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 antigenNucleoprotein1232Panbio Covid-19 Ag Rapid Test628Abbott Rapid DiagnosticsSwitzerlandYesYesYesCassetteLateral flowManualNear POC / POCAntigenNasal swabNasopharyngeal swabSARS-CoVTest was done in a pharmacy2021-07-23 09:42:00 CET1015Immuno-AntigenYesNoOtherQualitative15LOD0CalibrationEvaluatedCrossreactivityEvaluatedFp0FnJaPrecisionEvaluatedAccuracy100%ReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity98%Clinical Specificity99%Type of antigenOther1457Flowflex SARS-CoV-2 Antigen Rapid Test565Acon Biotech (Hangzhou) Co., LtdChinahttps://www.aconbio.com/YesCommercialisedYesYesCassetteLateral flowLab-basedNear POC / POCAntigenNasal swabNasopharyngeal swabSARS-CoV20A.23.1United Kingdom72AT.1Russia453B.1.1.7United Kingdom806B.1.351South Africa905B.1.427USA910B.1.429USA999B.1.525Nigeria1000B.1.526USA1100B.1.616France1102B.1.617.1India1103B.1.617.2India1104B.1.617.3India1108B.1.621Colombia1227C.37Peru1258P.1Japan/Brazil1260P.2Brazil1261P.3The PhilippinesN/A2021-10-04 08:46:09 CET1209Immuno-AntigenYesNoImmunochromatographyQualitativeMembrane-based15LOD160TCID50/mlCalibrationNot evaluatedCrossreactivityEvaluatedFp0.45%2 out of 435 (Nasal Swab)Fp0.56%1 out of 176 (Nasopharyngeal Swab)Fn2.94%5 out of 170 (Nasal Swab)Fn2.43%3 out of 123 (Nasopharyngeal Swab)PrecisionEvaluatedAccuracy98.7%Nasopharyngeal SwabAccuracy98.8%Nasal SwabReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.1%Nasal SwabClinical Sensitivity97.6%Nasopharyngeal SwabClinical Specificity99.5%Nasal SwabClinical Specificity99.4% Nasopharyngeal SwabType of antigenNucleocapsid protein1468Flowflex 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 antigennucleoprotein2108AESKU.RAPID SARS-CoV-2976Germanywww.aesku.comYesCommercialisedYesYesLateral flowNear POC / POCAntigenNasal swabThroat swabSARS-CoV453B.1.1.7United KingdomIntended use: The AESKU.RAPID SARS-CoV-2 rapid test is an immunochromatographic sandwich method with two specific antibodies for the qualitative detection of the N-protein antigen in human nasal swab samples. The point-of- care test is designed to detect SARS-CoV-2 N-protein antigens detectable during the acute phase of infection. The test should be performed by healthcare professionals familiar with in vitro diagnostic methods and appropriate infection control procedures. Test principle: The AESKU.RAPID SARS-CoV-2 rapid test is based on immunochromatographic polymer technology combined with the sandwich principle for the qualitative detection of the nucleocapsid protein antigen in human nasal swab samples. The sample is mixed with colored polymer-labeled SARS-CoV-2 monoclonal antibody 1 in the test device's sample well and chromatographed along the nitrocellulose membrane. If SARS-CoV-2 antigens are present in the sample, they will bind to SARS-CoV-2 antibody 1, and the mixture will bind to immobilized SARS-CoV-2 antibody 2 on the nitrocellulose membrane. The resulting complex of antibody 1, antigen, and antibody 2 forms the colored test line. The test device's control line is coated with secondary antibodies, resulting in a colored result during a standard test procedure.2021-06-18 12:48:10 CET1798Immuno-AntigenNoImmunoassayQualitativeSandwich, Double15LOD50AUCalibrationNot evaluatedCrossreactivityEvaluatedFp1.8%4 false positives out of 222 negative samplesFn3.66%4 false negatives out of 109 positive samplesPrecisionEvaluatedAccuracy%(Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96% (Antigen)Clinical Specificity98% (Antigen)Type of antigenNucleoprotein2130TestNOW® - COVID-19 Antigen Test987Affimedix, Inc.United Stateswww.affimedix.comYesCommercialisedYesYesCassetteNear POC / POCAntigenNasal swabNasopharyngeal swabAdenovirusCoronaviruses (HCoV)Alpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus OC43 (HCoV-OC43)Enterovirus A71 (EV-A71)Influenza AInfluenza A H1N1Influenza A H3N2Mycoplasma PneumoniaeParainfluenza Virus TypeParainfluenza Virus Type 1Parainfluenza Virus Type 2Parainfluenza Virus Type 3Parainfluenza Virus Type 4Respiratory Syncytial V (RSV) Type ARespiratory Syncytial V (RSV) Type BRhinovirus A453B.1.1.7United Kingdom806B.1.351South Africa905B.1.427USA910B.1.429USALOD: 1.26 x 102 TCID50/mL Digital Result Reading with a Reader2021-07-07 17:18:37 CET1820Immuno-AntigenNoImmunochromatographyQualitativeSandwichExtraction kit15LOD126TCID50/mlCalibrationEvaluatedCrossreactivityEvaluatedFp0.6%Fn3.9%PrecisionEvaluatedAccuracy98.4%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.1%Clinical Specificity99.4%Type 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 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-AntigenYesImmunoassay1815COVID-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 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 antigennucleoprotein768mariPOC 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%2079mariPOC Quick Flu+962ArcDia International Oy LtdFinlandhttps://www.arcdia.com/YesCommercialisedYesYesCartridgeAutomatedNear POC / POCAntigenNasopharyngeal swabWash aspirateSARS-CoVInfluenza AInfluenza A H1N1Influenza A H3N2Influenza A H5N1Influenza B VictoriaInfluenza B YamagataInfluenza BRespiratory Syncytial V (RSV)Respiratory Syncytial V (RSV) Type ARespiratory Syncytial V (RSV) Type B453B.1.1.7United Kingdom806B.1.351South Africa1260P.2BrazilmariPOC Quick Flu+ multianalyte rapid test includes mariPOC SARS-CoV-2 test reagents Clinical validation data: https://www.medrxiv.org/content/10.1101/2021.02.08.21250086v22021-07-13 17:53:23 CET1761Immuno-AntigenYesImmunoassayQuantitativeSandwich20LOD5.4AUCalibrationEvaluatedCrossreactivityEvaluatedFp0%No false positivesFn0%No false negativesPrecisionEvaluatedAccuracy100% (Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100% (Antigen)Clinical Specificity100%(Antigen)Type of antigenNucleoprotein2078mariPOC Respi+962ArcDia International Oy LtdFinlandhttps://www.arcdia.com/YesCommercialisedYesYesCartridgeOtherAutomatedNear POC / POCAntigenNasopharyngeal