-b-c-biological-technology-co-ltd/product-129056-952556.html2022-08-24 09:08:01 CET931Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15Clinical Sensitivity96.6%Clinical Specificity93.8%2178Diagnostic Kit for 2019-nCoV IgM/IgG Antibody (Colloidal Gold)927Shanghai BioGerm Medical Technology Co. Ltd.Chinahttp://en.bio-germ.com/YesCommercialisedNoNoManualAntibodyPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1GammaManual cassette colloidal gold2022-08-24 09:08:01 CET1879Immuno-AntibodyImmunoassayColloidal gold10LOD500AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positivesRequire clinical data comparisonFalse negativesRequire clinical data comparisonPrecisionEvaluatedAccuracy98.36%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.18%Clinical Specificity99.33%Type of antigenOther2312Chemtrue® COVID-19 (SARS-CoV-2) IgM/IgG Antibody Rapid Test Kit (Colloidal Gold)1076Shanghai Chemtron Biotech Co. Ltd.Chinahttp://www.chemtronbio.com/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole bloodOtherproduct code:8038C2022-08-24 09:08:01 CET2013Immuno-AntibodyYesImmunoassayQualitativeColloidal gold15LOD0AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0% IgGCompared with RT-PCR in Clincal datasFalse positives0% IgMCompared with RT-PCR in Clincal datasFalse negatives5.2% IgMcompared with RT-PCT in clincal datasFalse negatives6.9% IgGcompared with RT-PCT in clincal datasPrecisionEvaluatedAccuracy96.83% IgM(Compared with RT-PCR in Clincal datas)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.81% IgMcompared with RT-PCT in clincal datasClinical Sensitivity93.02% IgGcompared with RT-PCT in clincal datasClinical Specificity100% IgMcompared with RT-PCT in clincal datasClinical Specificity100% IgGcompared with RT-PCT in clincal datasType of antigenOther2516Chemtrue® Novel Coronavirus(2019-nCoV) IgG Antibody Diagnostic Kit (Colloidal Gold)1076Shanghai Chemtron Biotech Co. Ltd.Chinahttp://www.chemtronbio.com/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole bloodproduct code:8039C2022-08-24 09:08:01 CET2220Immuno-AntibodyImmunoassayQualitativeColloidal gold15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0% IgG(Compared with RT-PCR in Clincal datas)False negatives2.3% IgG(Compared with RT-PCR in Clincal datas)PrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.67% IgG(Compared with RT-PCR in Clincal datas)Clinical Specificity100% IgG(Compared with RT-PCR in Clincal datas)Type of antigenOther357Chemtrue® Novel Coronavirus(2019-nCoV) IgM Antibody Diagnostic Kit （Colloidal Gold)245Shanghai Chemtron Biotech Co. Ltd.Chinahttp://www.chemtronbio.com/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole bloodOtherproduct code:8035C2022-08-24 09:08:01 CET308Immuno-AntibodyYesImmunoassayQualitative10CalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity89.61% IgMClinical Specificity100% IgMType of antigenOther2311Chemtrue® Novel Coronavirus(2019-nCoV) IgM/IgG Antibody Diagnostic Kit (Colloidal Gold)1076Shanghai Chemtron Biotech Co. Ltd.Chinahttp://www.chemtronbio.com/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole bloodProduct code：8036C2022-08-24 09:08:01 CET2012Immuno-AntibodyImmunoassayQualitativeColloidal gold10LOD0AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0% IgGCompared with RT-PCR in Clincal datasFalse positives0% IgMCompared with RT-PCR in Clincal datasFalse negatives5% IgMCompared with RT-PCR in Clincal datasFalse negatives2% IgGCompared with RT-PCR in Clincal datasPrecisionEvaluatedAccuracy97.83% IgGCompared with RT-PCR in Clincal datasAccuracy96.03% IgMCompared with RT-PCR in Clincal datasReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.35% IgGCompared with RT-PCR in Clincal datasClinical Sensitivity93.51% IgMCompared with RT-PCR in Clincal datasClinical Specificity100% IgGCompared with RT-PCR in Clincal datasClinical Specificity100% IgMCompared with RT-PCR in Clincal datasType of antigenOther1023nCoV IgG/IgM combo test245Shanghai Chemtron Biotech Co. Ltd.Chinahttp://www.chemtronbio.com/YesCommercialisedNoNoNear POC / POCAntibodyWhole blood https://www.technogenetics.it/en/news-events/the-covid-epidemic-in-italy-technogenetics-at-the-forefront2022-08-24 09:08:01 CET937Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry10987COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)527Shanghai International Holding Corp. GmbH(Europe) (DE)Chinawww.cliawaived.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET768Immuno-AntibodyYesNoImmunoassayQualitative10Clinical Sensitivity90%871SARS-CoV-2 IgM/IgG Antibody (Colloidal Gold)239Shanghai Kehua Bio-engineering Co. Ltd.Chinahttp://www.skhb.comYesCommercialisedNoNoAutomatedManualAntibodyWhole blood http://www.deltachemie.it/news.php?id=36 "Diagnotic kit for" was removed from the name of the kit2022-08-24 09:08:01 CET848Immuno-AntibodyNoImmunoassayQualitativeColorimetry15614Novel Coronavirus (SARS-CoV-2) Antibody (IgM / IgG) Test (Colloidal Gold)378Shanghai Outdo Biotech Co. Ltd.Chinawww.superchip.com.cn/YesCommercialisedNoNoNear POC / POCAntibody2022-08-24 09:08:01 CET523Immuno-AntibodyYesImmunoassayColloidal gold2621SARS-CoV-2 Neutralizing Antibody Detection Kit(Fluorescence Immunoassay)993Shen Zhen Zi Jian Biotechnology Co. Ltd.Chinahttp://www.szzijian.com/YesCommercialisedNoNoManualAntibodyPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2Zetahttp://www.szzijian.com/2022-08-24 09:08:01 CET2326Immuno-AntibodyNoImmunoassayFluorescence15LOD1IU/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.03AUFalse negatives0.05AUPrecisionEvaluatedAccuracy95.47%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.16%Clinical Specificity97.44%Type of antigenOther2558SARS-CoV-2 Neutralizing Antibody Rapid Detection Kit (Colloidal Gold)993Shen Zhen Zi Jian Biotechnology Co. Ltd.Chinahttp://www.szzijian.com/YesCommercialisedNoNoManualAntibodyPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2Zetaspike proteinhttp://www.szzijian.com/2022-08-24 09:08:01 CET2263Immuno-AntibodyYesImmunoassayColloidal gold15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.03AUFalse negatives0.05AUPrecisionEvaluatedAccuracy95.47%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.16%Clinical Specificity97.44%Type of antigenSpike protein1998COVID-19 IgM/IgG Rapid Test Kit915Shenzhen Dakewe Bio-engineering Co. Ltd.Chinawww.dakewe.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood[Reagents and Materials Provided] COVID-19 IgM/IgG Rapid Test (20 each) Foil pouched test device containing one test strip which is encased in plastic device cassette, one pipette for blood transfer, and one piece of desiccants. Buffer Vial (1 each) The buffer vial contains 10ml phosphate buffered saline (PBS) for sample dilution. Package Insert (1 each) Instructions for use.2022-08-24 09:08:01 CET1675Immuno-AntibodyImmunochromatographyQualitative15LOD0AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives1.92%(7/364)False negatives6.12%(15/245)PrecisionEvaluatedAccuracy96.4%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity93.9%Clinical Specificity98.1%Type of antigenOther1161SARS-CoV-2 IgM/IgG Duo Test (Colloidal Gold)609Shenzhen Dymind Biotechnology Co. Ltd.Chinawww.dymind.comYesCommercialisedNoNoManualAntibodySerumWhole blood2022-08-24 09:08:01 CET942Immuno-AntibodyNoImmunoassayQualitativeColorimetry15False positives5AUFalse negatives10AU946SARS-CoV- IgM IgG Test Kit (Colloidal Gold)469Shenzhen GeneBioHealth Co. Ltd.Chinawww.genebiohealth.com/en/YesCommercialisedNoNoAutomatedManualAntibodyWhole blood2022-08-24 09:08:01 CET860Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry101345Novel Corona- virus IgM/IgG Combo Rapid Test653Shenzhen Highcreation Technology Co. Ltd.Chinawww.hkrgr.com/YesCommercialisedNoNoNear POC / POCAntibodyPeripheral bloodPlasmaSerumWhole bloodnucleocapsid protein2022-08-24 09:08:01 CET1126Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15LOD0.1AUFalse positives1%False negatives1%Accuracy98.1% IgGAccuracy96.7% IgMClinical Sensitivity93% IgGClinical Sensitivity91.6% IgMType of antigennucleoprotein1817SARS-CoV-2 Antibodies Test Kit (Latex particle-enhanced turbidimetric immunoassay)824Shenzhen Kisshealth Biotechnology Co. Ltd.Chinahttp://en.kisshealth.cn/YesCommercialisedNoNoManualAntibodySerum2022-08-24 09:08:01 CET1495Immuno-AntibodyImmunoassay10LOD0.5AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives1%≤1%False negatives0%NonePrecisionEvaluatedAccuracy96.79%ReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity96.25%Clinical Specificity97.37%1816SARS-CoV-2 Neutralizing Antibodies Test Kit (Latex particle-enhanced turbidimetric immunoassay)824Shenzhen Kisshealth Biotechnology Co. Ltd.Chinahttp://en.kisshealth.cn/YesCommercialisedNoNoManualAntibodySerum2022-08-24 09:08:01 CET1494Immuno-AntibodyImmunoassayNeutralization Antibody (NAb)10LOD0.5AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives1%≤1%False negatives0%NonePrecisionEvaluatedAccuracy98.2%ReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity98.32%Clinical Specificity98.1%2181fluorecare SARS-CoV-2 Antibody Test Kit (Colloidal Gold Chromatographic Immunoassay) 1010Shenzhen Microprofit Biotech Co. Ltd.Chinawww.microprofit-bio.comYesCommercialisedNoNoManualAntibodyPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351Betawww.microprofit-bio.com2022-08-24 09:08:01 CET1882Immuno-AntibodyNoImmunochromatographyQualitativeColloidal gold10LOD5AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives2%PrecisionEvaluatedAccuracy99.13 (97.48%～99.82%)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.33% (77.93%～99.18%)Clinical Specificity99.68% (98.24%～99.99%)Type of antigenOther2182fluorecare SARS-CoV-2 Antibody Test Kit (Fluorescence Immunoassay)1010Shenzhen Microprofit Biotech Co. Ltd.Chinawww.microprofit-bio.comYesCommercialisedNoNoManualAntibodyPlasmaSerum689B.1.1.7Alpha1032B.1.351Betawww.microprofit-bio.com2022-08-24 09:08:01 CET1883Immuno-AntibodyYesImmunochromatographyQuantitativeFluorescence15LOD0.001AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives6%False negatives0.3%PrecisionEvaluatedAccuracy99.13% (97.48%～99.82%)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.33%(77.93%～99.18%)Clinical Specificity99.68% (98.24%～99.99%)Type of antigenOther2168fluorecare SARS-CoV-2 Neutralizing Antibody Test Kit (Fluorescence Immunoassay)1010Shenzhen Microprofit Biotech Co. Ltd.Chinawww.microprofit-bio.comYesCommercialisedNoNoManualAntibodyPlasmaSerum689B.1.1.7Alpha1032B.1.351Betawww.microprofit-bio.com2022-08-24 