1574Zhenrui ®COVID-19 Antigen Test Cassette692Shenzhen Zhenrui Biotechnology Co., LtdChinaen.zr-bio.com/en/YesCommercialisedYesYesCassetteLateral flowNear POC / POCAntigenNasal swabSaliva2021-07-07 17:24:58 CET1253Immuno-AntigenYesYesImmunoassayQualitative15LOD12AUCalibrationevaluatedCrossreactivityevaluatedPrecisionevaluatedAccuracy96.5%AntigenReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity96%AntigenType of antigennucleoprotein1214Wondof SARS-CoV-2 Antigen Test (Lateral Flow Method)124Guangzhou Wondfo Biotech Co., LtdChinaen.wondfo.com.cn/YesCommercialisedNoNoLateral flowNear POC / POCAntigen2021-05-10 13:04:00 CET998Immuno-AntigenYesNoImmunoassayQualitativeColloidal gold1312Wondof 2019-nCoV Antigen Test (Lateral Flow Method)124Guangzhou Wondfo Biotech Co., LtdChinaen.wondfo.com.cn/YesCommercialisedNoNoLateral flowNear POC / POCAntigen2021-05-10 13:04:00 CET1082Immuno-AntigenYesImmunoassayQualitativeColloidal gold1437Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)124Guangzhou Wondfo Biotech Co., LtdChinaen.wondfo.com.cn/YesCommercialisedYesYesCassetteLateral flowNear POC / POCAntigenOther2021-05-10 20:07:30 CET1189Immuno-AntigenYesNoImmunoassayQualitativeFluorescence15LOD850AUCalibrationevaluatedCrossreactivityevaluatedPrecisionevaluatedAccuracysee IFUReproducibilityevaluatedRobustnessevaluatedClinical Sensitivitysee IFU1276Willi Fox COVID-19 Antigen rapid test549Willi Fox GmbHSwitzerlandwillifox.com/YesCommercialisedNoNoCassetteNear POC / POCAntigen2021-05-10 13:04:00 CET1051Immuno-AntigenYesImmunoassayQualitative15Clinical Sensitivity99.2%Clinical Specificity100%Type of antigennucleoprotein2162Wellion SARS-CoV-2 PLUS ANTIGEN Rapid Test1005MED TRUST Handelsges.m.b.H.Austriawww.wellion.atYesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabSARS-CoV453B.1.1.7United Kingdom806B.1.351South Africa1102B.1.617.1India1103B.1.617.2India1104B.1.617.3India1258P.1Japan/BrazilClinical evaluation study from Germany is available and uploaded to the database.2021-06-08 15:16:34 CET1863Immuno-AntigenYesNoImmunochromatographyQualitativeSandwichValidity test kit15LOD75.5AUCalibrationEvaluatedCrossreactivityEvaluatedFp0%(431 negative samples were tested and 0 of them were false positive)Fn3%(135 positive samples were tested and 5 of them were false negative)PrecisionEvaluatedAccuracy99% (Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.3% (Antigen)Clinical Specificity99.9% (Antigen)Type of antigenNucleoprotein1484Wantai SARS-CoV-2 Ag Rapid Test (FIA)49Beijing Wantai Biological Pharmacy Enterprise Co., LtdChinawww.ystwt.cn/YesCommercialisedYesYesNear POC / POCAntigenNasal swabOther2021-07-07 17:20:18 CET1236Immuno-AntigenYesYesImmunoassayQualitativeFluorescence20LOD5U/mlCalibrationEvaluatedCrossreactivityEvaluatedFp96.9%629/649 (CI: 95.29%-98.00%)Fn96.6%168/174 (CI: 92.68%-98.41%)PrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.6%Type of antigennucleoprotein1485Wantai SARS-CoV-2 Ag Rapid Test (colloidal gold)49Beijing Wantai Biological Pharmacy Enterprise Co., LtdChinawww.ystwt.cn/YesCommercialisedYesYesNear POC / POCAntigenNasal swabOther2021-07-14 14:19:53 CET1237Immuno-AntigenYesNoImmunoassayQualitativeFluorescence20LOD20AUCalibrationevaluatedCrossreactivityevaluatedFp0.9%99.1% (1036/1045) (CI: 98.37%~99.55%)Fn3.9%96.1% (173/180) (CI: 92.19%~98.10%)PrecisionevaluatedReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity96.1%Type of antigennucleoprotein1096VTRUST COVID-19 Antigen Rapid Test TD-4531588TaiDoc Technology Corp.Taiwan ROCtaidoc.com/YesCommercialisedNoNoLateral flowNear POC / POCAntigenNasopharyngeal swab https://www.testlinecd.com/file/1580/COVID-19_AN_NEW%20(002).pdf?version=202008131535 https://taidoc.com/covid-19-Antigen-rapid-test-td-4531/; https://taidoc.com/wp-content/uploads/2020/08/Covid-19-Antigen-rapid-test.pdf2021-05-10 13:04:00 CET877Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD126TCID50/mlCrossreactivity0% for virus, microorganisms and negatives matrices tested; EvaluatedClinical Sensitivity93.1%Clinical Specificity99.6%Type of antigennucleocapsid recombinant Antigen (NP)1379Vstrip Covid-19 Antigen Rapid Test658Taiwan ROCwww.pbf.com.tw/YesCommercialisedNoNoNear POC / POCAntigenNasal swabOther2021-05-10 13:04:00 CET1145Immuno-AntigenYesNoImmunoassayQualitativeColloidal gold10LOD157U/mlFp1.8%Fn8.7%Accuracy96.2%Clinical Sensitivity91.3%Type of antigennucleoprotein2163VivaDiag Wellion SARS-CoV-2 Antigen Rapid Test1006VivaChek Biotech (Hangzhou) Co., Ltd.Chinawww.vivachek.comYesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabAdenovirus 3Adenovirus 7Alpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)MERS-CoVMycobacterium TuberculosisMycoplasma PneumoniaeParainfluenza Virus TypeParainfluenza Virus Type 1Parainfluenza Virus Type 2Parainfluenza Virus Type 3Parainfluenza Virus Type 4453B.1.1.7United Kingdom806B.1.351South Africa1102B.1.617.1India1103B.1.617.2India1104B.1.617.3India1258P.1Japan/BrazilClinical Evaluation Study from Germany is available and uploaded.2021-06-08 15:11:09 CET1864Immuno-AntigenYesNoImmunochromatographyQualitativeSandwichValidity test kit15LOD675AUCalibrationNot evaluatedCrossreactivityEvaluatedFp4.54%(154 positive samples were tested and 7 of them were false negative)Fn0%(431 negative samples were tested and 0 of them were false positive)PrecisionNot evaluatedAccuracy98.8% (Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.45% (Antigen)Clinical Specificity99.99% (Antigen)Type of antigenNucleoprotein2105VivaDiag SARS-CoV-2 Ag FIA Test175VivaChek Biotech (Hangzhou) Co., LtdChinawww.vivachek.comYesCommercialisedNoNoCassetteLateral flowNear POC / POCSemi-automatedAntigenNasal swabNasopharyngeal swabOropharyngeal swabAdenovirus 3Adenovirus 7Adenovirus Subtype BAlpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)MERS-CoVMycobacterium TuberculosisMycoplasma PneumoniaeParainfluenza Virus TypeParainfluenza Virus Type 1Parainfluenza Virus Type 2Parainfluenza Virus Type 3Parainfluenza Virus Type 4453B.1.1.7United Kingdom806B.1.351South Africa1102B.1.617.1India1103B.1.617.2India1104B.1.617.3India1258P.1Japan/BrazilThe VivaDiag SARS-CoV-2 Ag FIA Test is a fluorescent immunochromatographic assay for the rapid and qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in human nasal swab or throat swab specimen that is automatically analyzed.2021-06-04 15:04:04 CET1788Immuno-AntigenYesYesImmunochromatographyQualitativeSandwichFluorescenceValidity test kit15LOD135AUCalibrationEvaluatedCrossreactivityEvaluatedFp0%431 negative Sample were tested and 0 of them were false positiveFn3.03%66 positive Sample were tested and 2 of them were false negative.PrecisionEvaluatedAccuracy99.6% (Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.97%(Antigen)Clinical Specificity99.9%(Antigen)Type of antigenNucleoprotein1246Vivadiag SARS CoV 2 Ag Rapid Test175VivaChek Biotech (Hangzhou) Co., LtdChinawww.vivachek.comYesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swab https://www.vivachek.com/en/prods/sarscov2-fluA-fluB-rapidtest.html2021-06-02 18:10:38 CET1075Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15Type of antigennucleoprotein2100Verino Pro SARS CoV 2 Ag Rapid Test175VivaChek Biotech (Hangzhou) Co., LtdChinawww.vivachek.comYesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabCoronaviruses (HCoV)453B.1.1.7United Kingdom806B.1.351South AfricaVerino Pro SARS-CoV-2 Ag Rapid Test is for the rapid, qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in human nasal swab, oropharyngeal swab or nasopharyngeal swab specimen.2021-05-27 14:47:58 CET1783Immuno-AntigenYesNoImmunochromatographyQualitativeSandwichValidity test kit15LOD75.5AUCalibrationEvaluatedCrossreactivityEvaluatedFp0%431 negative Sample were tested and 0 of them were false positiveFn3.7%135 positive Sample were tested and 5 of them were false negative.PrecisionEvaluatedAccuracy99.12% (Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.3 (Antigen)Clinical Specificity99.9(Antigen)Type of antigenNucleoprotein1324V-CHEK, 2019-nCoV Ag Rapid Test Kit (Immunochromatography)382Guangzhou Decheng Biotechnology Co., LTDChinawww.dochekbio.comYesCommercialisedYesYesNear POC / POCAntigenNasal swab2021-07-07 17:06:03 CET1091Immuno-AntigenYesImmunochromatographyQualitative15Rapid diagnostic test Card LOD100%Clinical Sensitivity96.67%(Antigen)Type of antigennucleoprotein1326V-CHEK, 2019-nCoV Ag Rapid Test Kit (Fluorescence Immunochromatographic Assay)382Guangzhou Decheng Biotechnology Co., LTDChinawww.dochekbio.comYesCommercialisedNoNoNear POC / POCAntigenNasal swab2021-05-10 13:04:00 CET1095Immuno-AntigenYesYesImmunochromatographyQualitativeFluorescence10LOD90AUClinical Sensitivity95.06%Type of antigennucleoprotein1883V-CHEK, 2019-nCoV Ag Rapid Test Card (Immunochromatography)382Guangzhou Decheng Biotechnology Co., LTDChinawww.dochekbio.comYesCommercialisedNoNoLateral flowNear POC / POCAntigenSaliva2019-nCoV Ag Saliva Rapid Test Card ; The Test Card is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from 2019-nCoV in saliva specimens directly collected from individuals who are suspected of COVID-19 by their healthcare provider within the first 7 days of symptom onset. This Card uses a double-antibody sandwich to detect the antigen presence of novel coronavirus (2019-nCoV) in saliva samples. During detection, the gold labeled anti-2019-nCoV monoclonal antibody in the labeling pad binds to the 2019-nCoV antigen in the sample to form a complex. The reaction complex moves along the nitrocellulose membrane under the action of chromatography. It is then captured by the anti-2019-nCoV monoclonal antibody pre-coated in the detection zone (T) on the nitrocellulose membrane, and finally a red color reaction line is formed in the T zone. If the sample does not contain 2019-nCoV antigen, a red color reaction line cannot be formed in the T zone. Regardless of whether the sample to be tested contains 2019-nCoV antigen, a red reaction line will always form in the quality control area (C).2021-05-10 13:04:00 CET1562Immuno-AntigenYesNoImmunochromatographyQualitative15LOD100%CalibrationEvaluatedCrossreactivityEvaluatedFpA reaction time of less than 15 minutes may lead to a false negative resultFnA reaction time of more than 15 minutes may lead a false positive result.PrecisionEvaluatedAccuracy97.12%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.65%Clinical Specificity98.44%Type of antigenNucleoprotein1325382Guangzhou Decheng Biotechnology Co., LTDChinawww.dochekbio.comYesCommercialisedNoNoCardNear POC / POCAntigenNasal swab2021-05-10 13:04:00 CET1092Immuno-AntigenYesYesImmunoassayQualitative15LOD1000Clinical Sensitivity96.67(Antigen);85.42(FLU A);85.34(FLU B)Type of antigennucleoprotein1317V-Chek SARS-CoV-2 Rapid Ag Test (IFA)405SGA MedikalTurkeywww.sgadx.com/YesCommercialisedNoNoNear POC / POCAntigenNasal swab2021-05-10 13:04:00 CET557Immuno-AntigenYesYesImmunoassayQualitativeFluorescence10LOD50AUFp1AUFn1AUAccuracy98.5%Clinical Sensitivity97.5%Type of antigennucleoprotein1357V-Chek SARS-CoV-2 Rapid Ag Test (colloidal gold)405SGA MedikalTurkeywww.sgadx.com/YesCommercialisedYesYesCardNear POC / POCAntigenNasal swab2021-07-07 17:10:17 CET1117Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD100AUFp1%Fn1%Accuracy98.40%Clinical Sensitivity96.60%Type of antigennucleoprotein1319V-Chek SARS-CoV-2 Ag Rapid Test Kit (Colloidal Gold)405SGA MedikalTurkeywww.sgadx.com/YesCommercialisedYesYesCassetteNear POC / POCAntigenNasal swab2021-07-07 17:24:45 CET560Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15Fp1%Fn1%Accuracy98.4%Clinical Sensitivity96.6%Type of antigennucleoprotein1314V-CHEK SARS-CoV-2 Ag Rapid Test Kit382Guangzhou Decheng Biotechnology Co., LTDChinawww.dochekbio.comYesCommercialisedNoNoCardNear POC / POCAntigenNasal swab2021-05-10 13:04:00 CET1084Immuno-AntigenYesNoImmunoassayQualitative15Clinical Sensitivity96.67%AntigenType of antigennucleoprotein1316V-CHEK 2019-nCoV Ag Rapid Test Kit382Guangzhou Decheng Biotechnology Co., LTDChinawww.dochekbio.comYesCommercialisedNoNoNear POC / POCAntigenNasal swab2021-05-10 13:04:00 CET527Immuno-AntigenYesYesImmunoassayQualitativeFluorescence10Rapid diagnostic test card fluorescence LOD90AUClinical Sensitivity95.06%(Antigen)Type of antigennucleoprotein1318382Guangzhou Decheng Biotechnology Co., LTDChinawww.dochekbio.comYesCommercialisedNoNoNear POC / POCAntigenNasal swab2021-05-10 13:04:00 CET1086Immuno-AntigenYesNoImmunoassayQualitative15Rapid diagnostic test Card LOD100AUClinical Sensitivity96.67%[85.42(FLU A);85.34(FLU B)]Type of antigennucleoprotein1170UNICELL-2019-nCoV Ag379SHENZHEN YHLO BIOTECH CO., LtdChinahttp://www.szyhlo.comYesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swabNasopharyngeal swab2021-05-10 13:04:00 CET954Immuno-AntigenYesYesImmunoassayQualitativeFluorescence15LOD160TCID50/mlFp2%Fn3%Accuracy99.03%Clinical Sensitivity97.37%1497Trueline COVID-19 Ag Rapid Test689TP Medicare GmbHGermanywww.tp-medicare.de/YesCommercialisedNoNoCassetteNear POC / POCAntigenNasopharyngeal swab2021-05-10 13:04:00 CET1247Immuno-AntigenYesNoImmunoassayQualitative15Fp0%0 of 21Fn2.7%1 of 37Accuracy98.1%Clinical Sensitivity93.8%Clinical Specificity100%Type of antigennucleocapside1722TOYO Covid-19 Ag Test758TurklabTurkeywww.turklab.com.tr/YesCommercialisedNoNoNear POC / POCAntigenNasal swabOther2021-05-10 13:18:20 CET1402Immuno-AntigenYesNoImmunoassayQualitative20LOD0AUCalibrationnot evaluatedCrossreactivityevaluatedPrecisionnot evaluatedAccuracy97.57%ReproducibilityevaluatedRobustnessnot evaluatedClinical Sensitivity93.18%Type of antigennucleoprotein1466TODA CORONADIAG Ag681TODA PHARMAFrancehttps://www.todapharma.com/YesCommercialisedYesYesLateral flowNear POC / POCAntigenNasal swab2021-05-10 20:07:30 CET1216Immuno-AntigenYesNoImmunoassayQualitative15LOD502.377AUCalibrationNot evaluatedCrossreactivityevaluatedFp0%(On 129 negative samples confirmed by RT-PCR, 129 were also negative with our test : 0 false positive)Fn1.37%On 73 positive samples confirmed by RT-PCR, 72 were also negative with our test : 1 false negativePrecisionevaluatedAccuracy99.5%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity98.6%Type of antigennucleoprotein1290Tigsun COVID-19 Antigen Saliva Rapid Test47Beijing Tigsun Diagnostics Co. LtdChinawww.tigsun.com/YesCommercialisedNoNoNear POC / POCAntigenSaliva2021-05-10 13:04:00 CET1064Immuno-AntigenYesImmunoassayType of antigenN protein1292Tigsun COVID-19 Antigen Rapid Test47Beijing Tigsun Diagnostics Co. LtdChinawww.tigsun.com/YesCommercialisedNoNoLateral flowNear POC / POCAntigenNasopharyngeal swabOropharyngeal swab2021-05-10 13:04:00 CET1065Immuno-AntigenYesImmunoassayQualitativeType of antigenN protein1773The SARS-CoV-2 Antigen Assay Kit (Immunochromatography)792Wuhan Life Origin Biotech Joint Stock Co., Ltd.Chinawww.szybio.comYesCommercialisedYesYesCardLateral flowNear POC / POCAntigenNasal swab2021-07-13 18:02:47 CET1452Immuno-AntigenYesYesImmunochromatographyQualitative15LOD0U/mlCalibrationEvaluatedCrossreactivityEvaluatedFp1.71%(6/350),95%CI(0.63%-3.69%)Fn7.33%(11/150),95%CI(3.72%-12.74%)PrecisionEvaluatedReproducibility96.6%(483/500), 95%CI (94.61%-98.01%)RobustnessEvaluatedClinical Sensitivity92.67%(139/150), 95%CI (87.26%-96.28%)1225Test Rapid Covid-19 Antigen (tampon nazofaringian)577DDS DIAGNOSTICRomaniawww.ddsdiagnostic.comYesCommercialisedYesYesCassetteNear POC / POCAntigenNasal swab2021-07-07 17:20:47 CET1009Immuno-AntigenYesNoImmunoassayQualitative15Accuracy98.95%Clinical Sensitivity98.77%Clinical Specificity99.03%1226Test Rapid Combo Covid-19/Influenza A+B Antigen (tampon nazofaringian))577DDS DIAGNOSTICRomaniawww.ddsdiagnostic.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabNasopharyngeal swab2021-05-10 13:04:00 CET1010Immuno-AntigenYesNoImmunoassayQualitative15Rapid diagnostic test cassette Accuracy98.95%Clinical Sensitivity98.77%Clinical Specificity99.03%1305Test Rapid Combo Covid-19/Influenza A+B Antigen577DDS DIAGNOSTICRomaniawww.ddsdiagnostic.comYesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swab2021-05-10 13:04:00 CET1077Immuno-AntigenYesNoImmunoassayQualitative15Fp1AUFn3AUAccuracy99%Clinical Sensitivity98.77%Clinical Specificity99.03%1275SureScreen COVID-19 Antigen Rapid Test Cassette288SureScreen DiagnosticsUnited Kingdomwww.surescreen.comYesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swabOropharyngeal swab2021-05-10 13:04:00 CET1050Immuno-AntigenYesImmunoassayQualitative152299SURE STATUS COVID-19 ANTIGEN CARD TEST1072PREMIER MEDICAL CORPORATION PRIVATE LIMITEDIndiawww.premiermedcorp.comYesCommercialisedNoNoCassetteManualNear POC / POCAntigenNasopharyngeal swabSARS-CoVLOD: 250 pfu/ml ~ 353 TCID50/ml2021-06-25 13:08:00 CET2000Immuno-AntigenYesNoImmunochromatographyQualitative20LOD353AUCalibrationNot evaluatedCrossreactivityEvaluatedFp3%Fn9%PrecisionEvaluatedAccuracy91% SENSTIVITY AND 97% SPECIFICITY In comparison with the RT-PCRReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity91%Clinical Specificity97%Type of antigenNucleoprotein2052STANDARD Q COVID-19 Ag Test Nasal224SD BIOSENSOR IncSouth Koreahttp://sdbiosensor.com/xe/YesCommercialisedYesYesLateral flowNear POC / POCAntigenNasal swabSARS-CoV453B.1.1.7United Kingdom806B.1.351South Africa1102B.1.617.1India1103B.1.617.2India1104B.1.617.3India1258P.1Japan/BrazilNone2021-07-07 17:13:37 CET1730Immuno-AntigenYesNoImmunochromatographyQualitative15LOD146.6AUCalibrationEvaluatedCrossreactivityEvaluatedFp0%Fn2%PrecisionEvaluatedAccuracy99%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.12%Clinical Specificity100%Type of antigenNucleoprotein345STANDARD Q COVID-19 Ag Test224SD BIOSENSOR IncSouth Koreahttp://sdbiosensor.com/xe/YesCommercialisedYesYesCassetteNear POC / POCAntigenNasopharyngeal swab2021-05-10 13:04:00 CET672Immuno-AntigenYesNoImmunochromatographyQualitativeMagnetic Electrochemical30LOD1981TCID50/mlCrossreactivityEvaluatedClinical Sensitivity96.52%Clinical Specificity99.68%344STANDARD F COVID-19 Ag FIA224SD BIOSENSOR IncSouth Koreahttp://sdbiosensor.com/xe/YesCommercialisedYesYesCassetteNear POC / POCAntigenNasopharyngeal swab2021-05-10 13:04:00 CET666Immuno-AntigenYesImmunoassayQualitativeFluorescence15Type of antigennucleoprotein 502Sona Nanotech COVID-19 Lateral Flow Assay Lateral flow screening test for S1 domain of SARS-CoV-2 S1 protein301Sona NanotechCanadasonanano.com/YesIn developmentNoNoLateral flowNear POC / POCAntigenNasopharyngeal swab2021-05-10 13:04:00 CET396Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD214TCID50/mlClinical Sensitivity84.6%Clinical Specificity90%2226SOFTEC Sars Cov-2 (Covid-19) Antigen Test Kit1034ZET medikal tekstil dis tic ltd stiTurkeywww.zetmedikal.com/enYesCommercialisedNoNoCassetteLateral flowNear POC / POCAntigenNasopharyngeal swabOropharyngeal swabSARS-CoV20A.23.1United Kingdom453B.1.1.7United Kingdom806B.1.351South Africa905B.1.427USA1100B.1.616France1258P.1Japan/Brazil1260P.2Brazil1261P.3The PhilippinesDear Sir/Madam, Our SOFTEC Sars Cov-2 Antigen test kit is evaluated by Paul Erlich Institute and approved. (You can check from www.pei.de) .Also registered at Bfarm Germany Antigen list ( With number AT167/20) . We want to add our Antigen test kit to EU lists. Kind Regards Mr.Mustafa DAGAR General Manager ZET medical textile foreign trade co Ltd2021-06-10 17:48:52 CET1927Immuno-AntigenYesNoImmunochromatographyQualitative15LOD2300AUCalibrationNot evaluatedCrossreactivityEvaluatedFp3.61%False positive 18 at totally 498 Positive Specimens detected with RT-PCRFn0.82%False Negative 6 at totally 726 Negative Specimens detected with RT-PCRPrecisionEvaluatedAccuracy98%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity96%Clinical Specificity99%Type of antigenNucleoprotein1097Sofia SARS Antigen FIA216Quidel CorporationUnited Stateswww.quidel.comYesCommercialisedYesYesLateral flowNear POC / POCAntigenNasal swabNasopharyngeal swab2021-05-10 13:04:00 CET878Immuno-AntigenYesYesImmunoassayQualitativeFluorescence15LOD113TCID50/mlCalibrationEvaluatedCrossreactivityEvaluatedFp0%Fn3.3%Accuracy99.5%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.7%Clinical Specificity100%Type of antigenNucleoprotein1344SMARAPIDTEST650APLUS Diagnostics Laboratuvar San.Tic.A.S.Turkeywww.aplustbd.comYesCommercialisedNoNoCassetteLateral flowNear POC / POCAntigenNasal swabSaliva2021-05-10 13:04:00 CET1111Immuno-AntigenYesNoImmunoassayQualitative15LOD15Fp52 out of 40 samples of Gold standard reagent Fn2.52 out of 80 samples of Gold standard reagent Accuracy96%Clinical Sensitivity95%1112Immuno-AntibodyYesNoImmunoassayQualitative15LOD0.10.1Calibrationnot evaluatedCrossreactivityevaluatedFp1.47%1 out of 68 samples of Gold standard reagent Fn10.1%10 out of 99 samples of Gold standard reagentPrecisionnot evaluatedAccuracy98% IgGAccuracy93% IgMReproducibilitynot evaluatedRobustnessevaluatedClinical Sensitivity97% IgGClinical Sensitivity87% IgM1650SINGUWAY COVID-19 Ag Test604SINGUWAY BIOTECH IncChinawww.singuway.com/english/index.phpYesCommercialisedNoNoCardNear POC / POCAntigenNasal swabOtherSaliva2021-05-10 13:18:20 CET1331Immuno-AntigenYesYesImmunoassayQualitativeColorimetry15LOD1.25AUCalibrationevaluatedCrossreactivityevaluatedPrecisionevaluatedAccuracy96%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity92.59%Type of antigennucleoprotein2127Sienna COVID-19 Antigen Rapid Test Cassette567Salofa OyFinlandhttps://www.salofa.comYesCommercialisedNoNoCassetteLateral flowManualAntigenNasopharyngeal swabSARS-CoV453B.1.1.7United Kingdom806B.1.351South AfricaThe SARS-CoV-2 Antigen Rapid Test Kit is a rapid chromatographic immunoassay for the for qualitative detection of SARS-CoV-2 nucleocapsid protein in human nasopharyngeal swab samples. It is intended to aid in the rapid diagnosis of COVID-19 infections. This rapid kit uses a fluorescence immunochromatography method to detect SARS-CoV-2 N antigen.2021-07-08 11:04:13 CET1817Immuno-AntigenYesNoImmunoassayQualitativeSandwich10LOD40AUCalibrationEvaluatedCrossreactivityEvaluatedFp3.44%5 of 145Fn1.34%6 of 446PrecisionEvaluatedAccuracy98.1%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.9%Clinical Specificity98.9%99.99% (100%))]]>Type of antigenNucleoprotein1114SGTi-flex COVID-19 Ag261Sugentech, IncSouth Koreasugentech.com/YesCommercialisedYesYesCassetteNear POC / POCAntigenNasopharyngeal swabOropharyngeal swab14 days from symptom onset to blood collectionMade in Taiwan ]]>2021-07-07 17:25:03 CET1019Immuno-AntigenYesNoImmunoassayQualitativeMagnetic Electrochemical20Clinical Sensitivity100%Clinical Specificity100%2003SG Diagnostics COVID-19 Antigen Rapid Test Kit (Colloidal Gold-Based)921SG Diagnostics Pte LtdSingaporehttps://www.sgdiagnostics.comYesCommercialisedNoNoCassetteLateral flowNear POC / POCAntigenDeep (cough) sputumNasal swabNasopharyngeal swabOropharyngeal swabSalivaSG Diagnostics COVID-19 Antigen Rapid Test Kit showed no cross-reactivity with the following potentially cross-reactive common organisms - Human coronavirus (229E, HKU1, OC43 and NL63), Middle East respiratory syndrome (MERS) coronavirus, Adenovirus, Enterovirus, Influenza A (H1N1 and H3N2) and B viruses, Avian influenza virus, Parainfluenza type 1-4, Measles virus, Human metapneumovirus, Mumps virus, Rhinovirus, Epstein-Barr virus, Respiratory syncytial virus, Staphylococcus aureus, Streptococcus pneumoniae, Staphylococcus epidermidis, Mycobacterium tuberculosis, Legionella pneumophila, Haemophilus influenza, Streptococcus pyogenes, Chlamydia pneumoniae, Mycoplasma pneumoniae, Candida albicans, organisms that make up normal respiratory flora, and organism(s) that causes parapertussis and pneumocystis.2021-05-10 13:04:00 CET1680Immuno-AntigenYesNoImmunochromatographyQualitativeMembrane-basedColloidal gold10LOD75AUCalibrationNot evaluatedCrossreactivityEvaluatedPrecisionEvaluatedAccuracy98.99%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity97.57%Clinical Specificity99.29%Type of antigenNucleoprotein1849Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Detection Kit (Colloidal Gold-Based)184Nanjing Vazyme Medical Technology Co., LtdChinawww.vazyme.comYesCommercialisedNoNoCassetteManualNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabSARS-CoV453B.1.1.7United Kingdom806B.1.351South Africa905B.1.427USA910B.1.429USA999B.1.525Nigeria1000B.1.526USA1001B.1.526.1USA1002B.1.526.2USA1100B.1.616France1102B.1.617.1India1103B.1.617.2India1104B.1.617.3India1258P.1Japan/Brazil1260P.2Brazil1261P.3The PhilippinesType of Antigen: N protein + S protein2021-07-05 18:13:22 CET1529Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich, DoubleColloidal goldOther10LOD50AUCalibrationNot evaluatedCrossreactivityEvaluatedFp2.43%Fn0.71%PrecisionEvaluatedAccuracy98.99%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.57%Clinical Specificity99.29%Type of antigenNucleoprotein1272Sensitest Joysbio Antigen Rapid Test for Covid-19638SensitestNetherlandswww.sensitest.com/index.php?p=sensitest-covid-corona-Antigen-testYesCommercialisedNoNoNear POC / POCAntigenNasal swab2021-05-10 13:04:00 CET1048Immuno-AntigenYesImmunoassayQualitative15Clinical Specificity99%1590Screentest Covid-19+FLU A/B701SCREEN ITALIA S.r.l.Italywww.screenitalia.itYesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swab2021-05-10 13:04:00 CET1270Immuno-AntigenYesNoImmunoassayQualitative15Accuracy98%ReproducibilityevaluatedClinical Sensitivity96.4%Clinical Specificity99.2%1847SCREEN TEST COVID-19 SALIVA701SCREEN ITALIA S.r.l.Italywww.screenitalia.itYesCommercialisedNoNoCassetteManualAntigenSalivaSputum* LOD: According to the study shown above, the lowest concentration that still led to a 100% detection rate was 100 TCID50/mL of inactivated SARS-COV-2 (Swab). Conclusion: Minimal detection limits of COVID-19 Antigen Rapid Test is 100pg/ml for recombine COVID-19 protein and 100TCID50/mL for inactivated SARS-COV-2.2021-05-10 13:18:20 CET1527Immuno-AntigenYesNoImmunochromatographyQualitativeOtherOther15LOD0AU0CalibrationNot evaluatedCrossreactivityEvaluatedFp2.15%2 on 93Fn0.96%10 on 313PrecisionEvaluatedAccuracy97%(95% CI*: 