swabWash aspirateAdenovirusAdenovirus 3Adenovirus 7Adenovirus Subtype BAdenovirus Subtype CBeta Coronavirus OC43 (HCoV-OC43)SARS-CoVHuman 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)Respiratory Syncytial V (RSV) Type ARespiratory Syncytial V (RSV) Type B453B.1.1.7United Kingdom806B.1.351South Africa1258P.1Japan/BrazilmariPOC Respi+ multianalyte test includes mariPOC SARS-CoV-2 test reagents Clinical validation data: https://www.medrxiv.org/content/10.1101/2021.02.08.21250086v22021-07-13 17:52:37 CET1760Immuno-AntigenYesImmunoassayQuantitativeSandwich120LODAU2.7CalibrationEvaluatedCrossreactivityEvaluatedFp0%No false positivesFn0%No false negativesPrecisionEvaluatedAccuracy100%(Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100% (Antigen)Clinical Specificity100% (Antigen)1618Artron 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 antigenNucleoprotein1654Asan Easy Test COVID-19 Ag741Asan Pharmaceutical CO., LTDSouth Koreawww.asanpharm.comYesCommercialisedYesYesCassetteLateral flowNear POC / POCAntigenNasal swab2021-07-07 17:19:48 CET1733Immuno-AntigenYesImmunoassay770ECOTEST COVID-19 Antigen Rapid Test Device455Assure Tech. (Hangzhou) Co., LtdChinawww.diareagent.comYesCommercialisedYesYesCassetteManualNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabAdenovirusBordetella PertussisChlamydia PneumoniaeAlpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Epstein-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.comYesCommercialisedYesYesLateral flowManualNear POC / POCAntigenNasopharyngeal swabOropharyngeal swabAdenovirusChlamydia PneumoniaeAlpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Epstein-Barr Virus (EBV)Human Metapneumovirus (HMPV)Influenza AInfluenza A H1N1Influenza A H3N2Influenza A H5N1Influenza B VictoriaInfluenza BInfluenza 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/BrazilNone2021-07-22 13:10:53 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 antigenNucleoprotein2010NOVA 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 antigennucleoprotein1800Ksmart® SARS-COV2 Antigen Rapid Test820AVALUN SASFranceavalun.com/YesCommercialisedYesYesSemi-automatedAntigenNasopharyngeal swab2021-07-07 17:12:25 CET1479Immuno-AntigenYesImmunochromatographyQualitativeColorimetry20LOD30U/mlCalibrationNot evaluatedCrossreactivityEvaluatedFp0.68%The specificity was tested using 441 negative specimens.3 False positives results vs the PCR assayFn6.81%The sensitivity was tested using 176 positive specimens.12 False negatives results vs the PCR assay.PrecisionEvaluatedAccuracy97.57%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity93.18%Clinical Specificity99.32%2101COVID-19 Antigen Rapid Test974AXIOM Gesellschaft für Diagnostica und Biochemica mbHYesCommercialisedYesYesCassetteNear POC / POCAntigenNasal swabNasopharyngeal 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 PhilippinesNo additional information2021-07-07 17:20:03 CET1784Immuno-AntigenNoImmunoassay10LOD0.05AUCalibrationEvaluatedCrossreactivityEvaluatedFp0%Fn0%PrecisionEvaluatedAccuracy99%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98%Clinical Specificity100%Type of antigenNucleoprotein1906COVID-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 antigenOther1065BD 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 antigenNucleoprotein1870Novel 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)Enterovirus A71 (EV-A71)Cytomegalovirus (CMV)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 antigenNucleoprotein1331SARS-CoV-2 Antigen Rapid Test Kit319Beijing Lepu Medical Technology Co., LtdChinaen.lepumedical.com/YesCommercialisedYesYesCardNear POC / POCAntigenNasal swabNasopharyngeal swab2021-07-27 11:43:24 CET1100Immuno-AntigenYesNoImmunochromatographyQuantitativeColloidal gold15Clinical Sensitivity95.06%Clinical Specificity99.62%1485WANTAI SARS-CoV-2 Ag Rapid Test (Colloidal Gold)49Beijing Wantai Biological Pharmacy Enterprise Co., LtdChinawww.ystwt.cnYesCommercialisedYesYesNear POC / POCAntigenAnterior nasal swabNasal swabNasopharyngeal swabOropharyngeal swabSaliva2021-07-23 09:30:21 CET1237Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich, Double20LOD20AUCalibrationevaluatedCrossreactivityevaluatedFp0.9%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 antigennucleoprotein1484Wantai SARS-CoV-2 Ag Rapid Test (FIA)49Beijing Wantai Biological Pharmacy Enterprise Co., LtdChinawww.ystwt.cnYesCommercialisedYesYesNear 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 antigennucleoprotein2031Coronavirus Ag Rapid Test Cassette (Swab)934Bio-Rad Laboratories / Zhejiang Orient Gene BiotechChinawww.bio-rad.comYesCommercialisedYesYesCassetteLateral flowManualNear POC / POCAntigenNasal swabNasopharyngeal swabProduct reference: 12015553 Packaging : 20 tests / box Storage : 2-30°C Total shelf life: 24 months2021-07-07 17:08:22 CET1709Immuno-AntigenNoImmunoassayQualitativeMembrane-based15LOD115AUCalibrationEvaluatedCrossreactivityEvaluatedFp0.4%Nasopharyngeal Swab: 3/743 , Nasal Swab: 0/128Fn1.71%Nasopharyngeal Swab: 2/117 , Nasal Swab: 3/106PrecisionEvaluatedAccuracy99%Nasopharyngeal Swab: 99,42% / Nasal Swab: 98,73%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98%Nasopharyngeal Swab: 98,32% / Nasal Swab: 97,25%Clinical Specificity99%Nasopharyngeal Swab: 99,6% / Nasal Swab: 100%Type of antigenNucleoprotein2247CoviGnost AG Test Device 1x201046BioGnost LtdCroatiawww.biognost.comYesCommercialisedYesYesCassetteManualAntigenNasopharyngeal swabSARS-CoV453B.1.1.7United Kingdom806B.1.351South Africa1258P.1Japan/BrazilThe Contract OEM manufacturer of the Test Device is Hangzhou Alltest Biotech CO., Ltd whose COVID-19 Antigen Rapid Test (Nasopharyngeal Swab) is allready on the Common list of rapid antigen tests, as agreed by Member States (May 10. pg.10) Our CoviGnost AG Test Device is validated at Croatian Institute of Public Health with excellent validation report. We sold CoviGnost AG Test Device in Croatia, Bulgaria, Italy and Greece, without