09:08:01 CET1869Immuno-AntibodyYesImmunochromatographyQuantitativeFluorescence15LOD1AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives4.3%PrecisionEvaluatedAccuracy100%( Neutralizing Antibody)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.06% (95% CI 90.50-97.84%)Clinical Specificity99% (95% CI 94.55-99.98%)Type of antigenOther808SARS-CoV-2 IgG & IgM Antibody Combined Test Kit (Colloidal Gold Chromatographic Immunoassay)563Shenzhen Microprofit Biotech Co. Ltd.Chinawww.microprofit-bio.comYesCommercialisedNoNoAutomatedManualAntibodyWhole blood2022-08-24 09:08:01 CET824Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry101227SARS-CoV-2 IgG and IgM Antibody Combined Test Kit (Fluorescence Immunoassay)563Shenzhen Microprofit Biotech Co. Ltd.Chinawww.microprofit-bio.comYesCommercialisedNoNoLab-basedAntibody2022-08-24 09:08:01 CET1012Immuno-AntibodyImmunoassay2620SARS-CoV-2 Neutralizing Antibody Test Kit (Colloidal Gold Chromatographic Immunoassay)1010Shenzhen Microprofit Biotech Co. Ltd.Chinawww.microprofit-bio.comYesCommercialisedNoNoManualAntibodyPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1321B.1.617.2Delta2041C.37Lambdawww.microprofit-bio.com2022-08-24 09:08:01 CET2325Immuno-AntibodyImmunochromatographyColloidal gold15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives3.5%PrecisionEvaluatedAccuracy98.25%98.25%( Neutralizing Antibody)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.5%( Neutralizing Antibody)Clinical Specificity100%( Neutralizing Antibody)Type of antigenSpike protein1076SARS-CoV-2 IgG assay576Shenzhen Mindray Bio-Medical Electronics Co. Ltd.Chinawww.mindray.com/en/index.htmlYesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET854Immuno-AntibodyImmunoassayChemiluminescenceCalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluated1071Severe Acute Respiratory Syndrome Coronavirus 2 IgG (CLIA)576Shenzhen Mindray Bio-Medical Electronics Co. Ltd.Chinawww.mindray.com/en/index.htmlYesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET847Immuno-AntibodyCLIAChemiluminescenceCalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluated1072Severe Acute Respiratory Syndrome Coronavirus 2 IgM (CLIA)576Shenzhen Mindray Bio-Medical Electronics Co. Ltd.Chinawww.mindray.com/en/index.htmlYesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET849Immuno-AntibodyImmunoassayChemiluminescenceCalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluated651COVID-19 IgG/IgM Rapid Test Kit399Shenzhen Reagent Technology Co. Ltd.YesCommercialisedNoNoNear POC / POCAntibody2022-08-24 09:08:01 CET548Immuno-AntibodyYesImmunoassay10842019-nCoV IgG Control379SHENZHEN YHLO BIOTECH Co. Ltd.Chinahttp://www.szyhlo.comYesCommercialisedNoNoOtherAntibody2022-08-24 09:08:01 CET867Immuno-AntibodyYesImmunoassay10852019-nCoV IgM Control379SHENZHEN YHLO BIOTECH Co. Ltd.Chinahttp://www.szyhlo.comYesCommercialisedNoNoOtherAntibody2022-08-24 09:08:01 CET868Immuno-AntibodyImmunoassay17062019-nCoV NAb Control (CLIA)379SHENZHEN YHLO BIOTECH Co. Ltd.Chinahttp://www.szyhlo.comYesCommercialisedNoNoAutomatedManualAntibodyOther2022-08-24 09:08:01 CET1386Immuno-AntibodyYesOtherChemiluminescence30LOD0AUCalibrationNot evaluatedAnalysis of cross reactivityNot evaluatedPrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluated1083GLINE-2019-nCoV IgA379SHENZHEN YHLO BIOTECH Co. Ltd.Chinahttp://www.szyhlo.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaWhole blood2022-08-24 09:08:01 CET524Immuno-AntibodyYesImmunoassayQualitativeColorimetry151082GLINE-2019-nCoV IgM/IgG379SHENZHEN YHLO BIOTECH Co. Ltd.Chinahttp://www.szyhlo.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole bloodhttps://pdf.medicalexpo.com/pdf/shenzhen-yhlo-biotech-co-ltd/reagent-sars-cov-2-poct/107786-227353.html2022-08-24 09:08:01 CET1589Immuno-AntibodyNoImmunoassayQualitativeColorimetry15Clinical Sensitivity88.55% IgMClinical Sensitivity94.58% IgGClinical Sensitivity96.39%1701GLINE-2019-nCoV NAb379SHENZHEN YHLO BIOTECH Co. Ltd.Chinahttp://www.szyhlo.comYesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET1381Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15LOD10AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0AUFalse negatives0AUPrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%5/51081iFlash-2019-nCoV IgA379SHENZHEN YHLO BIOTECH Co. Ltd.Chinahttp://www.szyhlo.comYesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET866Immuno-AntibodyYesImmunoassayQualitativeChemiluminescence1477iFlash-2019-nCoV NAb379SHENZHEN YHLO BIOTECH Co. Ltd.Chinahttp://www.szyhlo.comYesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET1226Immuno-AntibodyYesImmunoassayQualitativeNeutralization Antibody (NAb)LOD-1AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedReproducibilityEvaluatedRobustnessNot evaluated1079iFlash-SARS-CoV-2 IgG379SHENZHEN YHLO BIOTECH Co. Ltd.Chinahttp://www.szyhlo.comYesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum https://pdf.medicalexpo.com/pdf/shenzhen-yhlo-biotech-co-ltd/clia-iflash-3000/107786-227346.html2022-08-24 09:08:01 CET1851Immuno-AntibodyImmunoassay2697iFlash-SARS-CoV-2 IgG-S1233SHENZHEN YHLO BIOTECH Co. Ltd.ChinaYesCommercialisedNoNoAntibodyThe iFlash-SARS-CoV-2 IgG-S has obtained the CE marking, and its clinical performance verification and analytical performance verification has also been completed.2022-08-24 09:08:01 CET2402Immuno-Antibody37CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.74%2/270False negatives3.08%2/65PrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.92%IgG-SClinical Specificity99.26%IgG-SType of antigenSpike protein1080iFlash-SARS-CoV-2 IgM379SHENZHEN YHLO BIOTECH Co. Ltd.Chinahttp://www.szyhlo.comYesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum https://pdf.medicalexpo.com/pdf/shenzhen-yhlo-biotech-co-ltd/clia-iflash-3000/107786-227346.html2022-08-24 09:08:01 CET863Immuno-AntibodyYesImmunoassayQualitativeChemiluminescence30LOD10U/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity80.8%7 daysClinical Sensitivity92.3%8-14 days1478UNICELL-2019-nCoV NAb379SHENZHEN YHLO BIOTECH Co. Ltd.Chinahttp://www.szyhlo.comYesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET1227Immuno-AntibodyYesImmunoassayQualitative15LOD0AUCalibrationNot evaluatedAnalysis of cross reactivityNot evaluatedPrecisionEvaluatedReproducibilityEvaluatedRobustnessNot evaluated616SARS-Cov-2 IgG/IgM Antibody Assay Kit by Immunofluorescence Chromatography Method743Sichuan Xincheng Biological Co. Ltd.Chinawww.xinchengbio.com/en/YesCommercialisedNoNoNear POC / POCAntibodyWhole bloodnucleocapsid proteinspike protein2022-08-24 09:08:01 CET479Immuno-AntibodyYesYesChromatographyQualitativeFluorescence8Accuracy93.3%Type of antigenN-protein, S2-ECD, S1-RBD; N-protein, S2-ECD, S1-RBD; N-protein, S2-ECD, S1-RBD1661SARS-Cov-2 IgG/M Antibody Assay kit by Colloidal Gold Method743Sichuan Xincheng Biological Co. Ltd.Chinawww.xinchengbio.com/en/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET1340Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15LOD500AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.71%False negatives4.37%PrecisionEvaluatedAccuracy92.3% IgMAccuracy97.3% IgGReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity85.6% IgMClinical Sensitivity95.6% IgG2022ADVIA Centaur CP SARS-CoV-2 IgG (sCOVG)444Siemens HealthineersGermanywww.siemens-healthineers.comYesCommercialisedNoNoLab-basedOtherAntibodyOtherPlasmaSerumGood correlation and strong relationship between Index values and neutralizing antibody titers2022-08-24 09:08:01 CET1700Immuno-AntibodyImmunoassayQuantitativeSandwich50LOD0.5AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives-False negatives-PrecisionEvaluatedAccuracyIgGReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity96.41%@ 21 days after PCR : (95% CI: 92.74%–98.54%)Clinical Specificity99.9%(95% CI: 99.64%–99.99%)2023Atellica IM SARS-CoV-2 IgG (sCOVG)444Siemens HealthineersGermanywww.siemens-healthineers.comYesCommercialisedNoNoLab-basedAntibodyOtherPlasmaSerumGood correlation and strong relationship between Index values and neutralizing antibody titers.2022-08-24 09:08:01 CET1701Immuno-AntibodyNoImmunoassayQuantitativeSandwich25support: Magnetic particlesLOD0.5AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracyIgGReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.41%@ 21 days after PCR: (95% CI):92.74%–98.54%))Clinical Specificity99.9%(95% CI: 99.64%–99.99%)1049SARS-CoV-2 Total (COV2T) assay444Siemens HealthineersGermanywww.siemens-healthineers.comYesCommercialisedNoNoLab-basedAntibodyPlasmaSerum2022-08-24 09:08:01 CET820Immuno-AntibodyImmunoassayQualitativeChemiluminescenceClinical Sensitivity98.1%CI: 96.6 - 99.1Clinical Specificity99.9%CI: 99.4 - 1001731Antibody kit igg igm testing767Silversite diagnostics.corpUnited StatesWww.adam.comYesCommercialisedNoNoNear POC / POCAntibodySerum2022-08-24 09:08:01 CET1411Immuno-AntibodyNoImmunoassayQualitative15LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.9%Type of antigennucleoprotein1155COVID-19 IgG/IgM Detection Kit (Colloidal Gold)604SINGUWAY BIOTECH Inc.Chinawww.singuway.com/english/index.phpYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET930Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry10990SARS-CoV-2 Antibody Test strip (colloidal Gold Method)528SinocareChinawww.sinocareintl.comYesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET769Immuno-AntibodyYesNoImmunoassayQualitative20Clinical Sensitivity95%CI: 95-96.3Clinical Specificity99.2%CI: 99.2-99.62631SSmarTest COVID19 Spike Protein Ab(IgM/IgG) Test1201SLSBio Co. Ltd.South Koreawww.slabs.co.krYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood with anti-coagulantsmatrix equivalence study and Antibody class specificity test were conducted and test results confirmed that the test results for each matrix were 100% identical and there is no cross-reaction to class specificity of IgM to IgG.2022-08-24 09:08:01 CET2336Immuno-AntibodyNoImmunochromatographyQualitativeMembrane-based20CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives4.85%False positives are 5/103 samplesFalse negatives9.4%False negatives are 5/53 damplesPrecisionEvaluatedAccuracy92.86%IgG+IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90.57%IgG+IgMClinical Specificity95.15%IgG+IgMType of antigenSpike protein374MAGLUMI 2019-nCoV IgG (CLIA)255Snibe Co. Ltd.Chinawww.snibe.