2024-03-29 00:07:40 CET1232Panbio Covid-19 Ag Rapid Test628Abbott Rapid DiagnosticsGermanyhttps://www.globalpointofcare.abbott/en/index.htmlYesCommercialisedYesYesManualNear POC / POCAntigenNasal swabNasopharyngeal swab679B.1.1.7Alpha1022B.1.351Beta1471P.1Gamma1213B.1.525Eta1122B.1.427Epsilon1127B.1.429Epsilon1495P.3Theta3116B.1.6161310B.1.617.1Kappa1311B.1.617.2Delta1312B.1.617.31313B.1.621Mu15A.23.12016C.37Lambda1430C.3660AT.11214B.1.526IotaB.1.526.1B.1.526.2668B.1.1.529Omicron1494P.2Zetanucleocapsid proteinAvailable for Professional use (Nasal and Nasopharyngeal) and Self-Test (Nasal)2022-08-24 09:08:01 CET1015Immuno-AntigenYesYesNoImmunochromatographyQualitative15LOD0AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0AUPrecisionEvaluatedAccuracy100%ReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity98%Clinical Specificity99%Type of antigenOther4052Flowflex SARS-CoV-2 Antigen Rapid Test Slim(Self-Testing)565Acon Biotech (Hangzhou) Co. Ltd.Chinahttps://www.aconbio.com/YesCommercialisedNoNoOtherAntigenAnterior nasal swabSARS-CoVSARS-CoV-215A.23.160AT.1668B.1.1.529Omicron679B.1.1.7Alpha1022B.1.351Beta1122B.1.427Epsilon1127B.1.429Epsilon1213B.1.525Eta1214B.1.526IotaB.1.526.1B.1.526.23116B.1.6161310B.1.617.1Kappa1311B.1.617.2Delta1312B.1.617.31313B.1.621Mu1430C.362016C.37LambdaOther1471P.1Gamma1494P.2Zeta1495P.3Thetanucleocapsid proteinN.A2022-09-20 13:30:30 CET3814Immuno-AntigenYesYesNoImmunochromatographyQualitativeMembrane-basedN.A.15LOD160TCID50/mlCalibrationNot evaluatedAnalytical Sensitivity100%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives0%False negatives11.8%PrecisionEvaluatedAccuracy97.7%RobustnessEvaluatedClinical Sensitivity88.2%Clinical Specificity100%4051Flowflex SARS-CoV-2 Antigen Saliva Rapid Test Lollipop (Self-Testing)565Acon Biotech (Hangzhou) Co. Ltd.Chinahttps://www.aconbio.com/YesCommercialisedNoNoOtherAntigenSalivaSARS-CoVSARS-CoV-215A.23.160AT.1668B.1.1.529Omicron679B.1.1.7Alpha1022B.1.351Beta1122B.1.427Epsilon1127B.1.429Epsilon1213B.1.525Eta1214B.1.526IotaB.1.526.1B.1.526.23116B.1.6161310B.1.617.1Kappa1311B.1.617.2Delta1312B.1.617.31313B.1.621Mu1430C.362016C.37LambdaOther1471P.1Gamma1494P.2Zeta1495P.3Thetanucleocapsid proteinN.A2022-09-20 13:32:38 CET3816Immuno-AntigenYesYesNoImmunochromatographyQualitativeMembrane-basedN.A.15LOD320TCID50/mlCalibrationNot evaluatedAnalytical Sensitivity100%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives0%False negatives18.2%PrecisionEvaluatedAccuracy96.4%RobustnessEvaluatedClinical Sensitivity81.8%Clinical Specificity100%3579Quadruple Fast Test Pen (Latex) For SARS-CoV-2 & influenza A/B antigens and COVID-19 Neutralizing antibody1275AMPER Inc.United Stateshttp://www.amperbio.comYesCommercialisedNoNoManualNear POC / POCAntigenAnterior nasal swabSalivaAdenovirusAdenovirus 3Adenovirus 7Adenovirus Subtype BAdenovirus Subtype CAlpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Anti-Nuclear AntibodyBeta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Bordetella PertussisChlamydia PneumoniaeCoronaviruses (HCoV)Cytomegalovirus (CMV)Enterovirus A71 (EV-A71)Epstein-Barr Virus (EBV)Hemophilus InfluenzaeHepatitis A Virus (HAV)Hepatitis B Virus (HBV)Hepatitis C Virus (HCV)Herpes Simplex (HSV)Human Immunodeficiency Virus (HIV)Human Metapneumovirus (HMPV)Influenza AInfluenza A H1N1Influenza A H3N2Influenza A H5N1Influenza BInfluenza B VictoriaInfluenza B YamagataMERS-CoVMumps Virus (MuV)Mycobacterium TuberculosisMycoplasma PneumoniaeOtherParainfluenza Virus TypeParainfluenza Virus Type 1Parainfluenza Virus Type 2Parainfluenza Virus Type 3Parainfluenza Virus Type 4Respiratory Syncytial V (RSV)Respiratory Syncytial V (RSV) Type ARespiratory Syncytial V (RSV) Type BRhinovirusRhinovirus ARhinovirus BSARS-CoVVaricella Zoster Virus (VZV)668B.1.1.529Omicron679B.1.1.7Alpha1022B.1.351Beta1311B.1.617.2Deltanucleocapsid protein2022-08-24 09:08:01 CET3297Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD156TCID50/mlFalse positives4.76%False negatives1.67%5799RSV-SC2-Flu Quadruplex Fast Test (Colloidal Gold) For RSV SARS-CoV-2 & Influenza A/B antigens1275AMPER Inc.United Stateshttp://www.amperbio.comYesCommercialisedNoNoManualNear POC / POCAntigenAnterior nasal swabInfluenza AInfluenza A H1N1Influenza A H3N2Influenza A H5N1Influenza BInfluenza B VictoriaInfluenza B YamagataRespiratory Syncytial V (RSV)Respiratory Syncytial V (RSV) Type ARespiratory Syncytial V (RSV) Type BSARS-CoV-215A.23.160AT.1668B.1.1.529Omicron679B.1.1.7Alpha1022B.1.351Beta1122B.1.427Epsilon1127B.1.429Epsilon1213B.1.525Eta1214B.1.526IotaB.1.526.1B.1.526.23116B.1.6161310B.1.617.1Kappa1311B.1.617.2Delta1312B.1.617.31313B.1.621Mu1430C.362016C.37LambdaOther1471P.1Gamma1494P.2Zeta1495P.3Thetanucleocapsid protein2022-12-13 10:56:49 CET5382Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD625TCID50/mlfor RSV, COVID, Flu A/BCalibrationEvaluatedAnalytical Sensitivity95%for RSV, COVID, Flu A/BAnalytical Specificity100%for RSV, COVID, Flu A/BAnalysis of cross reactivityEvaluatedFalse positives%for RSV, COVID, Flu A/BFalse negatives9%for RSV, COVID, Flu A/BPrecisionEvaluatedAccuracy98%for RSV, COVID, Flu A/BRobustnessEvaluatedClinical Sensitivity90%for RSV, COVID, Flu A/BClinical Specificity100%for RSV, COVID, Flu A/B2169COVID-19-N-Antigen Schnelltest SARS-CoV-21011Aripa Biotec GmbHGermanywww.aripa-biotec.comYesCommercialisedNoNoManualNear POC / POCAntigenNasal swabNasopharyngeal swabSARS-CoV-215A.23.160AT.1668B.1.1.529Omicron679B.1.1.7Alpha1022B.1.351Beta1122B.1.427Epsilon1127B.1.429Epsilon1213B.1.525Eta1214B.1.526IotaB.1.526.1B.1.526.23116B.1.6161310B.1.617.1Kappa1311B.1.617.2Delta1312B.1.617.31313B.1.621Mu1430C.362016C.37LambdaOther1471P.1Gamma1494P.2Zeta1495P.3Thetanucleocapsid proteinPositive coincidence rate(Ct value < 25)(Sensitivity):99.33%(95% CI: 94.55%~99.82%) Negative coincidence rate(Specificity):99.20%(95%CI: 96.32%~99.87%) Total coincidence rate: 99.25% (95%CI: 97.15%~99.78%)2022-11-23 08:41:09 CET5337Immuno-AntigenYesYesNoImmunochromatographyQualitativeCaptureColloidal gold10LOD28.75AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1AUFalse negatives1AUPrecisionEvaluatedAccuracy99.25%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.33% IgGClinical Specificity99.2cqType of antigenNucleoprotein5779Artron COVID-19 Antigen Self Test721Artron Laboratories Inc.Canadahttp://www.artronlab.com/YesCommercialisedNoNoOtherAntigenNasal swabSARS-CoV-2668B.1.1.529Omicron679B.1.1.7Alpha1022B.1.351Beta1311B.1.617.2Delta1471P.1Gammanucleocapsid protein2022-11-21 09:03:12 CET5335Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD1000TCID50/mlCalibrationNot evaluatedAnalytical Sensitivity95%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives1sampleswithin 126 negative samplesFalse negativessampleswithin 47 positive samplesPrecisionEvaluatedAccuracy99.4%RobustnessEvaluatedClinical Sensitivity100%Clinical Specificity99.2%3106COVID-19 & Influenza A/B Antigen Nasal Test Kit455Assure Tech (Hangzhou) Co. Ltd.Chinawww.diareagent.comYesCommercialisedNoNoManualNear POC / POCAntigenNasal swabSARS-CoVInfluenza AInfluenza A H1N1Influenza A H3N2Influenza BInfluenza B VictoriaInfluenza B Yamagata679B.1.1.7Alpha1022B.1.351Beta1471P.1Gamma1213B.1.525Eta1122B.1.427Epsilon1127B.1.429Epsilon1495P.3Theta1310B.1.617.1Kappa1311B.1.617.2Delta1312B.1.617.31313B.1.621Mu2016C.37Lambda1214B.1.526Iota668B.1.1.529Omicron1494P.2Zetanucleocapsid proteinThe COVID-19&Influenza A/B Antigen Nasal Test Kit is an in vitro immunoassay. The assay is for the direct and qualitative detection of viral nucleocapsid proteins of SARS-CoV-2, Influenza A virus, and Influenza B virus from nasal secretions. The test is for self-testing use. Children aged between 2 and 18 years old, must be supervised or aided by an adult when carrying out the test. Negative results do not preclude these viral infections. Testing results should not be the sole basis for treatment or other management decisions. This test is intended for asymptomatic and people who with symptoms of COVID-19 within the first 7 days of symptom onset.2022-08-24 09:08:01 CET2812Immuno-AntigenYesYesNoImmunoassayQualitative15LOD251.2TCID50/ml1×10^2.4 TCID 50/mL (for SARS-CoV-2)CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.3%1/396 - Flu BFalse positives0.5%2/377 - Flu AFalse positives0.3%1/310 - COVID-19False negatives3.6%5/140 - COVID-19False negatives4.1%3/73 - Flu AFalse negatives5.6%3/54 - Flu BPrecisionEvaluatedAccuracy99.1%446/450 - Flu BAccuracy98.7%444/450 COVID-19Accuracy98.9%445/450 - Flu AReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.4%51/54 - Flu BClinical Sensitivity95.9%70/73 - Flu A Clinical Sensitivity96.4%135/140 - COVID-19Clinical Specificity99.7%309/310 - COVID-19Clinical Specificity99.5%375/377 - Flu AClinical Specificity99.7%395/396 - Flu BType of antigenNucleocapsid protein2037COVID-19 Antigen Saliva Test Kit455Assure Tech (Hangzhou) Co. Ltd.Chinawww.diareagent.comYesCommercialisedNoNoManualNear POC / POCAntigenSalivaSARS-CoV679B.1.1.7Alpha1022B.1.351Beta1122B.1.427Epsilon1127B.1.429Epsilon1213B.1.525Eta1214B.1.526Iota1310B.1.617.1Kappa1311B.1.617.2Delta1312B.1.617.31313B.1.621Mu2016C.37Lambda1471P.1Gamma1494P.2Zeta1495P.3Thetanucleocapsid protein2023-01-09 10:11:42 CET5425Immuno-AntigenYesYesNoImmunoassayQualitativeMembrane-basedColorimetry15LOD31.4TCID50/ml1.25×10^1.4 TCID50/mLCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.6%False negatives13.6%PrecisionEvaluatedAccuracy94.1%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity86.4%Clinical