any complaint.2021-07-22 13:11:38 CET1948Immuno-AntigenNoImmunochromatographyQualitativeMembrane-based15LOD0AUCalibrationNot evaluatedCrossreactivityEvaluatedFp2.44%3/123Fn1.23%1/81PrecisionEvaluatedAccuracy98%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity96%Clinical Specificity99%1286SARS-CoV-2 Antigen Rapid Test Kit (Fluorescence Immunochromatography)53BIOHIT HealthCare (Hefei) Co., LtdChinawww.biohit.cnYesCommercialisedYesYesNear POC / POCAntigenSerum2021-07-22 13:12:43 CET1060Immuno-AntigenYesImmunochromatographyQualitativeFluorescence15LOD20TCID50/mlLOD3.5pgper mlClinical Sensitivity96.77%Clinical Specificity98.9%2035SARS-CoV-2 Ag Rapid Test937BioMaxima SAPolandwww.biomaxima.comYesCommercialisedYesYesCassetteManualNear POC / POCAntigenNasopharyngeal swabCat. No. 1-367-K020, the SARS-CoV-2 Ag Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in nasopharyngeal swab specimens from individuals with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests.2021-07-22 13:13:31 CET1713Immuno-AntigenNoImmunochromatographyQualitativeCapture10LOD160AUCalibrationNot evaluatedCrossreactivityEvaluatedFp2AUFn5AUPrecisionEvaluatedAccuracy97%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 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%1223BIOSYNEX COVID-19 Ag BSS651BIOSYNEX S.A.Francewww.biosynex.comYesCommercialisedYesYesCassetteNear POC / POCAntigenOther2021-05-10 13:18:20 CET1007Immuno-AntigenYesNoImmunochromatographyQualitativeColorimetry15Type of antigennucleocapsid protein 1494BIOSYNEX 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 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 antigenNucleoprotein2013biotical SARS-CoV-2 Ag Card925Biotical Health S.L.U.Spainhttps://biotical.es/es/YesCommercialisedYesYesCardLateral flowManualNear POC / POCAntigenNasopharyngeal swab2021-07-22 13:14:13 CET1691Immuno-AntigenYesNoImmunochromatographyQualitative10LOD1000TCID50/mlLOD1ng/mLCalibrationNot evaluatedCrossreactivityEvaluatedFp0%Fn3%PrecisionEvaluatedAccuracy99%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96%Clinical Specificity99%Type of antigenNucleoprotein1989AFIAS COVID-19 Ag22Boditech Med IncSouth Koreahttps://www.boditech.co.kr/enYesCommercialisedYesYesCassetteLateral flowNear POC / POCSemi-automatedAntigenNasopharyngeal swabSARS-CoV2021-07-22 13:15:14 CET1665Immuno-AntigenYesYesImmunochromatographySemiquantitativeSandwichOther12LOD35.15AUCalibrationEvaluatedCrossreactivityEvaluatedFp3AUFn11AUPrecisionEvaluatedAccuracy95.5%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity91.7%Clinical Specificity98.7%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 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%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 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 antigennucleoprotein1225Test 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%1375DIAQUICK COVID-19 Ag Cassette526DIALAB GmbHAustriawww.dialab.at/en/home/YesCommercialisedYesYesCassetteNear POC / POCAntigenNasopharyngeal swab2021-05-10 20:07:30 CET1139Immuno-AntigenYesNoImmunoassayQualitativeColloidal gold15Type of antigenSARS-CoV-22242COVID-19 Antigen Detection Kit1042DNA DiagnosticDenmarkhttps://dna-diagnostic.com/YesCommercialisedYesYesCassetteLateral flowNear POC / POCAntigenNasal swabSARS-CoV453B.1.1.7United Kingdom806B.1.351South Africa1258P.1Japan/BrazilNo additional information2021-07-22 13:16:00 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 antigenNucleoprotein1243ActivXpress+ COVID-19 Antigen Complete Testing Kit88Edinburgh Genetics LimitedUnited Kingdomeggenetics.comYesCommercialisedYesYesCassetteNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabSARS-CoVThis product was evaluated by Paul-Ehrlich-Institute in Germany..2021-08-26 18:44:52 CET1024Immuno-AntigenYesNoImmunoassayQualitative15LOD3AUCalibrationEvaluatedCrossreactivityEvaluatedFpSpecificity 99.24%FnSensitivity 96.17%PrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.17%SalivaClinical Sensitivity97.27Nasopharyngeal swabClinical Sensitivity95.63Oropharyngeal swabClinical Specificity99.24%SalivaClinical Specificity99.62Nasopharyngeal swabClinical Specificity99.24Oropharyngeal swabType 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 antigennucleoprotein2147ESPLINE SARS-CoV-2994FujirebioJapanhttps://www.fujirebio.com/enYesCommercialisedYesYesCassetteNear POC / POCAntigenNasopharyngeal swabAdenovirusAdenovirus 3Adenovirus 7Adenovirus Subtype BAdenovirus Subtype CBordetella PertussisAlpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus OC43 (HCoV-OC43)MERS-CoVEnterovirus A71 (EV-A71)Hemophilus InfluenzaeHuman Metapneumovirus (HMPV)Influenza A H1N1Influenza A H3N2Mycoplasma PneumoniaeParainfluenza Virus Type 1Parainfluenza Virus Type 2Parainfluenza Virus Type 3Respiratory Syncytial V (RSV) Type ARhinovirusESPLINE SARS-CoV-2 is a cassette-style assay using a simple procedure without any special instruments. SARS-CoV-2 can be detected within 30 minutes.2021-07-07 17:12:38 CET1837Immuno-AntigenNoImmunochromatographyQualitativeEnzyme-linked30LOD50PFU/mL(Viral Copy equivalent = 1.09 x 10 exp5 copies/ml)CalibrationEvaluatedCrossreactivityEvaluatedFp0%Specificity = 100% (n=644, no false positives)Fn12.2%PrecisionEvaluatedAccuracy98.3%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity87.8%Clinical Specificity100%Type of antigenNucleoprotein1855GA CoV-2 Antigen Rapid Test351GA Generic Assays GmbHGermanywww.genericassays.comYesCommercialisedYesYesLateral 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.2021-07-22 13:16:51 CET1535Immuno-AntigenYesNoImmunochromatographyQualitativeMembrane-basedN.A.15LOD10AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0.8%4/500Fn2.94%3/102PrecisionEvaluatedAccuracy98%ReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity97.059%Clinical Specificity99.2%Type of antigenNucleoprotein1244Genbody COVID-19 Ag Test97GenBody, IncSouth KoreaYesCommercialisedYesYesCassetteNear POC / POCAntigenNasopharyngeal