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET318Immuno-AntibodyYesImmunoassayQuantitative30375MAGLUMI 2019-nCoV IgM (CLIA)255Snibe Co. Ltd.Chinawww.snibe.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET319Immuno-AntibodyYesImmunoassayQuantitative301491MAGLUMI SARS-CoV-2 Neutralizing Antibody (CLIA)255Snibe Co. Ltd.Chinawww.snibe.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET1241Immuno-AntibodyYesCLIAQualitativeChemiluminescence30LOD0AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy100%(93.69-100.00) % determined by testing 57 samples confirmed SARS-CoV-2 VNT50 ? 20ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity100%(93.69-100.00) % determined by testing 57 samples confirmed SARS-CoV-2 VNT50 ? 201299MAGLUMI SARS-CoV-2 S-RBD IgG (CLIA)255Snibe Co. Ltd.Chinawww.snibe.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET1069Immuno-AntibodyCLIAQuantitativeManual or automated other Clinical Sensitivity0-7days Post Onset of Symptoms: 74.5%; 8-14 days Post Onset of Symptoms: 97.9%; ? 15 days: 100%1086CoV-Check - COVID-19 IgG/IgM Test623Spark Diagnostics LLCIndiawww.sparkdiagnostics.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood https://sparkdiagnostics.com/cov-check/2022-08-24 09:08:01 CET1011Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracy94.74%IgG,IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity70.6% IgMClinical Sensitivity90.4% IgG2186LFA COVID-19 IgG & IgM Rapid Test Device1018Spartacus-BiomedFrancewww.spartacus-biomed.frYesCommercialisedNoNoManualAntibodyPeripheral bloodPlasmaSerumVenous whole bloodWhole bloodWhole blood with anti-coagulants689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2Zetanucleocapsid proteinAdditional and Independent validation by the French Reference Center (Pasteur Institute Paris) Validated by the French National Agency of Health product (ANSM) and Health Authorities (HAS). Referenced on the French Ministry of Health website for COVID (https://covid-19.sante.gouv.fr/tests) Registered by the Ministry of Health in Spain and Portugal.2022-08-24 09:08:01 CET1887Immuno-AntibodyYesNoImmunochromatographyQualitativeSandwich10LOD1CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0% IgGFalse positives1% IgMFalse negatives1% IgGFalse negatives2% IgMPrecisionEvaluatedAccuracy96% IgGAccuracy96% IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96% IgGClinical Sensitivity92% IgMClinical Specificity100% IgGClinical Specificity100% IgMType of antigenNucleoprotein2616SPESERA Covid-19 Antibody IgG-IgM Rapid Test Cassette1045SPESERA SAÄžLIK ÃœRÃœNLERÄ° İÇ VE DIÅž Ltd. ÅžTÄ°.Turkeywww.spesera.com.trYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole bloodWhole blood with anti-coagulantswww.spesera.com.tr2022-08-24 09:08:01 CET2321Immuno-AntibodyYesImmunochromatographyQualitativeMembrane-based15LOD580TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives5.04%17/337False negatives5.22%29/555PrecisionEvaluatedAccuracy95.09%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.19%Clinical Specificity95.03%Type of antigenOther2615SPESERA Covid-19 Antibody Neutralizing Rapid Test Cassette1045SPESERA SAÄžLIK ÃœRÃœNLERÄ° İÇ VE DIÅž Ltd. ÅžTÄ°.Turkeywww.spesera.com.trYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole bloodWhole blood with anti-coagulantswww.spesera.com.tr2022-08-24 09:08:01 CET2320Immuno-AntibodyYesImmunochromatographyQualitativeNeutralization Antibody (NAb)15LOD580TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.19%4/335False negatives0.81%3/366PrecisionEvaluatedAccuracy99.01%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.2%Clinical Specificity99.17%Type of antigenOther618COVID-19 IgG/IgM Rapid Test (colloidal gold-based)1397SPRING HEALTHCARE SERVICES SP Z O OPolandwww.springhealthcare.orgYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerum2022-08-24 09:08:01 CET526Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry10False positivesEvaluatedFalse negativesEvaluatedAccuracy97%Clinical Sensitivity91%Clinical Specificity99%1113SGT anti-SARS-CoV-2 total Ab ELISA261Sugentech Inc.South Koreawww.sugentech.comYesCommercialisedNoNoAutomatedManualAntibody from website (Clinical Specificity: 99.0%; Clinical Sensitivity: 87.5% (vs. RT-PCR confirmed samples); Accuracy: 96.8%); "MATERIALS PROVIDED1. CoV-Check COVID-19 IgG/IgM Test Device (Kit Size: 25 Tests / Box)2. Sample Buffer (1 Bottle – 3.0 ml)3. 2 ?L Capillary Pipette (25 pipettes / Bag)4. Instructions for Use – 1LIMITATIONS1. CoV-Check COVID-19 IgG/IgM Test Device is limited to the qualitative detection of anti-2019-nCoV antibody levels in serum, plasma, or whole blood specimen. The exact concentration of anti-2019-nCoV antibody cannot be determined by this assay.2. Although the test is very accurate in detecting anti-2019-nCoV antibody, a low incidence of false results can occur. Other clinically available tests are required if questionable results are obtained.3. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.4. In the early stage of infection, if IgM and IgG antibodies are not produced or the titer is very low, false negative results will occur. It is recommended that patients should collect samples again after 7-14 days, and test both the previously collected sample and the latest sample at the same time and compare the results to confirm whether there is serological positive conversion or significant increase in titer. In the later stage of infection, IgM titer will decrease or even be negative, while IgG will continue to increase" 2022-08-24 09:08:01 CET890Immuno-AntibodyNoYesELISA150Manual or automated 388SGTi-flex COVID-19 IgM/IgG (RDT)261Sugentech Inc.South Koreawww.sugentech.comYesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET326Immuno-AntibodyYesImmunoassayQualitativeColorimetry392SARS-CoV-2 IgG Ab Rapid Test262Sure Bio-Tech (USA) Co. Ltd.United Stateswww.surebiotech.com/YesCommercialisedNoNoNear POC / POCAntibodynucleocapsid protein2022-08-24 09:08:01 CET329Immuno-AntibodyYesImmunoassayQualitativeType of antigennucleocapsid protein391SARS-CoV-2 IgM Ab Rapid Test262Sure Bio-Tech (USA) Co. Ltd.United Stateswww.surebiotech.com/YesCommercialisedNoNoNear POC / POCAntibodynucleocapsid protein2022-08-24 09:08:01 CET328Immuno-AntibodyYesImmunoassayQualitativeType of antigennucleocapsid protein390SARS-CoV-2 IgM/IgG Ab Rapid Test262Sure Bio-Tech (USA) Co. Ltd.United Stateswww.surebiotech.com/YesCommercialisedNoNoNear POC / POCAntibodyWhole bloodnucleocapsid protein2022-08-24 09:08:01 CET327Immuno-AntibodyYesNoImmunoassayQualitative15Type of antigennucleocapsid protein466Rapid Immunoassay Test Cassette288SureScreen DiagnosticsUnited Kingdomwww.surescreen.comYesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET375Immuno-AntibodyYesNoImmunoassayQualitative10False positivesEvaluatedFalse negativesEvaluatedAccuracy99.6% IgGAccuracy97.8% IgMClinical Sensitivity100% IgGClinical Sensitivity91.8% IgMClinical Specificity99.5% IgGClinical Specificity97.2% IgM749SureScreen COVID19 IgM/IgG Rapid Test Cassette288SureScreen DiagnosticsUnited Kingdomwww.surescreen.comYesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET817Immuno-AntibodyYesNoImmunoassayQualitativeNot found10Analysis of cross reactivityEvaluatedAccuracy97.8% IgMAccuracy99.6% IgGClinical Sensitivity91%Clinical Specificity99%1932COVID-19 IgG/IgM Antibody Assay Kit(Colloidal Gold Method)884Surge Medical Inc.Chinawww.surgemedical.cnYesCommercialisedNoNoLab-basedAntibodyPlasmaSerumWhole blood689B.1.1.7Alpha1032B.1.351Beta1518P.2Zetanucleocapsid proteinI updated the website and country, and Variants detection. Thanks.2022-08-24 09:08:01 CET1608Immuno-AntibodyYesYesImmunoassayQualitativeColloidal gold15LOD0.01U/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2.04%(97.96)False negatives3.04%(96.96)PrecisionEvaluatedAccuracy95.87%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.96%Clinical Specificity97.96%Type of antigenNucleoprotein2762COVID-19 Neutralizing Antibody Test Kit884Surge Medical Inc.Chinawww.surgemedical.cnYesCommercialisedNoNoLab-basedManualAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET2467Immuno-AntigenNoImmunochromatographyNeutralization Antibody (NAb)10LOD10AU/mLCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.6%False negatives0.8%PrecisionEvaluatedAccuracy98.8%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.4%Clinical Specificity99.2%2042SARS-CoV-2 IgG (Chemiluminescent Immunoassay)942Suzhou Hybiome Biomedical Engineering Co. Ltd.Chinahttps://www.hybiome.com/YesCommercialisedNoNoAutomatedLab-basedAntibodyPlasmaSerumS-RBD, physical support= magnetic microparticles2022-08-24 09:08:01 CET1720Immuno-AntibodyYesCLIAQualitativeChemiluminescence60LOD0AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.1% IgGFalse negatives0.6% IgGPrecisionEvaluatedAccuracy99.1% IgGReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.4% IgGClinical Specificity98.9% IgGType of antigenOther2043SARS-CoV-2 IgM (Chemiluminescent Immunoassay)942Suzhou Hybiome Biomedical Engineering Co. Ltd.Chinahttps://www.hybiome.com/YesCommercialisedNoNoAutomatedLab-basedAntibodyPlasmaSerumS-RBD, physical support=Magnetic microparticles2022-08-24 09:08:01 CET1721Immuno-AntibodyYesCLIAQualitativeChemiluminescence60LOD0AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.3% IgMFalse negatives3% IgMPrecisionEvaluatedAccuracy98.3% IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97% IgMClinical Specificity98.7% IgMType of antigenOther2901SeroCap Anti-SARS-CoV-2 Neutralizing Kit1280Synbiotik BiotechnologyTurkeyhttps://synbiotiktr.comYesCommercialisedNoNoManualAntibodyPlasmaSerumspike proteinThe Synbiotik SeroCap Anti-SARS-CoV-2 Neutralizing ELISA is an enzyme-linked immunosorbent assay intended fot the qualitative and semi-quantitative detection of neutralizing antibodies to SARS-CoV-2 in human serum in vitro. The SeroCap Anti-SARS-CoV-2 Neutralizing ELISA is intended to us efor identifiying individuals with adaptive immune response to SARS-CoV-2, due to recent/prior infection. The SeroCap Neutralizing ELISA kits are designed to capture specifically neutralizing antibodies against SARS-CoV-2. SeroCap SARS-CoV-2 Neutralizing ELISA kit displayed 94% sensitivity and 100% specificity against clinical samples with known neutralizing antbody titers. The inter-assay and the intra-assay CV of OD ratios are less then 15%.2022-08-24 09:08:01 CET2606Immuno-AntigenNoYesELISASemiquantitativeNeutralization Antibody (NAb)150LOD500AUCalibrationEvaluatedAnalysis of cross reactivityNot evaluatedFalse positives3AUFalse