Specificity99.4%2956NOVA Test® SARS-CoV-2 Antigen Home Test Kit924Atlas Link Technology Co. Ltd.Chinahttp://www.atlas-link.com/english/YesCommercialisedNoNoManualNear POC / POCAntigenAnterior nasal swabAdenovirusBordetella PertussisChlamydia PneumoniaeCoronaviruses (HCoV)Alpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)MERS-CoVCytomegalovirus (CMV)Enterovirus A71 (EV-A71)Hemophilus InfluenzaeHepatitis B Virus (HBV)Hepatitis C Virus (HCV)Human Metapneumovirus (HMPV)Influenza AInfluenza BMycobacterium TuberculosisMycoplasma PneumoniaeParainfluenza Virus TypeParainfluenza Virus Type 1Parainfluenza Virus Type 2Parainfluenza Virus Type 3Parainfluenza Virus Type 4Respiratory Syncytial V (RSV)RhinovirusRhinovirus ARhinovirus B679B.1.1.7Alpha1022B.1.351Beta1471P.1Gamma1311B.1.617.2Delta668B.1.1.529Omicronnucleocapsid proteinNOVA Test®SARS-CoV-2 Antigen Home Test Kit is intended for detection of SARS-CoV-2 Virus (COVID-19 Virus) for self-testing at home or near patient circumstance when someone was suspected COVID-19 infection within the first 7 days after symptom onset and non-symptomatic population especially for those who have recently been in contact with suspected or positive patients. This kit uses a nasal swab sample to reduce discomfort which can be applied to any person ranging from age 18 to 70. Adolescents or children can be tested under adult supervision or tested by an adult. For infants, very young children, or adults older than 70 please consult with your physician before use.2022-08-24 09:08:01 CET2830Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, Double15LOD50TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%Compared with PCR test, 419 individuals, 0 false positiveFalse negatives0.81%Compared with PCR test, 123 individuals, 1 false negativeAccuracy99.8%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity99.2Clinical Specificity100Type of antigenNucleocapsid protein3082SARS-CoV-2 Ag Rapid Test (self-test)1038AUTOBIO DIAGNOSTICS. Ltd.Chinahttps://www.autobio.com.cn/YesCommercialisedNoNoManualAntigenNasal swabChlamydia PneumoniaeHemophilus InfluenzaeHuman Metapneumovirus (HMPV)Mycoplasma Pneumoniaenucleocapsid proteinThis assay is based on a colloidal gold method for the rapid, qualitative determination of SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2) nucleocapsid protein antigen in anterior nasal swab specimens. This test kit is intended for self-testing at home for individuals with symptoms of SARS-CoV-2 infection. This test kit shall not be used as a sole basis to diagnose or exclude SARS-CoV-2 infection.2022-08-24 09:08:01 CET2788Immuno-AntigenYesYesImmunoassay15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives5.45%False negatives0%PrecisionEvaluatedAccuracy98.94%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.55%Clinical Specificity100%Type of antigenNucleocapsid protein3622SARS-CoV-2 Antigen Rapid Test (Nasal Swab)1429Beijing Easy-Sweet Bio-medical Science and Technology Co., Ltd.ChinaYesCommercialisedNoNoManualAntigenNasal swabAdenovirus 3Adenovirus 7Alpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Hemophilus InfluenzaeInfluenza A H1N1Influenza A H3N2Influenza BMERS-CoV668B.1.1.529Omicronnucleocapsid protein2022-08-24 09:08:01 CET3334Immuno-AntigenYesYesNoImmunoassayQualitativeN.A.Colloidal gold15LOD115TCID50/mlAnalytical Sensitivity96%Analytical Specificity99.6%False positives96%False negatives99.6%Accuracy98.1%Clinical Sensitivity96%Clinical Specificity99.6%3071BIOBASE COVID-19 Antigen Rapid Test(Self-Test)1358Biobase Diagnostic Technology (Shandong) Co. Ltd.Chinahttps://www.biobase.cc/YesCommercialisedNoNoManualNear POC / POCAntigenAnterior nasal swabSARS-CoV-2668B.1.1.529Omicron679B.1.1.7Alpha1022B.1.351Beta1311B.1.617.2Delta1471P.1Gammanucleocapsid proteinThis assay is based on a colloidal gold method for the rapid, qualitative determination of SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2) nucleocapsid protein antigen in anterior nasal swab specimens. This test kit is intended for self-testing at home for individuals with symptoms of SARS-CoV-2 infection. This test kit shall not be used as a sole basis to diagnose or exclude SARS-CoV-2 infection.2022-11-07 14:20:27 CET5288Immuno-AntigenYesYesNoImmunochromatographyQualitativeMembrane-basedColloidal gold15LOD115TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives%False negatives7.27%PrecisionEvaluatedAccuracy98.62%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.73%Clinical Specificity100%Type of antigenNucleocapsid protein2902RAPID SARS-COV-2 ANTIGEN TEST CARD (self test)1376BioDetect (Xiamen) Biotechnology Co. Ltd.Chinahttp://biodetect.cn/YesCommercialisedNoNoNear POC / POCAntigenAnterior nasal swab679B.1.1.7Alpha1022B.1.351Beta1471P.1Gamma1213B.1.525Eta1122B.1.427Epsilon1127B.1.429Epsilon1495P.3Theta3116B.1.6161310B.1.617.1Kappa1311B.1.617.2Delta1312B.1.617.31313B.1.621Mu15A.23.12016C.37Lambda1430C.3660AT.11214B.1.526IotaB.1.526.1B.1.526.2668B.1.1.529Omicron1494P.2Zetanucleocapsid proteinEC Certificate No. 1434-IVDD-521/20212022-08-24 09:08:01 CET2607Immuno-AntigenYesYesYesImmunochromatographyQualitativeSandwich, Double15LOD100pg/mLCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.248%False negatives10%PrecisionEvaluatedAccuracy96.523%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90%AntigenClinical Specificity99.752%AntigenType of antigenNucleocapsid protein3487SARS-CoV-2 Antigen Test Kit 955BIOTEKE CORPORATION (WUXI) Co. Ltd.Chinahttps://www.bioteke.cn/YesCommercialisedNoNoNear POC / POCAntigenAnterior nasal swabAdenovirusAdenovirus 3Adenovirus 7Alpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Bordetella PertussisChlamydia PneumoniaeCytomegalovirus (CMV)Enterovirus A71 (EV-A71)Epstein-Barr Virus (EBV)Influenza AInfluenza A H1N1Influenza A H3N2Influenza A H5N1Influenza BInfluenza B VictoriaInfluenza B YamagataMERS-CoVMumps Virus (MuV)Mycoplasma PneumoniaeParainfluenza Virus TypeParainfluenza Virus Type 1Parainfluenza Virus Type 2Parainfluenza Virus Type 3Parainfluenza Virus Type 4Respiratory Syncytial V (RSV) Type ARhinovirus ARhinovirus BVaricella Zoster Virus (VZV)668B.1.1.529Omicron679B.1.1.7Alpha1022B.1.351Beta1311B.1.617.2Delta1471P.1Gammanucleocapsid protein2022-08-24 09:08:01 CET3209Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, DoubleOther15LOD1250TCID50/mlAnalytical Sensitivity96.36%Analytical Specificity100%False positives0%False negatives3.64%Accuracy99.29%Clinical Sensitivity96.36%Clinical Specificity100%3008BHM COVID-19 Antigen Rapid Test1333Birmingham Biotech Ltd.United Kingdomhttps://www.birminghambiotech.co.ukYesCommercialisedNoNoNear POC / POCAntigenNasal swab679B.1.1.7Alpha1022B.1.351Beta1471P.1Gamma1311B.1.617.2Delta2016C.37Lambda668B.1.1.529Omicronnucleocapsid proteinThe BHM® COVID-19 Antigen Rapid Test is intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 from individuals with or without symptoms or other epidemiological reasons to suspect COVID-19. Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in nasal and oral specimens during the acute phase of infection. Individuals who test negative and continue to experience COVID-19 like symptoms of fever, cough and/or shortness of breath may still have SARSCoV-2 infection and should seek follow up care with their general practitioner or healthcare provider.2022-08-24 09:08:01 CET2714Immuno-AntigenYesYesNoImmunoassayQualitativeSandwich, Double15LOD150TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives5.3%False negatives1%PrecisionEvaluatedAccuracy97.4%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.7%Clinical Specificity99%Type of antigenNucleocapsid protein1999See Now Coronavirus nCoV antigen test918CAMP MEDICA DISTRIBUTIONRomaniawww.campmedica.roYesCommercialisedNoNoLab-basedManualAntigenNasal swabNasopharyngeal swabOropharyngeal swabSaliva679B.1.1.7Alpha1022B.1.351Beta1471P.1Gamma1213B.1.525Eta1122B.1.427Epsilon1127B.1.429Epsilon1495P.3Theta3116B.1.6161310B.1.617.1Kappa1311B.1.617.2Delta1312B.1.617.31313B.1.621Mu15A.23.12016C.37Lambda1430C.3660AT.11214B.1.526IotaB.1.526.1B.1.526.2668B.1.1.529Omicron1494P.2Zetanucleocapsid proteinThe See Now -Coronavirus nCoV Antigen test is used for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 virus in nasal swabs, nasopharyngeal swabs, oropharyngeal swabs and/or saliva, from individuals suspected of COVID 19. See Now Coronavirus- nCoV Antigen test cannot be used as the basis to diagnose or exclude SARS-CoV-2 infection.2022-08-24 09:08:01 CET1676Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, Double10LOD1ng/mLAnalytical Sensitivity97%Analytical Specificity99%Analysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracy97.8%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.17%Clinical Specificity99.44%Type of antigenNucleocapside protein5817CHECK UP COVID19-INF A/B-RSV MULTI RAPID TEST KIT1232Cesna Biyoteknoloji AraÅŸtırma GeliÅŸtirme Laboratuvar Sist.Ä°nÅŸ.Müh.Dan.San.Tic.Ltd.Åžti.Turkeywww.cesnalaboratuvarsistemleri.comYesCommercialisedNoNoManualNear POC / POCAntigenNasal swabOther15A.23.160AT.1668B.1.1.529Omicron679B.1.1.7Alpha1022B.1.351Beta1122B.1.427Epsilon1127B.1.429Epsilon1213B.1.525Eta1214B.1.526IotaB.1.526.1B.1.526.23116B.1.6161310B.1.617.1Kappa1311B.1.617.2Delta1312B.1.617.31313B.1.621Mu1430C.362016C.37Lambda1471P.1Gamma1494P.2Zeta1495P.3Thetanucleocapsid proteinIn addition, our Covid19 test kit has been published by Common list with RAT number 2696.