swabOropharyngeal swab2021-07-07 17:20:53 CET1025Immuno-AntigenYesNoImmunoassayQualitativeSandwich, Double20LOD2870TCID50/mlAccuracy94%Clinical Sensitivity90%Clinical Specificity98%2012SARS-CoV-2 Antigen Test Kit (Colloidal Gold)472Genrui Biotech IncChinawww.genrui-bio.comYesCommercialisedYesYesLateral flowNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabAdenovirusBordetella PertussisChlamydia PneumoniaeAlpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)MERS-CoVEnterovirus A71 (EV-A71)Influenza AInfluenza BHemophilus InfluenzaeParainfluenza Virus TypeRespiratory Syncytial V (RSV)Rhinovirus806B.1.351South Africa1102B.1.617.1India1103B.1.617.2India1104B.1.617.3IndiaPEI Evaluation: Positive2021-07-20 14:00:56 CET1690Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich, DoubleColloidal goldValidity test kit15LOD180AUCalibrationEvaluatedCrossreactivityEvaluatedFp0.98%Fn8.85%PrecisionEvaluatedAccuracy94.88%Nasal SwabAccuracy97.15%NP SwabReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity91.15%Nasal SwabClinical Sensitivity95.03%NP SwabClinical Specificity99.02%Nasal SwabClinical Specificity99.02%NP SwabType of 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-AntigenYesImmunoassay151820SARS-CoV-2 Antigen (Colloidal Gold)112Getein Biotech, IncChinaen.bio-gp.com.cnYesCommercialisedYesYesLateral 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 antigennucleoprotein2183One 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 antigenNucleoprotein1197SARS-CoV-2 Antigen Kit (Colloidal Gold)117Goldsite Diagnostics IncChinaen.goldsite.com.cn/YesCommercialisedYesYesNear POC / POCAntigenNasal swabOther2021-07-13 18:05:32 CET983Immuno-AntigenYesNoImmunoassayQualitativeColloidal gold121144GENEDIA 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 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 antigenNucleoprotein1216COVID-19 Ag Rapid Test Kit (Immuno-Chromatography)569Guangdong Longsee Biomedical Co., LtdChinawww.longseemed.comYesCommercialisedYesYesNear POC / POCAntigenSaliva2021-07-13 17:42:33 CET1001Immuno-AntigenYesImmunochromatographyQualitativeColloidal goldRapid diagnostic test Colloidal Gold 1360COVID-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 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 antigennucleoprotein1437Wondfo 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 IFU1257COVID-19 Antigen Rapid Test126Hangzhou AllTest Biotech Co., LtdChinawww.alltests.com.cnYesCommercialisedYesYesCassetteNear POC / POCAntigenNasopharyngeal swab2021-08-10 09:23:51 CET1033Immuno-AntigenYesImmunoassayQualitative151610COVID-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 protein1363Covid-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 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 antigens1844Immunobio 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 antigenNucleoprotein2317SARS-CoV-2 Antigen Rapid Test843Hangzhou Immuno Biotech Co.,LtdChinawww.seinofy.comYesCommercialisedYesYesCartridgeCassetteLateral flowManualAntigenAnterior nasal swabNasopharyngeal swabOropharyngeal swabSputumSARS-CoVThe test is already in use in Germany, Austria, Romania and Spain. The test has been positively evaluated by German PEI.2021-07-23 12:29:27 CET2018Immuno-AntigenNoImmunoassayQualitative15LOD0AUCalibrationEvaluatedCrossreactivityEvaluatedFpThe relative Sensitivity and Specificity have been compared with the Gold Standard PCR TestFnThe relative Sensitivity and Specificity have been compared with the Gold Standard PCR TestPrecisionEvaluatedAccuracy99%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98%Clinical Specificity100%Type of antigenNucleoprotein1215LYHER 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 gold2139COVID-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 antigenNucleoprotein1392COVID-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 antigennucleoprotein1767Coronavirus Ag Rapid Test Cassette554Healgen ScientificUnited Stateswww.healgen.comYesCommercialisedYesYesCassetteNear POC / POCAntigenNasal swabNasopharyngeal swab2021-09-28 09:21:22 CET1446Immuno-AntigenYesNoImmunochromatographyQualitative15Accuracy98.73%Nasal swabAccuracy99.42%Nasopharyngeal swabClinical Sensitivity97.25%Nasal swabClinical Sensitivity98.32%Nasopharyngeal swabClinical Specificity100%Nasal swabClinical Specificity99.6%Nasopharyngeal swab1759SARS-CoV-2 Antigen Test Kit786Hubei Jinjian Biology Co., LtdChinaen.jinjianbio.com/YesCommercialisedYesYesCassetteAutomatedAntigenNasopharyngeal swabOropharyngeal swab2021-08-25 09:42:56 CET1437Immuno-AntigenYesYesImmunochromatographyQualitativeColorimetry15LOD115U/mlCalibrationNot EvaluatedCrossreactivityEvaluatedFp1%1 out of 100Fn1.35%2 out of 148PrecisionEvaluatedAccuracy98.8%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.02%Type of antigenNucleoprotein1263Humasis 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%2107Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit975Jiangsu Bioperfectus Technologies Co., Ltd.Chinahttps://www.bioperfectus.com/YesCommercialisedYesYesCassetteLateral flowNear POC / POCOtherAntigenNasal swabNasopharyngeal swabOropharyngeal swabOtherSARS-CoV453B.1.1.7United Kingdom806B.1.351South Africa1102B.1.617.1India1258P.1Japan/BrazilThe Bioperfectus Technologies Novel Corona Virus(SARS-CoV-2) Ag Rapid Test Kit is a rapid chromatographic immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid antigens in nasal swab specimens, nasopharyngeal swab specimens or oropharyngeal swab specimens from symptomatic individuals who are suspected of COVID-19 or asymptomatic individuals who have had contact with confirmed COVID-19 patients but didn't show any symptoms.2021-07-13 17:43:08 CET1790Immuno-AntigenNoImmunochromatographyQualitativeSandwich, DoubleOther15LODAU100CalibrationEvaluatedCrossreactivityEvaluatedFpPast medical history and other diagnostic information is necessary to determine infection status.FnNegative results should be treated as presumptive and confirmed