negatives0%PrecisionEvaluatedAccuracy97%NAbReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94%NAbClinical Specificity100%NAb619COVID-19 IgG/IgM Rapid Test Cassette371Syrona LimitedUnited Kingdomwww.syronawomen.com/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumnucleocapsid proteinspike protein2022-08-24 09:08:01 CET512Immuno-AntibodyYesImmunoassayQualitative10Type of antigenS1 subunit of the spike protein (S), Nucleocapid phosphoprotein (N)2700FORA SARS-CoV-2 Antibody Rapid Test (Neutralizing Antibody)588TaiDoc Technology Corp.Taiwan ROChttps://taidoc.com/YesCommercialisedNoNoManualAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET2405Immuno-AntibodyYesNoImmunochromatographyQualitativeNeutralization Antibody (NAb)15CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives≦1%False negatives≦6.7%PrecisionEvaluatedAccuracy≧97.7% (IgG)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity≧93.3% (IgG)Clinical Specificity≧99.0% (IgG)2701URIGHT SARS-CoV-2 Antibody Rapid Test (Neutralizing Antibody)588TaiDoc Technology Corp.Taiwan ROChttps://taidoc.com/YesCommercialisedNoNoManualAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET2406Immuno-AntibodyYesNoImmunochromatographyQualitativeNeutralization Antibody (NAb)15CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives≦1%False negatives≦6.7%PrecisionEvaluatedAccuracy≧97.7% (IgG)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity≧93.3% (IgG)Clinical Specificity≧99.0% (IgG)2702VTRUST SARS-CoV-2 Antibody Rapid Test (Neutralizing Antibody)588TaiDoc Technology Corp.Taiwan ROChttps://taidoc.com/YesCommercialisedNoNoManualAntibodyPlasmaSerumWhole bloodN/A2022-08-24 09:08:01 CET2407Immuno-AntibodyYesNoImmunochromatographyQualitativeNeutralization Antibody (NAb)15CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives≦1%False negatives≦6.7%PrecisionEvaluatedAccuracy≧97.7% (IgG)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity≧93.3% (IgG)Clinical Specificity≧99.0% (IgG)2649SARS-CoV-2 IgG/IGM Rapid t1210Taizhou ZECEN Biotech Co. Ltd.Chinahttp://www.zechengbio.comYesCommercialisedNoNoManualAntibodyPlasmaSerumWhole blood1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.3Antibody test, no antigen2022-08-24 09:08:01 CET2354Immuno-AntibodyNoNoImmunochromatographyQualitativeMembrane-based15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.3Test 153 negative samples, 2 results are postive;False negatives3.63Test 55 postive samples, 2results are negative;PrecisionEvaluatedAccuracy98.1%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.4%Clinical Specificity98.7%620COVID - 19 RAPID TEST KIT / Antibody IgG & IgM Test Kit383Tauschen Int. Ltd. (Tauschen Groups)Hong Kong S.A.Rwww.tauschenhk.com/YesCommercialisedNoNoNear POC / POCAntibodynucleocapsid protein https://www.testlinecd.com/file/1580/COVID-19_AN_NEW%20(002).pdf?version=202008131535 Additional info available only upon request2022-08-24 09:08:01 CET528Immuno-AntibodyYesImmunoassayType of antigennucleocapsid recombinant antigen (NP)1690SARS-CoV-2 IgM/IgG Ab Test1178Türklab Tibbi Mal. San. ve Tic. A.S.TurkeyYesCommercialisedNoNoNear POC / POCAntibody2022-08-24 09:08:01 CET1369Immuno-AntibodyYesNoImmunoassayQualitative15LOD15AU1723Toyo SARS-CoV-2 IgM/IgG Ab Test1178Türklab Tibbi Mal. San. ve Tic. A.S.TurkeyYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole bloodnucleocapsid protein2022-08-24 09:08:01 CET1403Immuno-AntibodyYesNoImmunoassayQualitative15LOD0AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedPrecisionNot evaluatedAccuracy96.17% IgGAccuracy93.33% IgMReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity92.88% IgGClinical Sensitivity87.54% IgMType of antigennucleoprotein1336TBG SARS-CoV-2 IgG/IgM Rapid Test Kit406TBG Biotechnology Corp.Australiawww.tbgbio.com/enYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET559Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry151337Corona Virus Disease-19(COVID-19)IgG/IgM Rapid649TBG BIOTECHNOLOGY XIAMEN Inc.Chinawww.tbgxm.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET1109Immuno-AntibodyYesImmunoassayQualitativeColorimetry151024RAPID TEST SARS-CoV-2 IgM/IgG GOLD540Technogenetics SRLItalywww.technogenetics.itYesCommercialisedNoNoNear POC / POCAntibodyWhole bloodenvelope proteinnon-structural protein NSP3nucleocapsid proteinORF1a polyproteinORF1ab polyproteinOtherspike protein https://www.testlinecd.com/file/1580/COVID-19_AN_NEW%20(002).pdf?version=202008131535 https://www.technogenetics.it/en/products-1/covid-192022-08-24 09:08:01 CET783Immuno-AntibodyYesNoImmunoassayQualitative15Type of antigenCombination of selected parts of the specific antigens of SARS-CoV-2 (NCP, RBD, Spike S2, E, ACE2, PLPro protein) and antigens for exclusion cross-reactivity with other endemic coronaviruses (MERS-CoV, SARS-CoV, HCoV 229E Np, HCoV NL63 Np).1100EIA COVID-19 NP IgA591TestLine Clinical Diagnostics s.r.o.Czechiawww.testlinecd.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum https://www.testlinecd.com/eia-covid-19-np-iga2022-08-24 09:08:01 CET891Immuno-AntibodyYesImmunoassaySemiquantitativeFluorescence90Clinical Sensitivity97.43%1101EIA COVID-19 NP IgG591TestLine Clinical Diagnostics s.r.o.Czechiawww.testlinecd.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum https://www.testlinecd.com/eia-covid-19-np-igg2022-08-24 09:08:01 CET892Immuno-AntibodyYesImmunoassaySemiquantitativeFluorescence90Clinical Sensitivity95.12%1102EIA COVID-19 NP IgM591TestLine Clinical Diagnostics s.r.o.Czechiawww.testlinecd.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum https://www.testlinecd.com/eia-covid-19-np-igm2022-08-24 09:08:01 CET893Immuno-AntibodyYesImmunoassaySemiquantitativeFluorescence90Clinical Sensitivity95.65%1136EIA COVID-19 RBD IgA591TestLine Clinical Diagnostics s.r.o.Czechiawww.testlinecd.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum pending patent issues 2022-08-24 09:08:01 CET925Immuno-AntibodyYesImmunoassayQualitativeFluorescence90Clinical Sensitivity96.6%1137EIA COVID-19 RBD IgG591TestLine Clinical Diagnostics s.r.o.Czechiawww.testlinecd.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum pending patent issues 2022-08-24 09:08:01 CET926Immuno-AntibodyYesImmunoassayQuantitativeFluorescence90Clinical Sensitivity99.9%1138EIA COVID-19 RBD IgM591TestLine Clinical Diagnostics s.r.o.Czechiawww.testlinecd.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerumPending patent issues 2022-08-24 09:08:01 CET927Immuno-AntibodyYesImmunoassayQualitativeFluorescence90Clinical Sensitivity97.5%1106Microblot-Array COVID-19 IgA591TestLine Clinical Diagnostics s.r.o.Czechiawww.testlinecd.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum https://www.testlinecd.com/microblot-array-covid-19-iga?d=2312022-08-24 09:08:01 CET882Immuno-AntibodyYesImmunoassayQuantitativeFluorescence75Clinical Sensitivity98.28%1107Microblot-Array COVID-19 IgG591TestLine Clinical Diagnostics s.r.o.Czechiawww.testlinecd.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum https://www.trivitron.com/uploads/brochure/15897931402Covid_Flyer_-_Biocard_Test_V.2.pdf https://www.testlinecd.com/microblot-array-covid-19-igg?d=2312022-08-24 09:08:01 CET884Immuno-AntibodyYesImmunoassayQuantitativeFluorescence75Clinical Sensitivity98.71%1108Microblot-Array COVID-19 IgM591TestLine Clinical Diagnostics s.r.o.Czechiawww.testlinecd.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum https://www.trivitron.com/uploads/brochure/15967069992Covid_Kavach_Anti-SARS_CoV-2_Human_IgG_ELISA_eBrochure.pdf https://www.testlinecd.com/microblot-array-covid-19-igm?d=2312022-08-24 09:08:01 CET886Immuno-AntibodyNoYesImmunoassayQuantitativeFluorescence75Clinical Sensitivity97.72%1103SmartEIA COVID-19 NP IgA591TestLine Clinical Diagnostics s.r.o.Czechiawww.testlinecd.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum https://www.testlinecd.com/smarteia-covid-19-np-iga?d=2312022-08-24 09:08:01 CET894Immuno-AntibodyYesImmunoassaySemiquantitativeFluorescence90Clinical Sensitivity97.43%1104SmartEIA COVID-19 NP IgG591TestLine Clinical Diagnostics s.r.o.Czechiawww.testlinecd.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum https://www.testlinecd.com/smarteia-covid-19-np-igg?d=2312022-08-24 09:08:01 CET895Immuno-AntibodyYesImmunoassaySemiquantitativeFluorescence90Clinical Sensitivity95.12%1105SmartEIA COVID-19 NP IgM591TestLine Clinical Diagnostics s.r.o.Czechiawww.testlinecd.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum https://www.testlinecd.com/smarteia-covid-19-np-igm?d=2312022-08-24 09:08:01 CET896Immuno-AntibodyYesImmunoassaySemiquantitativeFluorescence90Clinical Sensitivity95.65%Type of antigenSARS-CoV-2 antigen1148SmartEIA COVID-19 RBD IgA591TestLine Clinical Diagnostics s.r.o.Czechiawww.testlinecd.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum pending patent issues 2022-08-24 09:08:01 CET934Immuno-AntibodyNoImmunoassayQualitativeFluorescence90Clinical Sensitivity96.6%1149SmartEIA COVID-19 RBD IgG591TestLine Clinical Diagnostics s.r.o.Czechiawww.testlinecd.