We were verified by PEI in 2021.2023-01-09 10:08:59 CET5421Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD3200TCID50/mlfor Covid19CalibrationEvaluatedAnalytical Sensitivity100%for Covid19Analytical Specificity100%for Covid19Analysis of cross reactivityEvaluatedFalse positives0.33%for Covid19False negatives0.49%for Covid19PrecisionEvaluatedAccuracy99.6%for Covid19RobustnessEvaluatedClinical Sensitivity99.3%for Covid19Clinical Specificity99.7%for Covid195820CheckUp COVID-INF A/B-RSV COMBO RAPID NASAL TEST KIT1232Cesna Biyoteknoloji Araştırma Geliştirme Laboratuvar Sist.İnş.Müh.Dan.San.Tic.Ltd.Şti.Turkeywww.cesnalaboratuvarsistemleri.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabOther15A.23.160AT.1668B.1.1.529Omicron679B.1.1.7Alpha1022B.1.351Beta1122B.1.427Epsilon1127B.1.429Epsilon1213B.1.525Eta1214B.1.526IotaB.1.526.1B.1.526.23116B.1.6161310B.1.617.1Kappa1311B.1.617.2Delta1312B.1.617.31313B.1.621Mu1430C.362016C.37Lambda1471P.1Gamma1494P.2Zeta1495P.3Thetanucleocapsid proteinOur Covid19 clinical assessment was conducted by PEI in 2021.
In addition, our Covid19 diagnostic kit is on the list with the number of HS common List RAT 2696.2023-01-09 10:10:16 CET5422Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD3200TCID50/mlfor Covid19CalibrationEvaluatedAnalytical Sensitivity100%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives0.32%1 out of 306False negatives0.49%2 out of 407PrecisionEvaluatedAccuracy98.98%RSVAccuracy98.18%INFBAccuracy98.09%INFAAccuracy98.98%Covid19RobustnessEvaluatedClinical Sensitivity98.04%InfAClinical Sensitivity98.13%INFBClinical Sensitivity99.3%Covid19Clinical Sensitivity99.03%RSVClinical Specificity99.01%INFAClinical Specificity99.7%Covid19Clinical Specificity99.04%INFBClinical Specificity98.04%RSV5832CHECKUP COVID-INF A/B-RSV-ADENO RAPID TEST KIT1232Cesna Biyoteknoloji AraÅŸtırma GeliÅŸtirme Laboratuvar Sist.Ä°nÅŸ.Müh.Dan.San.Tic.Ltd.Åžti.Turkeywww.cesnalaboratuvarsistemleri.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabAdenovirusAdenovirus 3Adenovirus 7Adenovirus Subtype BAdenovirus Subtype CAlpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Anti-Nuclear AntibodyBeta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Bordetella PertussisChlamydia PneumoniaeCoronaviruses (HCoV)Cytomegalovirus (CMV)Enterovirus A71 (EV-A71)Epstein-Barr Virus (EBV)Hemophilus InfluenzaeHepatitis A Virus (HAV)Hepatitis B Virus (HBV)Hepatitis C Virus (HCV)Herpes Simplex (HSV)Human Immunodeficiency Virus (HIV)Human Metapneumovirus (HMPV)Influenza AInfluenza A H1N1Influenza A H3N2Influenza A H5N1Influenza BInfluenza B VictoriaInfluenza B YamagataMERS-CoVMumps Virus (MuV)Mycobacterium TuberculosisMycoplasma PneumoniaeOtherParainfluenza Virus TypeParainfluenza Virus Type 1Parainfluenza Virus Type 2Parainfluenza Virus Type 3Parainfluenza Virus Type 4Respiratory Syncytial V (RSV)Respiratory Syncytial V (RSV) Type ARespiratory Syncytial V (RSV) Type BRhinovirusRhinovirus ARhinovirus BSARS-CoVSARS-CoV-2Varicella Zoster Virus (VZV)15A.23.160AT.1668B.1.1.529Omicron679B.1.1.7Alpha1022B.1.351Beta1122B.1.427Epsilon1127B.1.429Epsilon1213B.1.525Eta1214B.1.526IotaB.1.526.1B.1.526.23116B.1.6161310B.1.617.1Kappa1311B.1.617.2Delta1312B.1.617.31313B.1.621Mu1430C.362016C.37LambdaOther1471P.1Gamma1494P.2Zeta1495P.3Thetanucleocapsid protein2023-01-10 11:26:59 CET5436Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD3200TCID50/ml(for Covid19)CalibrationEvaluatedAnalytical Sensitivity100%Analytical Specificity100%Analytical Specificity99.01%ınfaAnalysis of cross reactivityEvaluatedFalse positives0.32%1 out of 306False negatives0.49%2 out of 407PrecisionEvaluatedAccuracy99.25%adenoAccuracy98.18%ınfbAccuracy98.09%ınfaAccuracy98.98%rsvAccuracy98.98%covid19RobustnessEvaluatedClinical Sensitivity99.03%rsvClinical Sensitivity98.04%ınfaClinical Sensitivity98.13%ınfbClinical Sensitivity99.3%covid19Clinical Sensitivity99.26%adenoClinical Specificity98.04%rsvClinical Specificity99.7%covid19Clinical Specificity99.04%ınfbClinical Specificity99.06%adeno3864CHIL COVID-19 Antigen Rapid Test1156Chil Tıbbi Malzeme Sanayi ve Ticaret Limited ÅžirketiTurkeyhttps://www.chil.com.trYesCommercialisedNoNoManualAntigenNasal swabSARS-CoV668B.1.1.529Omicron679B.1.1.7Alpha1022B.1.351Betanucleocapsid protein2022-08-24 09:08:01 CET3530Immuno-AntigenYesYesNoImmunoassayQualitativeSandwichN.A.15LOD30TCID50/mlAnalytical Sensitivity100%Analytical Specificity100%False positives0.54%False negatives0.65%Accuracy99.67%Clinical Sensitivity98.75%Clinical Specificity99.72%1476COVID-19 Antigen Test for Self Testing659CITEST DIAGNOSTICS Inc.Canadawww.citestdiagnostics.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabAdenovirus 3Adenovirus 7Alpha Coronavirus 229E (HCoV-229E)15A.23.160AT.1668B.1.1.529Omicron679B.1.1.7Alpha1022B.1.351Beta1122B.1.427Epsilon1127B.1.429Epsilon1213B.1.525Eta1214B.1.526IotaB.1.526.1B.1.526.23116B.1.6161310B.1.617.1Kappa1311B.1.617.2Delta1312B.1.617.31313B.1.621Mu1430C.362016C.37Lambda1471P.1Gamma1494P.2Zeta1495P.3Thetanucleocapsid proteinThe COVID-19 Antigen Rapid Test (Swab) is a single-use test kit intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19 in self-collected nasal swab specimen from symptomatic / asymptomatic individuals who are suspected of being
infected with COVID-19. This test is designed for the use by layperson. A positive result indicates the presence of SARS-CoV-2. Individuals whose test results are positive should self-isolate and seek help from relevant healthcare institutions. A positive result may also be caused by bacterial infection or co-infection with other viruses. A negative result may also be infected with SARS-CoV-2. Individuals whose test results are negative continue to experience COVID-like symptoms should seek follow-up help from relevant healthcare institutions.The COVID-19 Antigen Rapid Test (Swab) only indicates a preliminary result. The confirmation of the final result should be based on the clinical diagnosis.2022-11-07 14:09:37 CET5286Immuno-AntigenYesYesNoImmunoassayQualitativeSandwichImmunofluorescence15LOD100AUEvaluatedAnalytical Specificity99.9%EvaluatedFalse positives3%False negatives%Accuracy99.1%EvaluatedReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97%Evaluated3001QuantiVirus SARS-CoV-2 Antigen Rapid Test1328Diacarta Inc.United Stateshttps://www.diacarta.com/YesCommercialisedNoNoManualAntigenAnterior nasal swab1311B.1.617.2Delta668B.1.1.529Omicronnon-structural protein NSP1non-structural protein NSP2non-structural protein NSP3non-structural protein NSP4non-structural protein NSP5N/A2022-08-24 09:08:01 CET2707Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, Double15LOD2000TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives11.76%6 out of 51PrecisionEvaluatedAccuracy100%PPVAccuracy92% NPVReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity88.24%95% CI: 76-95%Clinical Specificity100%95% CI: 94-100%Type of antigenNonstructural protein NS32647Dräger COVID-19 Home Test1209Dräger Safety AG & Co. KGaAGermanywww.draeger.comYesCommercialisedNoNoManualNear POC / POCAntigenNasal swab679B.1.1.7Alpha1022B.1.351Beta1471P.1Gamma1122B.1.427Epsilon1127B.1.429Epsilon1310B.1.617.1Kappa1311B.1.617.2Delta1214B.1.526Iota668B.1.1.529OmicronWe have updated the section on detected virus variants for ID2647. This update is based on a recent update of the corresponding technical documentation. ID2647 is the home-use version of the professional test ID2273. We have submitted an update to its section on detected virus variants, too. Thank you.2022-08-24 09:08:01 CET2352Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich15LOD200pgCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.32%1 out of 308 samples (symptomatic and asymptomatic PCR negative)False negatives10.1%7 out of 69 samples (overall, symptomatic PCR positive)PrecisionEvaluatedAccuracy98.9%Ct values < 26; 97.1% (overall)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.8%Ct values < 26Clinical Specificity99.7%Type of antigenNucleocapsid protein3995Dynamiker SARS-CoV-2 Ag Rapid Test1158Dynamiker Biotechnology(Tianjin) Co. Ltd.Chinahttps://en.dynamiker.com/YesCommercialisedNoNoManualAntigenNasal swabAdenovirusAdenovirus 3Adenovirus 7Alpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Bordetella PertussisChlamydia PneumoniaeCytomegalovirus (CMV)Enterovirus A71 (EV-A71)Epstein-Barr Virus (EBV)Hemophilus InfluenzaeHepatitis A Virus (HAV)Hepatitis B Virus (HBV)Hepatitis C Virus (HCV)Human Immunodeficiency Virus (HIV)Influenza AInfluenza A H1N1Influenza A H3N2Influenza A H5N1Influenza BInfluenza B VictoriaInfluenza B YamagataMERS-CoVMumps Virus (MuV)Mycobacterium TuberculosisMycoplasma PneumoniaeRespiratory Syncytial V (RSV)RhinovirusRhinovirus ARhinovirus BSARS-CoVVaricella Zoster Virus (VZV)668B.1.1.529Omicron679B.1.1.7Alpha1022B.1.351Beta1311B.1.617.2Delta1471P.1Gammanucleocapsid protein2022-08-24 09:08:01 CET3660Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwichColloidal gold10LOD160TCID50/mlAnalytical Sensitivity98.2%Analytical Specificity100%False positives0%False negatives1.8%Accuracy100%Clinical