with other diagnostic techniques.PrecisionEvaluatedAccuracy98.79%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.06%Clinical Specificity99.15%Type of antigenNucleoprotein1920COVID-19 Antigen Rapid Test Cassette (Colloidal Gold)877Jiangsu Diagnostics Biotechnology Co.,Ltd.Chinadiagnostics-bio.comYesCommercialisedYesYesLateral flowNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabThroat swabURL of instruction manual： https://maiimg.com/pdf/?e=agJOCeRyb8CMIm2021-07-13 17:48:08 CET1596Immuno-AntigenNoImmunoassayQualitativeCaptureSample preparation15LOD2338AUCalibrationEvaluatedCrossreactivityEvaluatedFp10AUThere were 10 false positive casesFn0%There was no false negativePrecisionEvaluatedAccuracy98.39%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.58%Clinical Specificity100%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 antigenNucleoprotein1333COVID-19 Rapid Antigen Test (Colloidal Gold)44Joinstar Biomedical Technology Co., LtdChinawww.joinstar.cnYesCommercialisedYesYesCassetteLateral flowNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabCoronaviruses (HCoV)20A.23.1United Kingdom453B.1.1.7United Kingdom806B.1.351South Africa905B.1.427USA910B.1.429USA999B.1.525Nigeria1102B.1.617.1India1103B.1.617.2India1104B.1.617.3India1258P.1Japan/BrazilEvaluation performed by Paul-Ehrlich Institut on 4th December 20202021-09-30 11:35:12 CET1105Immuno-AntigenYesNoImmunoassayQualitativeMembrane-basedColorimetry15LOD100pg/mLCrossreactivityEvaluatedFp1.86%(From 215 samples tested there were 4 false positives)Fn1.39%(From 215 samples tested there were 3 false negatives)PrecisionEvaluatedAccuracy97.6%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.1%Clinical Specificity98.1%Type of antigenNucleocapsid protein1764SARS-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%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 protein2128PocRoc®SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold)986Lumigenex (Suzhou) Co., LtdChinahttp://www.lumigenex.com/YesCommercialisedYesYesCassetteLateral flowManualNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabSARS-CoV20A.23.1United Kingdom453B.1.1.7United Kingdom806B.1.351South Africa1100B.1.616France1227C.37Peru1258P.1Japan/BrazilThe product PocRoc SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) was registered in Spain on 1st, Nov, 2020. We have sold millions of this product on the German market. Until now, there is no negative feedback from the market. After being listed by BfArM with AT455/20, the PocRoc SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) has positive results by PEI on Mar. 15,2021.2021-07-07 17:22:40 CET1818Immuno-AntigenNoImmunochromatographyQualitativeMembrane-basedColloidal goldOther20LOD121AUCalibrationEvaluatedCrossreactivityEvaluatedFp0.84%Fn6.67%PrecisionEvaluatedAccuracy97.38%(Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.33%(Antigen)Clinical Specificity99.16%(Antigen)Type of antigenNucleoprotein1267QuickProfile COVID-19 Antigen Test167LumiQuick Diagnostics IncUnited Stateslumiquick.co/YesCommercialisedYesYesStripNear POC / POCAntigen2021-05-10 20:07:30 CET1042Immuno-AntigenYesImmunoassayQualitative15LOD380TCID50/ml1268LumiraDx 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 antigennucleocapsid1180MEDsan 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%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 antigenNucleoprotein1775MEXACARE 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 antigenNucleoprotein1190mö-screen Corona Antigen Test532möLabGermanywww.moelab.de/startseite.htmlYesCommercialisedYesYesNear POC / POCAntigenNasopharyngeal swab2021-07-07 17:23:14 CET974Immuno-AntigenYesImmunoassayQualitative151481Rapid 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 antigennucleoprotein2104NADAL COVID -19 Ag +Influenza A/B Test182Nal von minden GmbHGermanyhttps://www.nal-vonminden.com/de/YesCommercialisedYesYesLateral flowNear POC / POCAntigenNasopharyngeal swabInfluenza AInfluenza B453B.1.1.7United Kingdom806B.1.351South AfricaLimit of Detection: COVID: 2 x 10^2,4 TCID50/mL (virustiter), 0,4 ng/mL (nucleoprotein) Influenza A: A2/Aichi/2/68(H3N2), 2,3×10^3 CEID50/Test* Influenza B: Hong Kong 5/72, 3,5×10^3 CEID50/Test* *CEID50: Chicken Embryo Infectious Dose2021-07-07 17:23:20 CET1787Immuno-AntigenNoImmunochromatographyQualitativeSandwich15LOD0.4AUCalibrationNot evaluatedCrossreactivityEvaluatedFp2.43%COVID: 3 out of 123, Influenza A: 13 out of 78, Influenza B: 15 out of 85Fn0%COVID: 0 out of 161, Influenza A: 9 out of 112, Influenza B: 6 out of 105PrecisionEvaluatedAccuracy99%(over 99 %)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97%(COVID); 83,3 %(Influenza A); 82,4 % (Influenza B)Clinical Specificity98%(COVID); 92 %(Influenza A); 94,3 % (Influenza B)Type of antigenNucleoprotein1162NADAL COVID-19 Ag Test182Nal von minden GmbHGermanyhttps://www.nal-vonminden.com/de/YesCommercialisedYesYesCardLateral flowNear POC / POCAntigenNasal swabSerumWhole blood2021-05-10 13:04:00 CET943Immuno-AntigenYesNoChromatographyQualitative15Clinical Sensitivity97.56%Ct-value: 20-30Clinical Specificity99.9%Type of antigenNucleoprotein1420FREND COVID-19 Ag354NanoEntekSouth Koreawww.nanoentek.comYesCommercialisedYesYesCartridgeAutomatedAntigenNasopharyngeal swabAdenovirus 3Adenovirus 7MERS-CoVInfluenza AInfluenza A H1N1Influenza A H3N2Influenza BMycoplasma 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 antigenNucleoprotein2200NanoRepro SARS-CoV-2 Antigen Rapid Test1027NanoRepro AGGermanyhttps://www.nanorepro.com/YesCommercialisedYesYesLateral flowNear POC / POCAntigenAnterior nasal swabNasopharyngeal swabOropharyngeal swabAdenovirusBordetella PertussisChlamydia PneumoniaeAlpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus OC43 (HCoV-OC43)MERS-CoVSARS-CoVHemophilus InfluenzaeHuman Metapneumovirus (HMPV)Influenza AInfluenza BParainfluenza 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 BRhinovirusDear Sir/Madam, We, NanoRepro AG, are manufacturer of