94.9%~98.5%)ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity90.1%(95% CI*:82.5%~95.1%)Clinical Specificity99.3%(95% CI*: 97.7%~99.9%)Type of antigenNucleoprotein1681SCREEN TEST COVID-19 AG - COVID-19 ANTIGEN RAPID TEST701SCREEN ITALIA S.r.l.Italywww.screenitalia.itYesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swabOther2021-05-10 13:18:20 CET1360Immuno-AntigenYesNoImmunoassayQualitative15LOD50AUCalibrationnot evaluatedCrossreactivityevaluatedFp1.23%1 on 81Fn2.44%3 on 123PrecisionevaluatedAccuracy98%(95%CI: 95.1%-99.5%)Reproducibilitynot evaluatedRobustnessnot evaluatedClinical Sensitivity96.4%(95%CI: 89.8%- 99.2%)Type of antigennucleoprotein1201ScheBo SARS CoV-2 Quick Antigen359ScheBo Biotech AGGermanywww.schebo.de/YesCommercialisedYesYesCassetteNear POC / POCAntigenNasopharyngeal swabOropharyngeal swabSerum2021-07-07 17:24:39 CET987Immuno-AntigenYesNoImmunochromatographyQualitativeFluorescence15LOD3.5U/mlCalibrationEvaluatedCrossreactivityEvaluatedFp1.12%6/534Fn3.44%4/116PrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.77%Clinical Sensitivity96.6%Ct 30Type of antigenNucleoprotein1320SARS-CoV2 Antigen Rapid Test410Monocent, IncUnited Stateswww.monocent.comYesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swab2021-05-10 13:04:00 CET564Immuno-AntigenYesNoImmunoassayQualitativeColorimetry20LODAU1FpAU0Fn%1Accuracy99.25Clinical Sensitivity98.25%Type of antigennucleoprotein2145SARS-CoV-2（COVID-19）Antigen Rapid Detection Kit (Lateral Flow Method)993Shen Zhen Zi Jian Biotechnology Co., Ltd.ChinaYesCommercialisedNoNoCardCassetteLateral flowStripNear POC / POCAntigenNasal swabOropharyngeal swabSalivaAlpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus OC43 (HCoV-OC43)Human Metapneumovirus (HMPV)MERS-CoVParainfluenza Virus Type 1Parainfluenza Virus Type 2Parainfluenza Virus Type 3Parainfluenza Virus Type 4453B.1.1.7United Kingdom806B.1.351South Africa1258P.1Japan/BrazilThis kit is intended to be used for in-vitro qualitative detection of SARS-CoV-2 antigens in human naso-/oropharyngeal swab and saliva samples. This kit uses colloidal gold immuno-lateral chromatography technology. Antigen detection is used for auxiliary diagnosis or epidemiological investigation of human infection with SARS-CoV-2.The test is for professional use only.2021-06-03 09:53:56 CET1835Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich, Double10LOD25.55AUCalibrationEvaluatedCrossreactivityEvaluatedFp2.31%Fn2.35%PrecisionEvaluatedAccuracy97.66%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.69%Clinical Specificity97.65%Type of antigenNucleoprotein1473SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae Antigen Combo Rapid Test659CITEST DIAGNOSTICS INCChinawww.citestdiagnostics.comYesCommercialisedNoNoNear POC / POCAntigenNasal swab no info in company website2021-05-10 13:04:00 CET1222Immuno-AntigenYesNoImmunoassayQualitative15Rapid diagnostic test LOD0AU0CalibrationNot evaluatedCrossreactivityevaluatedFp0.8%(0.9% Influenza A; 0.9% Influenza B; 3.8% RSV; 1.4% Adenovirus; 2% M.pneumoniae)Fn3.6%(5% Influenza A; 7.1% Influenza B; 5.7% RSV; 3.1% Adenovirus;8.2% M.pneumoniae)PrecisionevaluatedAccuracy98%(98.4 Influenza A; 98.1influenza B; 95.9 RSV; 98.4 Adenovirus; 97 M.pneumoniae)ReproducibilityevaluatedRobustnessnot evaluatedClinical Sensitivity96.4%(95 Influenza A; 92.9% Influenza B; 94.3 RSV; 96.9 Adenovirus; 91.8 M.pneumoniae)Type of antigennucleoprotein1472SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen659CITEST DIAGNOSTICS INCChinawww.citestdiagnostics.comYesCommercialisedNoNoNear POC / POCAntigenNasal swab2021-05-10 13:04:00 CET1221Immuno-AntigenYesNoImmunoassayQualitative15LOD0CalibrationNot evaluatedCrossreactivityevaluatedFp0.8%(S0.9% Influenza A; 0.9% Influenza B; 3.8% RSV; 1.4% Adenovirus)Fn3.6%(5% Influenza A; 7.1% Influenza B; 5.7% RSV; 3.1% Adenovirus)PrecisionevaluatedAccuracy98%(98.4 Influenza A; 98.1 Influenza B; 95.9 RSV; 98.4 Adenovirus)ReproducibilityevaluatedRobustnessnot evaluatedClinical Sensitivity96.4%(95 Influenza A; 92.9 Influenza B; 94.3 RSV; 96.9 Adenovirus)1474SARS-CoV-2/Influenza A+B/RSV Antigen Combo Rapid Test659CITEST DIAGNOSTICS INCChinawww.citestdiagnostics.comYesCommercialisedNoNoNear POC / POCAntigenNasal swab no info in company website2021-05-10 13:04:00 CET1223Immuno-AntigenYesNoImmunoassayQualitative15Rapid diagnostic test LOD0AUCalibrationNot evaluatedCrossreactivityevaluatedFp0.8%(0.9% Influenza A; 0.9% Influenza B; 3.8% RSV)Fn3.6%(5% Influenza A; 7.1% Influenza B; 5.7% RSV)PrecisionevaluatedAccuracy98%(98.4 Influenza A; 98.1 Influenza B; 95.9 RSV)ReproducibilityevaluatedRobustnessnot evaluatedClinical Sensitivity96.4%(95 Influenza A; 92.9 Influenza B; 94.3 RSV)Type of antigennucleoprotein177744Joinstar Biomedical Technology Co., LtdChinawww.joinstar.cnYesCommercialisedNoNoLateral flowManualAntigenNasal swab2021-05-10 13:04:00 CET1456Immuno-AntigenYesNoImmunochromatographyQualitativeColorimetry15LOD0U/mlCalibrationNot EvaluatedCrossreactivityEvaluatedFp3%Fn1%PrecisionEvaluatedAccuracy98.9%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.1%1228SARS-CoV-2 Spike Protein Test Kit (Fluorescence Immunoassay)563Shenzhen Microprofit Biotech Co., LtdChinawww.microprofit-bio.com/YesCommercialisedNoNoAntigen2021-05-10 13:04:00 CET1013Immuno-AntigenYesImmunoassayImmunoAssay-Antigen 1178SARS-CoV-2 Spike Protein Test Kit (Colloidal Gold Chromatographic Immunoassay)563Shenzhen Microprofit Biotech Co., LtdChinawww.microprofit-bio.com/YesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swab http://www.wellbioscience.com/products/detail/1fBC58b58H8G5607.html 2021-05-10 13:04:00 CET960Immuno-AntigenYesImmunoassayQualitativeColorimetry2228SARS-CoV-2 Rapid Antigen Test Nasal854Roche (SD BIOSENSOR)Switzerlandhttps://diagnostics.roche.com/YesCommercialisedYesYesCassetteLateral flowNear POC / POCAntigenNasal swabSARS-CoV453B.1.1.7United Kingdom806B.1.351South Africa905B.1.427USA1102B.1.617.1India1108B.1.621Colombia1258P.1Japan/BrazilThe SARS-CoV-2 Rapid Antigen Test Nasal is technically identical to the nasopharyngeal test launched in 2020 (SARS-CoV-2 Rapid Antigen Test), which is already included in the EU common list of COVID-19 rapid antigen tests.2021-07-07 17:05:08 CET1929Immuno-AntigenYesNoImmunochromatographyQualitative15LOD146.6AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0.91%5 false positives out of 546 PCR negative samples.Fn10.68%14 false negative results out of 131 PCR-positive samples for Ct ≤ 30PrecisionEvaluatedAccuracy95.5% (95% CI: 93.7 % - 97.0 %)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity89.6% (Ct ≤ 30) and 93.1 % (for Ct below LOD 27)Clinical Specificity99.1%Type of antigenNucleoprotein1946SARS-COV-2 rapid antigen test (Swab)126Hangzhou AllTest Biotech Co., LtdGermanyhttps://www.goldstandarddiagnostics.com/home/products/covid-19-antigen-rapid-test/YesCommercialisedNoNoCassetteLateral flowNear POC / POCAntigenNasal swabThe SARS-CoV-2 Antigen Rapid Test (Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 Nucleocapsid protein antigens in swab specimen from individuals with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2 Nucleocapsid protein Antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with SARS-CoV-2.2021-05-10 13:18:20 CET1622Immuno-AntigenYesImmunochromatographyQualitative15LOD100AUCalibrationEvaluatedCrossreactivityEvaluatedFp0.006AUFn0.066AUPrecisionEvaluatedAccuracy97.9%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.4%Clinical Specificity99.4%Type of antigenNucleoprotein2097SARS-CoV-2 Rapid Antigen Test (Colloidal Gold Method)972Sansure Biotech Inc.Chinawww.sansure.com.cnYesCommercialisedNoNoCassetteNear POC / POCAntigenNasopharyngeal swabAdenovirusBordetella PertussisChlamydia PneumoniaeCoronaviruses (HCoV)Hemophilus InfluenzaeHuman Metapneumovirus (HMPV)Influenza AInfluenza BMycoplasma PneumoniaeParainfluenza Virus Type 1Parainfluenza Virus Type 2Parainfluenza Virus Type 3Parainfluenza Virus Type 4Respiratory Syncytial V (RSV) Type ARhinovirus453B.1.1.7United Kingdom806B.1.351South Africa1258P.1Japan/BrazilThe SARS-CoV-2 Rapid Antigen Test (Colloidal Gold Method) is intended for the qualitative detection of the SARS-CoV-2 nucleocapsid protein in human nasopharyngeal or nasal swab sampled from individuals suspected of COVID- 19.2021-05-31 11:16:53 CET1780Immuno-AntibodyYesNoImmunochromatographyQualitativeMembrane-basedColloidal gold15LOD8AUCalibrationEvaluatedCrossreactivityEvaluatedFp1.6%Fn1.9%PrecisionEvaluatedAccuracy98.2%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.4%Clinical Specificity98.1%Type of antigenNucleoprotein1604SARS-CoV-2 Rapid Antigen Test854Roche (SD BIOSENSOR)Switzerlandhttps://diagnostics.roche.com/YesCommercialisedYesYesLateral flowNear POC / POCAntigenNasopharyngeal swab2021-06-30 10:21:31 CET1285Immuno-AntigenYesNoImmunoassayQualitative15Clinical Sensitivity96.52%Clinical Specificity99.2%Type of antigennucleocapside protein2143SARS-CoV-2 Antigen Test Kit（Lateral Flow Assay）991Chinawww.biohermes.comYesCommercialisedNoNoCardCassetteLateral flowNear POC / POCAntigenNasopharyngeal swabOropharyngeal swabAlpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Hemophilus InfluenzaeInfluenza AInfluenza BMycobacterium TuberculosisRespiratory Syncytial V (RSV)453B.1.1.7United Kingdom806B.1.351South Africa1258P.1Japan/BrazilBioHermes SARS-CoV-2 Antigen Test is a lateral flow immunoassay intended for the qualitative detection of antigen to SARS-CoV-2 in naso-/oropharyngeal swab. The test is to be used as an aid in the diagnosis of Coronavirus infection disease (COVID-19).2021-05-31 10:50:36 CET1833Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich15LOD2.5AUCalibrationEvaluatedCrossreactivityEvaluatedFp4.69%Fn1.98%PrecisionEvaluatedAccuracy97.11%(Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.31%(Antigen)Clinical Specificity98.02%(Antigen)Type of antigenNucleoprotein2006SARS-CoV-2 antigen Test Kit (LFIA)923Jiangsu Medomics medical technology Co.,Ltd.Chinahttp://www.medomics-dx.com/YesCommercialisedYesYesCardLateral flowNear POC / POCAntigenAnterior nasal swabNasopharyngeal swabThroat swabMedomics SARS-CoV-2 antigen Test Kit(LFIA) is used to qualitatively detect SARS-CoV-2 in human samples in vitro. Medomics SARS-CoV-2 antigen Test Kit(LFIA) detects the SARS-CoV-2 nucleocapsid antigens with colloidal gold immunochromatography using a double antibody sandwich assay.2021-07-07 17:13:27 CET1684Immuno-AntigenYesNoImmunochromatographyQualitativeSandwichColloidal goldValidity test kit152 nucleocapsid antigens LOD10AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0.49%Fn2.27%PrecisionEvaluatedAccuracy98.88%ReproducibilityNot evaluatedRobustnessNot evaluatedClinical Sensitivity97.73%Clinical Specificity99.51%Type of antigenNucleoprotein1968SARS-CoV-2 Antigen Test Kit (Fluorescence Immunoassay)563Shenzhen Microprofit Biotech Co., LtdChinawww.microprofit-bio.com/YesCommercialisedNoNoCassetteLateral flowManualAntigenNasal swabNasopharyngeal swabOropharyngeal swabwww.microprofit-bio.com2021-05-10 13:18:20 CET1644Immuno-AntibodyYesImmunochromatographyFluorescence15LOD25AUCalibrationEvaluatedCrossreactivityEvaluatedFp0%Fn4.3%PrecisionEvaluatedAccuracy97.6%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.65%Clinical Specificity100%Clinical specificity = 300/300 = 100% (95%CI:98.78% ~100%)2012SARS-CoV-2 Antigen Test Kit (Colloidal Gold)472Genrui Biotech IncChinawww.genrui-bio.com/YesCommercialisedYesYesLateral flowNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabEvaluation PEI: Positive2021-07-07 17:08:01 CET1690Immuno-AntigenYesNoImmunochromatographyQualitativeColloidal gold15LOD180AUCalibrationEvaluatedCrossreactivityEvaluatedFp0.98%Fn8.85%PrecisionEvaluatedAccuracy94.88%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity91.15%Clinical Specificity99.02%Type of antigenNucleoprotein1487SARS-CoV-2 Antigen Test Kit (colloidal gold method)848Bioteke Taizhou Biotechnology Co., LtdChinawww.bioteke.cn/YesCommercialisedNoNoNear POC / POCAntigenNasal swabSaliva2021-05-10 13:18:20 CET1230Immuno-AntigenYesNoImmunoassayQualitativeColloidal gold15Rapid diagnostic test colloidal gold LOD175CalibrationevaluatedCrossreactivityevaluatedFp2Fn3PrecisionevaluatedAccuracy98.58%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity95.95%Type of antigennucleoprotein2067SARS-CoV-2 Antigen Test Kit (colloidal gold method)955BIOTEKE CORPORATION (WUXI) CO., LTDChinahttps://www.bioteke.cn/YesCommercialisedYesYesCassetteNear POC / POCAntigenNasopharyngeal swabOropharyngeal swabCoronaviruses (HCoV)453B.1.1.7United Kingdom806B.1.351South Africa1258P.1Japan/Brazilhttps://www.bioteke.cn/2021-07-13 17:51:35 CET1747Immuno-AntigenYesNoImmunoassayQualitativeSandwich, DoubleColloidal goldValidity test kit15LOD175AUCalibrationEvaluatedCrossreactivityEvaluatedFp0.72%Fn3.51%PrecisionEvaluatedAccuracy98.47%(95%CI: 96.70%～99.44%)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.49(95%CI: 91.26%～99.04%)Clinical Specificity99.28(95%CI: 97.43%～99.91%)Type of antigenNucleoprotein1967SARS-CoV-2 Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay)563Shenzhen Microprofit Biotech Co., LtdChinawww.microprofit-bio.com/YesCommercialisedYesYesCassetteLateral flowManualAntigenNasal swabNasopharyngeal swabOropharyngeal swabwww.microprofit-bio.com2021-07-07 17:07:15 CET1643Immuno-AntibodyYesImmunochromatographyColloidal gold15LOD49AUCalibrationEvaluatedCrossreactivityEvaluatedFp0%Fn7%PrecisionEvaluatedAccuracy96.11%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.93%Clinical Specificity100%Clinical specificity = 300/300 = 100% (95%CI:98.78% ~100%)Type of antigenNucleoprotein1759SARS-CoV-2 Antigen Test Kit786Hubei Jinjian Biology Co., LtdChinaen.jinjianbio.com/YesCommercialisedNoNoCassetteAutomatedAntigenNasal swab2021-05-10 13:04:00 CET1437Immuno-AntigenYesYesImmunochromatographyQualitativeColorimetry15LOD115U/mlCalibrationNot EvaluatedCrossreactivityEvaluatedFp1%1 out of 100Fn1.35%2 out of 148PrecisionEvaluatedAccuracy98.8%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.02%Type of antigenNucleoprotein2017SARS-CoV-2 Antigen Test Kit926Shenzhen Ultra-Diagnostics Biotec.Co.,LtdChinawww.ud-bio.comYesCommercialisedYesYesCardCassetteLateral flowManualNear POC / POCAntigenNasal swabNasopharyngeal swabSaliva1. For in vitro diagnostic use only. 2. Proper specimen collection storage and transit are critical to the performance of this test. 3. Use only once. 4. Do not touch the reaction area of test strip. 5. Do not use test kit beyond the expiration date. 6. Do not use the kit if the pouch is punctured or sealed not well. 7. Testing should be applied by professionally trained staff working in certified laboratories or clinics. 8. The test result should be interpreted by the physician along with clinical findings and other laboratory test results. 9. Dispose of test cards and items in contact with samples as medical waste after use. 10.Do not freeze.2021-05-19 17:15:38 CET1695Immuno-AntigenYesNoImmunochromatographyQualitativeMembrane-basedValidity test kit15LOD625AUCalibrationNot evaluatedCrossreactivityEvaluatedFpReading result after 30 minutesFnthe concentration of virus is below LODPrecisionEvaluatedAccuracy97.35%Nasal),97.94(Nasopharyngeal),97.36(SalivaReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.33%Nasal),95.48(Nasopharyngeal),94.83(SalivaClinical Specificity99.16%Nasal),99.61(Nasopharyngeal),99.33(SalivaType of antigenNucleoprotein1644SARS-CoV-2 Antigen Test Cassette (Nasal Swab Specimen)753Jiangsu Mole Bioscience CO., LTDChinaen.molechina.com/YesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swab2021-05-10 13:18:20 CET1324Immuno-AntigenYesNoImmunoassayQualitativeColloidal gold15LOD100AUCalibrationevaluatedCrossreactivityevaluatedFp0.08%Fn0.6%PrecisionevaluatedAccuracy99%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity100%Type of antigennucleoprotein1146SARS-CoV-2 Antigen Test252LumiraDXUnited Kingdomwww.lumiradx.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabhttps://www.lumiradx.com/uk-en/what-we-do/diagnostics/test-technology/Antigen-test2021-05-10 13:04:00 CET315Immuno-AntigenYesYesImmunoassayQualitativeImmunofluorescence12LOD32TCID50/mlCrossreactivityno crossreactivity with Human coronavirus 229E; Human coronavirus OC43; Human coronavirus NL63; MERS coronavirus; Adenovirus (e.g. C1 Ad. 71); Human Metapneumovirus (hMPV); Parainfluenza virus Type 1; Parainfluenza virus Type 2; Parainfluenza virus Type Accuracy96.9%Clinical Sensitivity97.6%Clinical Specificity96.6Type of antigennucleocapsid protein (N-protein)1766SARS-CoV-2 Antigen Rapid Test Kit - Saliva (Colloidal Gold)516JOYSBIO (Tianjin) Biotechnology Co., LtdChinaen.joysbio.com/YesCommercialisedNoNoLateral flowNear POC / POCAntigenSaliva2021-05-10 13:18:20 CET1445Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD320U/mlCalibrationEvaluatedCrossreactivityEvaluatedFp0%0 out of 260 RT-PCR negative specimensFn4.9%5 out of 102 RT-PCR positive specimensPrecisionEvaluatedAccuracy98.62%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.1%Type of antigenNucleoprotein1286SARS-CoV-2 Antigen Rapid Test Kit (Fluorescence Immunochromatography)53BIOHIT HealthCare (Hefei) Co., LtdChinawww.biohit.cnYesCommercialisedNoNoNear POC / POCAntigenSerum2021-05-10 13:04:00 CET1060Immuno-AntigenYesImmunochromatographyQualitativeFluorescence15LOD20TCID50/mlLOD3.5pgper mlClinical Sensitivity96.77%Clinical Specificity98.9%1764SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold)516JOYSBIO (Tianjin) Biotechnology Co., LtdChinaen.joysbio.com/YesCommercialisedYesYesLateral flowNear POC / POCAntigenNasal swab2021-07-07 17:22:26 CET1442Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD160AUAnalytical Sensitivity98.13%Crossreactivity0AUFp3AUFn2AUAccuracy98.98%1595SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold)704Genesprint Group LimitedHong Kong S.A.Rwww.gsprint.coYesCommercialisedNoNoNear POC / POCAntigenNasal swab2021-05-10 13:04:00 CET1275Immuno-AntigenYesNoImmunoassayQualitativeColloidal gold5Rapid diagnostic test cassette colloidal gold LOD103AUCalibrationevaluatedCrossreactivityevaluatedFp5%(Less than 5%)Fn5%(Less than 5%)PrecisionevaluatedAccuracy99%ReproducibilityevaluatedRobustnessnot evaluatedClinical Sensitivity98.96%Type of antigennucleoprotein1276Immuno-AntigenYesNoImmunoassayQualitativeColloidal gold5Rapid diagnostic test cassette colloidal gold LOD103AUCalibrationevaluatedCrossreactivityevaluatedFp5%(Less than 5%)Fn5%(Less than 5%)PrecisionevaluatedAccuracy99%ReproducibilityevaluatedRobustnessnot evaluatedClinical Sensitivity98.96%Type of antigennucleoprotein2203SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold)906Diasia Biomedical Technology Co., Ltd.Chinawww.diasia.com.cnYesCommercialisedNoNoAntigenAnterior nasal swabSARS-CoV453B.1.1.7United KingdomLOD (U/ml) ：36pg/ml2021-06-10 15:59:36 CET1904Immuno-AntigenYesImmunochromatographyQualitativeColloidal gold15LOD36%CalibrationNot evaluatedCrossreactivityEvaluatedFp0.82%122 specimens were negative by both test reagent and control reagent, and there is 1 specimen of falFn0.76%131 specimens were negative by both test reagent and control reagent, and there is 1 specimen of falPrecisionEvaluatedAccuracy97.63%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.9%Clinical Specificity99.24%Type of antigenNucleoprotein1331SARS-CoV-2 Antigen Rapid Test Kit319Beijing Lepu Medical Technology Co., LtdChinaen.lepumedical.com/YesCommercialisedYesYesCardNear POC / POCAntigenNasal swab2021-05-10 13:04:00 CET1100Immuno-AntigenYesNoImmunochromatographyQualitativeColloidal gold15Accuracy96.67%Clinical Sensitivity92%1266SARS-CoV-2 Antigen Rapid Test Kit346Labnovation Technologies IncChinawww.labnovation.com/YesCommercialisedYesYesNear POC / POCAntigenNasopharyngeal swabOropharyngeal swab2021-07-07 17:22:32 CET1040Immuno-AntigenYesImmunoassayQualitativeColloidal gold15Type of antigennucleocapsid protein1465SARS-CoV-2 Antigen Rapid Test Kit677Triplex International Biosciences Co., LtdChinawww.tibchina.com/index_en.aspxYesCommercialisedYesYesNear POC / POCAntigenNasal swab2021-07-13 17:59:28 CET1207Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD0AUCalibrationNot evaluatedCrossreactivityevaluatedFp0%Fn1.49%PrecisionevaluatedAccuracy99.52%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity98.51Type of antigennucleoprotein2074SARS-CoV-2 Antigen Rapid Test Kit959Triplex International Biosciences (China) Co., LTD.Chinawww.tibchina.comYesCommercialisedYesYesCardNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabAdenovirusAdenovirus 3Adenovirus 7Alpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Bordetella PertussisChlamydia PneumoniaeEnterovirus A71 (EV-A71)Epstein-Barr Virus (EBV)Hemophilus InfluenzaeHuman Metapneumovirus (HMPV)Influenza A H1N1Influenza A H3N2Influenza B VictoriaInfluenza B YamagataMERS-CoVMycobacterium TuberculosisMycoplasma PneumoniaeParainfluenza Virus Type 1Parainfluenza Virus Type 2Parainfluenza Virus Type 3Parainfluenza Virus Type 4Respiratory Syncytial V (RSV)Respiratory Syncytial V (RSV) Type ARespiratory Syncytial V (RSV) Type BRhinovirus453B.1.1.7United Kingdom806B.1.351South Africa1258P.1Japan/BrazilThe SARS-CoV-2 Antigen Rapid Test Kit is a colloidal gold enhanced double antibody sandwich immunoassay for the qualitative determination of nucleocapsid protein (N protein) from SARS-CoV-2 antigen.2021-07-07 17:25:18 CET1756Immuno-AntigenYesNoImmunoassayQualitativeSandwich, Double15LOD0AUCalibrationEvaluatedCrossreactivityEvaluatedFp1.67%Fn0%PrecisionEvaluatedAccuracy99.58%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.33%AntigenClinical Specificity100%AntigenType of antigenNucleoprotein1780SARS-Cov-2 Antigen Rapid Test Cassette (swab)381Spring Healthcare Services AGSwitzerlandwww.springhealthcare.org/YesCommercialisedNoNoCardLateral flowNear POC / POCAntigenNasal swabNasopharyngeal swab2021-05-10 13:04:00 CET1459Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD125U/mlCalibrationEvaluatedCrossreactivityEvaluatedFp0AUFn1AUPrecisionEvaluatedAccuracy99.55%RobustnessEvaluatedClinical Sensitivity97.82%2029SARS-CoV-2 Antigen Rapid Test Cassette933Merlin Biomedical (Xiamen) Co., Ltd.Chinahttp://www.merlinbio.com.cn/en/YesCommercialisedYesYesCassetteNear POC / POCAntigenNasal swabNasopharyngeal swabBfArM Vorgangsnummer: AT214/20 Certificate TÜV Süd No. Q5 106286 0001 Rev. 00 CE number: BE-CA01/1-16963-00006-IVD2021-07-07 17:23:09 CET1707Immuno-AntigenYesNoImmunochromatographyQualitative15LOD160AUCalibrationEvaluatedCrossreactivityEvaluatedFp5AUFn1AUPrecisionEvaluatedAccuracy97%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.05%Clinical Specificity98.99%Type of antigenNucleoprotein1887SARS-CoV-2 Antigen Rapid Test (Sputum/Saliva/Stool)862Xiamen Wiz Biotech Co., LtdChinawww.wizbiotech.comYesCommercialisedNoNoCardManualAntigenSalivaSputumStoolNo2021-05-10 13:04:00 CET1566Immuno-AntigenYesImmunochromatographyQualitativeColorimetry15LOD170AUCalibrationEvaluatedCrossreactivityEvaluatedPrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluatedType of antigenOther1886SARS-CoV-2 Antigen Rapid Test (Saliva)862Xiamen Wiz Biotech Co., LtdChinawww.wizbiotech.comYesCommercialisedNoNoCardManualAntigenSalivaNO.2021-05-10 13:04:00 CET1565Immuno-AntigenYesImmunochromatographyQualitativeColorimetry20LOD170AUCalibrationEvaluatedCrossreactivityEvaluatedFp0%No false positives were found in 899 samples tested.Fn1.78%16 false negatives were found in 899 samples tested.PrecisionEvaluatedAccuracy98.22%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.35%Clinical Specificity100%1895SARS-CoV-2 Antigen Rapid Test (Nasal/Saliva)230Selfdiagnostics Deutschland GmbHGermanyselfdiagnostics.comYesCommercialisedNoNoCassetteLateral flowStripNear POC / POCAntigenNasal swabSalivaINTENDED USE The SARS-CoV-2 Antigen Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection the nucleocapsid protein antigen from SARS-CoV-2 in nasal and nasopharyngeal swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first seven days of the onset of symptoms. The SARSCoV- 2 Antigen Rapid Test can also be used for testing specimens from asymptomatic individuals. The SARS-CoV-2 Antigen Rapid Test does not differentiate between SARS-CoV and SARS-CoV-2. Results are for the identification of SARS-CoV-2 nucleocapsid antigen. This antigen is generally detectable in upper respiratory samples during the acute phase of infec-tion. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or coinfection with other viruses. The agent detected may not be the definite cause of disease. Negative results, from patients with symptom beyond seven days, should be treated as presumptive and confirmed with a molecular assay, if necessary, for patient management. Negative results do not rule out SARSCoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19. The SARS-CoV-2 Antigen Rapid Test is intended for use by trained clinical laboratory personnel and individuals trained in point of care settings. SARS-CoV-2 Antigen Rapid Test is intended to be used as an aid in the diagnosis of SARS-CoV-2 infection.2021-05-17 09:46:14 CET1572Immuno-AntigenYesImmunochromatographyQualitative15 SARS-CoV-2 antigen rapid test kit is a lateral flow chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigens in nasal swab or saliva specimens. LOD160AUCalibrationEvaluatedCrossreactivityEvaluatedPrecisionEvaluatedAccuracy98%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.1%(95% CI: 93.1%-98.9%)Clinical Specificity99.5%(95% CI: 98.2%-99.9%)Type of antigennucleocapsid1908SARS-CoV-2 Antigen Rapid Test (Nasal/Saliva)683ACON Laboratories, IncUnited Stateswww.aconlabs.comYesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swabSalivaN.A.2021-05-10 13:18:20 CET1583Immuno-AntigenYesImmunoassayMembrane-based15LOD160AUFp0.462 out of 435(Nasal Swab); 1 out of 236(Saliva)Fn2.945 out of 170(Nasal Swab); 9 out of 105(Saliva)PrecisionEvaluatedAccuracy98.8%98.8%(Nasal Swab); 97.1%(Saliva)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.1%97.1%(Nasal Swab); 91.4%(Saliva); Clinical Specificity99.5%99.5%(Nasal Swab); 99.6%(Saliva); Type of antigenNucleoprotein2257SARS-CoV-2 Antigen Rapid Test (Nasal Swab)1003Hangzhou AllTest Biotech Co., Ltd.Chinawww.alltests.com.cnYesCommercialisedNoNoCassetteLatexNear POC / POCAntigenNasal swabAdenovirus 3Adenovirus 7Alpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Influenza A H1N1Influenza A H3N2Influenza BMERS-CoVParainfluenza Virus Type 2Parainfluenza Virus Type 3Respiratory Syncytial V (RSV)20A.23.1United Kingdom72AT.1Russia453B.1.1.7United Kingdom806B.1.351South Africa905B.1.427USA910B.1.429USA999B.1.525Nigeria1000B.1.526USA1001B.1.526.1USA1002B.1.526.2USA1100B.1.616France1102B.1.617.1India1103B.1.617.2India1104B.1.617.3India1108B.1.621Colombia1224C.36Egypt1227C.37Peru1258P.1Japan/Brazil1260P.2Brazil1261P.3The PhilippinesThe SARS-CoV-2 Antigen Rapid Test (Nasal Swab) is a single-use test kit intended to detect the SARS-CoV-2 that causes COVID-19 with self-collected nasal swab specimen from symptomatic individuals who are suspected of being infected with COVID-19. Results are for the detection of SARS-CoV-2 Nucleocapsid protein Antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results are indicative of the presence of SARS-CoV-2. Individuals who test positive should self-isolate and seek additional care from their healthcare provider. Positive results do not rule out bacterial infection or co-infection with other viruses. Negative results do not preclude SARS-CoV-2 infection. Individuals who test negative and continue to experience COVID-like symptoms should seek follow up care from their healthcare provider.2021-07-08 11:27:01 CET1958Immuno-AntigenYesNoImmunoassayQualitativeSandwichValidity test kit15LOD100AUCalibrationEvaluatedCrossreactivityEvaluatedFp0.046AUFn0.006AUPrecisionEvaluatedAccuracy97.8%（Antigen）ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.4%（Antigen）Clinical Specificity99.4%(Antigen）Type of antigenNucleoprotein2166SARS-CoV-2 Antigen Rapid Test (Lateral Flow Assay)1009Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.ChinaYesCommercialisedNoNoCassetteLab-basedManualNear POC / POCAntigenAnterior nasal swabNasopharyngeal swabOropharyngeal swabAdenovirus 7Chlamydia PneumoniaeEpstein-Barr Virus (EBV)Influenza A H1N1Influenza A H3N2Influenza B VictoriaInfluenza B YamagataMERS-CoVMumps Virus (MuV)Mycoplasma PneumoniaeParainfluenza Virus Type 1Parainfluenza Virus Type 2Parainfluenza Virus Type 3Parainfluenza Virus Type 4Respiratory Syncytial V (RSV) Type ARespiratory Syncytial V (RSV) Type B453B.1.1.7United Kingdom806B.1.351South Africano additional information2021-06-03 10:02:44 CET1867Immuno-AntigenYesNoImmunochromatographyQualitative15LOD0.05AUCalibrationNot evaluatedCrossreactivityEvaluatedFp1%Fn4.81%PrecisionEvaluatedAccuracy96.71%(Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.19%(Antigen)Clinical Specificity98.17%(Antigen)Type of antigenNucleoprotein1341SARS-CoV-2 Antigen Rapid Test (Immunochromatography)286Qingdao Hightop Biotech Co., LtdChinawww.hightopbio.com/YesCommercialisedYesYesCassetteNear POC / POCAntigenNasal swab2021-07-07 17:23:59 CET1119Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD2000U/mlClinical Sensitivity95%Type of antigennucleoprotein1366SARS-CoV-2 Antigen Rapid Test (Immunochromatography)654SHANDONG KANGHUA BIOTECHNOLOGY CO., LTDChinaWWW.KHBIO.COMYesCommercialisedNoNoCassetteNear POC / POCAntigenNasopharyngeal swabOropharyngeal swab2021-05-10 13:04:00 CET1129Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD1400AUFp0.25%1 false positive to 400 negative samplesFn5%5 false negatives to 100 positive samplesAccuracy98.8%(Antigen)Clinical Sensitivity95%(Antigen)Clinical Specificity99.75%Type of antigennucleoprotein1884SARS-CoV-2 Antigen Rapid Test (Colloidal Gold)862Xiamen Wiz Biotech Co., LtdChinawww.wizbiotech.comYesCommercialisedYesYesCardManualAntigenAnterior nasal swab2021-07-07 17:26:18 CET1563Immuno-AntigenYesImmunochromatographyQualitativeMembrane-basedColloidal goldValidity test kit15LOD170AUCalibrationEvaluatedCrossreactivityEvaluatedFp0%No false positives were found in 899 samples tested.Fn1.56%14 false negatives were found in 899 samples tested.PrecisionEvaluatedAccuracy98.37%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.91%Clinical Specificity100%Type of antigenNucleoprotein (nucleocapside protein)1338SARS-CoV-2 Antigen Rapid Test649TBG BIOTECHNOLOGY XIAMEN IncChinawww.tbgxm.comYesCommercialisedNoNoNear POC / POCAntigenNasal swab2021-05-10 13:04:00 CET1107Immuno-AntigenYesNoImmunoassayQualitative20Type of antigennucleoprotein1616SARS-COV-2 Antigen Rapid Test719Zhuhai Encode Medical Engineering Co., LtdChinawww.encode.com.cn/YesCommercialisedNoNoCassetteNear POC / POCAntigenNasopharyngeal swab http://www.encode.com.cn/en/about.asp2021-05-10 13:04:00 CET1296Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15Clinical Sensitivity95%Clinical Specificity100%1964SARS-CoV-2 Antigen Rapid test834BN SantéFrancewww.biogyne.frYesCommercialisedNoNoAntigenNasal swab2021-05-26 16:14:54 CET1640Immuno-AntigenYesNoImmunochromatographyQualitative15LOD160AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0.5%Fn2.9%PrecisionEvaluatedAccuracy98.8%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.1%Clinical Specificity99.5%Type of antigenNucleoprotein1456SARS-CoV-2 Antigen Rapid Test862Xiamen Wiz Biotech Co., LtdChinawww.wizbiotech.comYesCommercialisedYesYesNear POC / POCAntigenNasal swabOther2021-07-07 17:26:12 CET1208Immuno-AntigenYesYesImmunoassayQualitativeColorimetry15LOD1.7AUCalibrationevaluatedCrossreactivityevaluatedFp0%(338 swabs samples prospectively collected,0 swaps samples False positives)Fn0.89%338 swabs samples prospectively collected,3 swaps samples False positivesPrecisionevaluatedAccuracy99.11%AntigenReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity96.3%AntigenType of antigennucleoprotein1685SARS-CoV-2 Antigen Rapid Qualitative Test756Xiamen Biotime Biotechnology Co., Ltd.Chinawww.biotime.cn/En_YesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swabOther2021-05-10 13:04:00 CET1364Immuno-AntigenYesNoImmunoassayQualitativeColorimetry20LOD0AUCalibrationevaluatedCrossreactivityevaluatedFp0Fn4%PrecisionevaluatedAccuracy98.98%(95%CI: 97.06%-99.79%)ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity96%(95%CI: 88.75%-99.17%)Type of antigennucleoprotein1801SARS-CoV-2 Antigen Rapid Qualitative Test821Innova Medical Group, Inc.United Stateswww.innovamedgroup.comYesCommercialisedNoNoLab-basedAntigenNasal swabSputumThroat swab2021-05-10 13:04:00 CET1480Immuno-AntigenYesImmunochromatographyQualitativeColorimetryCrossreactivityEvaluatedClinical Sensitivity96%CI95%:8 8.75%-99.17%Clinical Specificity100%CI95%: 98.34%-100.00%Type of antigennucleocapsid2151SARS-CoV-2 Antigen Rapid Detection Kit (Colloidal Gold Method)996JINAN BABIO BIOTECHNOLOGY CO., LTD.ChinaYesCommercialisedNoNoCardNear POC / POCAntigenNasal swabOropharyngeal swabSalivaAdenovirusAlpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus OC43 (HCoV-OC43)Influenza A H1N1Influenza BMERS-CoVRespiratory Syncytial V (RSV)453B.1.1.7United Kingdom806B.1.351South Africa1258P.1Japan/BrazilSARS-CoV-2 Antigen Rapid Detection Kit (Colloidal Gold Method) is a lateral flow immunoassay intended for the qualitative detection of nucleoprotein from SARS-CoV-2 innasal swabs,pharyngeal swabs,saliva. It is used by professionals as a test and provides a preliminary test result to aid in the diagnosis of infection with individuals suspected of COVID-19.2021-05-31 13:31:10 CET1841Immuno-AntigenYesImmunochromatographyQualitativeMembrane-basedColloidal gold15LOD0AUCalibrationEvaluatedCrossreactivityEvaluatedFp3.62%Fn0%PrecisionEvaluatedAccuracy98.79%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.38%（Antigen）Clinical Specificity100%Type of antigenNucleoprotein2152SARS-CoV-2 Antigen Rapid Detection Kit997Shenzhen CAS-Envision Medical Technology Co., Ltd.Chinawww.cas-envision.comYesCommercialisedNoNoCardCassetteStripNear POC / POCAntigenNasopharyngeal swabOropharyngeal swabAlpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Human Metapneumovirus (HMPV)MERS-CoVParainfluenza Virus Type 1Parainfluenza Virus Type 2Parainfluenza Virus Type 3Parainfluenza Virus Type 4453B.1.1.7United Kingdom806B.1.351South Africa1258P.1Japan/BrazilSARS-CoV-2 Antigen Rapid Detection Kit is a colloidal gold immunochromatography intended for the qualitative detection of nucleocapsid antigens from SARS-CoV-2 in human nasopharyngeal swab or oropharyngeal swab specimen.2021-05-31 13:35:57 CET1842Immuno-AntigenYesNoImmunochromatographyQualitativeColloidal gold15LOD34AUCalibrationEvaluatedCrossreactivityEvaluatedFp1.9%Fn0.5%PrecisionEvaluatedAccuracy98.8%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.1%Clinical Specificity99.5%Type of antigenNucleoprotein1197SARS-CoV-2 Antigen Kit (Colloidal Gold)117Goldsite Diagnostics IncChinaen.goldsite.com.cn/YesCommercialisedYesYesNear POC / POCAntigenNasal swabOther2021-07-13 18:05:32 CET983Immuno-AntigenYesNoImmunoassayQualitativeColloidal gold122026SARS-CoV-2 antigen IVD kit SWAB930Shenzhen Reagent Technology Co.,Ltd.Chinawww.reagen.cnYesCommercialisedNoNoCardManualAntigenNasopharyngeal swabOropharyngeal swabSARS-CoV453B.1.1.7United Kingdom806B.1.351South Africa1102B.1.617.1India1103B.1.617.2India1104B.1.617.3India1258P.1Japan/Brazil1260P.2BrazilDear JRC team, hereby we would like submit our antigen rapid test, so that it can be listed. For more information please feel free to contact us. Thanks, best regards, Serk2021-06-25 11:00:56 CET1704Immuno-AntigenYesYesImmunochromatographyQualitativeMembrane-basedSample preparation15LOD312.5AUCalibrationEvaluatedCrossreactivityEvaluatedFp2.2%3 false positives were detected in 155 negative samplesFn4.76%5 false negatives were detected in 105 positive samplesPrecisionEvaluatedAccuracy96.9%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.2%（95%CI:85.94%-98.86%）Clinical Specificity98.1%（95%CI:86.75%-99.12%）Type of antigenNucleoprotein1235SARS-Cov-2 Antigen Fluorescence Rapid Detection Kit414Beijing Savant Biotechnology Co., LtdChinawww.huaketai.com/YesCommercialisedNoNoCassetteNear POC / POCAntigenOropharyngeal swab2021-05-10 13:04:00 CET1017Immuno-AntigenYesNoImmunoassayQualitativeFluorescence15LOD50ng/mL1575SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Method)693Wenzhou OJA Biotechnology Co., LTD.Chinawww.ojabio.netYesCommercialisedNoNoCardNear POC / POCAntigenNasal swabOther2021-05-10 13:04:00 CET1254Immuno-AntigenYesNoImmunoassayQualitativeColorimetrySample preparation15LOD1AUCalibrationevaluatedCrossreactivityevaluatedFp1.712 of 117Fn0.451 of 220PrecisionevaluatedAccuracy99.1%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity98.29%Clinical Specificity99.55%Type of antigennucleoprotein1588SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Method)699Xiamen Jiqing Biomedical Technology Co., Ltd.Chinawww.wikang.com.cnYesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swabSalivaThroat swab2021-05-10 13:04:00 CET1268Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD10AUCalibrationevaluatedCrossreactivityevaluatedFp5.75AUFn0AUPrecisionevaluatedAccuracy97.58%(Antigen)ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity94.25%(Antigen)Type of antigennucleoprotein2116SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Immunochromatographic Assay)981PerGrande BioTech Development Co., Ltd.Chinawww.pergrande.com.cnYesCommercialisedYesYesLateral flowNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabSARS-CoV453B.1.1.7United Kingdom806B.1.351South Africa1258P.1Japan/BrazilPlease review, thanks.2021-07-07 17:23:47 CET1806Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold20LOD20AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0.89%Fn5.72%PrecisionEvaluatedAccuracy96.41%( 95.24%-97.30%)（Antigen）ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.28%( 92.33%-95.76% )（Antigen）Clinical Specificity99.11%( 97.94%-99.62%)（Antigen）Type of antigenNucleoprotein1660SARS-Cov-2 Antigen Assay kit by Latex Immunochromatography method743Sichuan Xincheng Biological Co., LTDChinawww.xinchengbio.com/en/YesCommercialisedNoNoLatexNear POC / POCAntigenNasal swab2021-05-10 13:04:00 CET1339Immuno-AntigenYesNoImmunoassayQualitative15LOD500AUCalibrationevaluatedCrossreactivityevaluatedFp0.95%Fn5.7%PrecisionevaluatedAccuracy96.9%(Antigen)ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity94.2%(Antigen)Type of antigennucleoprotein1820SARS-CoV-2 Antigen (Colloidal Gold)112Getein Biotech, IncChinaen.bio-gp.com.cn/YesCommercialisedYesYesLateral flowManualAntigenNasal swabSaliva453B.1.1.7United Kingdom806B.1.351South AfricaOne Step Test for SARS-CoV-2 Antigen (Colloidal Gold) is intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in human nasal swab samples or saliva samples from patients suspected of COVID-19 infection by a healthcare provider.2021-07-13 18:00:24 CET1498Immuno-AntigenYesNoImmunoassayQualitativeSandwichColloidal goldVisualisation system10The antigen test has been validated by Germany for the use. PEI report is availableLOD200AUCalibrationEvaluatedCrossreactivityEvaluatedFp2.9%5 of 170Fn2.9%5 of 170PrecisionEvaluatedAccuracy98.13%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.06%Clinical Specificity98.71%Type of antigennucleoprotein2111SARS-CoV-2 Ag Rapid Test175VivaChek Biotech (Hangzhou) Co., LtdChinawww.vivachek.comYesCommercialisedNoNoCassetteLateral flowNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabAdenovirus 3Adenovirus 7Adenovirus Subtype BAlpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)MERS-CoVMycobacterium TuberculosisMycoplasma PneumoniaeParainfluenza Virus TypeParainfluenza Virus Type 1Parainfluenza Virus Type 2Parainfluenza Virus Type 3Parainfluenza Virus Type 4453B.1.1.7United Kingdom806B.1.351South Africa1102B.1.617.1India1103B.1.617.2India1104B.1.617.3India1258P.1Japan/BrazilVivaDiag SARS-CoV-2 Ag Rapid Test is for the rapid, qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in human nasal swab, oropharyngeal swab or nasopharyngeal swab specimen2021-06-04 14:41:24 CET1801Immuno-AntigenYesNoImmunochromatographyQualitativeSandwichValidity test kit15LOD675AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0%431 negative Sample were tested and 0 of them were false positiveFn4.54%154 positive Sample were tested and 7 of them were false negative.PrecisionEvaluatedAccuracy98.8% (Antigen)ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity95.45%97.04(Antigen)Clinical Specificity99.9%(Antigen)Type of antigenNucleoprotein1769SARS-CoV-2 Ag Diagnostic Test Kit (Colloidal Gold)793Shenzhen Watmind Medical Co., LtdChinawww.watmind.comYesCommercialisedYesYesCassetteNear POC / POCAntigenNasal swabSaliva2021-05-10 20:07:30 CET1448Immuno-AntigenYesNoImmunochromatographyQualitativeColorimetry10LOD150U/mlCalibrationEvaluatedCrossreactivityEvaluatedFp1AUFn5AUPrecisionEvaluatedAccuracy93.7%Clinical Sensitivity95.15%for onset of symptoms within 7 daysType of antigenNucleoprotein1774SARS-CoV-2 / Influenza Virus A/ Influenza Virus B Antigen Assay Kit (Immunochromatography)792Wuhan Life Origin Biotech Joint Stock Co., Ltd.Chinawww.szybio.comYesCommercialisedNoNoCardLateral flowNear POC / POCAntigenNasal swab2021-05-10 13:04:00 CET1453Immuno-AntigenYesYesImmunochromatographyQualitative15LOD0U/mlCalibrationEvaluatedCrossreactivityEvaluatedFp1.7%PrecisionEvaluatedAccuracy96.6%(483/500), 95%CI(94.61%-98.01%).ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.67%(139/150), 95%CI(87.26%-96.28%).2157SARS CoV-2 Antigen Rapid Test1001Novatech Tıbbi Cihaz Ürünleri Sanayi ve Ticaret A.Ş.Turkeywww.novadiag.comYesCommercialisedNoNoCassetteNear POC / POCAntigenAnterior nasal swabNasal swabNasopharyngeal swabOropharyngeal swabSARS-CoV453B.1.1.7United Kingdom806B.1.351South Africa1102B.1.617.1India1103B.1.617.2India1104B.1.617.3India1260P.2BrazilIntended Use The Novacheck SARS-CoV-2 rapid diagnostic test is an immunochromatographic per-patient test based on the sandwich principle, which contains two specific antibodies for qualitative detection of N-protein antigen in human nasal swab samples. This test kit is used to detect the SARS-CoV-2 N-protein antigen that occurs in the acute phase of an infection. An antigen is generally detectable in upper respiratory specimen during the acute phase of the infection (within the first 5 to 7 days from symptom onset). The Novacheck SARS-CoV-2 rapid diagnostic test can be used in symptomatic and asymptomatic people for lay users.2021-06-29 12:10:32 CET1858Immuno-AntigenYesNoImmunochromatographyQualitativeSandwichExtraction kit15LOD1.7AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0%517 with negative PCR result There was no false positiv sample from the sample. 0/517Fn4.09%342 positive PCR result 14 false negative samples did not come out of the sample. 14/342PrecisionEvaluatedAccuracy98.37%ReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity95.91%Clinical Specificity100%Type of antigenN-protein2240Salocor SARS-CoV-2 Antigen Rapid Test Kit567Salofa OyFinlandhttps://www.salofa.comYesCommercialisedNoNoCassetteLateral flowManualNear POC / POCAntigenNasopharyngeal swabOropharyngeal swabSerumSARS-CoV453B.1.1.7United Kingdom806B.1.351South AfricaThe SARS-CoV-2 Antigen Rapid Test Kit is a rapid chromatographic immunoassay for the for qualitative detection of SARS-CoV-2 nucleocapsid protein in human serum and nasopharyngeal swab and/or oropharyngeal swab samples. It is intended to aid in the rapid diagnosis of COVID-19 infections. This rapid kit uses a fluorescence immunochromatography method to detect SARS-CoV-2 N antigen.2021-06-23 11:05:42 CET1941Immuno-AntigenYesImmunoassayQualitativeSandwich10LOD40AUCalibrationEvaluatedCrossreactivityEvaluatedFp0.4% 249/250 (Nasopharyngeal swab negative specimens) Fp1%(186/188 serum negative specimens)Fn2.88%(135/139 Nasopharyngeal swab positive specimens) Fn3.9%(97/101 serum positive specimens)PrecisionEvaluatedAccuracy99.5%(Nasopharyngeal swab) Accuracy97.9%(serum)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.04% (serum)Clinical Sensitivity97.12% (Nasopharyngeal swab) Clinical Specificity98.9% (serum)Clinical Specificity99.6% (Nasopharyngeal swab) Type of antigenNucleoprotein1782Saligen798Bakter Medical s.r.o.Czechiawww.saligen.comYesCommercialisedNoNoCardNear POC / POCAntigenSaliva2021-06-07 17:49:21 CET1461Immuno-AntigenYesNoImmunochromatographyQualitativeColorimetry10LOD0.1AUCalibration0Crossreactivity0Fp0%Fn1AUPrecision0Accuracy98.55%Robustness0Clinical Sensitivity97.1%Type of antigen01493S1 Covid-19 Rapid Antigen Test Kit687Sensing Self Pte., LtdSingaporewww.sensingself.meYesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swabOtherSaliva2021-05-10 13:04:00 CET1243Immuno-AntigenYesNoImmunoassayQualitative15LOD0.005AUCalibrationevaluatedCrossreactivityevaluatedFp1%Fn5%PrecisionevaluatedAccuracy96.9%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity94%Type of antigennucleoprotein2214RIDA®QUICK SARS-CoV-2 Antigen217R-Biopharm AGGermanywww.r-biopharm.comYesCommercialisedNoNoDipstickManualAntigenNasal swabNasopharyngeal swabSARS-CoVDer verwendete polyklonale Antikörper ist gegen das Nukleocapsidprotein gerichtet und insofern von den meisten Mutationen, die im Spikeprotein statfinden, nicht beeinflusst.2021-06-10 16:48:42 CET1915Immuno-AntigenYesNoImmunochromatographyQualitativeMembrane-basedSample preparation30LOD237AUCalibrationNot evaluatedCrossreactivityEvaluatedFp 5 Mio Keime/ml)]]>Fnbei Antigenkonzentrationen unterhalb 237 TCID50/mlPrecisionEvaluatedAccuracy95%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93%Clinical Specificity97%Type of antigenNucleoprotein1846RIDA®@QUICK SARS-CoV-2 Antigen217R-Biopharm AGGermanywww.r-biopharm.comYesCommercialisedNoNoDipstickLateral flowManualNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabThroat swabN/A2021-05-10 13:04:00 CET1522Immuno-AntigenYesNoImmunochromatographyQualitativeColorimetry20LOD237AUCalibrationEvaluatedCrossreactivityEvaluatedFpN/AFnN/APrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.7%Clinical Specificity97.4%Type of antigenNucleoprotein1295reOpenTest COVID-19 Antigen Rapid Test624Zhejiang Anji Saianfu Biotech Co., LtdChinawww.seinofy.comYesCommercialisedYesYesCassetteNear POC / POCAntigenNasal swabPlasmaSaliva2021-07-07 17:26:30 CET1094Immuno-AntigenYesImmunoassayQualitativeColorimetry15Fp95.8%Fn99%Accuracy97.9%Clinical Sensitivity95.8%Type of antigennucleoprotein2256Redtest Professional Sars-CoV-2 Antigen Rapid Test (Covid-19 Ag) 1051Sigmed Sp. z o.o.Polandhttps://redtest.euYesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swabThroat swabSARS-CoV20A.23.1United Kingdom72AT.1Russia453B.1.1.7United Kingdom806B.1.351South Africa905B.1.427USA910B.1.429USA999B.1.525Nigeria1000B.1.526USA1001B.1.526.1USA1002B.1.526.2USA1100B.1.616France1102B.1.617.1India1103B.1.617.2India1104B.1.617.3India1108B.1.621Colombia1224C.36Egypt1227C.37Peru1258P.1Japan/Brazil1260P.2Brazil1261P.3The PhilippinesBfArM Listed, PEI evaluated2021-06-23 12:29:09 CET1957Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich, DoubleValidity test kit10LOD6AUCalibrationEvaluatedCrossreactivityEvaluatedFp1%Fn0%PrecisionEvaluatedAccuracy96%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98%Clinical Specificity100%Type of antigenNucleoprotein1453RAPIDTECH Test Rapide Antigène SARS-CoV-2675Weifang Kanghua BiotechChinawww.khbio.com/EN/yxwl.aspxYesCommercialisedNoNoCardNear POC / POCAntigenNasal swabOther2021-05-10 13:04:00 CET1202Immuno-AntigenYesNoImmunoassayQualitative15LOD2000IU/mlCalibrationevaluatedCrossreactivityevaluatedFp9.1%3/33Fn0.1%1/1002PrecisionevaluatedAccuracy97%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity91%Type of antigennucleoprotein1823RAPIDIGEN COVID19 AG IMMUNOASSAY830Pharmaline ASTurkeypharmaline.com.tr/enYesCommercialisedNoNoCassetteLateral flowAutomatedAntigenNasal swabNasopharyngeal swabOropharyngeal swabThroat swab2021-05-10 13:04:00 CET1501Immuno-AntigenYesNoImmunochromatographyQualitativeMagnetic ElectrochemicalVisualisation system15LOD30AUCalibrationEvaluatedCrossreactivityEvaluatedFpSample contamination or not following the IFU protocolFnSample contamination or not following the IFU protocolPrecisionEvaluatedAccuracy98%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93%Clinical Specificity99%1443RapidFor SARS-CoV-2 Rapid Ag Test678Vitrosens Biotechnology Co., LtdTurkeywww.vitrosens.comYesCommercialisedYesYesCassetteNear POC / POCAntigenNasal swabSaliva2021-07-07 17:25:23 CET1194Immuno-AntigenYesNoImmunoassayQualitativeColorimetry10LOD100IU/mlCalibrationevaluatedCrossreactivityevaluatedFp1AUFn1AUPrecisionevaluatedAccuracy98.3%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity97.3%Type of antigennucleoprotein1458RapidFor SARS-CoV-2 Antigen Test Kit678Vitrosens Biotechnology Co., LtdTurkeywww.vitrosens.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabSaliva2021-05-10 13:04:00 CET1210Immuno-AntigenYesNoImmunoassayQualitativeColorimetry10LOD100IU/mlCalibrationevaluatedCrossreactivityevaluatedFp1%Fn1%PrecisionevaluatedAccuracy98%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity97.3%Type of antigennucleoprotein1751RAPIDAN TESTER Covid-19 Ag Test758TurklabTurkeywww.turklab.com.tr/YesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swabNasopharyngeal swabThroat swab2021-05-10 13:18:20 CET1429Immuno-AntigenYesNoImmunochromatographyQualitative20LOD30U/mlCalibrationNot evaluatedCrossreactivityEvaluatedFp12AUFn3AUPrecisionEvaluatedAccuracy97.57%RobustnessEvaluatedClinical Sensitivity93.18%Type of antigenNucleoprotein1602Rapid Test SARS-CoV-2 Ag531AMEDA Labordiagnostik GmbHAustriawww.amp-med.com/YesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swab2021-05-10 13:18:20 CET1283Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15Rapid diagnostic test cassette colloidal gold LOD115TCID50/mlCrossreactivityno cross reaction with RSV type A, RSV type B, novel influenza A H1N1,, Influenza A H3N2, Influenza A H5N1, Influenza B yamagata, Influenza B Victoria, Rhinovirus, Adenovirus 3, Adenovirus 7, EV-A71, Mycobacterium tuberculosis, Micoplasma pneumoniae, MumFp2.7%3 of 111Fn0%0 of 139Accuracy98.8%Clinical Sensitivity97.3%Clinical Specificity100%Type of antigennucleocapside protein1240RAPID TEST AntigenE GCCOV-502a760Zhezhiang Orient Gene Biotech Co., LtdChinawww.orientgene.com/YesCommercialisedNoNoCassetteNear POC / POCAntigenNasopharyngeal swabhttps://www.innoliving.it/nuovo-test-rapido-Antigene-naso-faringeo-presentato-da-innoliving/2021-05-10 13:18:20 CET1022Immuno-AntigenYesNoImmunoassayQualitative15Clinical Sensitivity86.7%Clinical Specificity100%Type of antigenspike proteins1495Rapid Test Ag 2019-nCov688Prognosis BiotechGreecewww.prognosis-biotech.com/YesCommercialisedYesYesStripNear POC / POCAntigenNasal swab2021-07-07 17:06:58 CET1245Immuno-AntigenYesNoImmunoassayQualitative15LOD2870AUCalibrationevaluatedCrossreactivityevaluatedFp6%Fn2%PrecisionevaluatedAccuracy98.69%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity95.56%Type of antigennucleoprotein1791Rapid SARS-Cov2 Antigen Test806Immunospark s.r.l.Italywww.immunospark.comYesCommercialisedNoNoCardNear POC / POCAntigenNasal swabSaliva2021-05-10 13:04:00 CET1470Immuno-AntigenYesNoImmunochromatographyQualitativeChemiluminescence10LOD3.22IU/mlFp0AUFn0AUAccuracy98.5%Clinical Sensitivity94.12%1278Rapid SARS-CoV-2 Antigen Test Card277Xiamen Boson Biotech Co. LtdChinabosonbio.com/YesCommercialisedYesYesCassetteNear POC / POCAntigenNasopharyngeal swab2021-06-18 12:05:16 CET1053Immuno-AntigenYesImmunochromatographyQualitative15LOD130TCID50/ml1481Rapid SARS-CoV-2 Antigen Test Card367MP BiomedicalsGermanyhttps://www.mpbio.com/eu/YesCommercialisedYesYesCassetteLateral flowNear POC / POCAntigenAnterior nasal swabNasal swabNasopharyngeal swabOropharyngeal swabWe would like it to beupdated that the company is MP Biomedicals Germany GmbH and also refer to the EU website that is in this update. What is currently online directs people to the USA company.2021-06-18 11:09:34 CET1232Immuno-AntigenYesNoImmunochromatographyQualitative15LOD1AUCalibrationEvaluatedCrossreactivityEvaluatedPrecisionEvaluatedAccuracy98.25%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.17%Clinical Specificity99.16%Type of antigennucleoprotein1783Rapid SARS-CoV-2 Antigen Test147InTec Products, IncChinahttp://www.intecasi.comYesCommercialisedNoNoCardCassetteNear POC / POCAntigenNasal swabNasopharyngeal swabThis product is for nasopharyngeal/nasal swab samples.2021-05-29 14:30:38 CET1462Immuno-AntigenYesNoImmunoassayQualitativeSandwichColorimetry15LOD0.13AU1684Rapid Response COVID-19 Antigen Rapid Test Cassette (Oral Fluid)62BTNX IncCanadawww.btnx.com/YesCommercialisedNoNoCassetteNear POC / POCAntigenSaliva2021-05-10 13:18:20 CET1363Immuno-AntigenYesNoImmunoassayQualitative10LOD1000AUCalibrationevaluatedCrossreactivityevaluatedFp0%Fn5%PrecisionevaluatedAccuracy99.5%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity95%Type of antigennucleoprotein1236Rapid Response COVID-19 Antigen Rapid Test62BTNX IncCanadawww.btnx.com/YesCommercialisedYesYesCassetteLateral flowNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swab https://www.btnx.com/files/1110032811V5_COVID-19_Antigen_Rapid_Test_Device.pdf2021-07-07 17:20:40 CET1018Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich15LOD502.38TCID50/mlCrossreactivityEvaluatedFp0AUFn5AUPrecisionEvaluatedAccuracy97.2%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90.2%Clinical Specificity100%Type of antigenNucleoprotein1822Rapid COVID-19 Antigen Test(Colloidal Gold)307Anbio (Xiamen) Biotechnology Co., LtdChinawww.anbio.com/YesCommercialisedYesYesCassetteLateral flowNear POC / POCAntigenNasal swabThroat swab1.This product was evaluated and approved by Paul-Ehrlich-Institute in Germany in Feb 2021. 