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum pending patent issues 2022-08-24 09:08:01 CET935Immuno-AntibodyNoImmunoassayQualitativeFluorescence90Clinical Sensitivity99.9%1150SmartEIA COVID-19 RBD IgM591TestLine Clinical Diagnostics s.r.o.Czechiawww.testlinecd.com/YesCommercialisedNoNoAutomatedManualAntibody2022-08-24 09:08:01 CET936Immuno-AntibodyNoImmunoassayQualitativeFluorescence90Clinical Sensitivity97.5%811Oy SARSPLEX482TeztedFinlandwww.tezted.com/YesCommercialisedNoNoAutomatedManualAntibodySerum2022-08-24 09:08:01 CET669Immuno-AntibodyYesImmunoassayQualitativeFluorescenceClinical Sensitivity100%Clinical Specificity100%874SARSPLEX: Anti-SARS-CoV-2 IgM / IgG / IgA ELISA (measure individual Ig easily)482TeztedFinlandwww.tezted.com/YesCommercialisedNoNoAutomatedManualAntibody2022-08-24 09:08:01 CET713Immuno-AntibodyELISAManual or automated Not found Not found 1414EliA SARS-CoV-2-Sp1 IgG test260Thermo Fisher ScientificUnited Stateswww.thermofisher.com/ch/en/home.htmlYesCommercialisedNoNoLab-basedAntibodyPlasmaSerum https://thermofisher.mediaroom.com/2020-10-12-Thermo-Fisher-Scientific-Further-Expands-COVID-19-Test-Portfolio-with-Two-New-Antibody-Tests2022-08-24 09:08:01 CET1175Immuno-AntibodyYesImmunoassayQuantitativeFluorescenceClinical Sensitivity100%Clinical Specificity99.7%Type of antigenspike glycoprotein (S protein)1426OmniPATH COVID-19 Total Antibody ELISA Test260Thermo Fisher ScientificUnited Stateswww.thermofisher.com/ch/en/home.htmlYesCommercialisedNoNoLab-basedAntibodySerum https://www.fda.gov/media/142700/download2022-08-24 09:08:01 CET1185Immuno-AntibodyYesELISAQualitativeMagnetic Electrochemical90Clinical Sensitivity96.7%Clinical Specificity97.5%Type of antigeneceptor binding domain (RBD) of the S1 subunit of the spike (S) protein624COVID-19 IgM/IgG Lateral Flow Assay372Tianjin Era Biology Technology Co. Ltd.Chinawww.era-bio.com/YesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET514Immuno-AntibodyYesNoImmunoassayQualitative10404Anti-COVID-19 virus IgM/IgG rapid test kit (Colloidal gold assay)326Tianjin MNCHIP Technologies Co. Ltd.Chinaen.mnchip.com/en/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole bloodnucleocapsid proteinspike protein2022-08-24 09:08:01 CET433Immuno-AntibodyYesImmunoassayQualitativeColorimetry15Accuracy100%Type of antigen N and S virus proteins1959Toda Coronadiag +681TODA PHARMAFrancehttps://www.todapharma.com/YesCommercialisedNoNoNear POC / POCAntibodyPeripheral bloodPlasmaSerumVenous whole bloodWhole bloodWhole blood with anti-coagulantsPlease kindly note that the above mentioned performance rates are valid for IgG and IgM. Please kindly note that the performance rates are based on specimen which have been assessed between Day 14 and Day 19 after onset of symptoms.2022-08-24 09:08:01 CET1635Immuno-AntibodyNoImmunochromatographyQualitativeSandwich, Double15LOD0AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy100% IgGAccuracy100% IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100% IgGClinical Sensitivity100% IgMClinical Specificity100% IgGClinical Specificity100% IgMType of antigenNucleoprotein1936Coronavirus (SARS-CoV 2) Ab IgG / IgM - Nucleocapsid (N protein)885Tody Laboratories Int.Romaniawww.todylaboratories.com/YesCommercialisedNoNoManualAntibodyPeripheral bloodPlasmaSerumWhole bloodNucleocapsid (N) protein as target. IgG Limit of Detection (LoD): 1:40 (0.025) IgM Limit of Detection (LoD): 1:8 (0.125)2022-08-24 09:08:01 CET1612Immuno-AntibodyNoImmunochromatographyQualitativeMembrane-based10LOD0.025AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives3.7%From studies performed by manufacturer, the false positive rate is 3.7% (specificity = 96.3%)False negatives3.1%From studies performed by manufacturer, the false negative rate is 3.1% (sensitivity = 96.9%)PrecisionEvaluatedAccuracy96.4%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.9%Clinical Specificity96.3%Type of antigenNucleocapsid (N protein)1933Coronavirus (SARS-CoV-2) Neutralizing Antibodies885Tody Laboratories Int.Romaniawww.todylaboratories.com/YesUnknownNoNoManualOtherAntibodyPeripheral bloodPlasmaSerumWhole bloodAnti-Spike Protein, Colloidal Gold2022-08-24 09:08:01 CET1609Immuno-AntibodyNoImmunochromatographyQualitativeNeutralization Antibody (NAb)10LOD0.025AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy97.9%ReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity95.7%Clinical Specificity100%Type of antigenOther10263gamma COVID-19 IgA / IgM / IgG608TregenaItalywww.3gamma.it/YesCommercialisedNoNoNear POC / POCAntibodyWhole blood 344 RT-PCR-confirmed cases containing 55 positive and 289 negative specimens are tested. The data above are >14 days from symptom onset to blood collectionMade in Taiwan http://www.3gamma.it/1/upload/brochure_3_gamma.pdf2022-08-24 09:08:01 CET938Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry20Clinical Sensitivity99%Clinical Specificity95.2%1461SARS-CoV-2 IgM/IgG Rapid Test Kit (Colloidal Gold)677Triplex International Biosciences (China) Co. Ltd.Chinawww.tibchina.com/index_en.aspxYesCommercialisedNoNoNear POC / POCAntibodySerumWhole bloodnucleocapsid protein2022-08-24 09:08:01 CET1206Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15LOD-1AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0AUFalse negatives0AUPrecisionEvaluatedAccuracy88.88% IgGAccuracy93.88% IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity75.3% IgGClinical Sensitivity87.65% IgMType of antigennucleoprotein1116Biocard Covid-19 Rapid Test19Trivitron Healthcare Pvt. Ltd.Indiawww.trivitron.com/YesCommercialisedNoNoManualAntibody The GENEDIA W COVID-19 Ag is an in vitro diagnostic single-use test and qualitative immunoassay to detect SARS-CoV-2 antigen in nasopharyngeal swab and sputum specimen from human. This assay is designed for professional personnel in laboratory and at point-of-care as an aid in screening patients suspected of being infected and asymptomatic patients. 2022-08-24 09:08:01 CET23Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry151117COVID KAVACH Anti-SARS CoV-2 Human IgG ELISA19Trivitron Healthcare Pvt. Ltd.Indiawww.trivitron.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum https://www.lumiradx.com/assets/pdfs/covid-19-antigen-test/sars-cov-2-ag-test-spec-sheet-ous.pdf; https://www.lumiradx.com/assets/pdfs/covid-19-antigen-test/sars-cov-2-ag-qc-product-insert-en-fr-de-it-es-se.pdf; https://www.lumiradx.com/assets/images/new/pdf/sars-cov-2-ag-qri-us-ous.pdf 2022-08-24 09:08:01 CET898Immuno-AntibodyNoYesELISAQualitativeMagnetic Electrochemical130Manual or automated Sandwich, Double colorimetry Clinical Sensitivity98% IgGClinical Specificity100% IgGType of antigenSARS-CoV-2 Nucleocapsid Protein (NP) antigen1118COVIDscreen Plus ELISA Kit19Trivitron Healthcare Pvt. Ltd.Indiawww.trivitron.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum https://www.lumiradx.com/assets/pdfs/covid-19-antibody-test/qri-ab-ous-ce.pdf 2022-08-24 09:08:01 CET899Immuno-AntibodyYesELISAQualitativeMagnetic Electrochemical90Manual or automated colorimetry Clinical Sensitivity%100Clinical Specificity%994892019-ncoV IgG/IgM Test508U2USystems (India) Pvt. Ltd.Singaporewww.u2uhealth.com/YesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET732Immuno-AntibodyYesNoImmunoassayQualitative102521Vaxxitest 2019-nCoV Neutralizing Antibody Test1150Unibioscience ASTurkeywww.unibioscience.comYesCommercialisedNoNoManualNear POC / POCAntibodyPlasmaSerumWhole bloodMAIN COMPONENTS of Vaxxitest™ Reagent: composed of test strips, plastic parts (box), buffer, and dropper; Test Strip main components: 1. Recombinant protein ACE-2 (fixed in the nitrocellulose membrane detection area), Goat anti-rabbit lgG polyclonal antibody (fixed on nitrocellulose membrane quality control area). 2. Colloidal gold-labelled novel coronavirus protein RBD (located on polyester cellulose membrane); colloidal gold-labelled rabbit lgG. Buffer: mainly composed of disodium hydrogen phosphate, sodium dihydrogen phosphate, sodium chloride. Colorimetric Card Additional preparation for testing: specimen collection containers and timer.2022-08-24 09:08:01 CET2225Immuno-AntibodyNoImmunochromatographyQualitativeNeutralization Antibody (NAb)15LOD20AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives6%False negatives2%PrecisionEvaluatedAccuracy96.24%ReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity97.98%Clinical Specificity94.74%Type of antigenSpike protein2133OnSight™ - COVID-19 IgG/IgM Combo Test988Unimed International Inc.United Stateswww.unimed.netYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood1132B.1.427Epsilon1137B.1.429EpsilonDigital result reading with a Reader,2022-08-24 09:08:01 CET1823Immuno-AntibodyNoImmunochromatographyQualitativeSandwich15LOD0AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positivesN.A.False negativesN.A.PrecisionEvaluatedAccuracy96.8%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.3%Clinical Specificity99.8%Type of antigenNucleoprotein18792019-nCoV Neutralizing Antibody Test Kit (Colloid Gold Immunoassay)860Ustar Biotechnologies (Hangzhou) Ltd.Chinaen.bioustar.comYesCommercialisedNoNoNear POC / POCAntibodyThe 2019-nCoV Neutralizing Antibody Test Kit (Colloid Gold Immunoassay) is intended for in-vitro diagnosis of novel coronavirus neutralizing antibodies in human serum, plasma, venous whole blood or peripheral whole blood.2022-08-24 09:08:01 CET1791Immuno-AntibodyImmunoassayColloidal gold7662019-nCoV IgG/IgM Rapid Testing Kit412VazymeChinawww.vazymebiotech.com/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumnucleocapsid protein2022-08-24 09:08:01 CET621Immuno-AntibodyYesNoImmunoassayQualitative10 RobustnessEvaluatedClinical Sensitivity91.54%Clinical Specificity97.02%Type of antigennucleoprotein28COVID-19/Influenza A virus/Influenza B virus test kit (Rare Earth Nano Fluorescence Immunochromatography)412VazymeChinawww.vazymebiotech.com/YesCommercialisedNoNoManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET1843Immuno-AntibodyYesImmunoassayQualitativeColloidal gold101463SARS-CoV-2-IgG-EIA-BEST680Vector-BestRussiawww.vector-best.ru/en/YesCommercialisedNoNoOtherAntibodyPlasmaSerum2022-08-24 09:08:01 CET1214Immuno-AntibodyYesImmunoassayQualitative90LOD0.13IU/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedPrecisionNot evaluatedAccuracy100% IgGReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity100% IgG1464SARS-CoV-2-IgM-EIA-BEST680Vector-BestRussiawww.vector-best.ru/en/YesCommercialisedNoNoAntibodyPlasmaSerum2022-08-24 09:08:01 CET1215Immuno-AntibodyYesImmunoassayQualitative90LOD1IU/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedPrecisionNot evaluatedAccuracy100% IgMReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity100% IgM1069COVID-19-CHECK-1 test574VEDALABFrancewww.vedalab.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole bloodnucleocapsid proteinVariable Cut off setting in IgG to increase the diagnostic value in different prevalence situations https://www.vedalab.com/videos/performing-covid-19-check-1-test/2022-08-24 09:08:01 CET845Immuno-AntibodyYesNoChromatographyQualitative10LOD0AUAnalysis of cross reactivityEvaluatedFalse positives3%CI 95% range: 91.06-99.61, using samples collected prior to September 2019False negatives7%CI 95% range: 85.09-94.46 versus PCR methodAccuracy94.42% (IgM+IgG) (CI 95%[90.92-96.80])ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity60.87% IgMClinical Sensitivity91.3% IgGType of antigennucleoprotein2336Rapid-VIDITEST anti- SARS-CoV-2 IgG/IgM951VIDIA spol. s r.o.Czechiahttps://www.vidia.czYesCommercialisedNoNoManualNear POC / POCAntibodyPeripheral bloodPlasmaSerumWhole bloodLimit of detection: IgG 1:40, S- IgM 1: 100; N-IgM 1: 25002022-08-24 09:08:01 CET2037Immuno-AntibodyNoImmunochromatographyQualitativeMembrane-based10LOD1AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives1AUFalse negatives5AUPrecisionEvaluatedAccuracy98.1%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.3%Clinical Specificity98.6%Type of antigenOther2081COVID-19 SPIKE QUANTITATIVE VIRCLIA® IgG MONOTEST963Vircell s.l.SpainWWW.VIRCELL.COMYesCommercialisedNoNoAntibodyPlasmaSerum689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu20A.23.12041C.37Lambda1439C.3670AT.11224B.1.526IotaB.1.526.1B.1.526.21518P.2Zetaall variants detected but not discriminated2022-08-24 09:08:01 CET1764Immuno-AntibodyImmunoassay60LOD3.11AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0% IgGFalse negativesInactivated samples: 3; Non-inactivated samples: 0PrecisionEvaluatedAccuracyVIRCLIA®: Bias (trueness / accuracy) = 14.50% VIRCLIA® LOTUS: Bias (trueness / accuracy) = 16.50%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity96% IgGInactivated samples: 96% Non-inactivated samples: 100%Clinical Specificity100% IgGInactivated samples: 100% Non-inactivated samples: 100%Type of antigenOther (spike)422COVID-19 VIRCLIA IgG MONOTEST78Vircell s.l.Spainwww.vircell.