Sensitivity98.2%Clinical Specificity100%2032EONBT COVID-19 Antigen935EON Biotechnology LimitedUnited Kingdomeonbt.comYesCommercialisedNoNoManualAntigenNasal swab679B.1.1.7Alpha1022B.1.351Beta1471P.1Gamma1213B.1.525Eta1122B.1.427Epsilon1127B.1.429Epsilon1495P.3Theta3116B.1.6161310B.1.617.1Kappa1311B.1.617.2Delta1312B.1.617.31313B.1.621Mu15A.23.12016C.37Lambda1430C.3660AT.11214B.1.526IotaB.1.526.1B.1.526.2668B.1.1.529Omicron1494P.2Zetanucleocapsid proteinISO13485 certified ISO 9001 certified CE marked2022-08-24 09:08:01 CET1710Immuno-AntigenYesYesNoImmunoassayQualitativeSandwich20LOD0.103ng/mLCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.76%3/170False negatives2.2%9/408PrecisionEvaluatedAccuracy98.95%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.89%Clinical Specificity99.25%Type of antigenNucleocapsid protein3453COVID-19 Antigen Rapid Test For Self Test1414Eternal Material Co.,Ltd.Taiwan ROChttps://www.eternal-group.com/Home/EngIndexYesCommercialisedNoNoManualNear POC / POCAntigenNasal swabAdenovirusAlpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus OC43 (HCoV-OC43)Influenza AInfluenza BParainfluenza Virus TypeRespiratory Syncytial V (RSV)Rhinovirus668B.1.1.529Omicron679B.1.1.7Alpha1127B.1.429Epsilon1311B.1.617.2Delta1471P.1Gammanucleocapsid protein2022-08-24 09:08:01 CET3189Immuno-AntigenYesYesNoImmunochromatographyQualitativeCaptureColloidal gold10LOD1255.9TCID50/mlAnalytical Sensitivity97.73%Analytical Specificity98.67%False positives1.33%False negatives2.27%Accuracy94.54%Clinical Sensitivity81.05%Clinical Specificity99.99%4055Covid-19 Antigen CARD Kit1239Fosun Diagnostics (Shanghai) Co. Ltd.Chinahttps://www.fosunpharma.com/en/product/medical-list.aspx?type=8YesCommercialisedNoNoNear POC / POCAntigenNasal swabSARS-CoV-2668B.1.1.529Omicron679B.1.1.7Alpha1022B.1.351Beta1310B.1.617.1Kappa1311B.1.617.2Delta1471P.1Gammanucleocapsid protein2022-09-20 13:49:58 CET3818Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD31.3TCID50/mlCalibrationNot evaluatedAnalytical Sensitivity96.75%Analytical Specificity98.26%Analysis of cross reactivityEvaluatedFalse positives1.7%False negatives3.3%PrecisionEvaluatedAccuracy97.91%RobustnessEvaluatedClinical Sensitivity96.75%Clinical Specificity98.26%4072RapiCov Rapid Antigen Test Kit for COVID‐191460Genes2me Private LTDIndiaYesCommercialisedNoNoManualAntigenNasopharyngeal swabAdenovirusAlpha Coronavirus 229E (HCoV-229E)Influenza A H1N1Influenza A H3N2Influenza BMERS-CoVMycoplasma PneumoniaeParainfluenza Virus Type 1Parainfluenza Virus Type 2Parainfluenza Virus Type 3Parainfluenza Virus Type 4Respiratory Syncytial V (RSV)RhinovirusSARS-CoVSARS-CoV-2679B.1.1.7Alpha1022B.1.351Beta1127B.1.429Epsilon1213B.1.525Eta1310B.1.617.1Kappa1311B.1.617.2Delta1312B.1.617.3Other1471P.1Gamma1494P.2ZetaOther2022-09-20 14:45:47 CET3833Immuno-AntigenYesYesNoImmunoassayQualitativeN.A.Other10LOD0.4ng/mLCalibrationEvaluatedAnalytical Sensitivity98.33%Analytical Specificity98.6%Analysis of cross reactivityEvaluatedFalse positives24ng/mLFalse negatives24ng/mLPrecisionEvaluatedAccuracy100%RobustnessEvaluatedClinical Sensitivity98.33%Clinical Specificity98.6%4159SARS-CoV-2 Antigen Test Kit (Colloidal Gold) (Self-Testing)472Genrui Biotech Inc.Chinawww.genrui-bio.comYesCommercialisedNoNoManualOtherAntigenNasal swabSARS-CoV-215A.23.160AT.1668B.1.1.529Omicron679B.1.1.7Alpha1022B.1.351Beta1122B.1.427Epsilon1127B.1.429Epsilon1213B.1.525Eta1214B.1.526IotaB.1.526.1B.1.526.23116B.1.6161310B.1.617.1Kappa1311B.1.617.2Delta1312B.1.617.31313B.1.621Mu1430C.362016C.37LambdaOther1471P.1Gamma1494P.2Zeta1495P.3Thetanucleocapsid protein2022-10-14 10:51:22 CET5192Immuno-AntigenYesYesN.A.ImmunochromatographyQualitativeSandwichColloidal gold15LOD180TCID50/mlCalibrationNot evaluatedAnalytical Sensitivity100%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives0%False negatives1.87%PrecisionEvaluatedAccuracy99.03%RobustnessEvaluatedClinical Sensitivity98.13%Clinical Specificity100%40882019-nCoV Antigen Test Kit (colloidal gold method) (for self-testing)779Guangdong Hecin Scientific Inc.Chinahttps://www.hecin-scientific.cn/YesCommercialisedNoNoNear POC / POCAntigenNasal swabSARS-CoV-215A.23.160AT.1668B.1.1.529Omicron679B.1.1.7Alpha1022B.1.351Beta1122B.1.427Epsilon1127B.1.429Epsilon1213B.1.525Eta1214B.1.526IotaB.1.526.1B.1.526.23116B.1.6161310B.1.617.1Kappa1311B.1.617.2Delta1312B.1.617.31313B.1.621Mu1430C.362016C.37Lambda1471P.1Gamma1494P.2Zeta1495P.3Thetanucleocapsid protein2022-09-20 17:22:27 CET3843Immuno-AntigenYesYesYesImmunochromatographyQualitativeSandwich, DoubleImmunofluorescence15LOD175TCID50/mlCalibrationNot evaluatedAnalytical Sensitivity100%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives0.22% (1 false positive out of 263 PCR negative samples.)False negatives2.91%(9 false negative results out of 101 PCR positive samples for Ct<=30.)PrecisionEvaluatedAccuracy99.28%RobustnessEvaluatedClinical Sensitivity97.09%Clinical Specificity99.78%5762V-Chek 2019-nCoV Ag Rapid Test Kit (Immunochromatography)382Guangzhou Decheng Biotechnology Co. Ltd.Chinawww.dochekbio.comYesCommercialisedNoNoManualAntigenNasal swabAdenovirus 3Alpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Bordetella PertussisChlamydia PneumoniaeEpstein-Barr Virus (EBV)Human Metapneumovirus (HMPV)Influenza A H1N1Influenza A H3N2Influenza A H5N1Influenza B VictoriaInfluenza B YamagataMERS-CoVMycobacterium TuberculosisMycoplasma PneumoniaeParainfluenza Virus Type 2Respiratory Syncytial V (RSV)Rhinovirus668B.1.1.529Omicron679B.1.1.7Alpha1022B.1.351Beta1127B.1.429Epsilon1310B.1.617.1Kappa1311B.1.617.2Delta1312B.1.617.31313B.1.621Mu1471P.1Gammanucleocapsid protein2022-11-21 09:01:32 CET5333Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD100TCID50/mlCalibrationNot evaluatedAnalytical Sensitivity%Analytical Specificity%Analysis of cross reactivityEvaluatedFalse positives0.58%False negatives3.45%PrecisionEvaluatedAccuracy98.39%RobustnessEvaluatedClinical Sensitivity96.55%Clinical Specificity99.42%5763V-Chek 2019-nCoV Ag Saliva Rapid Test Card (Immunochromatography)382Guangzhou Decheng Biotechnology Co. Ltd.Chinawww.dochekbio.comYesCommercialisedNoNoManualAntigenSalivaAdenovirus 3Alpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Bordetella PertussisChlamydia PneumoniaeEpstein-Barr Virus (EBV)Human Metapneumovirus (HMPV)Influenza A H1N1Influenza A H3N2Influenza A H5N1Influenza B VictoriaInfluenza B YamagataMERS-CoVMycobacterium TuberculosisMycoplasma PneumoniaeParainfluenza Virus Type 2Respiratory Syncytial V (RSV)Rhinovirus60AT.1668B.1.1.529Omicron679B.1.1.7Alpha1022B.1.351Beta1127B.1.429Epsilon1310B.1.617.1Kappa1311B.1.617.2Delta1312B.1.617.31313B.1.621Mu1471P.1Gammanucleocapsid protein2022-11-21 09:00:58 CET5332Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold10LOD100TCID50/mlCalibrationNot evaluatedAnalytical Sensitivity%Analytical Specificity%Analysis of cross reactivityEvaluatedFalse positives1.17%False negatives7.86%PrecisionEvaluatedAccuracy96.47%RobustnessEvaluatedClinical Sensitivity92.14%Clinical Specificity98.83%3459COVID-19 Antigen Rapid Test1404Guangzhou Weimi Bio-Tech Co., Ltd.Chinahttps://www.weimibio.cn/YesCommercialisedNoNoManualAntigenAnterior nasal swabOther668B.1.1.529Omicron679B.1.1.7Alpha1022B.1.351Beta1213B.1.525EtaOthernucleocapsid protein2022-08-24 09:08:01 CET3195Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwichColloidal gold20LOD250TCID50/mlAnalytical Sensitivity100%Analytical Specificity100%False positives0%False negatives4.59%Accuracy99.02%Clinical Sensitivity95.41%Clinical Specificity100%2908Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)-Self-test1285Guangzhou Wondfo Biotech Co. Ltd.Chinahttps://en.wondfo.com.cn/YesCommercialisedNoNoNear POC / POCAntigenNasal swabSARS-CoV679B.1.1.7Alpha1022B.1.351Beta1471P.1Gamma1311B.1.617.2Delta668B.1.1.529Omicronnucleocapsid proteinN.A.2022-08-24 09:08:01 CET2613Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, Double15LOD5000TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracy97.99%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.4%Clinical Specificity99.9%Type of antigenNucleocapsid protein4107SARS-CoV-2 (COVID-19) Antigen Rapid Test (Saliva) for self testing 1467Hangzhou AllTest Biotech Co LtdChinaYesCommercialisedNoNoNear POC / POCAntigenSalivaAdenovirus 3Adenovirus 7Alpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Influenza A H1N1Influenza A H3N2Influenza BMERS-CoVParainfluenza Virus Type 2Parainfluenza Virus Type 3Respiratory Syncytial V (RSV)15A.23.160AT.1668B.1.1.529Omicron679B.1.1.7Alpha1022B.1.351Beta1122B.1.427Epsilon1127B.1.429Epsilon1213B.1.525Eta1214B.1.526IotaB.1.526.1B.1.526.23116B.1.6161310B.1.617.1Kappa1311B.1.617.2Delta1312B.1.617.31313B.1.621Mu1430C.362016C.37LambdaOther1471P.1Gamma1494P.2Zeta1495P.3Thetanucleocapsid proteinThe SARS-CoV-2 (COVID-19) Antigen Rapid Test (Saliva) is a single-use test kit intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19 in human saliva. This test is designed for home use1 with self-collected saliva samples from symptomatic individuals who are suspected of being infected with SARS-CoV-2.