SARS-CoV-2 Antigen Rapid Test in Germany and would like to request you to add our product in your European Commision Common List of Rapid Antigen Tests. Our NanoRepro SARS-CoV-2 Antigen Rapid Test carries CE marking, have sensitivity ≥ 90% and specificity ≥ 97% and has been successfully validated in Germany according to the criteria of Paul Ehrlich Institute (PEI) by Biomex GmbH . This validation ,which was performed by Biomex GmbH , Heidelberg, has been accepted by Bundesinstitute für Arzneimittel und Medizinprodukte and Paul Ehrlich Institute. We look forward to receiving a positive response. Best Regards Ramila Sedai Regulatory Affairs Manager NanoRepro AG2021-07-13 17:55:54 CET1901Immuno-AntigenYesImmunochromatographyQualitativeSandwich, DoubleOther15LOD30AUCalibrationEvaluatedCrossreactivityEvaluatedFp1.63%Among 550 specimens, 9 test results were false positives.Fn2.8%Among 250 specimens, 7 test results were false regatives.PrecisionEvaluatedAccuracy98%(Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.2% (Antigen)Clinical Specificity98.4% (Antigen)Type of antigenNucleoprotein2241MARESKIT1041NESAPOR EUROPA SLSpainYesCommercialisedYesYesCassetteManualAntigenNasal swabSARS-CoVNucleocapside2021-07-22 13:17:55 CET1942Immuno-AntigenNoImmunoassayQualitative15LOD130AUCalibrationEvaluatedCrossreactivityEvaluatedFp0%Positive Predictive Value 100.00%Fn1.18%Negative Predictive Value 98.82%PrecisionEvaluatedAccuracy99.05% (95% CI: 96.21% to 99.92%)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.24% (95% CI: 83.84% to 99.42%)Clinical Specificity100% (95% CI: 97.22% to 100.00%)Type of antigenNucleoprotein1501COVID-19 Antigen Detection Kit690New Gene (Hangzhou) Bioengineering Co., LtdChinawww.new-gene.net/YesCommercialisedYesYesCassetteLateral flowStripManualNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabSalivaSputumAdenovirusAdenovirus 3Alpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)MERS-CoVSARS-CoVInfluenza A H1N1Influenza A H3N2Influenza A H5N1Influenza B VictoriaInfluenza B YamagataMumps Virus (MuV)Mycobacterium TuberculosisMycoplasma PneumoniaeParainfluenza Virus TypeParainfluenza Virus Type 2Respiratory Syncytial V (RSV)Rhinovirus453B.1.1.7United Kingdom806B.1.351South Africa905B.1.427USA910B.1.429USA1102B.1.617.1India1103B.1.617.2India1104B.1.617.3India1258P.1Japan/BrazilThe COVID-19 Antigen Detection Kit by New Gene (Hangzhou) Bioengineering Co., Ltd. has been widely used in practice in many EU member countries. Please visit the following links, and search search “New Gene” in their whitelists for more information. (Germany) https://antigentest.bfarm.de/ords/f?p=110:100:17097377707548 (France) https://covid-19.sante.gouv.fr/tests (Belgium) https://www.famhp.be/en/human_use/health_products/medical_devices_accessories/covid_19/tests ( Italy) https://www.salute.gov.it/interrogazioneDispositivi/RicercaDispositiviServlet?action=ACTION_MASCHERA (Portugal) https://www.infarmed.pt/web/Infarmed/pesquisa-dispositivos2021-09-14 08:47:13 CET1251Immuno-AntigenYesNoImmunoassayQualitativeSandwich, DoubleSample collection device30LOD0.05ng/mLCalibrationEvaluatedCalibrationEvaluatedCrossreactivityEvaluatedCrossreactivityEvaluatedFp0.87%1 out of 114Fn2.02%5 out of 247PrecisionEvaluatedAccuracy98.3%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98%AntigenClinical Specificity99.1%AntigenType of antigenNucleocapsid protein1762SARS CoV-2 Antigen Rapid Test661NovatechTurkeywww.novadiag.comYesCommercialisedYesYesCassetteNear POC / POCAntigenNasal swabNasopharyngeal 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.2021-07-23 09:12:05 CET1441Immuno-AntigenYesNoImmunochromatographyQualitative15LOD1.7U/mlAnalytical Sensitivity97.54%CrossreactivityEvaluatedFp0%(0/517 with negative PCR result There was no false positiv sample from the sample)Fn4.09(14/342 positive PCR result 14 false negative samples did not come out of the sample) PrecisionEvaluatedAccuracy98%RobustnessEvaluatedRobustnessNot evaluatedClinical Sensitivity95%Clinical Specificity100%Type of antigenNucleoprotein1199CAT610Oncosem 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%308PCL COVID19 Ag Rapid FIA202PCL IncSouth Koreawww.pclchip.com/YesCommercialisedYesYesNear POC / POCAntigen2021-05-10 20:07:30 CET260Immuno-AntigenYesImmunoassay2243PCL COVID19 Ag Gold1043PCL Inc.South Koreawww.pclchip.comYesCommercialisedYesYesNasal swabNasopharyngeal swabSalivaSARS-CoV20A.23.1United Kingdom72AT.1Russia453B.1.1.7United Kingdom806B.1.351South Africa905B.1.427USA910B.1.429USA999B.1.525Nigeria1000B.1.526USA1001B.1.526.1USA1001B.1.526.1USA1100B.1.616France1102B.1.617.1India1103B.1.617.2India1104B.1.617.3India1108B.1.621Colombia1224C.36Egypt1227C.37Peru1258P.1Japan/Brazil1260P.2Brazil1261P.3The Philippines2021-07-07 17:12:48 CET1944Immuno-AntigenNoImmunochromatographyQualitative10LOD0.1AUCalibrationEvaluatedCrossreactivityEvaluatedFp0%Fn0%PrecisionEvaluatedAccuracy96.25% (Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90.83% (Antigen)Clinical Specificity99.5% (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 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%1495Rapid 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 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 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 antigenNucleoprotein2290LIAISON® Quick Detect Covid Ag Assay1068Rapid Pathogen Screening, Inc.United Stateswww.lumosdiagnostics.comYesCommercialisedYesYesCassetteLateral flowStripNear POC / POCAntigenNasal swabNasopharyngeal swabSARS-CoV453B.1.1.7United KingdomLIAISON® Quick Detect Covid Ag Assay is a lateral flow immunochromatographic assay intended for the qualitative detection of the SARS-CoV-2 nucleocapsid protein antigen in nasal (NS) swabs and nasopharyngeal (NP) swabs from individuals who meet COVID-19 clinical and/or epidemiological testing criteria. The test is intended for professional use only.2021-07-22 13:18:29 CET1991Immuno-AntigenYesImmunoassayQualitativeOtherOther15LOD950AUCalibrationNot