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET98Immuno-AntibodyYesImmunoassayQualitativeChemiluminescence424COVID-19 VIRCLIA IgM+IgA MONOTEST78Vircell s.l.Spainwww.vircell.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET344Immuno-AntibodyYesImmunoassayQualitativeChemiluminescence1166VIROTECH SARS-CoV-2 IgA ELISA614VIROTECH Diagnostics GmbHGermanywww.virotechdiagnostics.comYesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum http://www.virotechdiagnostics.com/uploads/tx_multishop/images/cmsfiles/5f05d0d67d93d.pdf2022-08-24 09:08:01 CET951Immuno-AntibodyYesELISAQualitativeOthermanual or automated other Clinical Sensitivity100% IgAClinical Specificity98% IgA(>98%)1164VIROTECH SARS-CoV-2 IgG ELISA614VIROTECH Diagnostics GmbHGermanywww.virotechdiagnostics.comYesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum http://www.virotechdiagnostics.com/uploads/tx_multishop/images/cmsfiles/5f05d0d67d93d.pdf2022-08-24 09:08:01 CET949Immuno-AntibodyYesELISAQualitativeOtherClinical Sensitivity100% IgGClinical Specificity98% IgG(>98%)Type of antigennucleoprotein1165VIROTECH SARS-CoV-2 IgM ELISA614VIROTECH Diagnostics GmbHGermanywww.virotechdiagnostics.comYesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum https://medsan.shop/media/2a/67/fb/1603871653/MEDsan_SARS_CoV_2_Antigen_Rapid_Test_Flyer.pdf http://www.virotechdiagnostics.com/uploads/tx_multishop/images/cmsfiles/5f05d0d67d93d.pdf2022-08-24 09:08:01 CET950Immuno-AntibodyYesELISAQualitativeOthermanual or automated other Clinical Sensitivity100% IgMClinical Specificity98% IgM(>98%)1583RapidFor SARS-CoV-2 IgG/IgM Test Kit678Vitrosens Biotechnology Co. Ltd.Turkeywww.vitrosens.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET1263Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15LOD100%CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2AUFalse negatives1AUPrecisionEvaluatedAccuracy99%Accuracy95.4% IgMAccuracy97.3% IgGReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.2%Clinical Sensitivity92.3% IgMClinical Sensitivity96.6% IgGClinical Specificity98.3% IgMClinical Specificity98.08% IgG1658SARS-CoV-2 Neutralizing Antibody Test Kit678Vitrosens Biotechnology Co. Ltd.Turkeywww.vitrosens.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET1337Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives4AUFalse negatives1AUPrecisionEvaluatedAccuracy98.3%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.6%2114SARS-CoV-2 Neutralizing Antibody FIA Test Kit175VivaChek Biotech (Hangzhou) Co. Ltd.Chinawww.vivachek.comYesCommercialisedNoNoNear POC / POCSemi-automatedAntibodyOropharyngeal swabPeripheral bloodPlasmaSerumVenous whole bloodWhole bloodWhole blood with anti-coagulants689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.3nucleocapsid proteinSARS-CoV-2 Neutralizing Antibody FIA Test Kit is for the rapid, qualitative detection of antibodies against SARS-CoV-2 in human whole blood (from fingerstick or venipuncture), serum or plasma.2022-08-24 09:08:01 CET1804Immuno-AntibodyYesYesImmunochromatographyQuantitativeNeutralization Antibody (NAb)Fluorescence15LOD135AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%326 negative Sample were tested and 0 of them were false positiveFalse negatives1.77%169 positive Sample were tested and 3 of them were false negative.PrecisionEvaluatedAccuracy99.39%Accuracy99.39ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.22%Clinical Specificity99.9%Type of antigenNucleoprotein2117SARS-CoV-2 Neutralizing Antibody Rapid Test175VivaChek Biotech (Hangzhou) Co. Ltd.Chinawww.vivachek.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumVenous whole bloodWhole bloodWhole blood with anti-coagulants689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.3SARS-CoV-2 Neutralizing Antibody Rapid Test is for the rapid, qualitative detection of neutralizing antibodies to SARS-CoV-2 in whole blood(from venipuncture or fingerstick), serum or plasma. The VivaDiagTM SARS-CoV-2 Neutralizing Antibody Rapid Test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.2022-08-24 09:08:01 CET1807Immuno-AntibodyNoImmunochromatographyQualitativeNeutralization Antibody (NAb)15LOD30AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%326 negative Sample were tested and 0 of them were false positiveFalse negatives2.36%169 positive Sample were tested and 4 of them were false negative.PrecisionEvaluatedAccuracy99.19%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity97.63%Clinical Specificity100%Type of antigenOther428VivaDiag COVID-19 IgM/IgG Rapid Test175VivaChek Biotech (Hangzhou) Co. Ltd.Chinawww.vivachek.comYesCommercialisedNoNoNear POC / POCAntibodyWhole bloodnucleocapsid protein2022-08-24 09:08:01 CET231Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15Type of antigennucleoprotein2106VivaDiag SARS-CoV-2 Neutralizing Antibody FIA Test Kit175VivaChek Biotech (Hangzhou) Co. Ltd.Chinawww.vivachek.comYesCommercialisedNoNoNear POC / POCSemi-automatedAntibodyPlasmaSerumVenous whole bloodWhole bloodWhole blood with anti-coagulants689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.3VivaDiag SARS-CoV-2 Neutralizing Antibody FIA Test Kit is for the rapid, qualitative detection of antibodies against SARS-CoV-2 in human whole blood (from fingerstick or venipuncture), serum or plasma.2022-08-24 09:08:01 CET1789Immuno-AntibodyYesImmunochromatographyQuantitativeNeutralization Antibody (NAb)Fluorescence15LOD30AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%326 negative Sample were tested and 0 of them were false positiveFalse negatives1.77%169 positive Sample were tested and 3 of them were false negative.PrecisionEvaluatedAccuracy99.39%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.22%Clinical Specificity99.9%2803SARS-CoV-2 Neutralizing Antibody Test Kit (LFIA)1255Weihai Dishang Medical Technology Co. Ltd.Chinahttps://dsmedicaltech.comYesCommercialisedNoNoLab-basedManualAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET2508Immuno-AntibodyNoImmunochromatographyQualitativeNeutralization Antibody (NAb)15LOD300ng/mLCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2.08%False negatives9.62%PrecisionEvaluatedAccuracy94.76%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90.38%Clinical Specificity97.92%1027COVID-19 IgM/IgG Rapid Test (Colloidal Gold)612Well BiotechChinawww.wellbioscience.comYesCommercialisedNoNoNear POC / POCAntibodyWhole bloodhttp://www.wellbioscience.com/products/index/1u5858IP85x4R171.html2022-08-24 09:08:01 CET946Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry10Accuracy98.5%Clinical Sensitivity97.1%Clinical Specificity100%1630COVID-19 IgM/IgG Rapid Test726WHPMUnited Stateswww.whpm.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET1310Immuno-AntibodyYesImmunoassayQualitative15Accuracy99.2%Clinical Sensitivity97.5%Clinical Specificity100%983COVID-19 Test IgM/ IgG549Willi Fox GmbHSwitzerlandwww.willifox.comYesCommercialisedNoNoNear POC / POCAntibodyWhole bloodnucleocapsid protein LIMITATIONS1. The contents of this kit are to be used for the qualitative detection of SARS-CoV-2 viral antigen from the nasopharyngeal swab.2. A negative test result may occur if the level of an antigen in a sample is below the detection limit of the test.3. According to CDC’s guidance, the COVID-19 antigen test has the best sensitivity from day 1 to day 5 after the onset of symptoms. Antigen levelsin specimens collected beyond 5-7 days of the onset of symptoms may drop below the limit of detection of the test.4. Failure to follow the Test Procedure and interpretations of Test Results may adversely affect test performance and/or invalidate the Test Results.5. Test Results must be evaluated in conjunction with other clinical data available to the physician.6. Negative test results do not rule out other potential non-SARS-CoV-2 viral infections. Negative results should be confirmed by molecular diagnosis ifCOVID-19 disease is suspected.7. Positive test results do not rule out co-infections with other pathogens.8. Monoclonal antibodies may fail to detect or detect with less sensitivity, SARS-CoV-2 viruses that have undergone minor amino acid changes in thetarget epitope region. 