The SARS-CoV-2 (COVID-19) Antigen Rapid Test (Saliva) obtain a preliminary results only, the final confirmation should be based on clinical diagnosis results.2022-09-29 09:36:38 CET3892Immuno-AntigenYesYesNoImmunoassayQualitativeSandwichImmunofluorescence15LOD100AU/mLCalibrationEvaluatedAnalytical Sensitivity99%Analytical Specificity99.7%Analysis of cross reactivityEvaluatedFalse positives0.01%False negatives0.003%PrecisionEvaluatedAccuracy99.6%RobustnessEvaluatedClinical Sensitivity99%Clinical Specificity99.7%2690GSD NovaGen SARS-CoV-2 Ag Rapid Test (Nasal Swab) for self testing1003Hangzhou AllTest Biotech Co. Ltd.Chinawww.alltests.com.cnYesCommercialisedNoNoNear POC / POCAntigenNasal swab679B.1.1.7Alpha1022B.1.351Beta1471P.1Gamma1213B.1.525Eta1122B.1.427Epsilon1127B.1.429Epsilon1495P.3Theta3116B.1.6161310B.1.617.1Kappa1311B.1.617.2Delta1312B.1.617.31313B.1.621Mu15A.23.12016C.37Lambda1430C.3660AT.11214B.1.526IotaB.1.526.1B.1.526.21494P.2Zetanucleocapsid proteinThe SARS-CoV-2 Antigen Rapid Test (Nasal Swab) is a single-use test kit intended to detect the SARS-CoV-2 that causes COVID-19 with self-collected nasal swab specimen. The test is intended for use in symptomatic individuals meeting the case definition for COVID-19, and to test asymptomatic individuals limited to contacts of confirmed COVID-19 cases or probable cases and to at-risk health workers. Results are for the detection of SARS-CoV-2 Nucleocapsid protein Antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results are indicative of the presence of SARS-CoV-2. Individuals who test positive should self-isolate and seek additional care from their healthcare provider. Positive results do not rule out bacterial infection or co-infection with other viruses. Negative results do not preclude SARS-CoV-2 infection. Individuals who test negative and continue to experience COVID-like symptoms should seek follow up care from their healthcare provider.2022-08-24 09:08:01 CET2395Immuno-AntigenYesYesNoImmunoassayQualitativeSandwich15pathogens other: Human Rhinovirus 2 / Human Rhinovirus 14 / Human Rhinovirus 16 / Measles / MumpsLOD100%CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.046AUFalse negatives0.006AUPrecisionEvaluatedAccuracy97.8%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.4%AntigenClinical Specificity99.4%AntigenType of antigenNucleocapsid protein2529SARS-CoV-2 Antigen Rapid Test (Nasal Swab) for self testing126Hangzhou AllTest Biotech Co. Ltd.Chinawww.alltests.com.cnYesCommercialisedNoNoNear POC / POCAntigenNasal swabAdenovirus 3Adenovirus 7Alpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Influenza A H1N1Influenza A H3N2Influenza BMERS-CoVParainfluenza Virus Type 2Parainfluenza Virus Type 3Respiratory Syncytial V (RSV)15A.23.160AT.1668B.1.1.529Omicron679B.1.1.7Alpha1022B.1.351Beta1122B.1.427Epsilon1127B.1.429Epsilon1213B.1.525Eta1214B.1.526IotaB.1.526.1B.1.526.23116B.1.6161310B.1.617.1Kappa1311B.1.617.2Delta1312B.1.617.31313B.1.621Mu1430C.362016C.37Lambda1471P.1Gamma1494P.2Zeta1495P.3Thetanucleocapsid proteinThe SARS-CoV-2Antigen Rapid Test(Nasal Swab)is a single-use test kit intended to detect the SARS-CoV-2 that causes COVID-19 with self-collected nasal swab specimen from symptomatic individuals who are suspected of being infected with COVID-19. Results are for the detection of SARS-CoV-2 Nucleocapsid protein Antigens.An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive resultsare indicative of thepresence of SARS-CoV-2. ndividuals who test positive should self-isolate and seek additional care from their healthcare provider. Positive results do not rule out bacteria infection or co-infection with other viruses. Negative results do not precludeSARS-CoV-2 infection. Individuals who test negative and continue to experience COVID-like symptoms should seek follow up care from their healthcare provider.2022-10-12 09:39:01 CET3963Immuno-AntigenYesYesNoImmunoassayQualitativeSandwichImmunofluorescence15LOD100AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.028%False negatives0.005%PrecisionEvaluatedAccuracy98.6%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.2%AntigenClinical Specificity99.5%AntigenType of antigenNucleocapsid protein2139COVID-19 Antigen Rapid Test Device(Colloidal Gold)990HANGZHOU LYSUN BIOTECHNOLOGY Co. Ltd.Chinahttp://www.lysunbio.com/YesCommercialisedYesYesManualNear POC / POCAntigenAnterior nasal swabNasal swabNasopharyngeal swabOropharyngeal swabThroat swabAdenovirusAdenovirus 3Adenovirus 7Alpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Enterovirus A71 (EV-A71)Epstein-Barr Virus (EBV)Influenza AInfluenza A H1N1Influenza A H3N2Influenza A H5N1Influenza BInfluenza B VictoriaInfluenza B YamagataMumps Virus (MuV)RhinovirusRhinovirus ARhinovirus BSARS-CoV-2Varicella Zoster Virus (VZV)668B.1.1.529Omicron1310B.1.617.1Kappa1311B.1.617.2Delta1312B.1.617.3nucleocapsid protein2022-08-24 15:42:41 CET3702Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold10LOD150TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%479 of 479False negatives2.5%4 of 163PrecisionEvaluatedAccuracy99.38%95% CI: 98.41%~99.83%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.55%95%CI: 93.84%~99.33%Clinical Specificity100%95%CI: 99.38%~100%Type of antigenNucleocapsid protein3964SARS-Cov-2&Influenza A/B Combo Rapid Test Cassette (swab)1416Hangzhou Realy Tech Co., Ltd.Chinawww.realytech.comYesCommercialisedNoNoManualAntigenNasal swabSARS-CoV668B.1.1.529Omicron679B.1.1.7Alpha1022B.1.351Beta1127B.1.429Epsilon1311B.1.617.2Delta1471P.1Gammanucleocapsid protein2022-08-24 09:08:01 CET3629Immuno-AntigenYesYesNoImmunochromatographyQualitativeMembrane-basedColloidal gold15LOD625TCID50/mlAnalytical Sensitivity95.45%Analytical Specificity100%False positives0%False negatives4.5%Accuracy99.11%Clinical Sensitivity95.45%Clinical Specificity100%3146GENnasal SARS-CoV.2 Antigen Rapid Test1391Hangzhou Sejoy Electronics & Instruments Co. Ltd.ChinaYesCommercialisedNoNoManualAntigenNasal swabSARS-CoV679B.1.1.7Alpha1022B.1.351Beta1471P.1Gamma1213B.1.525Eta1122B.1.427Epsilon1127B.1.429Epsilon1311B.1.617.2Delta668B.1.1.529Omicronnucleocapsid proteinSensitivity, specificity and accuracy are from the newest performance evaluation - including false-positives and false-negatives. German Paul-Ehrlich-Institut (PEI) evaluated this test under test-ID AT 1269/212022-08-24 09:08:01 CET2854Immuno-AntigenYesYesNoImmunochromatographyQualitativeMembrane-based10LOD400TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1%False negatives6%PrecisionEvaluatedAccuracy98.5%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.5%Clinical Specificity99.9%Type of antigenNucleocapsid protein1929Corona Virus (COVID-19) Antigen Rapid Test (Colloidal Gold)883Hoyotek Biomedical Co. Ltd.Chinahttp://hoyotek.cn/YesCommercialisedYesYesManualNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabAdenovirusAlpha Coronavirus 229E (HCoV-229E)Influenza AInfluenza A H3N2Influenza BParainfluenza Virus Type 2Parainfluenza Virus Type 3Parainfluenza Virus Type 4Rhinovirus1311B.1.617.2Delta668B.1.1.529Omicronnucleocapsid proteinOtherThe nasal swab model of the product has been evaluated by Braizil lab and Thai RAMA Hospital. For Braizil lab: Sensitivity 97.1%, For RAMA hospital Sensitivity 95%, specificity 100%2022-08-24 09:08:01 CET1605Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold13antigen_epi: 45-181aa. Other pathogens tested for cross-reactivity: MERS-coronavirus,Adenovirus 71,Human Metapneumovirus,Enterovirus,RStreptococcus pneumoniae,espiratory syncytial virus A,Rhinovirus,Haemophilus influenza,Streptococcus pneumoniaeLOD200TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives1%Nasopharyngeal swab/AntigenFalse positives2.5%Oropharyngea swab/AntigenFalse positives5.45%Nasal swabFalse negatives4%Nasopharyngeal swab/AntigenFalse negatives7%Oropharyngea swab/AntigenFalse negatives0.21%Nasal swabPrecisionEvaluatedAccuracy98.4%Nasopharyngeal swab/AntigenAccuracy98.79%Nasal swabAccuracy94.8%Oropharyngea swab/AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93%Oropharyngea swabClinical Sensitivity96%Nasopharyngeal swabClinical Sensitivity94.55%Nasal swabClinical Specificity99%Nasopharyngeal swabClinical Specificity97.5%Oropharyngea swabClinical Specificity99.79%Nasal swabType of antigenNucleocapsid protein, Other3562Corona Virus (COVID-19) Antigen Rapid Test (Colloidal Gold) - self-testing1418Hoyotek Biomedical Co.,Ltd,Chinahttp://hoyotek.cn/YesCommercialisedNoNoManualNear POC / POCAntigenNasal swabAdenovirusAlpha Coronavirus 229E (HCoV-229E)Influenza AInfluenza A H3N2Influenza BParainfluenza Virus Type 2Parainfluenza Virus Type 3Parainfluenza Virus Type 4Rhinovirus15A.23.1668B.1.1.529Omicron679B.1.1.7Alpha1022B.1.351BetaB.1.526.1B.1.526.23116B.1.6161310B.1.617.1Kappa1311B.1.617.2Delta2016C.37Lambdanucleocapsid protein2022-08-24 09:08:01 CET3280Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold131575OJABIO SARS-CoV-2 Antigen Detection Test Kit (Colloidal Gold Method)1348Hunan Zhongke Lanhai Biotechnology Co. Ltd.Chinawww.ojabio.