2.This product was evaluated and approved by National Institutes for Food and Drug Control China in Dec 2020. 3.The LOD for this product was 425 TCID50/mL.2021-07-07 17:18:51 CET1732Immuno-AntigenYesImmunoassay1735Rapid COVID-19 Antigen Test554Healgen ScientificUnited Stateswww.healgen.comYesCommercialisedNoNoCardCassetteNear POC / POCAntigenNasal swabOther2021-05-10 13:18:20 CET1414Immuno-AntigenYesNoImmunoassayQualitativeColloidal gold15LOD115U/mlCalibrationNot EvaluatedCrossreactivityEvaluatedFp0.35%3 of 865Fn0.23%2 of 865PrecisionNot EvaluatedAccuracy99.42%ReproducibilityNot evaluatedRobustnessNot EvaluatedClinical Sensitivity98.32%Type of antigenNucleoprotein1182Rapid COVID-19 Antigen Qualitative Test Kit77Megna Health IncUnited Stateswww.megnahealth.comYesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swabOtherSalivaMegna Health requests the addition of this IVD Test Kit to the CE approved listing. The device is manufactured by Megna Health - and the EU Authorized Representative is MDSS (Germany). Notification of this COVID IVD has been made to the Competent Authority in Germany2021-05-10 13:04:00 CET964Immuno-AntigenYesNoImmunoassayQualitative201267QuickProfile COVID-19 Antigen Test167LumiQuick Diagnostics IncUnited Stateslumiquick.co/YesCommercialisedYesYesStripNear POC / POCAntigen2021-05-10 20:07:30 CET1042Immuno-AntigenYesImmunoassayQualitative15LOD380TCID50/ml2217PixoTest® POCT COVID-19 Antigen Test1031iXensorTaiwan ROChttps://www.ixensor.comYesCommercialisedNoNoCassetteLateral flowNear POC / POCSemi-automatedAntigenAnterior nasal swabNasal swabNasopharyngeal swabSARS-CoV453B.1.1.7United Kingdom806B.1.351South Africa1000B.1.526USA1102B.1.617.1India1103B.1.617.2India1104B.1.617.3India1258P.1Japan/Brazil1260P.2BrazilPixoTest POCT Antigen Testing solution is an analyzer based rapid antigen test designed for point-of-care. It provides an end-to-end fully digitalized solution from rapid antigen test, timely result with digital pass issuing and access control by cross-validating test results on the cloud through a suite of digital tools including PixoHealth Pass App, PixoHealth Pass Admin App and Web portal for enterprises to prevent potential outbreaks.2021-06-28 10:51:07 CET1918Immuno-AntigenYesYesImmunochromatographyQualitativeMembrane-based15LOD125AUCalibrationEvaluatedCrossreactivityEvaluatedFp2AUFn5AUPrecisionEvaluatedAccuracy97%(Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95% (Antigen)Clinical Specificity98% (Antigen) TaipeiType of antigenNucleoprotein1264PerfectPOC Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit145Jiangsu Bioperfectus Technologies Co. LtdChinawww.bioperfectus.comYesCommercialisedNoNoNear POC / POCAntigen2021-05-10 13:04:00 CET1039Immuno-AntigenYesImmunoassay2283Pelican COVID-19 Ultra-Rapid Mobile Test1065Canary Global IncCanadapelicancovidtest.comYesCommercialisedNoNoCartridgeNear POC / POCAntigenSaliva453B.1.1.7United Kingdom806B.1.351South Africa1102B.1.617.1India1103B.1.617.2India1104B.1.617.3India1258P.1Japan/Brazil1260P.2BrazilOur device is equipped with dual targeting system. One sensor is coated with monoclonal antibody to SARS-CoV-2 nucleocapsid protein and another with monoclonal antibody to SARS-CoV-2 spike protein. During testing SARS-CoV-2 antigens possibly present in the specimen react with the bio receptor antibody nanoparticles present in the test. . This immunological reaction results in a digital electrical signal that is recognized by the systems software on the mobile app which results in a plus (+) sign on mobile app indicating a positive result.. If the antigens are not present in the specimen, no digital electrical signal is generated which appears as a minus (-) sign on the app indicating a negative result.2021-06-29 13:23:58 CET1984Immuno-AntigenYesImmunoassayQualitativeOther2LOD100AUCalibrationEvaluatedCrossreactivityEvaluatedFp0.83%When 120 negative samples were tested, 1 sample showed false positive resultFn1.8%When 111 positive samples were tested, 2 samples showed false negative resultPrecisionEvaluatedAccuracy98.7%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.2%Clinical Specificity99.17%Type of antigenNucleocapside protein308PCL COVID19 Ag Rapid FIA202PCL IncSouth Koreawww.pclchip.com/YesCommercialisedYesYesNear POC / POCAntigen2021-05-10 20:07:30 CET260Immuno-AntigenYesImmunoassay2320PathoCatch1081Mylab Discovery Solutions Pvt. Ltd.Indiahttps://mylabdiscoverysolutions.com/YesCommercialisedNoNoCassetteLateral flowManualNear POC / POCAntigenMid-turbinates swabNasal swabNasopharyngeal swabCoronaviruses (HCoV)SARS-CoV20A.23.1United Kingdom72AT.1Russia453B.1.1.7United Kingdom806B.1.351South Africa905B.1.427USA910B.1.429USA999B.1.525Nigeria1000B.1.526USA1001B.1.526.1USA1002B.1.526.2USA1100B.1.616France1102B.1.617.1India1103B.1.617.2India1104B.1.617.3India1108B.1.621Colombia1224C.36Egypt1227C.37Peru1258P.1Japan/Brazil1260P.2Brazil1261P.3The Philippines2021-06-29 13:50:26 CET2021Immuno-AntigenYesNoImmunoassayQualitativeCaptureVisualisation system15LOD21.25AUCalibrationEvaluatedCrossreactivityEvaluatedFp0%Fn8%PrecisionEvaluatedAccuracy100%(Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%(Antigen)Clinical Specificity100%(Antigen)Type of antigenNucleoptotein1270Pantest Coronavirus Ag599Pantest SAPortugalwww.pantest.ptYesCommercialisedNoNoCassetteNear POC / POCAntigenNasopharyngeal swabOropharyngeal swab2021-05-10 13:04:00 CET1045Immuno-AntigenYesImmunoassayQualitative20Clinical Sensitivity96%Clinical Specificity100%1232Panbio COVID-19 Ag Rapid Test628Abbott Rapid DiagnosticsUnited Stateswww.globalpointofcare.abbott/YesCommercialisedYesYesCassetteLateral flowManualNear POC / POCAntigenNasal swabNasopharyngeal swabPanbio™ COVID-19 Ag Rapid Test clinical studies support: - the use for asymptomatic screening (93.8% sensitivity vs. nasal PCR reference, Ct values ≤ 30) - the self-administered sample collection with nasal swabs - the use on pediatric symptomatic and asymptomatic subjects Panbio™ COVID-19 Ag Rapid Test is WHO EUL qualified 2021-05-17 11:01:42 CET1015Immuno-AntigenYesNoImmunochromatographyQualitative15Accuracy97.8%Nasopharyngeal swabAccuracy99.4%Nasal swab (Ct values ≤ 33Clinical Sensitivity91.4%Nasopharyngeal swab (Ct values ≤ 33Clinical Sensitivity98.1%Nasal swab (Ct values ≤ 33Clinical Specificity99.8%Nasopharyngeal swab (Ct values ≤ 33Clinical Specificity99.8%Nasal swab (Ct values ≤ 33Type of antigenNucleoprotein1581OnSite COVID-19 Ag Rapid Test79CTK Biotech, IncUnited Stateshttps://ctkbiotech.com/YesCommercialisedYesYesCassetteLateral flowManualNear POC / POCAntigenNasal swabNasopharyngeal swabSARS-CoV453B.1.1.7United Kingdom806B.1.351South Africa905B.1.427USA910B.1.429USA999B.1.525Nigeria1000B.1.526USA1102B.1.617.1India1103B.1.617.2India1104B.1.617.3India1258P.1Japan/Brazil2021-07-07 17:10:05 CET1260Immuno-AntigenYesNoImmunoassayQualitativeSandwich, DoubleColorimetry15LOD280%CalibrationEvaluatedCrossreactivityEvaluatedFp0%Fn7.7%PrecisionEvaluatedAccuracy100%Accuracy98.9%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.3%Clinical Specificity100%Type of antigennucleoprotein1195OneStep COVID-19 Antigen RapiCard InstaTest582Diagnostic Automation/Cortez Diagnostics, IncUnited Stateswww.rapidtest.comYesCommercialisedNoNoNear POC / POCAntigenNasal swab2021-05-10 13:04:00 CET980Immuno-AntigenYesYesImmunoassay15LOD38.55AUClinical Sensitivity95.52%2183One Step Test for SARS-CoV-2 Antigen (Colloidal Gold)1017Getein Biotech, Inc.Chinaen.bio-gp.com.cnYesCommercialisedYesYesLateral flowStripManualAntigenNasal swabSaliva453B.1.1.7United Kingdom806B.1.351South AfricaOne Step Test for SARS-CoV-2 Antigen (Colloidal Gold) is intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in human nasal swab samples or saliva samples from patients suspected of COVID-19 infection by a healthcare provider.2021-07-07 17:21:07 CET1884Immuno-AntigenYesNoImmunoassayQualitativeSandwichColloidal goldVisualisation system10LOD200AUCalibrationEvaluatedCrossreactivityEvaluatedFp2.9%(5 of 170)Fn2.9%(5 of 170)PrecisionEvaluatedAccuracy98.13%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.06%Clinical Specificity98.71%Type of antigenNucleoprotein1242NowCheck COVID-19 Ag Test633Bionote, IncSouth Koreabionote.co.krYesCommercialisedYesYesLateral flowNear POC / POCAntigenNasal swabNasopharyngeal swabSARS-CoV453B.1.1.7United Kingdom806B.1.351South Africa1102B.1.617.1India1103B.1.617.2India1258P.1Japan/Brazilhttps://www.finddx.org/wp-content/uploads/2021/03/Bionote_Nasal_Ag-Public-Report_20210330-v1.pdf2021-07-07 17:07:07 CET1023Immuno-AntigenYesNoImmunoassayQualitative15LOD247TCID50/mlCrossreactivityEvaluatedFp0.57%3/527Fn9%2/22ReproducibilityEvaluatedClinical Sensitivity90.91%Clinical Specificity99.43%1289Novel SARS-CoV-2 Coronavirus Spike Glycoprotein Detection Kit (S Protein-ACE2 receptor)642Apollo Biomedical LLCUnited Stateswww.apollobiomedical.comYesCommercialisedNoNoNear POC / POCAntigenSputumStoolThroat swab2021-05-10 13:04:00 CET1063Immuno-AntigenYesN.A.ImmunoassayQualitativeRapid diagnostic test Type of antigenACE2 receptor1259Novel Coronavirus S Glycoprotein Detection Kit634Hangzhou Deangel Biological Engineering Co., LtdChinadagbio.en.alibaba.com/company_profile.htmlYesCommercialisedNoNoNear POC / POCAntigen2021-05-10 13:04:00 CET1035Immuno-AntigenYesImmunoassay1798Novel Coronavirus 2019-nCoV Antigen Test (Colloidal Gold) - Saliva328Beijing Hotgen Biotech Co., LtdChinawww.hotgen.com.cn/YesCommercialisedNoNoNear POC / POCAntigenSalivaThis kit is used for in vitro qualitative determination of novel coronavirus antigen in human saliva samples from posterior oropharynx. It is used as rapid investigation for suspected cases of novel coronavirus, can also be used as a reconfirmation method for nucleic acid detection in discharged cases. A positive test result indicates that the samples contained novel coronavirus antigen. A negative test result does not rule out the possibility of infection. This product is only used for clinical and emergency reserve during the pneumonia outbreak of novel coronavirus infection, and can not be used as a routine in vitro diagnostic reagent for clinical application . The test results of this kit are for clinical reference only. It is recommended to conduct a comprehensive analysis of the condition based on the patient's clinical manifestations and other laboratory tests. For professional use only.2021-05-10 13:18:20 CET1477Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD250CalibrationNot evaluatedCrossreactivityEvaluatedFp0Fn0PrecisionEvaluatedAccuracy98.79ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96%Clinical Specificity99.78%1870Novel Coronavirus 2019-nCoV Antigen Test (Colloidal Gold)328Beijing Hotgen Biotech Co., LtdChinawww.hotgen.com.cn/YesCommercialisedYesYesLateral flowStripNear POC / POCAntigenSalivaThis kit is used for in vitro qualitative determination of novel coronavirus antigen in human nasal swabs or throat swabs. It is used as rapid investigation for suspected cases of novel coronavirus, can also be used as a reconfirmation method for nucleic acid detection in discharged cases. A positive test result indicates that the samples contained novel coronavirus antigen. A negative test result does not rule out the possibility of infection. This product is only used for clinical and emergency reserve during the pneumonia outbreak of novel coronavirus infection, and can not be used as a routine in vitro diagnostic reagent for clinical application . The test results of this kit are for clinical reference only. It is recommended to conduct a comprehensive analysis of the condition based on the patient's clinical manifestations and other laboratory tests. For professional use only.2021-05-10 20:07:30 CET1547Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich15LOD250AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0%Fn0%PrecisionEvaluatedAccuracy98.87%ReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity97.1%Clinical Specificity99.76%Type of antigenNucleoprotein2072Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test Kit958Beijing Jinwofu Bioengineering Technology Co.,Ltd.Chinajwfbio.comYesCommercialisedYesYesCassetteLateral flowNear POC / POCAntigenAnterior nasal swabNasal swabNasopharyngeal swabOropharyngeal swabSalivaAdenovirusAdenovirus 3Adenovirus 7Adenovirus Subtype BAdenovirus Subtype CAlpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Cytomegalovirus (CMV)Enterovirus A71 (EV-A71)Epstein-Barr Virus (EBV)Influenza AInfluenza A H1N1Influenza A H3N2Influenza A H5N1Influenza B VictoriaInfluenza B YamagataParainfluenza Virus Type 1Parainfluenza Virus Type 2Parainfluenza Virus Type 3Parainfluenza Virus Type 4Respiratory Syncytial V (RSV)Respiratory Syncytial V (RSV) Type ARespiratory Syncytial V (RSV) Type BRhinovirus ARhinovirus B20A.23.1United Kingdom72AT.1Russia453B.1.1.7United Kingdom806B.1.351South Africa1100B.1.616France1108B.1.621Colombia1224C.36Egypt1227C.37Peru1258P.1Japan/Brazil1260P.2Brazil)Do not use this kit beyond the expiration date printed on the outside carton. 2)This test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; 3)To avoid erroneous results, specimens must be processed as indicated in the test procedure section.Proper specimen collection, storage and transport are critical to the performance of this test 4)The used Jinwofu Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test cards should be treated as hazardous waste. 5)Our company's novel coronavirus detection kit is a product developed for novel coronavirus nucleoprotein, which only detects nucleoprotein, but cannot detect spike protein and its variation structure. Therefore, spike protein and UK variant do not affect the detection ability and accuracy (sensitivity and specificity) of our company's novel coronavirus antigen detection kit for novel coronavirus.2021-07-13 17:54:34 CET1754Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich, DoubleValidity test kit30LOD100AUCalibrationEvaluatedCrossreactivityEvaluatedFp0%Fn3.125%PrecisionEvaluatedAccuracy98.82%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity%96.88%Clinical Specificity100%Type of antigenNucleoprotein1796Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (saliva)344Hangzhou Realy Tech Co., LtdChinawww.realytech.com/YesCommercialisedNoNoCassetteNear POC / POCAntigenSaliva2021-05-10 13:04:00 CET1475Immuno-AntigenYesNoImmunochromatographyQualitativeColorimetry20LOD125IU/mlFp0.42%Fn7.1%Accuracy96.79%Clinical Sensitivity92.9%1220Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab)344Hangzhou Realy Tech Co., LtdChinawww.realytech.com/YesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swab2021-05-10 13:04:00 CET1005Immuno-AntigenYesNoImmunochromatographyQualitativeColorimetry15LOD1250TCID50/mlCalibrationNot evaluatedAnalytical Sensitivity96.17%CrossreactivityEvaluatedFp0%450 samples are proven negative of 450 negative specimensFn3.83%8 samples are proven negative of 209 positive specimensPrecisionEvaluatedAccuracy98.79%RobustnessEvaluatedType of antigenNucleorpotein1743Novel Coronavirus (SARS-Cov-2) Antigen rapid test344Hangzhou Realy Tech Co., LtdChinawww.realytech.com/YesCommercialisedNoNoCassetteLateral flowNear POC / POCAntigenNasal swabThis product is being used currently by Westland Health on the Irish market with its customers. All positive candidates who have tested positive with the Realy antigen test kit, have been subsequently confirmed positive by the Irish Health Service. 2021-05-10 13:04:00 CET1421Immuno-AntigenYesNoImmunoassayQualitative15LOD1250U/mlCalibrationEvaluatedCrossreactivityEvaluatedFpNot FoundFnNot FoundPrecisionEvaluatedAccuracy98.79%ReproducibilityNot EvaluatedRobustnessEvaluatedClinical Sensitivity97.14%1972Novel Coronavirus (SARS-CoV-2) Antigen Detection Kit(Colloidal Gold)30Avioq Bio-Tech Co., LtdChinawww.avioqbio.com/YesCommercialisedNoNoCassetteManualAntigenAnterior nasal swabNasopharyngeal swabNone2021-05-10 13:18:20 CET1648Immuno-AntigenYesNoImmunochromatographyQualitativeSandwichColloidal goldOther15LOD100AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0%Fn10.64%(5/47)PrecisionEvaluatedAccuracy96.84%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity89.36%Clinical Specificity100%Type of antigenNucleoprotein2224Novel Coronavirus (COVID-19) Antigen Testkit (Colloidal Gold1033Hangzhou Laihe Biotech Co., Ltd.Chinawww.lyherbio.comYesCommercialisedNoNoCassetteLateral flowManualNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabThroat swab453B.1.1.7United Kingdom806B.1.351South Africa1000B.1.526USA1001B.1.526.1USA1002B.1.526.2USA1100B.1.616France1102B.1.617.1India1103B.1.617.2India1104B.1.617.3India1258P.1Japan/Brazil1260P.2BrazilIn case of questions kindly do not hesitate to contact us.2021-06-25 13:21:51 CET1925Immuno-AntigenYesNoImmunochromatographyQualitativeMembrane-basedColloidal goldOther15LOD135CalibrationNot evaluatedCrossreactivityEvaluatedFp10% prevalence, no more than 0,1%Fn10% prevalence, no more than 5,0%PrecisionEvaluatedAccuracy97%(96% to 98%)ReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity9595%)]]>Clinical Specificity9898%)]]>Type of antigenNucleoprotein1828Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold)834BN SantéFrancewww.biogyne.frYesCommercialisedNoNoNear POC / POCAntigenNasal swabNasopharyngeal swabNo additional information to update.2021-06-25 13:11:31 CET1505Immuno-AntigenYesNoImmunoassayQualitativeColloidal gold15LOD0.5AUCalibrationEvaluatedCrossreactivityEvaluatedFp1Fn8PrecisionEvaluatedAccuracy97.81%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity95%Clinical Specificity99.6%Type of antigenNucleoprotein1795Novel Coronavirus (2019-nCOV) Antigen Rapid Test Cassette (Quantum Dot-based Fluorescence Immunochromatography)344Hangzhou Realy Tech Co., LtdChinawww.realytech.com/YesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swab2021-05-10 13:04:00 CET1474Immuno-AntigenYesNoImmunochromatographyFluorescence20LOD1250IU/mlFp0%Fn3.83%Accuracy98.79%Clinical Sensitivity96.17%1362Novel Coronavirus (2019-nCoV) Antigen Detection Kit (Quantum Dot-Based Fluorescence Immunochromatography)652Beijing WSWY Technology Co.,.LtdChinawww.wswygs.comYesCommercialisedNoNoCardNear POC / POCAntigenNasal swab2021-05-10 13:04:00 CET1121Immuno-AntigenYesNoImmunoassayQualitativeFluorescence15LOD60AUFp0%0Fn8.43%Accuracy98.21%(Antigen)Clinical Sensitivity91.57%(Antigen)Type of antigennucleoprotein1189Novegent COVID-19 Antigen Rapid Test Kit620Chongqing Novegent Biotech Company LimitedChinawww.novegent.cnYesCommercialisedNoNoNear POC / POCAntigenNasal swab http://www.novegent.eu/Antigen/2021-05-10 13:04:00 CET970Immuno-AntigenYesNoImmunoassayQuantitativeColloidal gold15LOD7AUAccuracy98.7%Clinical Sensitivity98.3%Clinical Specificity100%2010NOVA Test® SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography)924Atlas Link Technology Co., Ltd.Chinahttp://www.atlas-link.com/english/YesCommercialisedYesYesCassetteLateral flowStripManualNear POC / POCAntigenNasal swabOropharyngeal swabOur NOVA Test® SARS-CoV-2 Antigen Rapid Test Kit has been posted on the antigen list of German BfArM, it has also been on the PEI list.2021-07-07 17:19:54 CET1688Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich, DoubleColloidal goldValidity test kit15LOD50AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0.6%Fn1.5%PrecisionNot evaluatedAccuracy99.1%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity98.5%Clinical Specificity99.4%Type of antigennucleoprotein2281Ninonasal-Autotest572NG BiotechFrancehttps://ngbiotech.com/YesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swabSARS-CoV453B.1.1.7United Kingdom806B.1.351South Africa905B.1.427USA910B.1.429USA1102B.1.617.1India1103B.1.617.2India1258P.1Japan/Brazil2021-07-08 11:08:36 CET1982Immuno-AntigenYesYesNoImmunochromatographyQualitativeOther20LOD1CalibrationNot evaluatedCrossreactivityEvaluatedFp0.51(2 out of 390)Fn2.34%(3 out of 128)PrecisionEvaluatedReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity98%Clinical Specificity99%Type of antigenNucleoprotein1880Ninonasal572NG BiotechFrancehttps://ngbiotech.com/YesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swabNasopharyngeal swab453B.1.1.7United Kingdom806B.1.351South Africa905B.1.427USA910B.1.429USA1102B.1.617.1India1103B.1.617.2India1258P.1Japan/Brazil2021-07-16 10:42:04 CET1559Immuno-AntigenYesNoImmunochromatographyQualitativeColorimetry20LOD1AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0.51%(2 false positive result out of 390 negative samples confirmed by RT-PCR)Fn2.34%(3 false negative results out of 128 positive samples confirmed by RT-PCR)PrecisionEvaluatedReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity98%Clinical Specificity99%Type of antigenNucleoprotein1646NG-Test SARS-CoV-2 Ag572NG BiotechFrancehttps://ngbiotech.com/YesCommercialisedNoNoLateral flowNear POC / POCAntigenNasopharyngeal swab453B.1.1.7United Kingdom806B.1.351South Africa1102B.1.617.1India1103B.1.617.2India1258P.1Japan/BrazilN/A2021-06-23 14:36:31 CET1327Immuno-AntigenYesNoImmunochromatographyQualitativeMembrane-based20LOD1AUCalibrationnot evaluatedCrossreactivityevaluatedFp0%0 false positive result out of 100 negative samples confirmed by RT-PCRFn17%17 false negative results out of 100 positive samples confirmed by RT-PCRPrecisionevaluatedReproducibilityevaluatedRobustnessnot evaluatedClinical Sensitivity87%Clinical Sensitivity83%Clinical Sensitivity100%Type of antigennucleoprotein1162NADAL COVID-19 Ag Test182Nal von minden GmbHGermanyhttps://www.nal-vonminden.com/de/YesCommercialisedYesYesCardLateral flowNear POC / POCAntigenNasal swabSerumWhole blood2021-05-10 13:04:00 CET943Immuno-AntigenYesNoChromatographyQualitative15Clinical Sensitivity97.56%Ct-value: 20-30Clinical Specificity99.9%Type of antigenNucleoprotein1490Multi-Respiratory Virus Antigen Test Kit(Swab) (Influenza A+B/ COVID-19)546Safecare Biotech (Hangzhou) Co. LtdChinaen.safecare.com.cn/YesCommercialisedYesYesNear POC / POCAntigenNasal swab2021-07-07 17:24:07 CET1235Immuno-AntigenYesNoImmunoassayQualitativeColorimetry10FP: FluA:0, FluB:0. FN: FluA:0.56%, FluB: 0. Accuracy: FluA:99.54%, FluB:100%. Clinical Sensitivity: FluA:100%, FluB:100%.LOD1.5AU1.5CalibrationevaluatedCrossreactivityevaluatedFp2.96%COVID-19Fn0.56%COVID-19PrecisionevaluatedAccuracy98.41%COVID-19:ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity97.04%COVID-19Type of antigennucleoprotein1190mö-screen Corona Antigen Test532möLabGermanywww.moelab.de/startseite.htmlYesCommercialisedYesYesNear POC / POCAntigenNasopharyngeal swab2021-07-07 17:23:14 CET974Immuno-AntigenYesImmunoassayQualitative151775MEXACARE COVID-19 Antigen Rapid Test794MEXACARE GmbHGermanywww.mexacare.comYesCommercialisedYesYesCassetteLateral flowNear POC / POCAntigenNasal swab2021-07-07 17:13:13 CET1454Immuno-AntigenYesNoChromatographyQualitative20LOD130TCID50/mlCalibrationNot EvaluatedCrossreactivityEvaluatedFp4.35%5 of 115Fn0.62%2 of 321PrecisionEvaluatedAccuracy98.39%ReproducibilityEvaluatedRobustnessEvaluatedClinical SensitivityEvaluatedClinical Sensitivity96.17%Type of antigenNucleoprotein1180MEDsan SARS-CoV-2 Antigen Rapid Test617MEDsan GmbHGermanywww.medsan.eu/en/YesCommercialisedYesYesLateral flowNear POC / POCAntigenNasopharyngeal swabOropharyngeal swab2021-05-10 20:07:30 CET961Immuno-AntigenYesNoImmunoassayQualitative15LOD14.4TCID50/mlAccuracy98.4%Clinical Sensitivity92.5%Clinical Specificity99.8%1749Mednano840Wuhan NanoDiagnosis for Health Biotechnology Co., LtdChinandh-biotech.comYesCommercialisedNoNoNear POC / POCAntigen2021-05-10 13:18:20 CET1427Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD3581.5AUCrossreactivity0AUFp1AUFn0AUPrecision0AUAccuracy100%Clinical Sensitivity96.88%1234MARK-B COVID-19 Ag S629BBB INC; Obelis S.A.