2022-08-24 09:08:01 CET869Immuno-AntibodyYesNoImmunoassayQualitativeClinical Sensitivity93.7% IgMClinical Sensitivity98.8% IgGClinical Specificity99.1% IgMClinical Specificity98.7% IgGType of antigennucleoprotein633Willi Fox Covid-19 IgM/ IgG rapid test549Willi Fox GmbHSwitzerlandwww.willifox.comYesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET796Immuno-AntibodyYesNoImmunoassayQualitativeNot found15Clinical Sensitivity98%Clinical Specificity99%432Novel Coronavirus IgG antibody test kit (colloidal gold method)273Wuhan EasyDiagnosis Biomedicine Co. Ltd.Chinawww.mdeasydiagnosis.com/YesCommercialisedNoNoNear POC / POCAntibodyWhole bloodnucleocapsid protein2022-08-24 09:08:01 CET361Immuno-AntibodyYesImmunoassayQualitativeType of antigennucleoprotein430Novel Coronavirus IgM antibody test kit (colloidal gold method)273Wuhan EasyDiagnosis Biomedicine Co. Ltd.Chinawww.mdeasydiagnosis.com/YesCommercialisedNoNoNear POC / POCAntibodyWhole bloodnucleocapsid protein   2022-08-24 09:08:01 CET359Immuno-AntibodyYesImmunoassayQualitativeType of antigennucleoprotein3996SARS-CoV-2 Neutralizing Antibody Quantitative Test Kit (Immunofluorescence Method)973Wuhan EasyDiagnosis Biomedicine Co. Ltd.Chinahttp://www.easydiagnosis.com.cn/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole bloodSARS-CoV678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta2041C.37Lambda1495P.1Gammaspike protein2022-08-24 09:08:01 CET3661Immuno-AntibodyYesNoYesImmunochromatographyQuantitativeNeutralization Antibody (NAb)Immunofluorescence15LOD20AU/mLAnalytical Sensitivity100%Analytical Specificity100%False positives0%False negatives0%Accuracy98.84%Clinical Sensitivity97.12%Clinical Specificity99.39%3988SARS-CoV-2 Neutralizing Antibody Test Kit973Wuhan EasyDiagnosis Biomedicine Co. Ltd.Chinahttp://www.easydiagnosis.com.cn/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole bloodSARS-CoV678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta2041C.37Lambda1495P.1Gammaspike protein2022-08-24 09:08:01 CET3653Immuno-AntibodyYesNoN.A.ImmunochromatographyQualitativeNeutralization Antibody (NAb)Colloidal gold15LOD400AU/mLAnalytical Sensitivity100%Analytical Specificity100%False positives0%False negatives0%Accuracy98.84%Clinical Sensitivity97.12%Clinical Specificity99.39%3994SARS-CoV-2 Neutralizing Antibody Test Kit (Immunofluorescence Method)973Wuhan EasyDiagnosis Biomedicine Co. Ltd.Chinahttp://www.easydiagnosis.com.cn/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole bloodSARS-CoV678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta2041C.37Lambda1495P.1Gammaspike protein2022-08-24 09:08:01 CET3659Immuno-AntibodyYesNoYesImmunochromatographySemiquantitativeNeutralization Antibody (NAb)Immunofluorescence15LOD0.156µg/mlAnalytical Sensitivity100%Analytical Specificity100%False positives0%False negatives0%Accuracy98.48%Clinical Sensitivity96.43%Clinical Specificity99.29%4002SARS-CoV-2 Neutralizing Antibody Test Kit (MCLIA)973Wuhan EasyDiagnosis Biomedicine Co. Ltd.Chinahttp://www.easydiagnosis.com.cn/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumSARS-CoVOtherspike protein2022-08-24 09:08:01 CET3667Immuno-AntibodyYesNoYesCLIAQuantitativeNeutralization Antibody (NAb)Chemiluminescence30LOD5%Analytical Sensitivity97%Analytical Specificity90%False positives0.48%False negatives2.41%Accuracy98.97%Clinical Sensitivity97.59%Clinical Specificity99.52%3997SARS-CoV-2 Total Antibody & Neutralizing Antibody Test Kit973Wuhan EasyDiagnosis Biomedicine Co. Ltd.Chinahttp://www.easydiagnosis.com.cn/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumVenous whole bloodWhole bloodSARS-CoV678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta2041C.37Lambda1495P.1Gammaspike protein2022-08-24 09:08:01 CET3662Immuno-AntibodyYesNoNoImmunochromatographyQualitativeNeutralization Antibody (NAb)Colloidal gold15LOD0.156µg/mlAnalytical Sensitivity100%Analytical Specificity100%False positives0%False negatives0%Accuracy99.26%Clinical Sensitivity97.06%Clinical Specificity100%1889SARS CoV 2 IgM/IgG Duo Test Kit (Colloidal Gold)863Wuhan HealthCare Biotechnology Co. Ltd.Chinahttp://www.healthcare-biotech.com/YesCommercialisedNoNoManualAntibodyPlasmaSerumWhole bloodWhole blood with anti-coagulantsnucleocapsid proteinNone2022-08-24 09:08:01 CET1567Immuno-AntibodyYesNoImmunochromatographyQualitativeMembrane-basedColloidal gold15LODAU0.00001CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives4.4%False negatives8.93%PrecisionEvaluatedAccuracy92.75%(IgM/IgG)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity91.07%(IgM/IgG)Clinical Specificity95.37%(IgM/IgG)Type of antigenNucleoprotein1770SARS-CoV-2 IgM/IgG Antibody Assay Kit (Immunochromatography)792Wuhan Life Origin Biotech Joint Stock Co. Ltd.Chinawww.szybio.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET1449Immuno-AntibodyYesYesImmunochromatographyQualitative15LOD0U/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1%(1/100),95%CI(0.03%-5.45%)False negatives12%(24/200),95%CI(7.84%-17.33%)Accuracy91.67%(275/300),95%CI(87.94%-94.53%)(IgM , IgG)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity88%(176/200）, 95%CI（82.77%-91.80%）(IgM , IgG)1765SARS-CoV-2 Neutralizing Antibody Assay Kit (ELISA)792Wuhan Life Origin Biotech Joint Stock Co. Ltd.Chinawww.szybio.comYesCommercialisedNoNoManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET1443Immuno-AntibodyYesELISAQualitative60LOD0AUCalibration0False positives1.14%False negatives4.55%1771SARS-CoV-2 Neutralizing Antibody Assay Kit (Immunochromatography)792Wuhan Life Origin Biotech Joint Stock Co. Ltd.Chinawww.szybio.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET1450Immuno-AntibodyYesYesImmunochromatographyQualitative15LOD0U/mlAnalysis of cross reactivityEvaluatedFalse positives1.56%(2/128),95% CI(0.19%-5.53%)False negatives5.36%(3/56),95% CI(1.12%-14.87%)PrecisionEvaluatedRobustnessEvaluated1757SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette ( Colloidal Gold Method)840Wuhan NanoDiagnosis for Health Biotechnology Co. Ltd.Chinandh-biotech.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole bloodThis kit applied chromatographic immunoassay technology as a blocking detection tool. This kit is intended for the qualitative detection of SARS-CoV-2 neutralizing antibodies in human serum, plasma, or whole blood specimen. This kit is intended for use as an aid in identifying individuals with an adaptive immune response to vaccination or natural infection.2022-08-24 09:08:01 CET1435Immuno-AntibodyYesNoChromatographyQualitativeColorimetry15LOD0AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0AUFalse negatives0AUPrecisionEvaluatedAccuracy100%neutralizing antibodiesReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity100%neutralizing antibodies634Covid-19 IgG/IgM Antibody Rapid Test Kit376Wuhan UNscience Biotechnology Co. Ltd.Chinawww.uni-science.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerum2022-08-24 09:08:01 CET521Immuno-AntibodyYesNoImmunoassayQualitative10Clinical Sensitivity98.81%Clinical Specificity98.02%9592019-nCoV IgG / IgM Detection Kit (Colloidal Gold-Based)790Xiamen AmonMed Biotechnology Co. Ltd.Chinawww.amonmed.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerum2022-08-24 09:08:01 CET861Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry10438SARS-CoV-2 IgG/IgM Rapid Qualitative Test Kit756Xiamen Biotime Biotechnology Co. Ltd.Chinawww.biotime.cn/En_YesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET704Immuno-AntibodyYesImmunoassayQualitativeColorimetry439Rapid 2019-nCoV IgG/IgM Combo Test Card277Xiamen Boson Biotech Co. Ltd.Chinahttp://www.bosonbio.com/YesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET351Immuno-AntibodyYesNoImmunoassayQualitative15 2843SARS-CoV-2 Neutralization Antibodies / IgG Detection Kit(Colloidal Gold Method)948Xiamen Jiqing Biomedical Technology Co. Ltd.Chinawww.wikang.com.cnYesCommercialisedNoNoManualAntibodyWhole blood689B.1.1.7Alpha1032B.1.351Beta678B.1.1.529OmicronThe neutralization antibody test uses immunochromatography. The test card contains:1) colloidal gold-labeled recombinant novel coronavirus S-RBD antigen, refering control and quality control antibody gold markers; 2) tow detection lines (T1 and T2) and one quality Control line (C line) of nitrocellulose membrane. The T line is immobilized with anti-human IgG for detecting novel coronavirus neutralizing antibody and the C line is immobilized with a quality control antibody. When an appropriate amount of the test sample is added to the sample hole of the test card, the sample will move forward along the test card under the action of the capillary. If the sample contains Novel coronavirus neutralizing antibody, the antibody will bind to the colloidal gold-labeled novel coronavirus antigen. The immune complex will be captured by the anti- human IgG antibody immobilized on the membrane to form a purple-red T line, showing that the novel coronavirus Neutralizing antibody is positive. The test card also contains a quality control line C.The fuchsia quality control line C should appear regardless of whether a test line appears. If the quality control line C does not appear, the test result is invalid, and the sample needs to be tested again with another test card. The IgG test is based on the principle of colloidal gold immunochromatography to quaitatively detect the new coronavirus SARS-CoV-2 IgG antibody in serum, plasma or whole blood samples. When the SARS-CoV-2 IgG level in the specimen is at or above the target cutoff (the detection limit of the test), the antibody bound to the antigen-dye conjugate are captured by anti-human IgG immobilized in the Test Region (T) of the device, and this produces a colored test band that indicates a positive result. When the SARS-CoV-2 IgG level in the specimen is zero or below the target cutoff, there is not a visible colored band in the Test Region (T) of the device. This indicates a negative result. To serve as a procedure control, a colored line will appear at the Control Region (C), if the test has been performed properly.2022-08-24 09:08:01 CET2548Immuno-AntibodyImmunoassayQualitativeMicrotiterColloidal gold15LODnAbs：L1～L3,L1 and L2 are positive,L3 is positive or negative. IgG：L4～L6,L4 is positive,L5 is positive or negative，L6 is negative.CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positivesAU0False negativesAU0PrecisionEvaluatedAccuracy99.86%95% CI:99.59%-99.97%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.95%95% CI:96.25%-99.87%Clinical Specificity99.86%95% CI:99.59%-99.97%440Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-COV-2862Xiamen Wiz Biotech Co. Ltd.Chinawww.wizbiotech.comYesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET705Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry151885SARS-CoV-2 Neutralizing Antibodies Test862Xiamen Wiz Biotech Co. Ltd.Chinawww.wizbiotech.comYesCommercialisedNoNoManualAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET1564Immuno-AntibodyImmunochromatographyQualitativeFluorescence15LOD0.3AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.537 false positives were found in 1311 samples tested.False negatives0.466 false negatives were found in 1311 samples tested.PrecisionEvaluatedAccuracy99.01%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.8%Clinical Specificity99.14%Type of antigenOther444Novel coronavirus(SARS-CoV-2) IgG/IgM Antibody Combined Test Kits285Yuno Diagnostics Co. Ltd.Chinawww.yuno-diagnostics.com/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole bloodnucleocapsid protein2022-08-24 09:08:01 CET371Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15Clinical Sensitivity100%Clinical Specificity100%Type of antigennucleoprotein1031COVID-19 IgG/IgM Rapid Test542Zenum TechnologiesSwitzerlandwww.zenumtechnologies.com/YesCommercialisedNoNoNear POC / POCAntibodyWhole blood2022-08-24 09:08:01 CET785Immuno-AntibodyYesNoImmunoassayQualitative15Clinical Sensitivity85% IgMIgM: 85 ; IgG: 99.9 Clinical Sensitivity99.9% IgGClinical Specificity96% IgMClinical Specificity98% IgG815COVISCREEN test for detection of IgM/IgG/IgA antibodies564Zephyr Biomedicals-Tulip GroupIndiawww.tulipgroup.com/Zephyr_New/comp_profile.htmYesCommercialisedNoNoAutomatedManualAntibodyWhole blood2022-08-24 09:08:01 CET826Immuno-AntibodyNoImmunoassayQualitative201298COVID-19 IgG IgM Test624Zhejiang Anji Saianfu Biotech Co. Ltd.Chinawww.reopentest.