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swab679B.1.1.7Alpha1022B.1.351Beta1471P.1Gamma1213B.1.525Eta1122B.1.427Epsilon1127B.1.429Epsilon1495P.3Theta3116B.1.6161310B.1.617.1Kappa1311B.1.617.2Delta1312B.1.617.31313B.1.621Mu15A.23.12016C.37Lambda1430C.3660AT.11214B.1.526IotaB.1.526.1B.1.526.2668B.1.1.529Omicron1494P.2Zetanucleocapsid proteinORF1ab polyproteinORF1b polyproteinNone2022-08-24 09:08:01 CET1254Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD116TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.66%11/661False negatives0.28%1/350PrecisionEvaluatedAccuracy99.1%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.29%Clinical Specificity99.54%Type of antigenNucleocapsid protein2484Rapid SARS-CoV-2 Antigen Test147InTec Products Inc.Chinahttp://www.intecasi.comYesCommercialisedNoNoNear POC / POCAntigenNasal swab679B.1.1.7Alpha1022B.1.351Beta1471P.1Gamma1213B.1.525Eta1122B.1.427Epsilon1127B.1.429Epsilon1495P.3Theta1310B.1.617.1Kappa1311B.1.617.2Delta2016C.37Lambda1214B.1.526Iota668B.1.1.529Omicron1494P.2Zetanucleocapsid proteinThe Rapid SARS-CoV-2 Antigen Test is a colloidal gold enhanced, rapid immunochromatographic assay for qualitative detection of SARS-CoV-2 antigens in the nasal specimen collected by swabs from individuals who are suspected of having COVID-19. The test is used as an aid in the diagnosis of SARS-CoV-2 infection. This test is for self-testing. The test is for self-test with self-collected anterior nasal swab samples. It is indicated for the use of individuals aged 18 years or older with symptoms of COVID-19 within the first seven (7) days of symptom onset. Testing of individuals without symptoms should be limited to contacts of confirmed or probable cases or to other epidemiological reasons to suspect a COVID-19 infection and should be followed by additional confirmatory testing with a molecular test.2022-08-24 09:08:01 CET2187Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, Double15Other variants detected: Delta-Plus (AY.1), Natural Wild Variant. Other pathogens tested for cross-reactivity: H7N9 avian influenza virus, Legionella, Streptococcus Pneumoniae, Enterovirus A, Enterovirus B, Staphylococcus aureusLOD425TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives6.36%7 in 110 casesFalse negatives0%0 in 470 casesPrecisionEvaluatedAccuracy98.79%95%CI: 97.53%-99.51%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.64%95%CI: 87.33%-97.40%Clinical Specificity100%95%CI: 99.22%-100.00%Type of antigenNucleocapsid protein2658SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method)-Nasal (self-test)1179Jiangsu Macro & Micro-Test Med-Tech Co. Ltd.Chinahttps://www.hongweitest.com/YesCommercialisedNoNoAutomatedNear POC / POCAntigenAnterior nasal swabVaricella Zoster Virus (VZV)679B.1.1.7Alpha1022B.1.351Beta1471P.1Gamma1310B.1.617.1Kappa1311B.1.617.2Delta1312B.1.617.3668B.1.1.529Omicronnucleocapsid proteinOur product "SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method)-Nasal " has obtained the EC Notified Body Certificate (CE1434) with EC Certificate No. 1434-IVDD-016/2022, comply with requirements of Annex III(Section 6) to Directive 98/79/EC.2022-08-24 09:08:01 CET2363Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD50000copies/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.22%A total 450 negative samples are tested, and 1 subject is tested false positive by the kit.False negatives3.8%A total 105 positive samples are tested, and 4 subjects are tested false negative by the kit.PrecisionEvaluatedAccuracy99.1%97.91% to 99.61%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.19%90.61% to 98.51%Clinical Specificity99.78%98.75% to 99.96%Type of antigenNucleocapsid protein3974SARS-CoV-2 & Influenza A/B Antigen Combo Rapid Test Kit (LFIA) 1446Jiangsu Medomics Medical Technology Co., LtdChinawww.medomics-dx.comYesCommercialisedNoNoManualAntigenAnterior nasal swabInfluenza AInfluenza A H1N1Influenza A H3N2Influenza BInfluenza B VictoriaInfluenza B YamagataOther668B.1.1.529Omicron679B.1.1.7Alpha1122B.1.427Epsilon1127B.1.429Epsilon1214B.1.526Iota1310B.1.617.1Kappa1311B.1.617.2Delta1471P.1Gammanucleocapsid protein2022-08-24 09:08:01 CET3639Immuno-AntigenYesYesNoImmunochromatographyQualitativeMembrane-basedColloidal gold15LOD10TCID50/mlAnalytical Sensitivity86.46%Analytical Specificity100%False positives0%False negatives13.54%Accuracy97.8%Clinical Sensitivity86.46%Clinical Specificity100%4099SARS-CoV-2 Antigen Rapid Test (Self-Testing) (Nasal)1466JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO. LTD.ChinaYesCommercialisedNoNoManualAntigenAnterior nasal swabSARS-CoVSARS-CoV-2668B.1.1.529Omicron679B.1.1.7Alpha1022B.1.351Beta1311B.1.617.2Deltanucleocapsid protein2022-09-29 09:02:26 CET3887Immuno-AntigenYesYesYesImmunochromatographyQuantitativeMembrane-basedColloidal gold10LOD500TCID50/mlCalibrationEvaluatedAnalytical Sensitivity93.55%Analytical Specificity99.9%Analysis of cross reactivityEvaluatedFalse positives0stripsFalse negatives8stripsPrecisionEvaluatedAccuracy98.61%RobustnessEvaluatedClinical Sensitivity93.55%Clinical Specificity99.9%3678Lomina SARS-CoV-2 Antigen LTX Selftest1430Lomina Sperbio a.s.Czechialomina.chYesCommercialisedNoNoNear POC / POCAntigenNasal swabSARS-CoV668B.1.1.529Omicron1311B.1.617.2Delta1471P.1Gammanucleocapsid protein2022-08-24 09:08:01 CET3365Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwichOther15False positives0.47%False negatives1.26%4070Lomina SARS-CoV-2 Antigen LTX Selftest1002Lomina Superbio a.s.Czechiawww.lomina.chYesCommercialisedNoNoNear POC / POCAntigenNasal swabSARS-CoV-2668B.1.1.529Omicron1022B.1.351Beta1311B.1.617.2Delta1471P.1GammaORF1a polyprotein2022-09-20 14:42:38 CET3832Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwichImmunofluorescence15LOD300000TCID50/ml3x10^5CalibrationEvaluatedAnalytical Sensitivity100%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives0.47%False negatives1.26%PrecisionEvaluatedAccuracy98.97%RobustnessEvaluatedClinical Sensitivity97.04%Clinical Specificity99.8%2923COVIFIND COVID-19 Antigen Self Test461Meril Diagnostics Pvt Ltd.Indiawww.merillife.comYesCommercialisedNoNoManualAntigenNasal swab679B.1.1.7Alpha1022B.1.351Beta1471P.1Gamma1213B.1.525Eta1122B.1.427Epsilon1127B.1.429Epsilon1495P.3Theta1310B.1.617.1Kappa1311B.1.617.2Delta1312B.1.617.32016C.37Lambda1214B.1.526Iota668B.1.1.529Omicron1494P.2Zetanucleocapsid proteinProduct is CE certified by the notifying body PCBC 14342022-08-24 09:08:01 CET2628Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich15LODLOD of COVIFIND Covid-19 antigen Self Test is ≥ 933 TCID50/ml.CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%The product is having zero False positive, specificity is 100%False negatives1.75%The product is having sensitivity of 98.25%, Gives 1.75% false negative resultsPrecisionEvaluatedAccuracy98.25%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.25%Clinical Specificity100%Type of antigenNucleocapsid protein2343CoviSelf COVID-19 Antigen Lateral Flow Test Device OTC Home Test1081Mylab Discovery Solutions Pvt. Ltd.Indiahttps://mylabdiscoverysolutions.com/YesCommercialisedNoNoManualAntigenAnterior nasal swabMid-turbinates swabNasal swab679B.1.1.7Alpha1022B.1.351Beta1471P.1Gamma1213B.1.525Eta1122B.1.427Epsilon1127B.1.429Epsilon1495P.3Theta3116B.1.6161310B.1.617.1Kappa1311B.1.617.2Delta1312B.1.617.31313B.1.621Mu15A.23.12016C.37Lambda1430C.3660AT.11214B.1.526IotaB.1.526.1B.1.526.21494P.2Zeta668B.1.1.529Omicronnucleocapsid protein2022-08-24 09:08:01 CET2044Immuno-AntigenYesYesNoImmunoassayQualitativeCapture15Ares(2022)4013819LOD85TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.81%6/736False negatives1.49%11/736PrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.18 (Antigen)Clinical Specificity98.9(Antigen)Type of antigenNucleocapsid protein4067SARS-CoV-2 Nucleocapsid (N) Antigen Rapid Detection Kit (Colloidal gold method)1459Nanjing Synthgene Medical Technology Co., Ltd.Chinawww.syngenemed.comYesCommercialisedNoNoManualAntigenAnterior nasal swabDeep (cough) sputumMid-turbinates swabNasal swabNasopharyngeal swabOropharyngeal swabSalivaSputumThroat swabAdenovirusAdenovirus 3Adenovirus 7Adenovirus Subtype BAdenovirus Subtype CAlpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Anti-Nuclear AntibodyBeta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Bordetella PertussisChlamydia PneumoniaeCoronaviruses (HCoV)Cytomegalovirus (CMV)Enterovirus A71 (EV-A71)Epstein-Barr Virus (EBV)Hemophilus InfluenzaeHepatitis A Virus (HAV)Hepatitis B Virus (HBV)Hepatitis C Virus (HCV)Herpes Simplex (HSV)Human Immunodeficiency Virus (HIV)Human Metapneumovirus (HMPV)Influenza AInfluenza A H1N1Influenza A H3N2Influenza A H5N1Influenza BInfluenza B VictoriaInfluenza B YamagataMERS-CoVMumps Virus (MuV)Mycobacterium TuberculosisMycoplasma PneumoniaeParainfluenza Virus TypeParainfluenza Virus Type 1Parainfluenza Virus Type 2Parainfluenza Virus Type 3Parainfluenza Virus Type 4Respiratory Syncytial V (RSV)Respiratory Syncytial V (RSV) Type ARespiratory Syncytial V (RSV) Type BRhinovirusRhinovirus ARhinovirus BSARS-CoVSARS-CoV-2Varicella Zoster Virus (VZV)15A.23.160AT.1668B.1.1.529Omicron679B.1.1.7Alpha1022B.1.351Beta1122B.1.427Epsilon1127B.1.429Epsilon1213B.1.525Eta1214B.1.526IotaB.1.526.1B.1.526.23116B.1.6161310B.1.617.1Kappa1311B.1.617.2Delta1312B.1.617.31313B.1.621Mu1430C.362016C.37LambdaOther1471P.1Gamma1494P.2Zeta1495P.3Thetanucleocapsid protein2022-09-20 14:33:39 CET3829Immuno-AntigenYesYesYesImmunoassayQualitativeSandwich, DoubleColloidal gold10LOD100TCID50/mlCalibrationEvaluatedAnalytical Sensitivity99.45%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives0%False negatives0.55%PrecisionEvaluatedAccuracy99.75%RobustnessEvaluatedClinical Sensitivity99.45%Clinical Specificity100%2983Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Detection Kit (Colloidal Gold-Based) - self-testing184Nanjing Vazyme Medical Technology Co. Ltd.Chinawww.vazyme.comYesCommercialisedNoNoManualNear POC / POCAntigenNasal swabSARS-CoV-2668B.1.1.529Omicron679B.1.1.7Alpha1022B.1.351Beta1122B.1.427Epsilon1127B.1.429Epsilon1213B.1.525Eta1214B.1.526Iota1310B.1.617.1Kappa1311B.1.617.2Delta2016C.37Lambda1471P.1Gammanucleocapsid proteinspike proteinVazyme has established independent process to ensure that variants are monitored in time. Each variant listed as “variant of concern” and “variant of interest” by World Health Organization (WHO) will be studied since the date of listing. And the study procedure is as follows:
Step one: In-silico analysis
Note: In in-silico analysis, the overlap of mutation site of new variant and the epitope of antibodies used in the test will be analyzed to identify potential impact on the performance of test kit.