(BE)South Koreawww.bbbtech.com/YesCommercialisedNoNoOtherAntigenNasopharyngeal swab2021-05-10 13:04:00 CET1016Immuno-AntigenYesYesImmunoassayQualitativePhotonic ring resonance10Atomated Sandwich, Magnetic Electrochemical LOD24TCID50/mlClinical Sensitivity98.5%Clinical Specificity98.5%768mariPOC SARS-CoV-2454ArcDia International LtdFinlandwww.arcdia.comYesCommercialisedYesYesMicroplateNear POC / POCAntigenNasopharyngeal swab2021-07-07 17:19:16 CET622Immuno-AntigenYesYesImmunoassayQuantitativeFluorescence20Crossreactivity0 with MERS, seasonal coro-naviruses (229E, HKU1, NL63, OC43) or other common respiratory tract pathogens or normal bacterial floraClinical Sensitivity92%Clinical Specificity100%1215LYHER Novel Coronavirus (COVID-19) Antigen Test Kit(Colloidal Gold)302Hangzhou Laihe Biotech Co., LtdChinawww.lyherbio.com/YesCommercialisedYesYesCassetteNear POC / POCAntigenNasal swab2021-07-07 17:21:53 CET1041Immuno-AntigenYesNoImmunoassayQualitativeColloidal gold1268LumiraDx SARS-CoV-2 Ag Test252LumiraDXUnited Kingdomwww.lumiradx.comYesCommercialisedYesYesStripNear POC / POCAntigenNasal swab2021-05-10 13:18:20 CET1043Immuno-AntigenYesNoImmunoassayQualitativeFluorescence12LOD32TCID50/mlClinical Sensitivity97.6%Clinical Specificity96.6%Type of antigennucleocapsid1667LooK SPOT746Laipac Technology Inc.Canadawww.laipac.comYesCommercialisedNoNoCassetteAutomatedAntigenNasal swabSARS-CoV20A.23.1United Kingdom72AT.1Russia453B.1.1.7United Kingdom806B.1.351South Africa905B.1.427USA910B.1.429USA999B.1.525Nigeria1000B.1.526USA1001B.1.526.1USA1002B.1.526.2USA1100B.1.616France1102B.1.617.1India1103B.1.617.2India1104B.1.617.3India1108B.1.621Colombia1224C.36Egypt1227C.37Peru1258P.1Japan/Brazil1260P.2Brazil1261P.3The PhilippinesLow-cost LooK SPOT to read over thousands of tests. Look SPOT access AI Cloud for the diagnosis of the images and it provides consistent test results including low positive cases. Under SPEED mode, it can provide test results within 30 seconds.2021-07-05 18:46:06 CET1346Immuno-AntigenYesYesImmunoassayQualitativeOtherColorimetryOther1LOD129000TCID50/mlCalibrationevaluatedCrossreactivityevaluatedFp2%Limited to less than 2%Fn2%Limited to less than 2%PrecisionevaluatedAccuracy95%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity97.4%Clinical Specificity98.3%Type of antigennucleoprotein1442Livzon Test for SARS-CoV-2 Antigen (Fluorescence Immunochromatographic Assay)225Zhuhai Livzon Diagnostics IncChinawww.livzondiagnostics.com/en-us/list/39.htmlYesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swab2021-05-10 13:04:00 CET1193Immuno-AntigenYesYesImmunoassayQualitativeFluorescence15Rapid diagnostic test lateral flow fluorescence LOD100AU100CalibrationevaluatedCrossreactivityevaluatedPrecisionevaluatedAccuracynot foundReproducibilityevaluatedRobustnessnot evaluatedClinical Sensitivity97%Clinical Specificity98.3%Type of antigennucleoprotein1441Livzon Rapid Test for SARS-CoV-2 Antigen (Lateral Flow)225Zhuhai Livzon Diagnostics IncChinawww.livzondiagnostics.com/en-us/list/39.htmlYesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swab2021-05-10 13:04:00 CET1192Immuno-AntigenYesNoImmunoassayQualitative15LOD100%CalibrationevaluatedCrossreactivityevaluatedPrecisionevaluatedAccuracynot foundReproducibilityevaluatedRobustnessnot evaluatedClinical Sensitivity90.9%Clinical Specificity100%Type of antigennucleoprotein1605Lab-On-Time COVID-19 Antigen Rapid Test Device (Integrated Throat Swab)611BMT DiagnosticsIsraelwww.bmtdiagnostics.comYesCommercialisedNoNoNear POC / POCAntigenOtherThroat swab no info on website about preformance 2021-05-10 13:04:00 CET1286Immuno-AntigenYesNoImmunoassayQualitative15Rapid diagnostic test Dipstick LOD1000AUCalibrationevaluatedCrossreactivityevaluatedFp2.43%3 of 123Fn1.23%1 of 81PrecisionevaluatedAccuracy98%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity96.4%Type of antigennucleoprotein1322Kwork Covid-19 Ag Rapid Test Device(Saliva/Sputum/Feces)648Zhejiang Quark Biotechnology Co., LtdChinawww.zjkuake.comYesCommercialisedNoNoNear POC / POCAntigenSaliva2021-05-10 13:04:00 CET1088Immuno-AntigenYesNoImmunoassayQualitative15Accuracy96.7%Clinical Sensitivity90%1285Kewei COVID-19 Antigen Rapid Test Kit (Fluorescence)43Beijing Kewei Clinical Diagnostic Reagent IncChinaen.keweidiagnostic.com/YesCommercialisedNoNoNear POC / POCAntigenNasal swabThroat swab2021-05-10 13:04:00 CET1059Immuno-AntigenYesImmunoassayQualitativeFluorescence15Rapid diagnostic test Lateral Flow fluorescence Clinical Sensitivity85%Clinical Specificity100%Type of antigennucleocapsid70Kewei COVID-19 Antigen Rapid Test Kit (FIA)43Beijing Kewei Clinical Diagnostic Reagent IncChinaen.keweidiagnostic.com/YesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swabOropharyngeal swab2021-05-10 13:04:00 CET390Immuno-AntigenYesYesImmunoassayQualitativeFluorescence15LOD140TCID50/mlAccuracy97.5%Clinical Sensitivity85%Clinical Specificity100%1284Kewei COVID-19 Antigen Rapid Test Kit (Colloidal Gold)43Beijing Kewei Clinical Diagnostic Reagent IncChinaen.keweidiagnostic.com/YesCommercialisedNoNoNear POC / POCAntigenNasal swabThroat swab2021-05-10 13:04:00 CET1058Immuno-AntigenYesImmunoassayQualitativeColorimetry15Rapid diagnostic test Lateral Flow Clinical Sensitivity85%Clinical Specificity100%Type of antigennucleocapsid2085KaiBiLi COVID-19 Antigen964Hangzhou GENESIS Biodetection and Biocontrol CO.,LTDChinawww.hgb.com.cn/ENYesCommercialisedNoNoCassetteManualNear POC / POCAntigenNasal swabNasopharyngeal swabSARS-CoV20A.23.1United Kingdom72AT.1Russia453B.1.1.7United Kingdom806B.1.351South Africa905B.1.427USA910B.1.429USA999B.1.525Nigeria1000B.1.526USA1001B.1.526.1USA1002B.1.526.2USA1100B.1.616France1102B.1.617.1India1103B.1.617.2India1104B.1.617.3India1108B.1.621Colombia1224C.36Egypt1227C.37Peru1258P.1Japan/Brazil1260P.2Brazil1261P.3The PhilippinesOur KaiBiLi COVID-19 Antigen is marketed in countries including Spain, Cyprus, Netherland, etc. It's been listed with different authorities of France, Germany, Belgium, and Czech.2021-05-27 13:20:14 CET1768Immuno-AntigenYesNoImmunochromatographyQualitativeCapture15LOD74.8AUFp0%ZeroFn0.4%(clinical sensitivity 96.6)PrecisionEvaluatedAccuracy98.9%ReproducibilityEvaluatedReproducibilityEvaluatedRobustnessEvaluatedRobustnessEvaluatedClinical Sensitivity96.6%Clinical Specificity100%Type of antigenNucleoprotein1725Jinwofu® Novel Coronavirus (SARS-CoV-2) Antigen-Rapid-Test765Beijing Jinwofu Bioengineering Technology Co.,LtdChinawww.jwfbio.com/en/YesCommercialisedNoNoCardNear POC / POCAntigenNasal swabOther2021-05-10 13:04:00 CET1405Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD100CalibrationevaluatedCrossreactivityevaluatedFp0AUFn10AUPrecisionevaluatedAccuracy98.82%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity96.88%Type of antigennucleoprotein1678Instant-view® PLUS COVID-19 Antigen Test17Alfa Scientific Designs IncUnited Stateswww.alfascientific.com/YesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swab2021-05-10 13:18:20 CET1357Immuno-AntigenYesNoImmunoassayQualitative3LOD2800AUCalibrationnot evaluatedCrossreactivityevaluatedFp3 out of 171Fn3 out of 40Precisionnot evaluatedAccuracy97.2%ReproducibilityevaluatedRobustnessnot evaluatedClinical Sensitivity92.5Type of antigennucleoprotein1444Instant SARS-CoV-2 Rapid Ag Test678Vitrosens Biotechnology Co., LtdTurkeywww.vitrosens.comYesCommercialisedNoNoDipstickNear POC / POCAntigenNasal swabOtherSaliva2021-05-10 13:18:20 CET1195Immuno-AntigenYesNoImmunoassayQualitativeColorimetry5LOD100IU/mlCalibrationevaluatedCrossreactivityevaluatedFp1AUFn1AUPrecisionevaluatedAccuracy98.3%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity97.3%Type of antigennucleoprotein1301Influenza A+B Antigen Test Kit (Colloidal Gold)851Nantong Diagnos Biotechnology Co., LtdChinawww.diagnosbio.comYesCommercialisedNoNoNear POC / POCAntigenNasal swab2021-05-10 13:18:20 CET1071Immuno-AntigenYesYesImmunoassayQualitative15LOD0.05AUAccuracy97.6%Clinical Sensitivity96.67%Type of antigenNucleoprotein1844Immunobio SARS-CoV-2 Antigen ANTERIOR NASAL Rapid Test Kit (minimal invasive)843Hangzhou Immuno Biotech Co.,LtdChinawww.seinofy.comYesCommercialisedYesYesCassetteManualAntigenNasal swabNasopharyngeal swabBfArM Listed, PEI evaluated2021-07-07 17:21:47 CET1521Immuno-AntigenYesNoImmunochromatographyQualitative10LOD6AUCalibrationEvaluatedCrossreactivityEvaluatedFp5.61%94,39Fn0%100PrecisionEvaluatedAccuracy97.67%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94%Clinical Specificity100%Type of antigenNucleoprotein1928ImmTek COVID-19 Antigen Rapid Test882Metas Biomedical Inc.Taiwan ROCwww.metasbiomedical.comYesCommercialisedNoNoCassetteDipstickLateral flowStripNear POC / POCAntigenNasal swabNasopharyngeal swabSARS-CoV453B.1.1.7United Kingdom806B.1.351South Africa905B.1.427USA1000B.1.526USA1258P.1Japan/BrazilNone2021-06-18 12:25:20 CET1604Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich10LOD313AUCalibrationEvaluatedCrossreactivityEvaluatedFp0.86AUFn6.52AUPrecisionEvaluatedAccuracy97.53%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.48%Clinical Specificity99.14%Type of antigenNucleoprotein1169iFlash-2019-nCoV Antigen379SHENZHEN YHLO BIOTECH CO., LtdChinahttp://www.szyhlo.comYesCommercialisedNoNoCassetteAutomatedAntigenNasal swabCytomegalovirus (CMV)453B.1.1.7United Kingdom806B.1.351South Africa1102B.1.617.1India1103B.1.617.2India1104B.1.617.3India1258P.1Japan/BrazilThe iFlash-2019-nCoV Antigen has obtained the CE marking, and its clinical performance verification and analytical performance verification has also been completed.2021-06-23 14:28:17 CET948Immuno-AntigenYesYesImmunoassayQualitativeSandwichChemiluminescence30LOD120AUCalibrationEvaluatedCrossreactivityEvaluatedFp0.46%(1/215)Fn2.94%(1/34)PrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.1%Clinical Specificity99.5%Type of antigenNucleoprotein1728iD Rapid® COVID-19 Antigen766Innovative DiagnosticsFrancewww.innovative-diagnostics.com/YesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swab2021-05-10 13:04:00 CET1408Immuno-AntigenYesNoImmunoassayQualitative15LOD1800AUCalibrationnot evaluatedCrossreactivityevaluatedFp0%Fn2.47%2 false negative on 81 samples tested positive by PCRPrecisionevaluatedAccuracy96.9%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity97.7%1990ichroma™ COVID-19 Ag22Boditech Med IncSouth Koreahttps://www.boditech.co.kr/enYesCommercialisedNoNoCassetteChipLateral flowManualNear POC / POCAntigenNasopharyngeal swabSARS-CoV20A.23.1United Kingdom453B.1.1.7United Kingdom806B.1.351South Africa1102B.1.617.1India1103B.1.617.2India1258P.1Japan/BrazilIn the link I have attached, you may see that the sensitivity of iChroma COvid 19 Ag is "Ct ≤ 25" The clinical evaluation can be found on the website of FIND : https://www.finddx.org/wp-content/uploads/2021/02/iChroma_Ag-Public-Report_v1_20210223.pdf2021-06-21 10:16:55 CET1666Immuno-AntigenYesYesImmunochromatographySemiquantitativeSandwichOther12LOD35.15AUCalibrationEvaluatedCalibrationEvaluatedCrossreactivityEvaluatedCrossreactivityEvaluatedFp2AUFn12AUPrecisionEvaluatedAccuracy95.2%Accuracy95.2 %ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity90.9%Clinical Specificity98.7%Type of antigenNucleoprotein1262Humasis COVID-19/Flu Ag Combo Test140HumasisSouth Koreahttp://www.humasis.com/en/YesCommercialisedNoNoCassetteNear POC / POCAntigenNasopharyngeal swab2021-05-10 13:04:00 CET1037Immuno-AntigenYesImmunoassayQualitative151263Humasis COVID-19 Ag Test140HumasisSouth Koreahttp://www.humasis.com/en/YesCommercialisedYesYesCassetteNear POC / POCAntigenNasal swab2021-05-10 20:07:30 CET1038Immuno-AntigenYesImmunochromatographyQualitative15LOD0AUFp0%Fn5.6%Accuracy97.4%Clinical Sensitivity95.3%2109Green Spring SARS-CoV-2 Antigen-Rapid test-Set977Shenzhen Lvshiyuan Biotechnology Co., Ltd.Chinahttps://www.lsybt.com/YesCommercialisedYesYesLateral flowManualNear POC / POCAntigenAnterior nasal swabNasal swabNasopharyngeal swabOropharyngeal swabCoronaviruses (HCoV)SARS-CoV453B.1.1.7United Kingdom806B.1.351South Africa1258P.1Japan/BrazilDer Green Spring® SARS-CoV-2-Antigen-Schnelltest dient dem schnellen qualitativen Nachweis des Nukleocapsid-Protein-Antigens von SARS-CoV-2 in menschlichen Nasen-, Nasen-Rachen oder Rachenabstrichproben. Die Ergebnisse dienen dem Nachweis von SARS-CoV-2-Antigenen.2021-07-07 17:24:52 CET1799Immuno-AntigenYesNoImmunoassayQualitativeCapture15LOD400AUCalibrationEvaluatedCrossreactivityEvaluatedFp0%0 of 210 (100% specificity)Fn2%2 of 100 (98% sensitivity)PrecisionEvaluatedAccuracy99% (antigen)Accuracy99.35% (Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98% (Antigen)Clinical Specificity100% (Antigen)Type of antigenNucleoprotein1854Gmate® COVID-19 Ag Saliva715Philosys Co., Ltd.South Koreawww.philosys.comYesCommercialisedNoNoCartridgeManualAntigenSalivaN.A2021-05-10 13:04:00 CET1534Immuno-AntigenYesNoImmunoassayQualitativeColorimetryN.A.15LOD5.07AUCalibrationNot evaluatedCrossreactivityEvaluatedFp-Fn-PrecisionEvaluatedAccuracy98.87%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.83%Clinical Specificity99.6%Type of antigenNucleoprotein1611Gmate® COVID-19 Ag715Philosys Co., Ltd.South Koreawww.philosys.comYesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swab2021-05-10 13:04:00 CET1291Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD5.07U/mlCalibrationNot EvaluatedCrossreactivityEvaluatedPrecisionEvaluatedAccuracy96.67%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity91.11%1893GLINE-2019-nCoV Ag Saliva379SHENZHEN YHLO BIOTECH CO., LtdChinahttp://www.szyhlo.comYesCommercialisedNoNoCassetteLateral flowManualNear POC / POCAntigenSalivaCoronaviruses (HCoV)453B.1.1.7United Kingdom806B.1.351South Africa1102B.1.617.1India1103B.1.617.2India1104B.1.617.3India1258P.1Japan/BrazilThe GLINE-2019-nCoV Ag Saliva has obtained CE marking, and its clinical performance verification and analytical performance verification has also been completed.2021-06-23 14:00:58 CET1850Immuno-AntigenYesImmunoassayQualitativeSandwich20LOD425TCID50/mlCrossreactivityEvaluatedFp0%(0 out of 123)Fn5.2%(26 out of 500)RobustnessEvaluatedClinical Sensitivity95.27% (95%CI: 93.15%-96.89%)Clinical Specificity100% (95%CI: 97.05%-100%)Type of antigenNucleoprotein1347GLINE-2019-nCoV Ag379SHENZHEN YHLO BIOTECH CO., LtdChinahttp://www.szyhlo.comYesCommercialisedNoNoCassetteLateral flowManualNear POC / POCAntigenNasal swabNasopharyngeal swabCoronaviruses (HCoV)453B.1.1.7United Kingdom806B.1.351South Africa1102B.1.617.1India1103B.1.617.2India1104B.1.617.3India1258P.1Japan/BrazilThe GLINE-2019-nCoV Ag has obtained the CE marking, and its clinical performance verification and analytical performance verification has also been completed.2021-06-23 14:07:20 CET1849Immuno-AntigenYesImmunoassayQualitativeSandwich15LOD200AUCrossreactivityEvaluatedFp0.75%(3/400)Fn3.5%(4/114)RobustnessEvaluatedClinical Sensitivity97.37% (95%CI: 92.50% - 99.45%)Clinical Specificity99.25% (95%CI: 97.82% - 99.85%)Type of antigenNucleoprotein1253GenSure COVID-19 Antigen Rapid Kit340GenSure Biotech IncChinawww.gensbio.com/YesCommercialisedYesYesNear POC / POCAntigenNasal swabGenSure COVID-19 Antigen Rapid Kit (REF: P2004)2021-07-07 17:20:59 CET1029Immuno-AntigenYesImmunoassay151593GeneFinder COVID-19 Ag Rapid Test702OSANG Healthcare Co., LtdSouth Koreawww.osanghc.com/YesCommercialisedNoNoCassetteNear POC / POCAntigen2021-05-10 13:04:00 CET1273Immuno-AntigenYesNoImmunoassayQualitative15LOD0AUCalibrationnot evaluatedCrossreactivityevaluatedReproducibilityevaluatedRobustnessnot evaluatedClinical Sensitivity96.7%(PPA)Type of antigennucleoprotein1144GENEDIA W COVID-19 Ag600Green Cross Medical Science Corp.South Koreawww.greencrossms.com/eng/main.do?lang=ENYesCommercialisedYesYesCassetteNear POC / POCAntigenAnterior nasal swabNasopharyngeal swab2021-05-11 09:31:09 CET921Immuno-AntigenYesNoImmunoassayQualitative10LOD750TCID50/mlCalibrationEvaluatedCrossreactivityEvaluatedPrecisionEvaluatedAccuracy95.3%RobustnessEvaluatedClinical Sensitivity100%Clinical Sensitivity90.1%Type of antigenNucleoprotein1297GenBody FIA COVID-19 Ag97GenBody, IncSouth KoreaYesCommercialisedNoNoCassetteNear POC / POCAntigenNasopharyngeal swabOropharyngeal swab2021-05-10 13:04:00 CET1067Immuno-AntigenYesNoImmunoassayQualitative20LOD898TCID50/mlAccuracy92.95%Clinical Sensitivity89.47%Clinical Specificity96.43%1244Genbody COVID-19 Ag Test97GenBody, IncSouth KoreaYesCommercialisedYesYesCassetteNear POC / POCAntigenNasopharyngeal swabOropharyngeal swab2021-07-07 17:20:53 CET1025Immuno-AntigenYesNoImmunoassayQualitativeSandwich, Double20LOD2870TCID50/mlAccuracy94%Clinical Sensitivity90%Clinical Specificity98%1585GenaBio SARS-CoV-2 Antigen Lateral Flow Test698GenaBio Diagnostics Inc.United Stateswww.genabio.comYesCommercialisedNoNoCassetteLateral flowNear POC / POCAntigenNasal swab Issue between the data (colloidal gold and the website link provided: immunofluorescence 2021-05-10 13:04:00 CET1265Immuno-AntigenYesNoImmunoassayQualitativeColloidal gold15LOD1AUCalibrationevaluatedCrossreactivityevaluatedFp4.93%Fn0.26%PrecisionevaluatedReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity95.07%(Antigen)Type of antigennucleoprotein1855GA CoV-2 Antigen Rapid Test351GA Generic Assays GmbHGermanywww.genericassays.comYesCommercialisedNoNoLateral flowManualAntigenNasopharyngeal swabGA CoV-2 Antigen Rapid Test is used for the qualitative determination of SARS-Coronavirus 2 (COVID-19) Antigen in human nasopharynx specimen. The test is intended for use by trained clinical laboratory personnel.2021-05-10 13:04:00 CET1535Immuno-AntigenYesNoImmunochromatographyQualitativeMembrane-basedN.A.15LOD10AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0.8%4/500Fn2.94%3/102PrecisionEvaluatedAccuracy98%ReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity97.059%Clinical Specificity99.2%Type of antigenNucleoprotein1580GA CoV-2 Antigen Rapid351GA Generic Assays GmbHGermanywww.genericassays.comYesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swab in instruction manual: Limit of detection: 100 pg/ml of the recombinant protein 2021-05-10 13:04:00 CET1259Immuno-AntigenYesNoImmunoassayQualitative15LOD70AUCalibrationnot evaluatedCrossreactivityevaluatedFp3.6%It was compared with results of the RT-PCR reference method and found a sensitivity 96.4%Fn0.8%It was compared with results of the RT-PCR reference method and found a specificity 99.2%Precision99%99%]]>Accuracy98%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity96.4%Clinical Specificity99.2%Type of antigennucleoprotein2428FUJIFILM COVID-19 Ag Test1110FUJIFILM CorporationJapanhttps://www.fujifilm.com/YesCommercialisedNoNoCartridgeLateral flowManualNear POC / POCAntigenNasopharyngeal swabSARS-CoVFUJIFILM COVID-19 Ag Test is using Fujifilm’s proprietary silver amplification immunochromatographic method for signal amplification to increase the sensitivity and giving results in less than 15minutes. Yamaoka et al., Highly specific monoclonal antibodies and epitope identification against SARS-CoV-2 nucleocapsid protein for antigen detection tests, Cell Reports Medicine (2021), https://doi.org/10.1016/j.xcrm.2021.1003112021-07-14 17:48:44 CET2131Immuno-AntigenYesNoImmunochromatographyQualitativeOther11LOD110AUCalibrationEvaluatedCrossreactivityEvaluatedFp0%- Specificity 100% (104/104)Fn9.1%PrecisionEvaluatedAccuracy100% (Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90.9% (Antigen)Clinical Specificity100% (Antigen)Type of antigenNucleoprotein1420FREND COVID-19 Ag354NanoEntekSouth Koreawww.nanoentek.comYesCommercialisedYesYesCartridgeAutomatedAntigenNasopharyngeal swabAdenovirus 3Adenovirus 7Influenza AInfluenza A H1N1Influenza A H3N2Influenza BMERS-CoVMycoplasma PneumoniaeParainfluenza Virus Type 1Parainfluenza Virus Type 2Parainfluenza Virus Type 3Parainfluenza Virus Type 4Respiratory Syncytial V (RSV)Respiratory Syncytial V (RSV) Type ARespiratory Syncytial V (RSV) Type BRhinovirusRhinovirus ARhinovirus B453B.1.1.7United Kingdom806B.1.351South Africa1260P.2Brazil-2021-07-07 17:23:26 CET1180Immuno-AntigenYesYesImmunoassayQuantitativeOther3Microfluidic testLOD147AUCalibrationEvaluatedCrossreactivity0%EvaluatedFp0%Fn5.9%PrecisionEvaluatedAccuracy97.06% (antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.12%Clinical Sensitivity94.12%Clinical Specificity100%Clinical Specificity100%Type of antigenNucleoprotein1208Formosa One Sure SARS-CoV-2 Ag Rapid Test Kit626Formosa Biomedical Technology Corp.Taiwan ROCwww.fbc.com.tw YesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swab2021-05-10 13:04:00 CET993Immuno-AntigenYesNoImmunoassayQualitative15Clinical Sensitivity88%1192FORA COVID-19 Antigen Rapid Test588TaiDoc Technology Corp.Taiwan ROCtaidoc.com/YesCommercialisedNoNoLateral flowNear POC / POCAntigenNasopharyngeal swab https://www.testlinecd.com/file/1580/COVID-19_AN_NEW%20(002).pdf?version=202008131535 https://www.foracare.ch/covid-19-Antigen-rapid-test/; https://www.foracare.ch/wp-content/uploads/2020/11/20201104_FORA_TD-4531_Covid-19_quick-user-guide_EN_V3.pdf2021-05-10 13:04:00 CET978Immuno-AntigenYesImmunoassayQualitativeMagnetic Electrochemical15LOD126TCID50/mlClinical Sensitivity91.3%Clinical Specificity98.6%Type of antigennucleocapsid recombinant Antigen1664FluCov2529DyonMed SAGreecedyonmedical.com/en/home/YesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swab2021-05-10 13:04:00 CET1343Immuno-AntigenYesNoImmunoassayQualitative15LOD1AUCalibrationevaluatedCrossreactivityevaluatedFp7.75%Compared to PCR (n=142) 11 FPFn0%Compared to PCR (n=66) no false negativesPrecisionevaluatedAccuracy95%(Antigen)ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity92.25%(Antigen)Type of antigennucleoprotein1370FLUA-FLUB-RSV-ADV-COVID-19 Combo Test Device455Assure Tech. (Hangzhou) Co., LtdChinawww.diareagent.comYesCommercialisedNoNoNear POC / POCAntigenOther immunochromatography?2021-05-10 13:04:00 CET1141Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15Rapid diagnostic test colloidal gold LOD2102.4AUFpNot availableFnNot availableAccuracy98.5%(COVID-19:98.5%; Influenza A:88.4%, Influenza B:88.9%, RSV:97.4%, Adenovirus:96.3%)Clinical Sensitivity97.3%(COVID-19:97.3%; Influenza A:83.3%, Influenza B:82.4%, RSV:96.2%, Adenovirus:95.2%)1470Flu+COVID-19 Ag Test Kit655Guangdong Wesail Biotech Co., LtdChinaen.wesailbio.comYesCommercialisedNoNoNear POC / POCAntigenNasal swab2021-05-10 13:04:00 CET1217Immuno-AntigenYesNoImmunoassayQualitativeColloidal gold15LOD560AUCalibrationNot evaluatedCrossreactivityevaluatedFp10Fn0.8PrecisionevaluatedAccuracy95.6%Reproducibilitynot evaluatedRobustnessnot evaluatedClinical Sensitivity91.1%1713Flu A/Flu B/SARS-CoV-2 Antigen (GICA)761MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.Chinawww.medcaptain.comYesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swab2021-05-10 13:04:00 CET1393Immuno-AntigenYesNoImmunoassayQualitativeColloidal gold15LOD1250AUCalibrationnot evaluatedCrossreactivityevaluatedFp1.9%Fn2.8%PrecisionevaluatedAccuracy98%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity97.2%(Antigen)Type of antigennucleoprotein1468Flowflex SARS-CoV-2 Antigen rapid test683ACON Laboratories, IncUnited Stateswww.aconlabs.comYesCommercialisedYesYesCassetteLateral flowNear POC / POCAntigenNasal swab2021-05-10 20:07:30 CET1219Immuno-AntigenYesNoImmunochromatographyQualitative15LOD160U/mlCalibrationNot EvaluatedCrossreactivityEvaluatedFp0.5%Fn3.1%PrecisionEvaluatedAccuracy98.8ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.9Type of antigenNucleoproteinType of antigennucleoprotein1724First Sign SARS-CoV-2-Antigen-Test726WHPMUnited Stateswww.whpm.comYesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swab2021-05-10 13:04:00 CET1404Immuno-AntigenYesNoImmunoassayQualitative15LOD160000AUCalibrationnot evaluatedCrossreactivityevaluatedFp98.82%2/170Fn98.82%2/170PrecisionevaluatedAccuracy97.6%AntigenReproducibilitynot evaluatedRobustnessevaluatedClinical Sensitivity94.6%AntigenType of antigennucleoprotein1669FIAflex SARS-CoV-2 Antigen FIA565Acon Biotech (Hangzhou) Co., LtdChinawww.aconbio.com/YesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swab2021-05-10 13:18:20 CET1348Immuno-AntigenYesNoImmunoassayQualitative15LOD95AUCalibrationnot evaluatedCrossreactivityEvaluatedPrecisionevaluatedAccuracy98.9%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity97.5%Type of antigennucleoprotein1670FIAflex SARS-CoV-2 Antigen FIA683ACON Laboratories, IncUnited Stateswww.aconlabs.comYesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swab2021-05-10 13:04:00 CET1349Immuno-AntigenYesNoImmunochromatographyQualitative15LOD95%Calibrationnot evaluatedCrossreactivityevaluatedPrecisionevaluatedAccuracy98.9%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity97.5%Type of antigennucleoprotein1271Exdia COVID-19 Ag637Precision Biosensor, IncSouth Koreawww.precision-bio.com/en/YesCommercialisedYesYesNear POC / POCAntigenNasopharyngeal swab2021-07-07 17:23:54 CET1046Immuno-AntigenYesImmunoassayQualitative20Clinical Sensitivity93.9%Clinical Specificity98%2161EONBT COVID-19 ANTIGEN-SALIVA1004Manufactured by Eon Biotechnology LimitedUnited Kingdomwww.eonbt.comYesCommercialisedNoNoCassetteLateral flowManualNear POC / POCAntigenSalivaSARS-CoV20A.23.1United Kingdom72AT.1Russia453B.1.1.7United Kingdom806B.1.351South Africa905B.1.427USA910B.1.429USA999B.1.525Nigeria1000B.1.526USA1001B.1.526.1USA1002B.1.526.2USA1100B.1.616France1102B.1.617.1India1103B.1.617.2India1104B.1.617.3India1108B.1.621Colombia1224C.36Egypt1227C.37Peru1258P.1Japan/Brazil1260P.2Brazil1261P.3The Philippines2021-06-03 12:27:03 CET1862Immuno-AntigenYesNoImmunochromatographyQualitativeMembrane-based20LOD4AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0.7% (In trial of 428 negative samples compared with RTqPCR test ,3 False Positives were detected)Fn8.05% (In trial of 149 positive samples compared with RTqPCR test, 12 False negatives were detected)PrecisionEvaluatedAccuracy99.04%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity91.95%Clinical Specificity99.27%Type of antigenNucleoprotein2156Elecsys® SARS-CoV-2 Antigen221ROCHE DiagnosticsGermanyhttps://diagnostics.roche.com/global/en/products/params/elecsys-anti-sars-cov-2-s.htmlYesCommercialisedNoNoCartridgeAutomatedLab-basedAntigenNasopharyngeal swabOropharyngeal swabSARS-CoV20A.23.1United Kingdom72AT.1Russia453B.1.1.7United Kingdom806B.1.351South