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole bloodnucleocapsid protein2022-08-24 09:08:01 CET1068Immuno-AntibodyYesNoImmunoassayQualitative10 LOD100AUAccuracy91%Clinical Sensitivity96.2% IgGClinical Sensitivity97.2% IgMType of antigennucleoprotein1840SARS-CoV-2 Neutralizing Antibody Rapid Test624Zhejiang Anji Saianfu Biotech Co. Ltd.Chinawww.reopentest.comYesCommercialisedNoNoManualAntibodyPlasmaSerumWhole bloodsend email to us2022-08-24 09:08:01 CET1517Immuno-AntibodyImmunoassaySemiquantitativeNeutralization Antibody (NAb)15LOD0.25AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives10%False negatives5.5%PrecisionEvaluatedAccuracy92%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90%Clinical Specificity94.5%452Novel Coronavirus (2019-nCoV) IgM/IgG Antibodies Detection Kit282Zhejiang Gene Science Co. Ltd.Chinahttp://www.gene-science.com/YesCommercialisedNoNoNear POC / POCAntibodyWhole blood   2022-08-24 09:08:01 CET366Immuno-AntibodyYesNoImmunoassayQualitative2569Rapid SARS-CoV-2 Neutralizing Antibody Test Kit (Colloidal Gold)282Zhejiang Gene Science Co. Ltd.Chinahttp://www.gene-science.com/YesCommercialisedNoNoManualNear POC / POCAntibodyPlasmaSerumWhole bloodNone2022-08-24 09:08:01 CET2274Immuno-AntibodyNoNoImmunochromatographyQualitativeNeutralization Antibody (NAb)Colloidal gold15CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%Clinical Specificity100%Type of antigenOther2310COVID-19 Neutralizing Antibody Multiple Detection Kit1078Zhejiang Hongyu Medical Commodity Co. Ltd.Chinahttp://www.cnhongyu.cn/YesCommercialisedNoNoManualNear POC / POCOtherAntibodyPeripheral bloodPlasmaSerumVenous whole bloodWhole bloodWhole blood with anti-coagulantsthe LOD value of Neutralizing Antibody of the COVID-19 Neutralizing Antibody multiple Detection Kit is 1:512. The LOD value of IgG of the COVID-19 Neutralizing Antibody multiple Detection Kit is 1:512.2022-08-24 09:08:01 CET2011Immuno-AntigenYesImmunochromatographyQualitativeNeutralization Antibody (NAb)15LOD512IgGLOD512AUN AbCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives8.4% IgGFirst vaccinated in 14 daysFalse positives3.4%(N Ab) - Completely vaccinated more than 28 days False positives1.6% IgGCompletely vaccinated more than 28 days False negatives0% IgGFirst vaccinated in 14 daysFalse negatives0%(N Ab) - Completely vaccinated more than 28 daysFalse negatives0% IgGCompletely vaccinated more than 28 daysPrecisionEvaluatedAccuracy100% IgGCompletely vaccinated more than 28 daysAccuracy%(N Ab) - Completely vaccinated more than 28 daysAccuracy100% IgGFirst vaccinated in 14 daysReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity91.6First vaccinated in 14 days: Clinical Sensitivity98.6% IgGCompletely vaccinated more than 28 daysClinical Sensitivity96.6%(N Ab) - Completely vaccinated more than 28 daysClinical Specificity100%(NP swab)Clinical Specificity100% IgG(OP swab)Clinical Specificity100%(Stool)Clinical Specificity100%(Sputum/oropharyngeal saliva)Clinical Specificity100%(Front Nostril)Type of antigenOther1966COVID-19 NAb Rapid Test900Zhejiang Kuaye Biotechnology Co. Ltd.Chinawww.zjky-bio.comYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumVenous whole bloodWhole bloodN.A.2022-08-24 09:08:01 CET1642Immuno-AntibodyImmunochromatographyQualitativeMembrane-based15LOD10AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%(0 out of 100)False negatives6.25% (5 out of 75)PrecisionEvaluatedAccuracy97.22%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.75%Clinical Specificity100%Type of antigenOther646COVID-19 IgG/IgM Rapid Test1184Zhejiang Orient Gene Biotech Co. Ltd.YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerum2022-08-24 09:08:01 CET532Immuno-AntibodyYesNoImmunoassayQualitative10Clinical Sensitivity87.9% IgGClinical Sensitivity97.2% IgMClinical Specificity100% IgGClinical Specificity100% IgM2497Sars_Cov_2 NEUTRALIZING ANTIBODY Rapid Test Cassette GCCOV(NAb)-402b1136Zhejiang Orient Gene Biotech Co. Ltd.Chinahttps://www.orientgene.com/YesCommercialisedNoNoManualNear POC / POCOtherSemi-automatedAntibodyPeripheral bloodPlasmaSerumVenous whole bloodWhole blood689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1132B.1.427Epsilon3939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta20A.23.1B.1.526.1The SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette (Whole Blood/Serum/Plasma) is a lateral flow immunochromatographic assay based on the principle of competitive binding. Neutralizing antibodies which may be present in the specimen compete against S-RBD conjugate for binding sites on the ACE2. When an adequate volume of test specimen is dispensed into the sample well of the test cassette, the specimen migrates by capillary action along the cassette. Neutralizing antibodies to SARS-CoV-2, if not present in the specimen, will not saturate the binding sites of S-RBD coated on the particles. The S-RBD coated particles will then be captured by the ACE2, which is pre-coated on test line region, and a visible colored line will show up in the test line region. The color intensity of the test line decreases as the concentration of neutralizing antibodies increases. The colored line will not form in the test line region if there are sufficient neutralizing antibodies in the specimen, because they will saturate all the binding sites of the S-RBD coated on the particles. To serve as a procedural control, a red line will always appear in the control line region (C) indicating that proper volume of sample has been added and membrane wicking has occurred.2022-08-24 09:08:01 CET2200Immuno-AntibodyNoImmunochromatographyQualitativeNeutralization Antibody (NAb)10CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%0 on 68False negatives0%0 on 59PrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%Clinical Specificity100%Type of antigenSpike protein453BIOCELL COVID-19 IgG ELISA test292Zhengzhou Humanwell Biocell Biotechnology Co. Ltd.Chinawww.cnbiocell.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET379Immuno-AntibodyYesELISAQualitativeFluorescence454BIOCELL COVID-19 IgM ELISA test292Zhengzhou Humanwell Biocell Biotechnology Co. Ltd.Chinawww.cnbiocell.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2022-08-24 09:08:01 CET380Immuno-AntibodyYesELISAQualitativeFluorescenceType of antigennucleocapsid antigen985SARS-CoV-2 IgG/IgM Rapid Test Device719Zhuhai Encode Medical Engineering Co. Ltd.Chinahttp://www.encode.com.cn/YesCommercialisedNoNoNear POC / POCAntibodynucleocapsid protein2022-08-24 09:08:01 CET790Immuno-AntibodyYesImmunoassayType of antigennucleocapsid1186COVID-19 IgG/IgM Detection Kit (Colloidal Gold)619Zhuhai Lituo Biotechnology Co. Ltd.Chinawww.lituo.com.cnYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole bloodnucleocapsid protein2022-08-24 09:08:01 CET967Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry10Accuracy96.9%Clinical Sensitivity93.8%Type of antigennucleocapsid antigen879Diagnostic Kit for IgM / IgG Antibody to Coronavirus (SARS-CoV-2) (Lateral Flow)225Zhuhai Livzon Diagnostics Inc.Chinahttp://www.livzondiagnostics.com/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumVenous whole bloodnucleocapsid protein2022-08-24 09:08:01 CET287Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15Accuracy95.3%Clinical Sensitivity90.6%Clinical Specificity99.2%Type of antigennucleocapsid22202019-nCoV Neutralizing Antibody Assay (Colloidal Gold)1028Zybio Inc.Chinahttps://www.zybio.com/en/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood2022-08-24 09:08:01 CET1921Immuno-AntibodyNoImmunochromatographyQualitativeNeutralization Antibody (NAb)Colloidal gold15LOD1.25AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives1.22%False negatives1.67%PrecisionEvaluatedAccuracy98.02%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.59%Clinical Specificity98.32%Type of antigenOther2213SARS-CoV-2 Antibody Assay (CLIA)1028Zybio Inc.Chinahttps://www.zybio.com/en/YesCommercialisedNoNoAutomatedAntibodyPlasmaSerum2022-08-24 09:08:01 CET1914Immuno-AntibodyYesCLIAQualitativeOtherChemiluminescence23LOD30000AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives1.06%False negatives1.43%PrecisionEvaluatedAccuracy96.12%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.41%Clinical Specificity95.38%Type of antigenOther637SARS-CoV-2 IgM and IgG Antibody Assay Kit384Zybio Inc.Chinawww.zybio.com/enYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerum2022-08-24 09:08:01 CET797Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry102209SARS-CoV-2 IgM IgG Antibody Assay Kit (Colloidal Gold Method)1028Zybio Inc.Chinahttps://www.zybio.com/en/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole bloodN/A2022-08-24 09:08:01 CET1910Immuno-AntibodyNoImmunochromatographyQualitativeOtherColloidal gold15LOD0.25AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives8.89%False negatives1.33%PrecisionEvaluatedAccuracy95.83%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.67%Clinical Specificity91.11%Type of antigenOther2212SARS-CoV-2 Neutralizing Antibody Assay (CLIA)1028Zybio Inc.Chinahttps://www.zybio.com/en/YesCommercialisedNoNoAutomatedAntibodyPlasmaSerum2022-08-24 09:08:01 CET1913Immuno-AntibodyYesCLIAQuantitativeOtherChemiluminescence23LOD0.301AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives1.91%PrecisionEvaluatedAccuracy98.5%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.31%Clinical Specificity98.55%Type of antigenOther2216SARS-CoV-2 Neutralizing Antibody Assay (ELISA)1028Zybio Inc.Chinahttps://www.zybio.com/en/YesCommercialisedNoNoManualAntibodyPlasmaSerumN/A2022-08-24 09:08:01 CET1917Immuno-AntibodyYesELISAQuantitativeEnzyme-linked90LOD0.08AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives3.37%False negatives0.88%PrecisionEvaluatedAccuracy98.52%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.73%Clinical Specificity99.13%Type of antigenOther