evaluatedCrossreactivityEvaluatedFp4AUFn3AUPrecisionEvaluatedAccuracy96.7%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.1%Clinical Specificity97%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 protein2228SARS-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 antigenNucleoprotein1489COVID-19 Antigen Rapid Test Kit (Swab)546Safecare Biotech (Hangzhou) Co. LtdChinawww.safecare.com.cnYesCommercialisedYesYesNear POC / POCAntigenNasal swab2021-05-12 12:58:25 CET1234Immuno-AntigenYesNoImmunoassayQualitativeColorimetry10LOD0.5AUCalibrationNot EvaluatedCrossreactivityEvaluatedFp2.96%Fn0.56%PrecisionEvaluatedAccuracy98.41%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.04%Type of antigennucleoprotein1490Multi-Respiratory Virus Antigen Test Kit(Swab) (Influenza A+B/ COVID-19)546Safecare Biotech (Hangzhou) Co. LtdChinawww.safecare.com.cnYesCommercialisedYesYesNear 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 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 antigenNucleoprotein344STANDARD F COVID-19 Ag FIA224SD BIOSENSOR IncSouth Koreahttp://sdbiosensor.com/xe/YesCommercialisedYesYesCassetteNear POC / POCAntigenNasopharyngeal swab2021-05-10 13:04:00 CET666Immuno-AntigenYesImmunoassayQualitativeFluorescence15Type of antigennucleoprotein 345STANDARD 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%2052STANDARD 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 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 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 antigennucleoprotein2109Green Spring SARS-CoV-2 Antigen-Rapid test-Set977Shenzhen Lvshiyuan Biotechnology Co., Ltd.Chinahttps://www.lsybt.com/YesCommercialisedYesYesLateral flowManualNear POC / POCAntigenAnterior nasal swabNasal swabNasopharyngeal swabOropharyngeal swabSalivaCoronaviruses (HCoV)SARS-CoV453B.1.1.7United Kingdom806B.1.351South Africa1102B.1.617.1India1103B.1.617.2India1104B.1.617.3India1258P.1Japan/BrazilDer Green Spring® SARS-CoV-2-Antigen-Schnelltest dient dem schnellen qualitativen Nachweis des Nukleocapsid-Protein-Antigens von SARS-CoV-2 in menschlichen Lolli-, Nasen-, Nasen-Rachen oder Rachenabstrichproben. Die Ergebnisse dienen dem Nachweis von SARS-CoV-2-Antigenen.2021-08-06 08:51:49 CET1799Immuno-AntigenYesNoImmunoassayQualitativeCapture15LOD400AUCalibrationEvaluatedCrossreactivityEvaluatedFp0%0 of 210 (100% specificity)Fn2%2 of 100 (98% sensitivity)PrecisionEvaluatedAccuracy99%AntigenAccuracy99.35%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98%AntigenClinical Specificity100%AntigenType of antigenNucleoproteinType of antigenNucleocapsid protein1967SARS-CoV-2 Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay)563Shenzhen Microprofit Biotech Co., LtdChinawww.microprofit-bio.comYesCommercialisedYesYesCassetteLateral 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 antigenNucleoprotein1178SARS-CoV-2 Spike Protein Test Kit (Colloidal Gold Chromatographic Immunoassay)563Shenzhen Microprofit Biotech Co., LtdChinawww.microprofit-bio.comYesCommercialisedYesYesCassetteManualAntigenNasal swabNasopharyngeal swabOropharyngeal swabSARS-CoV453B.1.1.7United Kingdom806B.1.351South Africa1103B.1.617.2India1227C.37Peru1258P.1Japan/Brazilwww.microprofit-bio.com2021-09-03 13:08:25 CET960Immuno-AntigenYesYesImmunoassayQualitativeSandwich, DoubleColorimetry15LOD39TCID50/mlCalibrationEvaluatedCrossreactivityEvaluatedFp0%Fn13.71%PrecisionEvaluatedAccuracy95.99%(Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity86.29%(Antigen)Clinical Specificity100% (Antigen)Type of antigenSpike protein2017SARS-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 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 antigenNucleoprotein1768SARS-CoV-2 Ag Diagnostic Test Kit (Immuno-fluorescence)793Shenzhen Watmind Medical Co., LtdChinawww.watmind.comYesCommercialisedYesYesCardLateral flowAutomatedNear POC / POCAntigenNasal swab2021-07-07 17:10:50 CET1447Immuno-AntigenYesImmunochromatographyQualitativeFluorescence10LOD80U/mlCalibrationEvaluatedCrossreactivityEvaluatedFp1AUFn9AUPrecisionEvaluatedAccuracy96.3%ReproducibilityEvaluatedClinical Sensitivity97.83%CT value ≤33Clinical Sensitivity90.08%CT value ≤36Type of antigenNucleoprotein1574Zhenrui ®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 antigennucleoprotein1218CLINITEST 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 proteins1114SGTi-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%1466TODA 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 antigennucleoprotein2074SARS-CoV-2 Antigen Rapid Test Kit959Triplex International Biosciences (China) Co., LTD.Chinawww.tibchina.comYesCommercialisedYesYesCardNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabAdenovirusAdenovirus 3Adenovirus 7Bordetella PertussisChlamydia PneumoniaeAlpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)MERS-CoVEnterovirus A71 (EV-A71)Epstein-Barr Virus (EBV)Hemophilus InfluenzaeHuman Metapneumovirus (HMPV)Influenza A H1N1Influenza A H3N2Influenza B VictoriaInfluenza B YamagataMycobacterium 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 antigenNucleoprotein1465SARS-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 antigennucleoprotein1443RapidFor 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 antigennucleoprotein2103VivaDiag Pro SARS-CoV-2 Ag Rapid Test175VivaChek Biotech (Hangzhou) Co., LtdChinawww.vivachek.comYesCommercialisedYesYesLateral flowNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabAdenovirus 3Adenovirus 7Adenovirus Subtype BBeta Coronavirus OC43 (HCoV-OC43)Beta Coronavirus HKU1 (HCoV-HKU1)Alpha Coronavirus Nl63 (HCoV-Nl63)Alpha Coronavirus 229E (HCoV-229E)MERS-CoVMycobacterium TuberculosisMycoplasma PneumoniaeParainfluenza Virus Type 4Parainfluenza Virus Type 3Parainfluenza Virus Type 2Parainfluenza Virus Type 1Parainfluenza Virus Type453B.1.1.7United Kingdom806B.1.351South Africa1102B.1.617.1India1103B.1.617.2India1104B.1.617.3India1258P.1Japan/BrazilVivaDiag 