Africa905B.1.427USA910B.1.429USA999B.1.525Nigeria1000B.1.526USA1001B.1.526.1USA1002B.1.526.2USA1100B.1.616France1102B.1.617.1India1103B.1.617.2India1104B.1.617.3India1108B.1.621Colombia1224C.36Egypt1227C.37Peru1258P.1Japan/Brazil1260P.2Brazil1261P.3The PhilippinesSpecimen collection and preparation: Nasopharyngeal and oropharyngeal specimens, collected using flocked or polyester-tipped swabs, placed in 3 mL of Copan Universal Transport Medium (UTM-RT), BD Universal Viral Transport (UVT), Viral Transport Media (VTM, prepared according to CDC SOP#: DSR 052 05), or sterile saline (0.9% NaCl).2021-06-01 14:18:59 CET1857Immuno-AntigenYesYesImmunoassayQualitativeSandwich, Double12LOD22.5TCID50/mlCalibrationEvaluatedCrossreactivityEvaluatedPrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.5% (95% CI: 90.4-97.2)Clinical Specificity99.9% (95% CI: 99.6-100)Type of antigenNucleoprotein770ECOTEST COVID-19 Antigen Rapid Test Device455Assure Tech. (Hangzhou) Co., LtdChinawww.diareagent.comYesCommercialisedYesYesCassetteManualNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabAdenovirusAlpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Bordetella PertussisChlamydia PneumoniaeEpstein-Barr Virus (EBV)Human Metapneumovirus (HMPV)Influenza A H1N1Influenza A H3N2Influenza A H5N1Influenza B VictoriaInfluenza B YamagataMumps Virus (MuV)Parainfluenza Virus Type 1Parainfluenza Virus Type 2Parainfluenza Virus Type 3Respiratory Syncytial V (RSV) Type ARespiratory Syncytial V (RSV) Type BRhinovirus453B.1.1.7United Kingdom806B.1.351South Africa1102B.1.617.1India1103B.1.617.2India1104B.1.617.3India1258P.1Japan/BrazilNone2021-07-13 17:38:51 CET623Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15Rapid diagnostic test LOD502AUCalibrationEvaluatedCalibrationEvaluatedCrossreactivityEvaluatedCrossreactivityEvaluatedFp0.75%A total of 1190 SARS-CoV-2 negative samples were tested, 9 samples were positive by this test.Fn7.5%A total of 160 SARS-CoV-2 positive samples were tested, 12 samples were negative by this RDT.Accuracy98.5%Clinical Sensitivity92.5%Clinical Specificity99.2%Type of antigenNucleoprotein2350ECOTEST COVID-19 Antigen Rapid Test Device1059Assure Tech. (Hangzhou) Co., Ltd.Chinawww.diareagent.comYesCommercialisedNoNoLateral flowManualNear POC / POCAntigenNasopharyngeal swabOropharyngeal swabAdenovirusAlpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Chlamydia PneumoniaeEpstein-Barr Virus (EBV)Human Metapneumovirus (HMPV)Influenza AInfluenza A H1N1Influenza A H3N2Influenza A H5N1Influenza BInfluenza B VictoriaInfluenza B YamagataParainfluenza Virus Type 1Parainfluenza Virus Type 2Parainfluenza Virus Type 3Respiratory Syncytial V (RSV)453B.1.1.7United Kingdom806B.1.351South Africa1102B.1.617.1India1103B.1.617.2India1104B.1.617.3India1258P.1Japan/BrazilNone2021-07-02 18:44:51 CET2051Immuno-AntigenYesImmunoassay15LOD502AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0.86%A total of 1036 SARS-CoV-2 negative samples were tested, 9 samples were positive by this test.Fn2.3%A total of 128 SARS-CoV-2 positive samples were tested, 3 samples were negative by this RDT.PrecisionEvaluatedAccuracy99%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.7%Clinical Specificity99.1%Type of antigenNucleoprotein1739EBS SARS-CoV-2 Ag Rapid Test294Eurobio ScientificFrancehttps://www.eurobio-scientific.com/YesCommercialisedYesYesLateral flowNear POC / POCAntigenNasal swabEBS1020, EBS SARS-CoV-2 Ag Rapid Test2021-07-07 17:06:15 CET1417Immuno-AntigenYesYesImmunoassayQualitativeColorimetry10LOD95AUCalibrationnot evaluatedCrossreactivityevaluatedPrecisionnot evaluatedReproducibilityevaluatedRobustnessnot evaluatedClinical Sensitivity95.7%A/(A+C) x 100= 95.7% (95% CI 90.2 98.1%)Type of antigennucleoprotein1651DyonCovidAg529DyonMed SAGreecedyonmedical.com/en/home/YesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swab2021-05-10 13:04:00 CET1332Immuno-AntigenYesNoImmunoassayQualitativeColloidal gold15LOD2000AUCalibrationevaluatedCrossreactivityevaluatedPrecisionevaluatedAccuracy97%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity91%Type of antigennucleoprotein1250Dynamiker SARS-CoV-2 Ag Rapid Test86Dynamiker Biotechnology (Tianjin) Co., LtdChinaen.dynamiker.com/YesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swabOropharyngeal swab2021-05-10 13:04:00 CET1028Immuno-AntigenYesImmunoassay101733DROP-TECH768Promoitalia Group SpAItalywww.webpromoitalia.comYesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swabSaliva2021-05-10 13:04:00 CET1412Immuno-AntigenYesNoImmunoassayQualitative15LOD320AUCalibrationevaluatedCrossreactivityevaluatedFpBased on the accuracy confirmed by studies, fales positives are not likely to occur.FnBased on the accuracy confirmed by studies, fales negatives are not likely to occur.PrecisionevaluatedAccuracy98%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity92.59%Type of antigennucleoprotein2273Dräger Antigen Test SARS-CoV-21060Germanywww.draeger.comYesCommercialisedNoNoCassetteLateral flowStripManualNear POC / POCAntigenNasal swabSARS-CoV453B.1.1.7United KingdomLOD is 200 pg/Test Osmanodja, B. et al. (2021) ‘Accuracy of a Novel SARS-CoV-2 Antigen-Detecting Rapid Diagnostic Test from Standardized Self-Collected Anterior Nasal Swabs’, Journal of Clinical Medicine, 10(10), p. 2099. doi: 10.3390/jcm10102099. Clinical Validation at Charité, Berlin, Germany2021-06-18 11:03:36 CET1974Immuno-AntigenYesNoImmunochromatographyQualitativeSandwichSample collection device15LOD200pgCalibrationNot evaluatedAnalytical Sensitivity96.8%CrossreactivityEvaluatedFp0.321 out of 308 samples (symptomatic and asymptomatic PCR negative)Fn10.17 out of 69 samples (symptomatic PCR positive)PrecisionEvaluatedAccuracy97.1 (symptomatic overall); Accuracy98.9%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity89.9%(overall); Clinical Specificity99.7% (overall)Type of antigenNucleoprotein1375DIAQUICK COVID-19 Ag Cassette526DIALAB GmbHAustriawww.dialab.at/en/home/YesCommercialisedYesYesCassetteNear POC / POCAntigenNasopharyngeal swab2021-05-10 20:07:30 CET1139Immuno-AntigenYesNoImmunoassayQualitativeColloidal gold15Type of antigenSARS-CoV-21274Diagnostic Kit for SARS-CoV-2 Ag (Fluorescence Immunochromatographic Assay)262Sure Bio-Tech (USA) Co., LtdUnited Stateswww.surebiotech.com/YesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swabOropharyngeal swab2021-05-10 13:04:00 CET1049Immuno-AntigenYesImmunoassayFluorescence1663CovidAg529DyonMed SAGreecedyonmedical.com/en/home/YesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swab2021-05-10 13:04:00 CET1342Immuno-AntigenYesNoImmunoassayQualitative15LOD0AUCalibrationevaluatedCrossreactivityevaluatedFp9.4%Compared to PCR (n=117) 11 FPFn0.55%Compared to PCR (n=183) 1 false negativesPrecisionevaluatedAccuracy96%(Antigen)ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity90.59%(Antigen)Type of antigennucleoprotein2261Covid19Check-SAL1052Multi-G bvbaBelgiumwww.covid19check-mg.comYesCommercialisedNoNoCassetteLateral flowManualAntigenSalivaSARS-CoV20A.23.1United Kingdom72AT.1Russia453B.1.1.7United Kingdom806B.1.351South Africa905B.1.427USA910B.1.429USA999B.1.525Nigeria1000B.1.526USA1001B.1.526.1USA1002B.1.526.2USA1100B.1.616France1102B.1.617.1India1103B.1.617.2India1104B.1.617.3India1108B.1.621Colombia1224C.36Egypt1227C.37Peru1258P.1Japan/Brazil1260P.2Brazil1261P.3The PhilippinesAll additional data is available on demand. This test is validated by the Belgian Health agency : https://www.famhp.be/en/human_use/health_products/medical_devices_accessories/covid_19/tests2021-06-16 17:24:42 CET1962Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich, Double15LOD22.5AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0.9% (NPA 99.1%)Fn2.4% (PPA 97.6%, 99.35% for Ct values ≤25)PrecisionEvaluatedAccuracy98.7%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.6%Clinical Specificity99.1%Type of antigenNucleoprotein2260Covid19Check-NAS1052Multi-G bvbaBelgiumwww.covid19check-mg.comYesCommercialisedNoNoCassetteLateral flowManualAntigenNasal swabSARS-CoV20A.23.1United Kingdom72AT.1Russia453B.1.1.7United Kingdom806B.1.351South Africa905B.1.427USA910B.1.429USA999B.1.525Nigeria1000B.1.526USA1001B.1.526.1USA1002B.1.526.2USA1100B.1.616France1102B.1.617.1India1103B.1.617.2India1104B.1.617.3India1108B.1.621Colombia1224C.36Egypt1227C.37Peru1258P.1Japan/Brazil1260P.2Brazil1261P.3The PhilippinesAll additional data is available on demand. This test is validated by the Belgian Health agency : https://www.famhp.be/en/human_use/health_products/medical_devices_accessories/covid_19/tests2021-06-16 17:21:17 CET1961Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich, Double15LOD1600AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0.5% (NPA 99.5%)Fn3% (PPA 97%, 99.35% for Ct values ≤25)PrecisionEvaluatedAccuracy98.97%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97% (99.35% for Ct values ≤25)Clinical Specificity99.5%Type of antigenNucleoprotein2258Covid19Check-GEN1052Multi-G bvbaBelgiumwww.covid19check-mg.comYesCommercialisedNoNoCassetteManualAntigenNasopharyngeal swabOropharyngeal swabSARS-CoV20A.23.1United Kingdom72AT.1Russia453B.1.1.7United Kingdom806B.1.351South Africa905B.1.427USA910B.1.429USA999B.1.525Nigeria1000B.1.526USA1001B.1.526.1USA1002B.1.526.2USA1100B.1.616France1102B.1.617.1India1103B.1.617.2India1104B.1.617.3India1108B.1.621Colombia1224C.36Egypt1227C.37Peru1258P.1Japan/Brazil1260P.2Brazil1261P.3The PhilippinesAll additional data is available on demand. This test is validated by the Belgian Health agency : https://www.famhp.be/en/human_use/health_products/medical_devices_accessories/covid_19/tests2021-06-16 17:15:22 CET1959Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich, Double15LOD30AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0.7%(NPA 99.3%)Fn6.8% (PPA 93.18%, 100% for Ct values ≤33)PrecisionEvaluatedAccuracy97.57%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.18% (100% for Ct values ≤33)Clinical Specificity99.3%Type of antigenNucleoprotein1778COVID19 Antigen Rapid Test Kit43Beijing Kewei Clinical Diagnostic Reagent IncChinaen.keweidiagnostic.com/YesCommercialisedNoNoCardLateral flowNear POC / POCAntigenNasal swab2021-05-10 13:04:00 CET1457Immuno-AntigenYesNoImmunochromatographyQualitativeColorimetry15LOD19.3U/mlCalibrationEvaluatedCrossreactivityEvaluatedFp0%Fn3.82%PrecisionEvaluatedAccuracy98.56%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.18%1833COVID-VIRO837AAZ-LMBFrancewww.covid19aaz.comYesCommercialisedYesYesCassetteNear POC / POCAntigenNasal swabNasopharyngeal swab2021-05-17 11:02:12 CET1512Immuno-AntigenYesNoImmunochromatographyQualitativeMembrane-based16LOD1.15AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0%Fn3.4%PrecisionEvaluatedAccuracy98.74ReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity96.6%Clinical Specificity100%Type of antigenNucleoprotein1365COVID-19/Influenza A+B Antigen Combo Rapid Test413Hangzhou Clongene Biotech Co., LtdChinaen.clongene.com/YesCommercialisedYesYesNear POC / POCAntigenNasopharyngeal swab2021-07-07 17:21:41 CET1125Immuno-AntigenYesNoImmunoassayQualitative15LOD2300TCID50/mlClinical Sensitivity91%95% CI: 82.8%-95.6%Clinical Specificity100%95% CI: 98.2%-100%Type of antigenSARcov2, influenza A+B viral nucleoprotein antigens1454COVID-19/Flu A/B Antigen Combo Rapid Test340GenSure Biotech IncChinawww.gensbio.com/YesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swab2021-05-10 13:04:00 CET1204Immuno-AntigenYesNoImmunoassayQualitative15Accuracy: 97.5 (Influenza A); 96.9 (Influenza B). Clinical sensitivity: 91.7 (Influenza A); 86.2 (Influenza B)LOD50AUCalibrationNot evaluatedCrossreactivityevaluatedFpThe samples collected were contaminated, do not follow the instructions manual, etc. FnSamples collected contained low levels of the virus, do not follow the instructions manual, etc. PrecisionevaluatedAccuracy98.9%(COVID-19)Reproducibilitynot evaluatedRobustnessnot evaluatedClinical Sensitivity96.9%(COVID-19)Type of antigennucleoprotein1956COVID-19-CHECK-1 Antigen574VEDALABFrancewww.vedalab.comYesCommercialisedNoNoCassetteLateral flowManualAntigenNasal swabNasopharyngeal swabProfessional test version is CE marked. The self-testing version is pending for CE marking2021-06-09 10:56:46 CET1632Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich20LOD0.05AUCalibrationEvaluatedCrossreactivityEvaluatedFp0%Specificity 100%Fn1.75%PrecisionEvaluatedAccuracy98.7%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.25%Clinical Specificity100%Type of antigenNucleoprotein1281COVID-19 Viral Antigen Test Kit (Colloidal Gold Immunochromatography)640Beijing Abace Biology Co., LtdChinawww.abace-biology.com/YesCommercialisedNoNoNear POC / POCAntigen2021-05-10 13:04:00 CET1056Immuno-AntigenYesImmunochromatographyRapid diagnostic test 1237COVID-19 Viral Antigen Test Kit415CamtechSingaporecovid19-test.com/YesCommercialisedNoNoNear POC / POCAntigenOropharyngeal swab Additional info available only upon request https://covid19-test.com/assets/Camtech_Covid19AntigenTestKit.pdf2021-05-10 13:18:20 CET1020Immuno-AntigenYesImmunoassayQualitativeFluorescence20Rapid diagnostic test cassette Fluorescence LODng/mL100 ng/mlAccuracy82.4%Clinical Sensitivity88.66%Clinical Specificity94.55%1333COVID-19 Rapid Antigen Test (Colloidal Gold)44Joinstar Biomedical Technology Co., LtdChinawww.joinstar.cnYesCommercialisedYesYesLateral flowNear POC / POCAntigenNasal swab2021-05-10 20:07:30 CET1105Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15Fp1.86%From 215 samples tested there were 4 false positivesFn1.39%From 215 samples tested there were 3 false negativesAccuracy97.6%Clinical Sensitivity96.1%Clinical Specificity98.1%Type of antigennucleoprotein1756COVID-19 Antigen/Flu A+B Antigen Combo Rapid Test Cassette840Wuhan NanoDiagnosis for Health Biotechnology Co., LtdChinandh-biotech.comYesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swab2021-05-10 13:18:20 CET1434Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD1774TCID50/mlSARS-CoV-2 CalibrationNot evaluatedCrossreactivityEvaluatedFp1AUFn0AUPrecisionEvaluatedAccuracy100AntigenRobustnessNot evaluatedClinical Sensitivity96.88%Antigen1279COVID-19 Antigen Test Kit (Rare Earth Nano Fluorescence Immunochromatography)790Xiamen AmonMed Biotechnology Co., LtdChinawww.amonmed.comYesCommercialisedNoNoNear POC / POCAntigen2021-05-10 13:18:20 CET1054Immuno-AntigenYesImmunoassayFluorescenceRapid diagnostic test 1648COVID-19 Antigen Test Kit (Dry Fluorescence Immunoassay)739Lansion Biotechnology Co., Ltd.Chinawww.lansionbio.com/YesCommercialisedNoNoStripNear POC / POCAntigenNasal swab2021-05-10 13:04:00 CET1329Immuno-AntigenYesYesImmunoassayQuantitativeFluorescence15LOD0AUCalibrationevaluatedCrossreactivityevaluatedFp3%Fn2%PrecisionevaluatedAccuracy98%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity95%Type of antigennucleoprotein1353COVID-19 Antigen Test Kit (Colloidal Gold)851Nantong Diagnos Biotechnology Co., LtdChinawww.diagnosbio.comYesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swabNasopharyngeal swabThroat swabkit name COVID-19 Ag test; (2019-nCoV) New coronavirus Antigen test (colloidal gold)2021-05-10 13:18:20 CET1127Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD0.05Accuracy96%(Antigen)Clinical Sensitivity92.59%(Antigen)Type of antigennucleoprotein2333COVID-19 Antigen Test Kit (Colloidal Gold)1085Shenzhen Yilifang Biotech Co., LTD.Chinahttp://www.yilifangbio.com/en/YesCommercialisedNoNoCassetteLateral flowNear POC / POCAntigenNasopharyngeal swabOropharyngeal swabAdenovirus 3Adenovirus 7Alpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Enterovirus A71 (EV-A71)Epstein-Barr Virus (EBV)Influenza AInfluenza A H1N1Influenza A H3N2Influenza BInfluenza B VictoriaInfluenza B YamagataMERS-CoVMumps Virus (MuV)Mycoplasma PneumoniaeRespiratory Syncytial V (RSV)Rhinovirus ARhinovirus BSARS-CoVVaricella Zoster Virus (VZV)20A.23.1United Kingdom453B.1.1.7United Kingdom806B.1.351South Africa905B.1.427USA910B.1.429USA999B.1.525Nigeria1000B.1.526USA1001B.1.526.1USA1102B.1.617.1India1103B.1.617.2India1104B.1.617.3IndiaPlease check the official website for details. http://www.yilifangbio.com/en/2021-07-01 09:46:54 CET2034Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich, DoubleColloidal goldValidity test kit15LOD35AUCalibrationEvaluatedCrossreactivityEvaluatedFp7.18%(12 false positives in 167 sample)Fn1.5%(5 false negatives in 333 sample)PrecisionEvaluatedAccuracy97%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.88%Clinical Specificity96.47%Type of antigenNucleoprotein1700COVID-19 Antigen Test Cassette (For Analyzer)890Acro Biotech IncUnited Stateswww.acrobiotech.comYesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swab2021-05-10 13:18:20 CET1380Immuno-AntigenYesYesImmunoassayQualitative10LOD0AUCalibrationevaluatedCrossreactivityevaluatedFp6.7AUFn1.6AUPrecisionevaluatedAccuracy96.2(Antigen)ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity93.3%(Antigen)Type of antigennucleoprotein1254COVID-19 Antigen Test cassette (FIA)126Hangzhou AllTest Biotech Co., LtdGermanyhttps://www.goldstandarddiagnostics.com/home/products/covid-19-antigen-rapid-test/YesCommercialisedNoNoCassetteNear POC / POCAntigenNasopharyngeal swab2021-05-10 13:04:00 CET1030Immuno-AntigenYesImmunoassayQualitativeFluorescence15FIA method1392COVID-19 Antigen Test Cassette131Hangzhou Testsea Biotechnology Co., LtdChinawww.testsealabs.com/YesCommercialisedYesYesCassetteNear POC / POCAntigenNasal swab2021-07-07 17:22:21 CET1158Immuno-AntigenYesNoImmunoassayQualitative10LOD0.1AUCalibrationNot evaluatedFp2AUFn8AUAccuracy96.5%Clinical Sensitivity92.1%Clinical Specificity98.1%Type of antigennucleoprotein1476COVID-19 Antigen Test Cassette659CITEST DIAGNOSTICS INCChinawww.citestdiagnostics.comYesCommercialisedNoNoNear POC / POCAntigenNasal swab no info in company website2021-05-10 13:04:00 CET1225Immuno-AntigenYesImmunoassayQualitative10Rapid diagnostic test LOD0AUCalibrationevaluatedCrossreactivityevaluatedFp4.4%Fn1.6%PrecisionevaluatedAccuracy97.2%(Antigen)ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity95.6%(Antigen)Type of antigennucleoprotein1455COVID-19 Antigen Test (Nasopharyngeal Swab)657Ulti Med Products GmbHGermanywww.ultimed.orgYesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swab2021-05-10 13:04:00 CET1205Immuno-AntigenYesNoImmunoassayQualitative15LOD100AUCalibrationNot evaluatedCrossreactivityevaluatedFp0.61%2 from 330Fn6.01%8 from 133PrecisionevaluatedAccuracy97.8%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity94%1238COVID-19 Antigen test631RDSM nvBelgiumwww.rdsm.eu/YesCommercialisedNoNoLateral flowNear POC / POCAntigenNasopharyngeal swabOropharyngeal swab https://www.rdsm.eu/covid19-Antigen-test.html2021-05-10 13:04:00 CET1021Immuno-AntigenYesNoImmunoassay15Clinical Sensitivity99.9%Clinical Specificity80.2%Clinical Specificity97.6%1378COVID-19 Antigen test657Ulti Med Products GmbHGermanywww.ultimed.orgYesCommercialisedNoNoN.A.Near POC / POCAntigenNasal swab2021-05-10 13:04:00 CET1143Immuno-AntigenYesNoImmunoassayQualitative15LOD100AUCrossreactivityEavaluatedFp1.23%Fn2.44%Accuracy98%Clinical Sensitivity96.4%Clinical Specificity99.2%1715COVID-19 Antigen Test762Redcell BiyoteknolojiTurkeyen.redcell.com.tr/YesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swab2021-05-10 13:04:00 CET1395Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD50000AUCalibrationnot evaluatedCrossreactivityevaluatedFp1.15%Out of 261 samples 3 of them were false positivesFn4.92%Out of 122 samples 6 of them were false negativesPrecisionevaluatedAccuracy99.2%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity95.08%Type of antigennucleoprotein2075COVID-19 Antigen Sealing tube test strip (Colloidal Gold)960Amazing Biotech (Shanghai) Co.,LTDChinaYesCommercialisedNoNoStripNear POC / POCAntigenNasal swabOropharyngeal swabSalivaAdenovirusAdenovirus Subtype CAlpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Influenza AInfluenza A H3N2Influenza A H5N1Influenza B VictoriaMERS-CoVParainfluenza Virus TypeParainfluenza Virus Type 1Parainfluenza Virus Type 2Parainfluenza Virus Type 3Respiratory Syncytial V (RSV)453B.1.1.7United Kingdom806B.1.351South Africa1258P.1Japan/BrazilAmazing COVID-19 Antigen Sealing Tube Test Strip is a rapid lateral flow immunoassay for the qualitative detection and diagnosis of COVID-19 directly from nasal cavity, saliva or/and oropharynx swabs, without viral transport media. The Amazing COVID-19 Antigen Sealing Tube Test Strip contains all components required to carry out an assay for COVID-19.2021-05-20 15:10:47 CET1757Immuno-AntigenYesNoImmunochromatographyQualitativeSandwichColloidal gold15LOD0AUCalibrationNot evaluatedCrossreactivityEvaluatedFp2.885% (Nasal Swab)Fn0.746% (Nasal Swab)PrecisionEvaluatedAccuracy98.2% (Antigen) (Nasal Swab)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.115% (Antigen) (Nasal Swab)Clinical Specificity99.254%(Antigen) (Nasal Swab)Type of antigenNucleoprotein1617COVID-19 Antigen Saliva Test Kit (Colloidal Gold)851Nantong Diagnos Biotechnology Co., LtdChinawww.diagnosbio.comYesCommercialisedNoNoCassetteNear POC / POCAntigenSaliva2021-05-10 13:18:20 CET1297Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD0.05AUCalibrationnot evaluatedCrossreactivityevaluatedFp0.67%Fn1.9%PrecisionevaluatedAccuracy98.82%(Antigen) ReproducibilityevaluatedRobustnessnot evaluatedClinical Sensitivity98.1%(Antigen) Type of antigennucleoprotein1579COVID-19 Antigen Saliva Test Kit455Assure Tech. (Hangzhou) Co., LtdChinawww.diareagent.comYesCommercialisedNoNoManualAntigenSaliva2021-05-10 13:04:00 CET1258Immuno-AntigenYesNoImmunoassayQualitative15LOD0AUCalibrationevaluatedCrossreactivityevaluatedPrecisionevaluatedAccuracy95.3%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity90%1598COVID-19 Antigen Rapid Test, Sienna873Canadawww.td-diagnostics.comYesCommercialisedNoNoNear POC / POCAntigen2021-05-10 13:04:00 CET1279Immuno-AntigenYesImmunoassay2249COVID-19 ANTIGEN RAPID TEST NASAL1047Unioninvest Ltd.Turkeywww.unibioscience.comYesCommercialisedNoNoCassetteLateral flowManualAntigenNasal swabSARS-CoV453B.1.1.7United Kingdom806B.1.351South Africa1260P.2Brazil2021-06-15 13:49:03 CET1950Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich, DoubleVisualisation system15LOD7.57AUCalibrationEvaluatedCrossreactivityEvaluatedFp0.25%1/400Fn1%4/400PrecisionEvaluatedAccuracy99 (Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99% (Antigen)Clinical Specificity99% (Antigen)Type of antigenNucleoprotein1937COVID-19 Antigen Rapid Test Kit(Swab)886Chongqing iSIA BIO-Technology Co., LtdChinawww.isiabio.com.cnYesCommercialisedNoNoLateral flowNear POC / POCAntigen2021-06-01 11:17:35 CET1613Immuno-AntigenYesImmunoassay15LOD0.9AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0%Fn0%PrecisionEvaluatedAccuracy98%ReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity97%Clinical Specificity100%Type of antigenOther1819COVID-19 Antigen Rapid Test Kit(Saliva)546Safecare Biotech (Hangzhou) Co. LtdChinaen.safecare.com.cn/YesCommercialisedNoNoLateral flowNear POC / POCAntigenSaliva2021-05-10 13:18:20 CET1497Immuno-AntigenYesNoImmunochromatographyQualitativeSandwichVisualisation system15LOD0.25AUCalibrationEvaluatedCrossreactivityEvaluatedFp0.55%Fn1.5%PrecisionEvaluatedAccuracy99.05%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.5%Clinical Specificity99.45%1489COVID-19 Antigen Rapid Test Kit (Swab)546Safecare Biotech (Hangzhou) Co. LtdChinaen.safecare.com.cn/YesCommercialisedYesYesNear POC / POCAntigenNasal swab2021-05-12 12:58:25 CET1234Immuno-AntigenYesNoImmunoassayQualitativeColorimetry10LOD0.5AUCalibrationNot EvaluatedCrossreactivityEvaluatedFp2.96%Fn0.56%PrecisionEvaluatedAccuracy98.41%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.04%Type of antigennucleoprotein1763COVID-19 Antigen Rapid Test Kit (Colloidal Gold)790Xiamen AmonMed Biotechnology Co., LtdChinawww.amonmed.comYesCommercialisedYesYesCassetteLateral flowNear POC / POCAntigenNasal swabThroat swab2021-07-07 17:26:04 CET1444Immuno-AntigenYesNoImmunochromatographyQualitativeColloidal gold15LOD170U/mlCalibrationNot evaluatedCrossreactivityEvaluatedFp0.45%Fn6.8%Accuracy97.52%ReproducibilityNot evaluatedRobustnessNot evaluatedClinical Sensitivity93.2%Clinical Specificity99.55Type of antigenNucleoprotein1899COVID-19 Antigen Rapid Test Kit (Colloidal Gold)867Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd.Chinaen.konsung.com/YesCommercialisedNoNoCardManualAntigenNasal swabNasopharyngeal swabOropharyngeal swabNone2021-05-10 13:04:00 CET1575Immuno-AntigenYesImmunochromatographyQualitativeColorimetryOther15LOD50AUCalibrationNot evaluatedCrossreactivityEvaluatedFp8AUFn5AUPrecisionEvaluatedAccuracy99.06%ReproducibilityNot evaluatedRobustnessNot evaluatedClinical Sensitivity97.14%Clinical Specificity99.34%Type of antigenNucleoprotein1310Covid-19 Antigen Rapid Test Kit35Beijing Beier Bioengineering Co., LtdChinawww.mediport.comYesCommercialisedNoNoLateral flowManualNear POC / POCAntigenNasal swab2021-05-10 13:04:00 CET1080Immuno-AntigenYesImmunoassayQualitativeColloidal gold15Accuracy98.5%Clinical Sensitivity96.5%95% CI: 93.7%~99.3%Type of antigenNucleoprotein1363Covid-19 Antigen Rapid Test Kit413Hangzhou Clongene Biotech Co., LtdChinaen.clongene.com/YesCommercialisedYesYesCassetteNear POC / POCAntigenNasal swab2021-05-10 13:04:00 CET1122Immuno-AntigenYesNoImmunochromatographyQualitative15LOD2300AUFp0%Fn1.5%Accuracy99.6%Clinical Sensitivity98.5%Type of antigennucleoprotein1573COVID-19 Antigen Rapid Test Kit691Nantong Egens Biotechnology Co.,LtdChinawww.egens-bio.comYesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swab2021-05-10 13:04:00 CET1252Immuno-AntigenYesNoImmunoassayQualitativeColloidal gold15LOD38.5AUCalibrationevaluatedCrossreactivityevaluatedFp0.2%Fn4.2%PrecisionevaluatedAccuracy98.5%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity95.8%2139COVID-19 Antigen Rapid Test Device（Colloidal Gold）990HANGZHOU LYSUN BIOTECHNOLOGY CO., LTD.Chinahttp://www.lysunbio.com/YesIn developmentYesYesCassetteManualNear POC / POCAntigenNasal swabSARS-CoV453B.1.1.7United Kingdom806B.1.351South Africa1102B.1.617.1IndiaNone2021-07-07 17:22:14 CET1829Immuno-AntigenYesYesImmunochromatographyQualitativeSandwich, DoubleColloidal goldExtraction kit10LOD150AUCalibrationEvaluatedCrossreactivityEvaluatedFp0%Fn3.54%PrecisionEvaluatedAccuracy98.44% (95%CI: 96.92%~99.96%)Accuracy98.44% (95%CI: 96.92%~99.96%)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.46 (95%CI: 93.05%~99.87%)Clinical Specificity100 (95%CI: 100%~100%)Type of antigenNucleoprotein678COVID-19 Antigen Rapid Test Device; SARS-CoV-2 (N)protein Antigen rapid test (Fluorescence Immunochromatics assay)166LOMINA AGSwitzerlandwww.lomina.ch/YesCommercialisedNoNoCassetteNear POC / POCAntigenOropharyngeal swab2021-05-10 13:04:00 CET807Immuno-AntigenYesYesImmunochromatographyQualitativeFluorescenceN.A.15LOD100ng/mLCalibrationEvaluatedAccuracy96.63%Clinical Sensitivity94.55%Clinical Specificity99.9%Type of antigenSARS-CoV-2 Nucleocapsid Protein Antigen263COVID-19 Antigen Rapid Test Device160Liming Bio-Products Co., LtdChinawww.limingbio.com/YesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swabOropharyngeal swab2021-05-10 13:04:00 CET212Immuno-AntigenYesNoImmunoassayQualitative15LODEvaluatedCrossreactivityEvaluatedClinical Sensitivity93.1%Clinical Specificity100%1261COVID-19 Antigen Rapid Test Device635Chinawww.hgb.com.cn/YesCommercialisedNoNoNear POC / POCAntigenNasal aspirationThroat swab2021-05-10 13:04:00 CET1036Immuno-AntigenYesImmunoassay151906COVID-19 Antigen Rapid Test Device871Azure Biotech IncUnited Stateswww.azure.bioYesCommercialisedYesYesCassetteNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swab2021-07-07 17:20:10 CET1672Immuno-AntigenYesImmunoassayAccuracy98.9%Clinical Sensitivity94.3%1682Immuno-AntigenYesNoImmunoassay15specimen = Nasal swabCalibrationEvaluatedCrossreactivityEvaluatedPrecisionEvaluatedAccuracy98.7%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95%Clinical Specificity99.2%Type of antigenOther2270COVID-19 Antigen Rapid Test Device1059Assure Tech. (Hangzhou) Co., Ltd.Chinawww.diareagent.comYesCommercialisedNoNoCassetteManualNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabAdenovirusAlpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Bordetella PertussisChlamydia PneumoniaeEpstein-Barr Virus (EBV)Human Metapneumovirus (HMPV)Influenza A H1N1Influenza A H3N2Influenza A H5N1Influenza B VictoriaInfluenza B YamagataMumps Virus (MuV)Parainfluenza Virus Type 1Parainfluenza Virus Type 2Parainfluenza Virus Type 3Respiratory Syncytial V (RSV)Rhinovirus453B.1.1.7United Kingdom806B.1.351South Africa1102B.1.617.1India1103B.1.617.2India1104B.1.617.3India1258P.1Japan/BrazilNone2021-06-25 11:34:13 CET1971Immuno-AntigenYesNoImmunoassayQualitative15LOD502AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0.86%A total of 1036 SARS-CoV-2 negative samples were tested, 9 samples were positive by this test.Fn2.34%A total of 128 SARS-CoV-2 positive samples were tested, 3 samples were negative by this RDT.PrecisionEvaluatedAccuracy99%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.7%Clinical Specificity99.1%Type of antigenNucleoprotein1746COVID-19 Antigen Rapid Test Cassette(Saliva)413Hangzhou Clongene Biotech Co., LtdChinaen.clongene.com/YesCommercialisedNoNoCardCassetteLateral flowNear POC / POCAntigenSaliva2021-05-10 13:04:00 CET1424Immuno-AntigenYesNoImmunoassayQualitative15LOD3470U/mlCalibrationNot EvaluatedCrossreactivityEvaluatedFp3.2AUFn0.4AUPrecisionEvaluatedAccuracy99%ReproducibilityEvaluatedRobustnessNot EvaluatedClinical Sensitivity96.8%Type of antigenNucleoprotein1868COVID-19 Antigen Rapid Test Cassette (Nasopharyngeal Swab)128Hangzhou Biotest Biotech Co., LtdChinaen.biotests.com.cnYesCommercialisedNoNoCassetteNear POC / POCAntigenNasopharyngeal swab2021-05-10 13:18:20 CET1545Immuno-AntigenYesImmunoassayQualitative10LOD0AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0.83%3/363Fn5%2/40PrecisionEvaluatedAccuracy98.8%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95%Clinical Specificity99.2%Type of antigenNucleoprotein1610COVID-19 Antigen Rapid Test Cassette413Hangzhou Clongene Biotech Co., LtdChinaen.clongene.com/YesCommercialisedYesYesCassetteLateral flowNear POC / POCAntigenNasopharyngeal swab2021-07-07 17:10:38 CET1290Immuno-AntigenYesNoImmunoassayQualitativeN.A.15LOD2338TCID50/mlFp0%0 of 64Fn2.71%6 of 221Clinical Sensitivity91.4%Clinical Specificity100%Type of antigennucleocapside protein1467Covid-19 Antigen Rapid Test Cassette682Swedicine ABSwedenwww.swedicine.comYesCommercialisedNoNoCassetteLateral flowNear POC / POCAntigenNasal swab2021-05-10 13:04:00 CET1218Immuno-AntigenYesNoImmunoassayQualitative15LOD5.07AUCalibrationevaluatedCrossreactivityevaluatedPrecisionevaluatedAccuracy98%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity96.4%Type of antigennucleoprotein1451COVID-19 Antigen Rapid Test (Vstrip)676AnTaimmu BioMedTaiwan ROCwww.antaimmu.comYesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swab2021-05-10 13:04:00 CET1203Immuno-AntigenYesNoImmunoassayQualitativeColorimetry10LOD1.571035AUCalibrationevaluatedCrossreactivityevaluatedFp92.31%Positive predictive value: % (95%CI: 62.97%- 98.83%) Fn96.49%Negative predictive value: 96.49% (95%CI: 88.40%-99.00%) PrecisionevaluatedAccuracy95.71%CI95%:: 87.98%-99.11%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity85.71%CI95%: 57.19%- 98.22%Type of antigennucleoprotein2300COVID-19 Antigen Rapid Test (Swab)659CITEST DIAGNOSTICS INCChinawww.citestdiagnostics.comYesCommercialisedNoNoCassetteLateral flowNear POC / POCAntigenNasal swabNasopharyngeal swabAdenovirus 3Adenovirus 7Alpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Influenza A H1N1Influenza A H3N2Influenza BMERS-CoVParainfluenza Virus Type 2Parainfluenza Virus Type 3Respiratory Syncytial V (RSV)20A.23.1United Kingdom72AT.1Russia453B.1.1.7United Kingdom806B.1.351South Africa905B.1.427USA910B.1.429USA999B.1.525Nigeria1000B.1.526USA1001B.1.526.1USA1002B.1.526.2USA1100B.1.616France1102B.1.617.1India1103B.1.617.2India1104B.1.617.3India1108B.1.621Colombia1224C.36Egypt1227C.37Peru1258P.1Japan/Brazil1260P.2Brazil1261P.3The PhilippinesThe COVID-19 Antigen Rapid Test (Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 Nucleocapsid Protein antigens in swab specimens from individuals with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2 Antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.2021-06-25 13:30:33 CET2001Immuno-AntigenYesNoImmunoassayQualitativeSandwichValidity test kit15LOD100AUCalibrationEvaluatedCrossreactivityEvaluatedFp0.036AUNasopharyngeal SwabFp0.071AUNasal SwabFn0.01AUNasopharyngeal SwabFn0.001AUNasal SwabPrecisionEvaluatedAccuracy96.2%Nasal SwabAccuracy98.2%Nasopharyngeal SwabReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.4%Nasopharyngeal SwabClinical Sensitivity92.9%Nasal SwabClinical Specificity99%Nasopharyngeal SwabClinical Specificity99.9%Nasal SwabType of antigenNucleoprotein2159COVID-19 Antigen Rapid Test (Oral Fluid) SELFTESTING1003Hangzhou AllTest Biotech Co., Ltd.Chinawww.alltests.com.cnYesCommercialisedNoNoCassetteLateral flowNear POC / POCAntigenSalivaAdenovirus 3Adenovirus 7Alpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Influenza A H1N1Influenza A H3N2Influenza BMERS-CoVParainfluenza Virus Type 2Parainfluenza Virus Type 3Respiratory Syncytial V (RSV)20A.23.1United Kingdom72AT.1Russia453B.1.1.7United Kingdom806B.1.351South Africa905B.1.427USA910B.1.429USA999B.1.525Nigeria1001B.1.526.1USA1002B.1.526.2USA1100B.1.616France1102B.1.617.1India1103B.1.617.2India1104B.1.617.3India1108B.1.621Colombia1224C.36Egypt1227C.37Peru1258P.1Japan/Brazil1260P.2Brazil1261P.3The PhilippinesThe COVID-19 Antigen Rapid Test (Oral Fluid) is a single-use test kit intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19 in human oral fluid. This test is designed for home use with self-collected oral fluid samples from symptomatic individuals who are suspected of being infected with COVID-19. The COVID-19 Antigen Rapid Test (Oral Fluid) obtain a preliminary results only, the final confirmation should be based on clinical diagnostic results.2021-06-01 14:55:29 CET1860Immuno-AntigenYesNoImmunoassayQualitativeSandwichValidity test kit15LOD100AUCalibrationEvaluatedCrossreactivityEvaluatedFp0.099%Fn0.007%PrecisionEvaluatedAccuracy97%(Antigen）ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90.1%(Antigen）Clinical Specificity99.3%(Antigen）Type of antigenNucleoprotein1947COVID-19 Antigen Rapid Test (Oral Fluid)126Hangzhou AllTest Biotech Co., LtdGermanyhttps://www.goldstandarddiagnostics.com/home/products/covid-19-antigen-rapid-test/YesCommercialisedNoNoCassetteLateral flowNear POC / POCAntigenSalivaThe COVID-19 Antigen Rapid Test (Oral Fluid) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in oral fluid specimens from individuals with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2 nucleocapsid protein antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.2021-05-10 13:18:20 CET1623Immuno-AntigenYesImmunochromatographyQualitative15LOD100AUCalibrationEvaluatedCrossreactivityEvaluatedFp0.007AUFn0.0099AUPrecisionEvaluatedAccuracy97%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90.1%Clinical Specificity99.3%Type of antigenNucleoprotein1949COVID-19 Antigen Rapid Test (Oral Fluid)890Acro Biotech IncUnited Stateswww.acrobiotech.comYesCommercialisedNoNoCassetteLateral flowNear POC / POCAntigenSalivaAdenovirus 3Adenovirus 7Alpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Influenza A H1N1Influenza A H3N2Influenza BMumps Virus (MuV)Parainfluenza Virus Type 2Parainfluenza Virus Type 3Respiratory Syncytial V (RSV)20A.23.1United Kingdom72AT.1Russia453B.1.1.7United Kingdom806B.1.351South Africa905B.1.427USA910B.1.429USA999B.1.525Nigeria1000B.1.526USA1001B.1.526.1USA1002B.1.526.2USA1100B.1.616France1102B.1.617.1India1103B.1.617.2India1104B.1.617.3India1108B.1.621Colombia1224C.36Egypt1227C.37Peru1258P.1Japan/Brazil1260P.2Brazil1261P.3The PhilippinesThe COVID-19 Antigen Rapid Test (Oral Fluid) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in oral fluid specimens from individuals with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2 nucleocapsid protein antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.2021-07-09 10:48:04 CET1625Immuno-AntigenYesNoImmunoassayQualitativeSandwichValidity test kit15LOD100AUCalibrationEvaluatedCrossreactivityEvaluatedFp0.007AUFn0.097AUPrecisionEvaluatedAccuracy96.8%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90.3%Clinical Specificity99.3%Type of antigenNucleoprotein1205COVID-19 Antigen Rapid Test (Latex)44Joinstar Biomedical Technology Co., LtdChinawww.joinstar.cnYesCommercialisedNoNoLateral flowNear POC / POCAntigenOtherSaliva2021-05-10 13:04:00 CET990Immuno-AntigenYesNoImmunoassayQualitative15Fp0%Compared to PCR (n=60) no FP in each of saliva, and sputum.sputum, samplesFn13.33%Compared to PCR (n=60) 5 false negatives in saliva and 3 in sputum1480COVID-19 Antigen Rapid Test (For Reader)659CITEST DIAGNOSTICS INCChinawww.citestdiagnostics.comYesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swab2021-05-10 13:04:00 CET1229Immuno-AntigenYesYesImmunoassayQualitative15LOD0AUCalibrationevaluatedCrossreactivityevaluatedFp0.08%Fn3.6%PrecisionevaluatedAccuracy98%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity96.4%Type of antigennucleoprotein1702COVID-19 Antigen Rapid Test (For Reader)890Acro Biotech IncUnited Stateswww.acrobiotech.comYesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swab2021-05-10 13:18:20 CET1382Immuno-AntigenYesYesImmunoassayQualitative15LOD0AUCalibrationevaluatedCrossreactivityevaluatedFp2.3AUFn1AUPrecisionevaluatedAccuracy98.6%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity97.7%Type of antigennucleoprotein1446COVID-19 Antigen Rapid Test (Colloidal Gold Method)533Hangzhou Singclean Medical Products Co., LtdChinawww.singclean.netYesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swabSaliva2021-05-10 13:04:00 CET1196Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD4AUCalibrationevaluatedCrossreactivityevaluatedFp1.44%98.56Fn0.97%99.03PrecisionevaluatedAccuracy98.84%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity98.56%Type of antigennucleoprotein1257COVID-19 Antigen Rapid Test126Hangzhou AllTest Biotech Co., LtdGermanyhttps://www.goldstandarddiagnostics.com/home/products/covid-19-antigen-rapid-test/YesCommercialisedYesYesCassetteNear POC / POCAntigenNasopharyngeal swab2021-06-18 12:47:01 CET1033Immuno-AntigenYesImmunoassayQualitative151792COVID-19 Antigen Rapid Test503DIAsource ImmunoAssaysBelgiumwww.diasource-diagnostics.com/YesCommercialisedNoNoCardNear POC / POCAntigenNasal swabThis test is recommended by the belgian autohorities (FAMHP)2021-06-09 11:12:22 CET1749Immuno-AntigenYesImmunoassay1198COVID-19 Antigen Rapid Test624Zhejiang Anji Saianfu Biotech Co., LtdChinawww.seinofy.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabOtherSaliva http://www.reopentest.com/ifu2021-05-10 13:04:00 CET984Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD7200AU/mLAccuracy91%Clinical Sensitivity90%Clinical Specificity98%1387COVID-19 Antigen Rapid Test659CITEST DIAGNOSTICS INCChinawww.citestdiagnostics.comYesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swab2021-05-10 13:04:00 CET1153Immuno-AntigenYesNoImmunoassayQualitative15LOD0AUCalibrationNot evaluatedFp0.08%Fn3.6%Accuracy98%Clinical Sensitivity96.4%1596COVID-19 Antigen Rapid Test705Chinawww.lhbiotech.com.cn/YesCommercialisedNoNoNear POC / POCAntigen2021-05-10 13:04:00 CET1277Immuno-AntigenYesImmunoassayQualitative1797COVID-19 Antigen Rapid Test808PRIMA LabSwitzerlandprimahometest.com/en/YesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swabOther2021-05-10 13:04:00 CET1476Immuno-AntigenYesNoImmunochromatographyQualitative15The test can be used both with nasopharyngeal and nasal swab. Functionality confirmed with the most known SARS-CoV-2 Variants including English, Brazilian and South African.LOD100IU/mlFp0Fn0Accuracy98%Clinical Sensitivity96.4%1688COVID-19 Antigen Rapid Test890Acro Biotech IncUnited Stateswww.acrobiotech.comYesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swabOther2021-05-10 13:18:20 CET1367Immuno-AntigenYesNoImmunoassayQualitative15LOD0Calibrationnot evaluatedCrossreactivityevaluatedFp1AUFn2.3AUPrecisionevaluatedAccuracy98.6%(Antigen)ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity97.7%(Antigen)2277COVID-19 Antigen Nasal Test Kit1059Assure Tech. (Hangzhou) Co., Ltd.Chinawww.diareagent.comYesCommercialisedNoNoLateral flowManualNear POC / POCAntigenOtherAdenovirusAdenovirus 3Adenovirus 7Alpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus OC43 (HCoV-OC43)Bordetella PertussisChlamydia PneumoniaeEnterovirus A71 (EV-A71)Epstein-Barr Virus (EBV)Human Metapneumovirus (HMPV)Influenza A H1N1Influenza A H3N2Influenza B VictoriaInfluenza B YamagataParainfluenza Virus Type 1Parainfluenza Virus Type 2Parainfluenza Virus Type 3Parainfluenza Virus Type 4Respiratory Syncytial V (RSV)Respiratory Syncytial V (RSV) Type ARespiratory Syncytial V (RSV) Type BRhinovirus ARhinovirus BSARS-CoVNone2021-06-21 10:25:15 CET1978Immuno-AntigenYesImmunoassay15LOD251AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0%NoneFn5.82%(A total of 103 SARS-CoV-2 positive samples were tested, 6 samples were negative by this RDT)PrecisionEvaluatedAccuracy97.3%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.5%Clinical Specificity100%Type of antigenNucleoprotein1187COVID-19 Antigen Detection Kit (Immunofluorescence Assay)619Zhuhai Lituo Biotechnology Co., LtdChinawww.lituo.com.cnYesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swab http://www.lituo.com.cn/en/showpro.php?id=3272021-05-10 13:04:00 CET971Immuno-AntigenYesYesImmunoassayQualitativeFluorescence15Type of antigennucleoprotein1957COVID-19 Antigen Detection Kit (Colloidal Gold)619Zhuhai Lituo Biotechnology Co., LtdChinawww.lituo.com.cnYesCommercialisedYesYesLateral flowNear POC / POCAntigenNasal swabNasopharyngeal swabAdenovirusAlpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Bordetella PertussisChlamydia PneumoniaeCoronaviruses (HCoV)Enterovirus A71 (EV-A71)Hemophilus InfluenzaeHepatitis B Virus (HBV)Human Metapneumovirus (HMPV)Influenza AInfluenza A H1N1Influenza B YamagataMERS-CoVMycobacterium TuberculosisMycoplasma PneumoniaeParainfluenza Virus Type 1Parainfluenza Virus Type 2Parainfluenza Virus Type 3Parainfluenza Virus Type 4Respiratory Syncytial V (RSV)RhinovirusSARS-CoV20A.23.1United Kingdom453B.1.1.7United Kingdom806B.1.351South Africa999B.1.525Nigeria1102B.1.617.1India1103B.1.617.2India1104B.1.617.3India1258P.1Japan/BrazilUpdated on 12th July 2021. PEI positive evaluation.2021-07-13 18:03:58 CET1633Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich, DoubleColloidal goldValidity test kit10The microbial interference and endogenous interference study are also evaluated. LOD428AUCalibrationEvaluatedCrossreactivityEvaluatedFp0.41%Fn1%PrecisionEvaluatedAccuracy99.42%NP swab: Accuracy98.87%Nasal swab: ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99%NP swab Clinical Sensitivity96.12%Clinical Specificity99.59%NP swab Clinical Specificity100%Type of antigenNucleoprotein1501COVID-19 Antigen Detection Kit690New Gene (Hangzhou) Bioengineering Co., LtdChinawww.new-gene.net/YesCommercialisedYesYesLateral flowNear POC / POCAntigenNasal swab2021-07-07 17:23:34 CET1251Immuno-AntigenYesNoChromatography30LOD0.05AUCalibrationnot evaluatedCrossreactivityevaluatedFp2%Fn0.9%PrecisionevaluatedAccuracy98.3%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity98%Type of antigennucleocapside2242COVID-19 Antigen Detection Kit1042DNA DiagnosticDenmarkhttps://dna-diagnostic.com/YesCommercialisedNoNoCassetteLateral flowNear POC / POCAntigenNasal swabSARS-CoV453B.1.1.7United Kingdom806B.1.351South Africa1258P.1Japan/BrazilNo additional information2021-06-23 13:23:51 CET1943Immuno-AntigenYesNoImmunochromatographyQualitative15LOD160TCID50/mlCalibrationNot evaluatedCrossreactivityEvaluatedFp0.44%1 out of 226 true negatives compared to PCRFn6.25%9 out of 144 true positives compared to PCRPrecisionEvaluatedAccuracy97.3%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity93.8%Clinical Specificity99.6%Type of antigenNucleoprotein1258COVID-19 and Influenza A+B Antigen Combo Rapid Test with Reader126Hangzhou AllTest Biotech Co., LtdGermanyhttps://www.goldstandarddiagnostics.com/home/products/covid-19-antigen-rapid-test/YesCommercialisedNoNoNear POC / POCAntigen2021-05-10 13:04:00 CET1034Immuno-AntigenYesImmunoassay1471COVID-19 and Influenza A+B Antigen Combo Rapid Test Cassette659CITEST DIAGNOSTICS INCChinawww.citestdiagnostics.comYesCommercialisedNoNoNear POC / POCAntigenNasal swab no info in company website2021-05-10 13:04:00 CET1220Immuno-AntigenYesNoImmunoassayQualitative15Rapid diagnostic test lateral flow LOD0AUCalibrationNot evaluatedCrossreactivityevaluatedFp0.08%(0.9% Influenza A); (0.9% Influenza B)Fn3.6%(5.0% Influenza A); (7.1% Influenza B)PrecisionevaluatedAccuracy98%(98.4 Influenza A); (98.1 Influenza B)ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity96.4%(95.0 Influenza A); (92.9 Influenza B)1391COVID-19 and Influenza A+B Antigen Combo Rapid Test (Nasopharyngeal Swab)657Ulti Med Products GmbHGermanywww.ultimed.orgYesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swab2021-05-10 13:04:00 CET1157Immuno-AntigenYesNoImmunoassayQualitative15LOD100AUFp0.82%Fn3.61%Accuracy98%Clinical Sensitivity96.4%Clinical Specificity99.2%1256COVID-19 and Influenza A+B Antigen Combo Rapid Test126Hangzhou AllTest Biotech Co., LtdGermanyhttps://www.goldstandarddiagnostics.com/home/products/covid-19-antigen-rapid-test/YesCommercialisedNoNoNear POC / POCAntigen2021-06-08 15:56:19 CET1032Immuno-AntigenYesImmunoassay1360COVID-19 Ag Test Kit655Guangdong Wesail Biotech Co., LtdChinaen.wesailbio.comYesCommercialisedYesYesLateral flowNear POC / POCAntigenNasal swab2021-07-07 17:21:35 CET1132Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD552AUFp4/500Fn5/500Accuracy98.4%Clinical Sensitivity90%Clinical Specificity98%Type of antigennucleoprotein1689Covid-19 Ag Test 758TurklabTurkeywww.turklab.com.tr/YesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swabOther2021-05-10 13:18:20 CET1368Immuno-AntigenYesNoImmunoassayQualitative20LOD30AU133COVID-19 Ag Respi-Strip73Coris BioConceptBelgiumwww.corisbio.com/YesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swab2021-05-10 13:04:00 CET92Immuno-AntigenYesNoImmunoassayQualitativeColorimetry30LOD5000TCID50/mlLOD0.25ng/mLCalibrationNot ReportedCrossreactivityCross-reactivity: no cross-reactivity for bacteria and virus tested including seasonal Coronaviruses (HKU1, 229E, OC43, NL63), positive for SARS-CoVAccuracy97.9%Clinical Sensitivity91.2%Clinical Specificity99.4%1216COVID-19 Ag Rapid Test Kit (Immuno-Chromatography)569Guangdong Longsee Biomedical Co., LtdChinawww.longseemed.comYesCommercialisedYesYesNear POC / POCAntigenSaliva2021-07-13 17:42:33 CET1001Immuno-AntigenYesImmunochromatographyQualitativeColorimetryRapid diagnostic test Colloidal Gold 2144COVID-19 Ag Rapid Test Device992Jiangsu Well Biotech Co., Ltd.ChinaYesCommercialisedNoNoStripNear POC / POCAntigenNasal swabAlpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Coronaviruses (HCoV)Human Metapneumovirus (HMPV)Parainfluenza Virus Type 1Parainfluenza Virus Type 2Parainfluenza Virus Type 3Parainfluenza Virus Type 4453B.1.1.7United Kingdom806B.1.351South Africa1258P.1Japan/BrazilCOVID-19 Ag Rapid Test Device is a rapid chromatographic immunoassay for the qualitative detection of N antigen to SARS-CoV- 2 present in human nasal swabs. This test is for professional used only, as an aid to early diagnosis of SARS-CoV-2 infection in patient. The result of this test should not be the sole basis for the diagnosis; confirmatory testing is required.2021-06-02 18:18:10 CET1834Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich, Double15LOD1AUCalibrationEvaluatedCrossreactivityEvaluatedFp5.26%Fn1%PrecisionEvaluatedAccuracy97.9%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.74%Clinical Specificity99%Type of antigenNucleoprotein1736COVID-19 (SARS-CoV-2) Antigen Test Kit(Colloidal Gold)24Anhui Deep Blue Medical Technology Co., LtdChinawww.dbluemedical.com/YesCommercialisedYesYesCassetteNear POC / POCAntigenNasal swabOther2021-07-07 17:19:10 CET1415Immuno-AntigenYesNoImmunoassayQualitativeColorimetry20LOD320Calibrationnot evaluatedCrossreactivityevaluatedFp2.27%5 of 220Fn0.9%2 of 220PrecisionevaluatedAccuracy98ReproducibilityevaluatedRobustnessnot evaluatedClinical Sensitivity95.7Type of antigennucleoprotein1815COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold) - Nasal Swab24Anhui Deep Blue Medical Technology Co., LtdChinawww.dbluemedical.com/YesCommercialisedYesYesLateral flowNear POC / POCAntigenAnterior nasal swabNasal swabPlease check attached UK national systematic evaluation report with the detailed data from UK government validation, performed by University of Oxford. Public Health England Porton Down. 132 brands were tested and only 4 suppliers have passed all of the Phase 3B validation, including ANHUI DEEPBLUE MEDICAL. The link of this report: https://www.medrxiv.org/content/10.1101/2021.01.13.21249563v1.full-text Please check attached UK national systematic evaluation report with the detailed data from UK government validation, performed by University of Oxford. Public Health England Porton Down. 132 brands were tested and only 4 suppliers have passed all of the Phase 3B validation, including ANHUI DEEPBLUE MEDICAL. The link of this report: https://www.medrxiv.org/content/10.1101/2021.01.13.21249563v1.full-text And we have attached the MHRA registration certificate. Also the registration in Germany, registration in Italy, registration in Portugal and so on.2021-07-07 17:18:58 CET1493Immuno-AntigenYesNoImmunochromatographyQualitativeColorimetry20LOD320AUCalibrationEvaluatedCrossreactivityEvaluatedFp0.2%Fn3.6%PrecisionEvaluatedAccuracy99.03%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.4%Clinical Specificity99.8%Type of antigenNucleoprotein1589COVID-19 (Sars-CoV-2) Antigen Test Kit (Colloidal Gold)24Anhui Deep Blue Medical Technology Co., LtdChinawww.dbluemedical.com/YesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swabSaliva website not accessible (considered suspicious for the EC) 2021-05-10 13:18:20 CET1269Immuno-AntigenYesNoImmunoassayQualitativeColorimetry20Rapid diagnostic test cassette LOD320AUCalibrationevaluatedCrossreactivityevaluatedFp0Fn3.6PrecisionevaluatedAccuracy99.03%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity96.4%Type of antigennucleoprotein1372455Assure Tech. (Hangzhou) Co., LtdChinawww.diareagent.comYesCommercialisedNoNoNear POC / POCAntigenOther immunochromatography?2021-05-10 13:04:00 CET1146Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15Rapid diagnostic test colloidal gold LOD0AUAccuracy87.8%(COVID-19:87.8%; M. pneumoniae:96.6%)Clinical Sensitivity75.8%(COVID-19:75.8%, M. pneumoniae:91.4%)1371455Assure Tech. (Hangzhou) Co., LtdChinawww.diareagent.comYesCommercialisedNoNoNear POC / POCAntigenOther immunochromatography?2021-05-10 13:04:00 CET1144Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15Rapid diagnostic test colloidal gold FpNot availableFnNot availableAccuracy98.5%(COVID-19:98.5%, Influenza A:88.4%, Influenza B:88.9%)Clinical Sensitivity97.3%(COVID-19:97.3%, Influenza A:83.3%, Influenza B:82.4%)1354851Nantong Diagnos Biotechnology Co., LtdChinawww.diagnosbio.comYesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swabNasopharyngeal swabThroat swab2021-05-10 13:18:20 CET1128Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15Accuracy: 97.60% Influenza. Clinical sensitivity 96.67% InfluenzaLOD0.05%Accuracy96%Clinical Sensitivity92.59%Type of antigennucleoprotein1313CovBELD647EMBIO Diagnostics LTDCypruswww.embiodiagnostics.euYesCommercialisedNoNoNear POC / POCAntigenNasal swabSaliva2021-05-10 13:04:00 CET1083Immuno-AntigenYesYesImmunoassayQualitative3LOD4000U/mlCalibrationEvaluatedCrossreactivityNot EvaluatedFp2.2%3 on 136Fn7.27%8 of 110PrecisionEvaluatedAccuracy95.52%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.73%Type of antigennucleoprotein1196CoV-Check DIRECT Covid-19 Antigen Test623Spark Diagnostics LLCIndiawww.sparkdiagnostics.comYesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swab2021-05-10 13:04:00 CET981Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD380AUFp0.9%Fn8.6%Accuracy95.7%Clinical Sensitivity93.1%1343Coronavirus Ag Rapid Test Cassette (Swab)760Zhezhiang Orient Gene Biotech Co., LtdChinawww.orientgene.com/YesCommercialisedYesYesCassetteLateral flowManualNear POC / POCAntigenNasal swabNasopharyngeal swab2021-05-10 13:18:20 CET1124Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD115AUCalibrationNot evaluatedCrossreactivityEvaluatedFp2.5%2/120Fn0.27%2/745PrecisionEvaluatedAccuracy99.42%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.32%Clinical Specificity99.6%Type of antigennucleoprotein1831Coronavirus Ag Rapid Test Cassette (Swab)836Van Oostveen Medical B.V.Netherlandswww.romed.nl/enYesCommercialisedNoNoCassetteManualNear POC / POCAntigenNasal swabNasopharyngeal swab2021-05-10 13:04:00 CET1509Immuno-AntigenYesNoImmunochromatographyQualitativeColorimetry15LOD115AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0.34%3 false positives / 874 true negative (sum of nasopharyngeal and nasal swab samples)Fn2.19%5 false negatives / 228 true positive (sum of nasopharyngeal and nasal swab samples)PrecisionEvaluatedAccuracy99.42%99.42 (antigen-nasopharyngeal), 98.73 (antigen-nasal)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.32%98.32 (antigen-nasopharyngeal), 97.25 (antigen-nasal)Clinical Specificity99.6%99.60 (antigen-nasopharyngeal), 100 (antigen-nasal)Type of antigenNucleoprotein2154Coronavirus Ag Rapid Test Cassette (Swab)999Shandong ThinkLab Biotechnology Co.,Ltd.ChinaYesCommercialisedNoNoCardCassetteNear POC / POCAntigenNasopharyngeal swabAdenovirus 3Adenovirus 7Adenovirus Subtype CCoronaviruses (HCoV)Influenza A H1N1Influenza BMERS-CoVMumps Virus (MuV)Mycoplasma PneumoniaeParainfluenza Virus Type 1Parainfluenza Virus Type 2Parainfluenza Virus Type 3Respiratory Syncytial V (RSV)Respiratory Syncytial V (RSV) Type ARespiratory Syncytial V (RSV) Type BRhinovirus ARhinovirus BSARS-CoVVaricella Zoster Virus (VZV)453B.1.1.7United Kingdom806B.1.351South Africa1258P.1Japan/BrazilThe coronavirus AG rapid detection box (swab) is an in vitro immunochromatographic test for qualitative detection of the SARS-CoV-2 nuclear capsimal hemoglobin antigen in nasopharyngeal and nasal swab samples directly or to the viral transport medium of individuals whose health care providers suspect carrying COVID-19.2021-06-01 13:11:23 CET1855Immuno-AntigenYesNoImmunochromatographyQualitativeMembrane-based15LOD0AUCalibrationEvaluatedCrossreactivityEvaluatedFp5.8%Fn1.7%PrecisionEvaluatedAccuracy96.2%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.2%Clinical Specificity98.3%Type of antigenNucleoprotein1767Coronavirus Ag Rapid Test Cassette554Healgen ScientificUnited Stateswww.healgen.comYesCommercialisedYesYesCassetteNear POC / POCAntigenNasopharyngeal swab2021-05-10 13:18:20 CET1446Immuno-AntigenYesNoImmunochromatographyQualitative15Clinical Sensitivity80.6%C.I. 95, range: 72.7-86.6Clinical Specificity99.7%C.I. 95, range: 98.9-99.976Coronavirus (SARS-Cov-2) N protein Detection Kit (Fluorescence immunochromatography)414Beijing Savant Biotechnology Co., LtdChinawww.huaketai.com/YesCommercialisedNoNoCassetteAutomatedManualAntigenThroat swab2021-05-10 13:04:00 CET569Immuno-AntigenYesYesImmunochromatographyQualitativeFluorescence15LOD50ng/mLCrossreactivityEvaluated1935Coronavirus (SARS-CoV 2) Antigen - Swab Specimen885Tody Laboratories Int.Romaniawww.todylaboratories.com/YesCommercialisedNoNoCassetteManualAntigenNasal swabNasopharyngeal swab99.9% Accuracy: 96.2% False positives (nasal swab specimen): From studies performed by manufacturer, the false positive rate is <0.1% (specificity = >99.9%) False negatives (nasal swab specimen): From studies performed by manufacturer, the false negative rate is 7.1% (sensitivity = 92.9%)]]>2021-05-10 13:04:00 CET1611Immuno-AntigenYesNoImmunochromatographyQualitativeMembrane-basedN.A.15LOD100AUCalibrationEvaluatedCrossreactivityEvaluatedFp1%From studies performed by manufacturer, the false positive rate is 1.0% (specificity = 99.0%)Fn3.6%From studies performed by manufacturer, the false negative rate is 3.6% (sensitivity = 96.4%)PrecisionEvaluatedAccuracy98.2%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.4%Clinical Specificity99%Type of antigenNucleocapsid (N) protein1934Coronavirus (SARS-CoV 2) Antigen - Oral Fluid885Tody Laboratories Int.Romaniawww.todylaboratories.com/YesCommercialisedNoNoCassetteManualAntigenDeep (cough) sputumSalivaSputumMinimum detection limit = 100 pg/ml2021-07-13 18:06:56 CET1610Immuno-AntigenYesNoImmunochromatographyQualitativeMembrane-based15LOD100AUCalibrationEvaluatedCrossreactivityEvaluatedFpFrom studies performed by manufacturer, the false positive rate is 0.7% (specificity = 99.3%)FnFrom studies performed by manufacturer, the false negative rate is 9.9% (sensitivity = 90.1%)PrecisionEvaluatedAccuracy97%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90.1%Clinical Specificity99.3%Type of antigenNucleoprotein1662CORONA-Ag529DyonMed SAGreecedyonmedical.com/en/home/YesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swabOtherSaliva2021-05-10 13:04:00 CET1341Immuno-AntigenYesNoImmunoassayQualitative15LOD0AUCalibrationevaluatedCrossreactivityevaluatedFp0%Compared to PCR (n=60) no FP in each of saliva, and sputum.sputum, samplesFn8.3%Compared to PCR (n=60) 5 false negatives in saliva and 3 in sputumPrecisionevaluatedAccuracy97%AntigenReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity95%AntigenType of antigennucleoprotein1810CORMAY RAPID SARS-CoV-2 ANTIGEN TEST KIT579CORMAYPolandcormay.pl/index.php?lang=_enYesCommercialisedNoNoCassetteManualAntigenNasopharyngeal swabOropharyngeal swabFully functional kit contains: cassettes, swabs, extraction buffers, extraction tubes, nozzles with filters and clear IFU.2021-05-10 13:04:00 CET1489Immuno-AntigenYesNoImmunochromatographyQualitativeCapture15LOD1.25AUCalibrationEvaluatedCrossreactivityEvaluatedFp-Fn-PrecisionEvaluatedAccuracy96%ReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity95%Clinical Specificity98%1919Coretests COVID-19 Ag Test420Core Technology Co., LtdChinawww.coretests.comYesCommercialisedYesYesCassetteNear POC / POCAntigenNasopharyngeal swabCOVID-19 Ag Test is the chromatographic immunoassay test used for qualitative detection of the COVID-19 antigen in human nasopharyngeal swab specimens. This test kit uses COVID-19 monoclonal antibody and goat anti-mouse IgG polyclonal antibodies that are respectively immobilized on a nitrocellulose membrane. It uses colloidal gold to label sufficient COVID-19 monoclonal antibody. Using nano-colloidal gold technology and applying highly specific antibody-antigen reaction and immunochromatographic analysis technology principle. When testing, the novel coronavirus antigen in the sample combined with the colloidal gold-labeled COVID-19 monoclonal antibody to form a complex, which was then combined with the COVID-19 monoclonal antibody coated in the T line during chromatography, at this time there is one red line in the T area .When the samples do not contain novel coronavirus antigen, colloidal gold-labeled COVID-19 monoclonal antibody cannot combined with COVID-19 monoclonal antibody in the T line region, so there is no red colored line in the T area .Regardless of the presence of novel coronavirus antigen in the sample, a red line will form in the quality control area (C). The red line appears in the quality control area (C) serves as: 1.verification that sufficient volume is added. 2.that proper flow is obtained 3. and as a control for the reagents.2021-05-10 20:12:51 CET1595Immuno-AntigenYesNoImmunoassayQualitativeSandwich15LOD22.5AUCalibrationEvaluatedCrossreactivityEvaluatedFp0.4%Fn1.9%PrecisionEvaluatedAccuracy99.2%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.1%Clinical Specificity99.6%Type of antigenNucleoprotein1781CORA-CHECK-19-comfort777fameditec GmbHGermanyhttps://www.fameditec.de/YesCommercialisedNoNoCassetteManualNear POC / POCAntigenSalivaSARS-CoV20A.23.1United Kingdom72AT.1Russia453B.1.1.7United Kingdom806B.1.351South Africa905B.1.427USA910B.1.429USA999B.1.525Nigeria1000B.1.526USA1001B.1.526.1USA1002B.1.526.2USA1100B.1.616France1102B.1.617.1India1103B.1.617.2India1104B.1.617.3India1108B.1.621Colombia1224C.36Egypt1227C.37Peru1258P.1Japan/Brazil1260P.2Brazil1261P.3The PhilippinesAll study results can be provided upon request.2021-06-11 17:42:20 CET1460Immuno-AntigenYesNoImmunoassayQualitativeMembrane-basedColorimetryOther15LOD250AUCalibrationEvaluatedCrossreactivityEvaluatedFp0.95% (further results can be provided upon request)Fn3.3% (further results can be provided upon request)PrecisionEvaluatedAccuracy97.76%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.3%Clinical Specificity99.13%Type of antigenNucleoprotein1744CORA CHECK-19777fameditec GmbHGermanyhttps://www.fameditec.de/YesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swab2021-05-10 13:04:00 CET1422Immuno-AntigenYesNoImmunochromatographyQualitativeColorimetry15LOD1.25U/mlCalibrationEvaluatedFp209AUFn450AUPrecisionEvaluatedAccuracy98.79%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.17%1218CLINITEST Rapid Covid-19 Antigen Test444Siemens HealthineersGermanywww.siemens-healthineers.comYesCommercialisedYesYesCassetteNear POC / POCAntigenNasal swabNasopharyngeal swab2021-05-10 13:04:00 CET1002Immuno-AntigenYesNoImmunochromatographyQualitative15Fp0.23%2 out of 865Fn0%0Accuracy98.74%Clinical Sensitivity97.25%Nasal SwabClinical Sensitivity98.32%Nasopharyngeal swabClinical Specificity100%Nasal SwabType of antigenS1, S1-RBD, S2, N proteins1691CHIL COVID-19 Antigen Rapid Test (Nasopharyngeal / Oropharyngeal Swab-Casette)589CHIL Medical Supplies LtdTurkeyhttps://www.chil.com.tr/YesCommercialisedNoNoCassetteNear POC / POCAntigenNasopharyngeal swabOropharyngeal swabSARS-CoVThe CHIL® COVID-19 antigen rapid test is an immunochromatographic in-vitro test for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct nasopharyngeal and oropharyngeal swabs directly from people. This instruction for use (IFU) must be read and followed carefully prior to use. The reliability of assay results cannot be guaranteed in case of any discrepancies from the instructions for use. This product is intended exclusively for professional use in the laboratory and at the point of care.2021-07-12 16:36:06 CET1370Immuno-AntigenYesNoImmunoassayQualitativeSandwichOther15LOD30%CalibrationevaluatedCrossreactivityevaluatedFp0.49%2 False Positives out of 405Fn0.85%4 False Negatives out of 466PrecisionevaluatedAccuracy99.54%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity99.01%Clinical Specificity99.57%Type of antigennucleoprotein1173CerTest SARS-CoV-2 Card test737CerTest BiotecSpainwww.certest.esYesCommercialisedYesYesCassetteNear POC / POCAntigenNasopharyngeal swab2021-05-10 13:18:20 CET957Immuno-AntigenYesNoImmunoassayQualitativeMagnetic Electrochemical10LOD1000TCID50/mlLOD1ng/mLCrossreactivity0AUClinical Sensitivity92.9%Clinical Specificity99.6%1199CAT610Oncosem Onkolojik Sistemler San. ve Tic. A.S.Turkeywww.oncosem.comYesCommercialisedYesYesLateral flowNear POC / POCAntigenNasal swab https://oncosem.com/cat/2021-07-07 17:23:41 CET985Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD0.01AUFp6.25%out of 32 confirmed positive people 2 of them were diagnosed as negative 30 of them succesfulFn1.96%out of 204 confirmed negative people 4 of them were diagnesed as positive 200 of them succesfulAccuracy97.46%Clinical Sensitivity93.75%Clinical Specificity98.04%1988Biozek covid-19 Antigen Rapidtest BCOV-502910Inzek International tradingNetherlandswww.inzek.nl/YesCommercialisedNoNoCassetteLateral flowManualAntigenNasal swabNasopharyngeal swabFor more information Check IFU. Sales organisation Mach-E BV The Netherlands2021-05-10 13:04:00 CET1664Immuno-AntigenYesNoImmunochromatographyQualitative10LOD100AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0.34(2 / 589)Fn5%(5 / 100)PrecisionEvaluatedAccuracy98.98%ReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity95%Clinical Specificity99.66%Type of antigennucleocapsid protein 2013biotical SARS-CoV-2 Ag Card925Biotical Health S.L.U.Spainhttps://biotical.es/es/YesCommercialisedNoNoCardLateral flowManualNear POC / POCAntigenNasopharyngeal swab2021-05-18 17:53:36 CET1691Immuno-AntigenYesNoImmunochromatographyQualitative10LOD1000TCID50/mlLOD1ng/mLCalibrationNot evaluatedCrossreactivityEvaluatedFp0%Fn3%PrecisionEvaluatedAccuracy99%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96%Clinical Specificity99%Type of antigenNucleoprotein1494BIOSYNEX COVID-19 Ag+ BSS651BIOSYNEX S.A.Francewww.biosynex.comYesCommercialisedYesYesLateral flowNear POC / POCAntigenOther2021-07-07 17:08:11 CET1244Immuno-AntigenYesNoImmunoassayQualitative10LOD750AUCalibrationnot evaluatedCrossreactivityevaluatedFp0%Clinical data: 0 false positive result out of 583 negative samples confirmed by RT-PCRFn2.53%Clinical data: 2 false negative results out of 79 positive samples confirmed by RT-PCRPrecisionevaluatedAccuracy99.7%95%CI: 98.9-100%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity97.5%95%CI: 91.1-99.7%Type of antigennucleoprotein1223BIOSYNEX COVID-19 Ag BSS651BIOSYNEX S.A.Francewww.biosynex.comYesCommercialisedYesYesCassetteNear POC / POCAntigenOther2021-05-10 13:18:20 CET1007Immuno-AntigenYesNoImmunochromatographyQualitativeColorimetry15Type of antigennucleocapsid protein 2379BioSpeedia COVID19 Non-Invasive Antigen Test_BSD-5041024BioSpeedia InternationalSwitzerlandwww.biospeedia.comYesCommercialisedNoNoCassetteManualNear POC / POCAntigenNasal swabThroat swabSARS-CoV20A.23.1United Kingdom72AT.1Russia453B.1.1.7United Kingdom806B.1.351South Africa905B.1.427USA910B.1.429USA999B.1.525Nigeria1000B.1.526USA1001B.1.526.1USA1100B.1.616France1102B.1.617.1India1103B.1.617.2India1104B.1.617.3India1108B.1.621Colombia1224C.36Egypt1227C.37Peru1258P.1Japan/Brazil1260P.2Brazil1261P.3The Philippines.2021-07-09 09:37:58 CET2081Immuno-AntigenYesNoImmunochromatographyQualitativeMembrane-basedSample collection device15LOD4510.6851AUCalibrationNot evaluatedCrossreactivityEvaluatedFp5.26%Fn0.5%PrecisionEvaluatedAccuracy98.3%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95%Clinical Specificity99%Type of antigenNucleoprotein1599Biomerica COVID-19 Antigen Rapid Test (nasopharyngeal swab)708Biomerica, Inc.United Statesbiomerica.com/index.aspYesCommercialisedYesYesNear POC / POCAntigenNasal swabNasopharyngeal swab data available upon request 2021-07-07 17:10:27 CET1280Immuno-AntigenYesNoImmunoassayQualitative15Rapid diagnostic test lateral flow LOD0.0001AUCalibrationevaluatedCrossreactivityevaluatedFp1AUFn8AUPrecisionevaluatedAccuracy98%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity94.7%Type of antigennucleoprotein689Bioeasy 2019-Novel Coronavirus (2019-nCoV) Ag GICA Rapid Test393Shenzhen Bioeasy Biotechnology Co., LtdChinaen.bioeasy.com.tr/YesCommercialisedNoNoCassetteNear POC / POCAntigenWhole blood2021-05-10 13:04:00 CET541Immuno-AntigenYesNoImmunoassayQualitativeColorimetry10365Bioeasy 2019-nCoV Ag Fluorescence Rapid Test Kit (Time-Resolved Fluorescence)393Shenzhen Bioeasy Biotechnology Co., LtdChinaen.bioeasy.com.tr/YesCommercialisedNoNoCassetteNear POC / POCAntigenDeep (cough) sputumNasal swabSaliva2021-05-10 13:04:00 CET681Immuno-AntigenYesYesImmunoassayQualitativeFluorescenceSample preparation101606BIOCREDIT COVID-19 Ag - SARS-CoV 2 Antigen test220RapiGEN IncSouth Korearapigen-inc.comYesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swab2021-07-13 17:19:06 CET1287Immuno-AntigenYesNoImmunoassayQualitative10Clinical Sensitivity90.2%Clinical Specificity100%335BIOCREDIT COVID-19 Ag480BioVendorCzechiawww.biovendor.com/YesCommercialisedNoNoCassetteNear POC / POCAntigenNasopharyngeal swab2021-05-10 13:04:00 CET665Immuno-AntigenYesNoImmunoassayQualitativeColorimetry8Clinical Sensitivity90.2%Clinical Specificity100%1687biocomma®COVID-19 Antigen Test Kit757Biocomma limitedChinawww.biocomma.comYesCommercialisedNoNoNear POC / POCAntigenNasal swab2021-05-10 13:04:00 CET1366Immuno-AntigenYesYesChromatographyQualitative15LOD312.5AUCalibrationEvaluatedCrossreactivityEvaluatedFp0.55%Fn17.9%PrecisionEvaluatedAccuracy97.13%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity82.14%Type of antigennucleoprotein1065BD Veritor™ System for Rapid Detection of SARS CoV 242Becton DickinsonUnited Stateshttps://www.bd.com/en-usYesCommercialisedYesYesCartridgeLateral flowNear POC / POCAntigenNasal swab2021-07-07 17:13:00 CET49Immuno-AntigenYesYesImmunochromatographyQualitativeMagnetic Electrochemical15LOD140TCID50/mlCrossreactivityEvaluatedPrecisionEvaluatedAccuracy98.1%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity91.1%Clinical Specificity99.6%Type of antigenNucleoproteinType of antigenNucleoprotein1761Asan Easy Test Flu/COVID-19 Ag Combo741Asan Pharmaceutical CO., LTDSouth Koreawww.asanpharm.comYesCommercialisedNoNoCassetteManualAntigenNasal swab2021-05-10 13:04:00 CET1440Immuno-AntigenYesNoImmunochromatographyQualitativeColorimetry15LOD1230U/mlCalibrationNot evaluatedCrossreactivityEvaluatedReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity94.7%Clinical Specificity97.4%1654Asan Easy Test COVID-19 Ag741Asan Pharmaceutical CO., LTDSouth Koreawww.asanpharm.comYesCommercialisedYesYesCassetteLateral flowNear POC / POCAntigenNasal swab2021-07-07 17:19:48 CET1733Immuno-AntigenYesImmunoassay1618Artron COVID-19 Antigen Test721Artron Laboratories IncCanadahttp://www.artronlab.com/YesCommercialisedYesYesCassetteNear POC / POCAntigenNasal swabNasopharyngeal swabThe unit of LoD is TCID50/mL2021-07-13 17:53:59 CET1298Immuno-AntigenYesNoImmunochromatographyQualitative15Rapid diagnostic test cassette LOD1000AUCrossreactivityEvaluatedCrossreactivityEvaluatedPrecisionEvaluatedPrecisionEvaluatedAccuracy99.67% (Nasal), Accuracy98.25%(Nasopharyngeal)ReproducibilityEvaluatedRobustnessEvaluatedRobustnessEvaluatedClinical Sensitivity96.67% (Nasal)Clinical Sensitivity91.67% (Nasopharyngeal)Clinical Specificity100%(Nasal, Nasopharyngeal)Type of antigennucleoproteinType of antigenNucleoprotein1594Antigen Rapid Test COVID-19 Coretests420Core Technology Co., LtdChinawww.coretests.comYesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swab2021-05-10 13:04:00 CET1274Immuno-AntigenYesNoImmunoassayQualitative151608ANTIGEN RAPID TEST CASSETTE SARS-COV-2 (SWAB)713A. Menarini DiagnosticsItalywww.menarinidiagnostics.comYesCommercialisedNoNoCassetteNear POC / POCAntigenNasopharyngeal swab2021-05-10 13:04:00 CET1288Immuno-AntigenYesNoImmunoassayQualitative15Accuracy98.74%95%CI: 96.80%-99.66%Clinical Sensitivity96.72%95%CI: 88.65%-99.60%Clinical Specificity99.22%95%CI: 97.21%-99.91%Type of antigennucleocapside protein1592Antigen Rapid Test Ag SARS-CoV-2703Lifotronic Technology Co, LtdChinaen.lifotronic.com/YesCommercialisedNoNoNear POC / POCAntigen2021-05-10 13:04:00 CET1272Immuno-AntigenYesImmunoassayQualitative10Clinical Sensitivity91%Clinical Specificity98%1843AndLucky SARS-CoV-2 Antigen SPUTUM Rapid Test Kit (non-invasive)624Zhejiang Anji Saianfu Biotech Co., LtdChinawww.seinofy.comYesCommercialisedNoNoManualAntigenOropharyngeal swabSputumThroat secretionThroat swabBfArM Listed, PEI Evaluated2021-05-10 13:18:20 CET1520Immuno-AntigenYesNoImmunochromatographyQualitative10LOD6AUCalibrationEvaluatedCrossreactivityEvaluatedFp6.5%93,5Fn0.6%99,40PrecisionEvaluatedAccuracy97%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93%Clinical Specificity99%Type of antigenNucleoprotein1296AndLucky COVID-19 Antigen Rapid Test624Zhejiang Anji Saianfu Biotech Co., LtdChinawww.seinofy.comYesCommercialisedYesYesCassetteNear POC / POCAntigenNasal swabSaliva2021-07-07 17:26:23 CET1102Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD5.75AUFp95.8AUFn99AUAccuracy97.9%AntigenClinical Sensitivity95.8%AntigenType of antigennucleoprotein1304AMP Rapid Test SARS-CoV-2 Ag531AMEDA Labordiagnostik GmbHAustriawww.amp-med.com/YesCommercialisedYesYesCassetteNear POC / POCAntigenNasal swabNasopharyngeal swab2021-06-25 12:29:39 CET1076Immuno-AntigenYesImmunochromatographyQualitative15CrossreactivityEvaluatedPrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessEvaluatedRobustnessEvaluatedClinical Sensitivity97.3%Type of antigenNucleoproteinType of antigenNucleoprotein1647AllCheck COVID19 Ag738CALTH Inc.South Koreawww.thecalth.comYesCommercialisedNoNoCartridgeNear POC / POCAntigenNasopharyngeal swab2021-05-10 13:04:00 CET1328Immuno-AntigenYesNoImmunoassayQualitative10LOD250TCID50/mlPositive control40AUNegative control60AUAnalytical Sensitivity97.5%Analitical Specificity100%Clinical Sensitivity97.12%Clinical Specificity93.98%Throughputsingle cartridges1989AFIAS COVID-19 Ag22Boditech Med IncSouth Koreahttps://www.boditech.co.kr/enYesCommercialisedNoNoCassetteLateral flowNear POC / POCSemi-automatedAntigenNasopharyngeal swabSARS-CoV2021-06-21 10:28:57 CET1665Immuno-AntigenYesYesImmunochromatographySemiquantitativeSandwichOther12LOD35.15AUCalibrationEvaluatedCrossreactivityEvaluatedFp3AUFn11AUPrecisionEvaluatedAccuracy95.5%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity91.7%Clinical Specificity98.7%Type of antigenNucleoprotein1243ActivXpress+ COVID-19 Antigen Complete Testing Kit88Edinburgh Genetics LimitedUnited Kingdomeggenetics.comYesCommercialisedYesYesCassetteNear POC / POCAntigenNasopharyngeal swabOropharyngeal swab2021-07-13 17:50:37 CET1024Immuno-AntigenYesNoImmunochromatographyQualitative15LOD35ng/mLClinical Sensitivity94.7%Clinical Specificity100%1981Absoludy COVID-19 Ag Rapid909Absology Co., Ltd.South Koreawww.absology.co.krYesCommercialisedNoNoCardLateral flowManualNear POC / POCAntigenNasopharyngeal swabOropharyngeal swabSARS-CoVAbsoludy COVID-19 Ag Rapid is based on immunochromatography for the qualitative determination of SARS-CoV-2 virus specific antigens in human Nasopharyngeal and Oropharyngeal swab specimen.2021-07-16 09:57:22 CET1657Immuno-AntigenYesNoImmunochromatographyQualitativeMembrane-based15LOD125AUCalibrationEvaluatedCrossreactivityEvaluatedFp0%Fn12%(12/100)PrecisionEvaluatedAccuracy95.8%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity88%(100/100)Clinical Specificity100%(184/184)Type of antigenNucleoprotein18092019-nCoV/IAV/IBV Antigen Test Kit (colloidal gold method)779Guangdong Hecin Scientific, Inc.Chinawww.hecin-scientific.cn/YesCommercialisedNoNoCassetteNear POC / POCAntigen2021-05-10 13:04:00 CET1487Immuno-AntigenYesImmunoassayQualitativeColorimetry15LOD1AUCalibrationEvaluatedCrossreactivityEvaluatedFp2AUFn2AUPrecisionEvaluatedAccuracy98.51%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.23%Clinical Specificity99.07%Type of antigennucleoprotein17472019-nCoV Antigen Test Kit (colloidal gold method)779Guangdong Hecin Scientific, Inc.Chinawww.hecin-scientific.cn/YesCommercialisedYesYesCardNear POC / POCAntigenNasopharyngeal swab2021-07-07 17:21:29 CET1425Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD175TCID50/mlCrossreactivityEvaluatedFp2AUFn2AUPrecisionEvaluatedAccuracy98.51%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.23%Type of antigenNucleoprotein16742019-nCoV Antigen Test Kit750Chinawww.MDfastcheck.comYesCommercialisedNoNoCassetteLab-basedAntigenNasal swab2021-05-10 13:04:00 CET1353Immuno-AntigenYesYesImmunoassayQualitativeColorimetry15LOD0.05AUCalibrationEvaluatedCrossreactivityEvaluatedPrecisionEvaluatedAccuracy99.26%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.83%Type of antigenNucleoprotein17902019-nCoV Antigen Rapid Test Kit (Colloidal Gold Immunochromatography)319Beijing Lepu Medical Technology Co., LtdChinaen.lepumedical.com/YesCommercialisedNoNoCardOtherAntigenNasal swabOther2021-05-10 13:04:00 CET1469Immuno-AntigenYesNoImmunochromatographyQualitativeColorimetry15LOD200IU/mlCalibrationNot evaluatedCrossreactivityEvaluatedFp0.38%Fn4.94%PrecisionEvaluatedPrecisionEvaluatedAccuracy97.44%ReproducibilityEvaluatedRobustnessNot EvaluatedClinical Sensitivity95.06%Type of antigenNucleoprotein12832019-nCoV Antigen Rapid Test Kit (colloidal gold assay)38Beijing Diagreat Biotechnologies Co., LtdChinawww.diagreat.com/YesCommercialisedNoNoNear POC / POCAntigenNasal swab2021-05-10 13:04:00 CET1093Immuno-AntigenYesImmunoassayQualitativeColorimetry15Type of antigenN protein12732019-nCoV Antigen Rapid Test (Colloidal Gold)262Sure Bio-Tech (USA) Co., LtdUnited Stateswww.surebiotech.com/YesCommercialisedNoNoNear POC / POCAntigenNasal swabThroat swab2021-05-10 13:04:00 CET1047Immuno-AntigenYesImmunoassayQualitativeColorimetry15Clinical Sensitivity92.5%Clinical Specificity99.16%12032019-nCoV Antigen Device561AMS UK (NI) LtdUnited Kingdomhttps://www.amslabs.co.uk/YesCommercialisedNoNoNear POC / POCAntigenNasal swabSaliva2021-05-10 13:04:00 CET989Immuno-AntigenYesNoImmunochromatographyQualitative15Rapid diagnostic test Lateral flow Fp0.9%Fn9.1%Accuracy97.5%Clinical Sensitivity90.9%12022019-nCoV Antigen Device575Prestige DiagnosticsUnited Kingdomwww.prestigediagnostics.co.ukYesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swabSaliva2021-05-10 13:04:00 CET988Immuno-AntigenYesNoImmunoassayQualitative15Fp0.9%Fn9.1%Accuracy97.5%Clinical Sensitivity90.9%17482019-nCoV Ag Rapid Test Kit - REF: CY-F006-AG25780Huachenyang (Shenzhen) Technology Co., Ltd.Chinawww.chenyanglobal.comYesCommercialisedNoNoCassetteOtherAntigenNasal swabNasopharyngeal swabSaliva2021-05-10 13:04:00 CET1426Immuno-AntigenYesNoImmunochromatographyQualitative15LOD50U/mlCrossreactivityEvaluatedFp6.6%4 false positives out of 61 testsFn0.22%1 false negatives out of 449 testsPrecisionEvaluatedAccuracy99.02%ReproducibilityEvaluatedRobustnessNot EvaluatedClinical Sensitivity96.67%Type of antigenNucleoprotein