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.2021-07-07 17:25:29 CET1786Immuno-AntigenNoImmunochromatographyQualitativeSandwichValidity test kit15LOD75.5AUCalibrationEvaluatedCrossreactivityEvaluatedFp0%431 negative Sample were tested and 0 of them were false positiveFn2.96%135 positive Sample were tested and 4 of them were false negative.PrecisionEvaluatedAccuracy99.29% (Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.04%(Antigen)Clinical Specificity99.9%(Antigen)Type of antigenNucleoprotein2098COVID-19 (SARS-CoV-2) Antigen Test Kit973Wuhan EasyDiagnosis Biomedicine Co., Ltd.Chinahttp://www.easydiagnosis.com.cn/YesCommercialisedYesYesCassetteLateral flowOtherNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabSARS-CoV453B.1.1.7United Kingdom806B.1.351South Africa1260P.2BrazilThe COVID-19 (SARS-CoV-2) Antigen Test Kit manufactured by Wuhan EasyDiagnosis Biomedicine Co., Ltd. has passed PEI evaluation and approved with CE certification(DE/CA22/1311-538.1-IVD ), if you need any information please contact sales@easydiagnosis.com.cn2021-07-07 17:25:36 CET1781Immuno-AntigenNoImmunochromatographyQualitativeSandwich15LOD500AUCalibrationNot evaluatedCrossreactivityEvaluatedFpNot yet foundFnNot yet foundPrecisionEvaluatedAccuracy98%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.1%Clinical Specificity100%Type of antigenNucleoprotein1773The 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%)2090SARS-CoV-2 Antigen Rapid Test Kit968Wuhan UNscience Biotechnology Co., Ltd.Chinawww.uni-science.comYesCommercialisedYesYesCassetteLateral flowLab-basedManualAntigenMid-turbinates swabNasal swabNasopharyngeal swabOropharyngeal swabAdenovirusAdenovirus 3Adenovirus 7Adenovirus Subtype BAdenovirus Subtype CAnti-Nuclear AntibodyBordetella PertussisChlamydia PneumoniaeCoronaviruses (HCoV)Alpha Coronavirus 229E (HCoV-229E)Beta Coronavirus OC43 (HCoV-OC43)Beta Coronavirus HKU1 (HCoV-HKU1)Alpha Coronavirus Nl63 (HCoV-Nl63)Cytomegalovirus (CMV)SARS-CoVMERS-CoVEpstein-Barr Virus (EBV)Hemophilus InfluenzaeHepatitis C Virus (HCV)Hepatitis B Virus (HBV)Hepatitis A Virus (HAV)Herpes Simplex (HSV)Human Immunodeficiency Virus (HIV)Human Metapneumovirus (HMPV)Influenza B YamagataInfluenza B VictoriaInfluenza BInfluenza A H5N1Influenza A H3N2Influenza A H1N1Influenza AMumps Virus (MuV)Mycobacterium TuberculosisParainfluenza Virus Type 4Parainfluenza Virus Type 3Parainfluenza Virus Type 2Parainfluenza Virus Type 1Respiratory Syncytial V (RSV) Type BRespiratory Syncytial V (RSV) Type ARespiratory Syncytial V (RSV)Varicella Zoster Virus (VZV)Rhinovirus BRhinovirus ARhinovirus20A.23.1United Kingdom453B.1.1.7United Kingdom806B.1.351South Africa1000B.1.526USA1001B.1.526.1USA1002B.1.526.2USA1102B.1.617.1India1103B.1.617.2India1104B.1.617.3India1258P.1Japan/Brazil1260P.2Brazil2021-07-07 17:13:58 CET1773Immuno-AntigenYesNoImmunochromatographyQualitativeSandwichOther10LOD50000AUCalibrationEvaluatedCrossreactivityEvaluatedFp0.43%Fn3.67%PrecisionEvaluatedAccuracy100% (Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.33% (Antigen)Clinical Specificity99.57% (Antigen)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 antigenNucleoprotein1278Rapid SARS-CoV-2 Antigen Test Card277Xiamen Boson Biotech Co. LtdChinabosonbio.com/YesCommercialisedYesYesCassetteNear POC / POCAntigenNasopharyngeal swab2021-06-18 12:05:16 CET1053Immuno-AntigenYesImmunochromatographyQualitative15LOD130TCID50/ml1456SARS-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 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)1296Andlucky™ COVID-19 Antigen Rapid Test624Zhejiang Anji Saianfu Biotech Co., LtdChinawww.seinofy.comYesCommercialisedYesYesCassetteStripLab-basedAntigenNasal swabNasopharyngeal swabOropharyngeal swabBeta Coronavirus OC43 (HCoV-OC43)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 Philippinesmore information please visit www.seinofy.com2021-09-30 09:30:27 CET1102Immuno-AntibodyYesNoImmunochromatographyQualitativeSandwich, DoubleColorimetry15LOD116TCID50/mlCalibrationEvaluatedCrossreactivityEvaluatedFp0.88%3/340Fn3%7/228PrecisionEvaluatedAccuracy98.24%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.93%Clinical Specificity99.12%Type of antigenORF1b protein1295reOpenTest COVID-19 Antigen Rapid Test624Zhejiang Anji Saianfu Biotech Co., LtdChinawww.seinofy.comYesCommercialisedYesYesCassetteLateral flowAutomatedNear POC / POCAntigenNasal 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 PhilippinesLoD 5.75 x 10^2 TCID50/ml2021-09-27 09:57:41 CET1094Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD575TCID50/mlCrossreactivityEvaluatedFp2%Fn4AUPrecisionEvaluatedAccuracy98.47%AntigenReproducibilityEvaluatedClinical Sensitivity97.52%AntigenClinical Specificity99.13%AntigenType of antigenNucleocapsid protein1343Coronavirus Ag Rapid Test Cassette (Swab)1184Zhejiang Orient Gene Biotech Co.,Ltd.YesCommercialisedYesYesCassetteLateral flowManualNear POC / POCAntigenNasal swabNasopharyngeal swab2021-09-02 10:16:37 CET1124Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD115AUCalibrationNot evaluatedCrossreactivityEvaluatedFp2.5%2/120Fn0.27%2/745PrecisionEvaluatedAccuracy99.42%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.32%Clinical Specificity99.6%Type of antigennucleoprotein1957COVID-19 Antigen Detection Kit (Colloidal Gold)619Zhuhai Lituo Biotechnology Co., LtdChinawww.lituo.com.cnYesCommercialisedYesYesLateral flowNear POC / POCAntigenNasal swabNasopharyngeal swabAdenovirusBordetella PertussisChlamydia PneumoniaeCoronaviruses (HCoV)Alpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)MERS-CoVSARS-CoVEnterovirus A71 (EV-A71)Hemophilus InfluenzaeHepatitis B Virus (HBV)Human Metapneumovirus (HMPV)Influenza AInfluenza A H1N1Influenza B YamagataMycobacterium TuberculosisMycoplasma PneumoniaeParainfluenza Virus Type 1Parainfluenza Virus Type 2Parainfluenza Virus Type 3Parainfluenza Virus Type 4Respiratory Syncytial V (RSV)Rhinovirus20A.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 antigenNucleoprotein