Step two: Validation of Limit of Detection (LOD) in form of TCID50/mL, if necessary.
Step three:Clinical performance validation of Positive Percent Agreement (PPA), if necessary.2022-11-03 08:47:43 CET5277Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, DoubleColloidal goldDetection Kit10LOD50TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives%False negatives6%PrecisionEvaluatedAccuracy98.15%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94%AntigenClinical Specificity100%AntigenType of antigenNucleocapsid protein (N) Spike protein (S1501COVID-19 Antigen Detection Kit1074New Gene (Hangzhou) Bioengineering Co. Ltd.Chinawww.new-gene.net/YesCommercialisedYesYesLab-basedManualNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swab679B.1.1.7Alpha1022B.1.351Beta1122B.1.427Epsilon1127B.1.429Epsilon1310B.1.617.1Kappa1311B.1.617.2Delta1312B.1.617.31471P.1Gamma1213B.1.525Eta1495P.3Theta3116B.1.6161313B.1.621Mu15A.23.12016C.37Lambda1430C.3660AT.11214B.1.526IotaB.1.526.1B.1.526.2668B.1.1.529Omicron1494P.2Zetanucleocapsid proteinThe COVID-19 Antigen Detection Kit by New Gene (Hangzhou) Bioengineering Co., Ltd. has been widely used in practice in many EU member countries. Please visit the following links, and search search “New Gene” in their whitelists for more information. (Germany) https://antigentest.bfarm.de/ords/f?p=110:100:17097377707548 (France) https://covid-19.sante.gouv.fr/tests (Belgium)https://www.famhp.be/en/human_use/health_products/medical_devices_accessories/covid_19/tests ( Italy) https://www.salute.gov.it/interrogazioneDispositivi/RicercaDispositiviServlet?action=ACTION_MASCHERA (Portugal) https://www.infarmed.pt/web/Infarmed/pesquisa-dispositivos2022-08-24 09:08:01 CET1251Immuno-AntigenYesYesNoImmunoassayQualitativeSandwich, Double30LOD0.05ng/mLCalibrationEvaluatedCalibrationEvaluatedAnalysis of cross reactivityEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.87%1 out of 114False negatives2.02%5 out of 247PrecisionEvaluatedAccuracy98.3%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98%AntigenClinical Specificity99.1%AntigenType of antigenNucleocapsid protein2303COVID-19 Antigen Detection Kit - Nasal Swab (for Self-Test use)1074New Gene (Hangzhou) Bioengineering Co. Ltd.Chinawww.new-gene.net/YesCommercialisedNoNoLab-basedManualNear POC / POCAntigenAnterior nasal swabNasal swabSARS-CoV-215A.23.160AT.1668B.1.1.529Omicron679B.1.1.7Alpha1022B.1.351Beta1122B.1.427Epsilon1127B.1.429Epsilon1213B.1.525Eta1214B.1.526IotaB.1.526.1B.1.526.23116B.1.6161310B.1.617.1Kappa1311B.1.617.2Delta1312B.1.617.31313B.1.621Mu1430C.362016C.37Lambda1471P.1Gamma1494P.2Zeta1495P.3Thetanucleocapsid proteinThe COVID-19 Antigen Detection Kit - Nasal Swab by New Gene (Hangzhou) Bioengineering Co., Ltd. has got NBCE certificate (EC Certificate No. 1434-IVDD-476/2021) for SELF-TEST use by laypeople.2022-12-07 08:45:18 CET5362Immuno-AntigenYesYesNoImmunoassayQualitativeSandwich, DoubleColloidal gold30LOD0.05ng/mLCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.5%1/201False negatives3.2%7/220PrecisionEvaluatedAccuracy98.1%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.8%AntigenClinical Specificity99.1%AntigenType of antigenNucleocapsid protein2845COVID-19 and Influenza A+B Rapid Antigen Combo Test1267NewScen Coast Bio-Pharmaceutical Co. Ltd. (NewScen)Chinahttps://newscenbiotech.com/YesCommercialisedNoNoManualNear POC / POCAntigenThroat swab679B.1.1.7Alpha1022B.1.351Beta1471P.1Gamma1213B.1.525Eta1122B.1.427Epsilon1127B.1.429Epsilon1495P.3Theta3116B.1.6161310B.1.617.1Kappa1311B.1.617.2Delta1312B.1.617.31313B.1.621Mu15A.23.12016C.37Lambda1430C.3660AT.11214B.1.526IotaB.1.526.1B.1.526.2668B.1.1.529Omicron1494P.2Zeta2022-08-24 09:08:01 CET2550Immuno-AntigenYesYesYesImmunoassayQualitativeSandwich, Double15LOD250TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy99.6%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.8%Clinical Specificity99.8%Type of antigenNucleocapsid protein2281Ninonasal-Autotest572NG BiotechFrancehttps://ngbiotech.com/YesCommercialisedNoNoNear POC / POCAntigenNasal swab679B.1.1.7Alpha1022B.1.351Beta1471P.1Gamma1213B.1.525Eta1122B.1.427Epsilon1127B.1.429Epsilon1310B.1.617.1Kappa1311B.1.617.2Delta1313B.1.621Mu2016C.37Lambda1214B.1.526Iota668B.1.1.529Omicronnucleocapsid proteinUpdated list of variants2022-08-24 09:08:01 CET1982Immuno-AntigenYesYesNoImmunochromatographyQualitativeMembrane-based20LOD1AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.512 false positive result out of 390 negative samples confirmed by RT-PCR)False negatives2.34%3 false negative results out of 128 positive samples confirmed by RT-PCRPrecisionEvaluatedReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity98%Clinical Specificity99%Type of antigenNucleocapsid protein4049SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Method)1388NINGBO LVTANG BIOTECHNOLOGY Co. Ltd.Chinawww.lvtangbio.comYesCommercialisedYesYesManualAntigenNasal swabSARS-CoV668B.1.1.529Omicron679B.1.1.7Alpha1022B.1.351Beta1311B.1.617.2Delta1313B.1.621Mu2016C.37Lambda1471P.1Gammanon-structural protein NSP1non-structural protein NSP10non-structural protein NSP12non-structural protein NSP13non-structural protein NSP14non-structural protein NSP15non-structural protein NSP16non-structural protein NSP2non-structural protein NSP3non-structural protein NSP4non-structural protein NSP5non-structural protein NSP6non-structural protein NSP7non-structural protein NSP8non-structural protein NSP9nucleocapsid protein2022-09-20 12:46:21 CET5461Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD350TCID50/mlCalibrationEvaluatedAnalytical Sensitivity97.97%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives1.3%False negatives4.5%PrecisionEvaluatedAccuracy97.8%RobustnessEvaluatedClinical Sensitivity95.5%Clinical Specificity98.7%2868Surety1274NulifeIndianulifecare.inYesCommercialisedNoNoManualNear POC / POCAntigenNasal swabNasopharyngeal swab679B.1.1.7Alpha1022B.1.351Beta1213B.1.525Eta1122B.1.427Epsilon1127B.1.429Epsilon3116B.1.6161310B.1.617.1Kappa1311B.1.617.2Delta1312B.1.617.31313B.1.621Mu1214B.1.526IotaB.1.526.1B.1.526.2668B.1.1.529Omicronnon-structural protein NSP1non-structural protein NSP10non-structural protein NSP12non-structural protein NSP13non-structural protein NSP14non-structural protein NSP15non-structural protein NSP16non-structural protein NSP2non-structural protein NSP3non-structural protein NSP4non-structural protein NSP5non-structural protein NSP6non-structural protein NSP7non-structural protein NSP8non-structural protein NSP9nucleocapsid proteinspike proteinThe test has been CE approved by Global Euro Accreditation Centre. It is manufactured in India by NuLife (IS09001/2015 & CMP certified company) under contract for E.J. Bodkin + Co, Dublin, Ireland. Accuracy rates are independently assessed and verified by Indian government.2022-08-24 09:08:01 CET2573Immuno-AntigenYesYesNoImmunochromatographySandwich15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1.4%98.6False negatives0%100PrecisionEvaluatedAccuracy98.6%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.6%AntigenClinical Specificity100%AntigenType of antigenNucleocapsid protein3100GeneFinder™ COVID-19 Ag Dipstick Self Test702OSANG Healthcare Co. Ltd.South Koreahttp://www.osanghc.com/enYesCommercialisedNoNoNear POC / POCAntigenNasal swabSARS-CoV679B.1.1.7Alpha1022B.1.351Beta1471P.1Gamma1311B.1.617.2Delta668B.1.1.529Omicron1494P.2Zetanucleocapsid proteinUsing Dipstick Self test, FIND is providing Osang Healthcare with a support package that following an open call for proposals to accelerate the availability of affordable SARS-CoV-2 self-tests(Nasal swab) in low- and middle-income countries (LMICs)2022-08-24 09:08:01 CET2806Immuno-AntigenYesYesNoImmunoassayQualitativeCapture15lineages_performances 1. Positve standard material : 750 TCID50/mL 2. B.1.1.7 (Alpha) : 750 TCID50/mL 3. B.1.351 (Beta) : 750 TCID50/mL 4. B.1.617.2 (Delta) : 750 TCID50/mL 5.. P.1 (Gamma) : 750 TCID50/mL 6. B.1.1.529 (Omicron) : 750 TCID50/mL; antigen_epi Monoclonal anti-SARS-CoV-2 nucleoprotein antibody (detection Ab) Epitope Target : 47-173 Monoclonal anti-SARS-CoV-2 nucleoprotein antibody (capture Ab) Epitope arget : 44-175; other lineages detected: BA2.0 (Stealth)LOD750TCID50/mlRdRP/S gene : Ct value 27.23CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%Predict Postivie Value : 100% (95% CI : 93.79 - 100.00)False negatives1.68%Predict Negative Value : 98.32% (95% CI : 94.08 - 99.54)PrecisionEvaluatedAccuracy99.32%95% CI : 96.25 - 99.88, 146/147ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.67%95% CI : 83.33 - 99.41, 29/30Clinical Specificity100%95% CI : 96.82 - 100.00, 117/117Type of antigenNucleocapsid protein2806GeneFinder™ COVID-19 Ag Self Test702OSANG Healthcare Co. Ltd.South Koreahttp://www.osanghc.com/enYesCommercialisedNoNoNear POC / POCAntigenNasal swabSARS-CoV679B.1.1.7Alpha1022B.1.351Beta1471P.1Gamma1311B.1.617.2Delta1494P.2Zeta668B.1.1.529Omicronnucleocapsid proteinMFDS 22-106 approved by Korea FDA A. OI-01SA-SE : CE COC (Certification No. 1434-IVDD-082-2022) B. OI-01SA-SH : FDA EUA (EUA No. 220037) C. G-Tech COVID-19 Ag Rapid Test : ANVISA (No. 0440463227)2022-08-24 09:08:01 CET2511Immuno-AntigenYesYesNoImmunoassayQualitativeCapture15antigen_epi Monoclonal anti-SARS-CoV-2 nucleoprotein antibody (detection Ab) Epitope Target : 47-173 Monoclonal anti-SARS-CoV-2 nucleoprotein antibody (capture Ab) Epitope arget : 44-17; lineages_performances 1. Positve standard material : 750 TCID50/mL 2. B.1.1.7 (Alpha) : 750 TCID50/mL 3. B.1.351 (Beta) : 380 TCID50/mL 4. B.1.617.2 (Delta) : 750 TCID50/mL 5.. P.1 (Gamma) : 750 TCID50/mL 6. B.1.1.529 (Omicron) : 750 TCID50/mL; other lineages detected: BA2.0 (Stealth)LOD750TCID50/mlCt value (RdRP/S) 27.23CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%Predict Postivie Value : 100% (95% CI : 93.79 - 100.00)False negatives1.68%Predict Negative Value : 98.32% (95% CI : 94.08 - 99.54)PrecisionEvaluatedAccuracy98.8795% CI : 95.97 - 99.69 - (175/177)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.67%95% CI: 88.64 – 99.08 - (58/60)Clinical Specificity100%95% CI: 96.82 – 100.00 - (117/117)Type of antigenNucleocapsid protein3694PCL SELF TEST - COVID19 Ag1043PCL Inc.South Koreawww.pclchip.comYesCommercialisedNoNoManualAntigenNasal swabSalivaSARS-CoV668B.1.1.529Omicron679B.1.1.7Alpha1022B.1.351Beta1127B.1.429Epsilon1213B.1.525Eta1310B.1.617.1Kappa1311B.1.617.2Delta1471P.1Gammanucleocapsid protein2022-08-24 09:08:01 CET3377Immuno-AntigenYesYesNoImmunochromatographyQualitativeMembrane-basedColloidal gold10LOD562TCID50/mlAnalytical Sensitivity100%Analytical Specificity100%False positives0.3%False negatives9.9%Accuracy97.31%Clinical Sensitivity90.1%Clinical Specificity99.68%2830SoluM COVID 19-Ag1262PhilosysSouth Koreawww.philosys.comYesCommercialisedNoNoNear POC / POCAntigenNasal swab668B.1.1.529OmicronVarious variants of SARS-CoV-2 virus are emerged majorly due to the mutation of Spike protein(S) • Therefore, accuracy of PCR test, vaccine are affected as they aim at Spike protein • On the other hand, accuracy of Gmate COVID-19 Ag test kit is not affected as it aims at Nucleocapsid (N) for its test2022-08-24 09:08:01 CET2535Immuno-AntigenYesYesNoImmunoassayQualitative15LOD5.07U/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives9.09%10 out of 110False negatives9.09%100 out of 110PrecisionEvaluatedAccuracy96.67%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95%Clinical SpecificityschwalbachType of antigenSpike protein2829SoluM COVID-19 Ag Saliva1262PhilosysSouth Koreawww.philosys.comYesCommercialisedNoNoManualAntigenSaliva668B.1.1.529Omicronspike proteinVarious variants of SARS-CoV-2 virus are emerged majorly due to the mutation of Spike protein(S) • Therefore, accuracy of PCR test, vaccine are affected as they aim at Spike protein • On the other hand, accuracy of Gmate COVID-19 Ag test kit is not affected as it aims at Nucleocapsid (N) for its test2022-08-24 09:08:01 CET2534Immuno-AntigenYesYesNoImmunoassayQualitative15LOD5.07AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives9.09%10 out of 110False negatives9.09%100 out of 110PrecisionEvaluatedAccuracy96.67%Accuracy98.87%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.84%Clinical SpecificityschwalbachType of antigenNucleocapsid protein1341SARS-CoV-2 Antigen Rapid Test286Qingdao Hightop Biotech Co. Ltd.Chinawww.hightopbio.comYesCommercialisedYesYesManualNear POC / POCAntigenAnterior nasal swabNasal swabNasopharyngeal swabOropharyngeal swabSARS-CoV15A.23.160AT.1668B.1.1.529Omicron679B.1.1.7Alpha1022B.1.351Beta1122B.1.427Epsilon1127B.1.429Epsilon1213B.1.525Eta1214B.1.526IotaB.1.526.1B.1.526.23116B.1.6161310B.1.617.1Kappa1311B.1.617.2Delta1312B.1.617.31313B.1.621Mu1430C.362016C.37Lambda1471P.1Gamma1494P.2Zeta1495P.3Thetanucleocapsid proteinHIGHTOP SARS-COV-2 ANTIGEN RAPID TEST, CAN BE USED FOR SELF-TESTING AND FOR PROFESSIONAL TESTING, CONTACT FOR ORDERS ALLEN@HIGHTOPBIO.COM2022-11-17 09:51:03 CET5319Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, DoubleColorimetry15LOD8TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives%False negatives1.96%PrecisionEvaluatedAccuracy99.5%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.04%Clinical Specificity100%Type of antigenNucleocapsid protein3972Red Cell COVID-19 Self Test1445Red Cell Biyoteknoloji A.Ş.Turkeywww.redcell.com.trYesCommercialisedNoNoManualNear POC / POCAntigenAnterior nasal swabMid-turbinates swabNasal swabOther15A.23.160AT.1668B.1.1.529Omicron679B.1.1.7Alpha1022B.1.351Beta1122B.1.427Epsilon1127B.1.429Epsilon1213B.1.525Eta1214B.1.526IotaB.1.526.1B.1.526.23116B.1.6161310B.1.617.1Kappa1311B.1.617.2Delta1312B.1.617.31313B.1.621Mu1430C.362016C.37Lambda1471P.1Gamma1494P.2Zeta1495P.3Thetanucleocapsid protein2022-08-24 09:08:01 CET3637Immuno-AntigenYesYesNoImmunochromatographyQualitativeMembrane-basedOther15LOD33PFU/mLAnalytical Sensitivity100%Analytical Specificity100%False positives0N.A.False negatives0.025ng/mLAccuracy97.9%Clinical Sensitivity96.3%Clinical Specificity99.5%2938Reszon COVID-19 Rapid Antigen Test (Nasal Swab)1174Reszon Diagnostics International Sdn. Bhd.Malaysiahttps://reszonics.com/YesCommercialisedNoNoManualNear POC / POCAntigenAnterior nasal swab679B.1.1.7Alphanucleocapsid proteinReszon COVID-19 Rapid Antigen Test (Nasal Swab) is an immunochromatographic assay designed for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in human anterior nasal swab specimen. It is intended to be used for the detection of SARS-CoV-2 virus infection. The results obtained should not be the sole determinant for clinical decision. The Reszon COVID-19 Rapid Antigen Test (Nasal Swab) is intended for use by clinical laboratories or healthcare workers for point-of-care testing and home self-testing.2022-08-24 09:08:01 CET2644Immuno-AntigenYesYesNoImmunochromatographyQualitativeMembrane-based15LOD150TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%0 out of 140 negative samplesFalse negatives2.8%3 out of 107 positive samplesPrecisionEvaluatedAccuracy98.8%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.27%AntigenClinical Specificity100%AntigenType of antigenNucleocapsid protein3039BioGerm SARS-CoV-2 Antigen Self Test927Shanghai BioGerm Medical Technology Co. Ltd.Chinahttp://en.bio-germ.com/YesCommercialisedNoNoNear POC / POCAntigenAnterior nasal swabSARS-CoV679B.1.1.7Alpha1022B.1.351Beta1471P.1Gamma1213B.1.525Eta1122B.1.427Epsilon1127B.1.429Epsilon3116B.1.6161310B.1.617.1Kappa1311B.1.617.2Delta1313B.1.621Mu2016C.37Lambda1214B.1.526Iota1494P.2Zeta668B.1.1.529Omicronnucleocapsid protein2022-08-24 09:08:01 CET2745Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, Double10LOD200TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedAccuracy95.05%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity97.17%Clinical Specificity99.68%Type of antigenNucleocapsid protein3080Chemtrue® COVID-19(SARS-CoV-2)Antigen Rapid Test Kit (Nasal Swab) - self-test1359Shanghai Chemtron Biotech Co. Ltd.Chinawww.chemtronbio.comYesCommercialisedNoNoManualAntigenNasal swab679B.1.1.7Alpha1022B.1.351Beta1213B.1.525Eta1122B.1.427Epsilon3116B.1.6161311B.1.617.2Delta1312B.1.617.3B.1.526.1B.1.526.2668B.1.1.529OmicronORF1ab polyproteinChemtrue® COVID-19 (SARS-CoV-2)Antigen Rapid Test Kit(Nasal Swab); Evaluated by Centralne Laboratorium Kliniczne Uniwersyteckie Centrum Kliniczne, 80-214 Gdansk, Ul. Mariana Smoluchowskiego 17 ( University Clinical Center, 80-214 Gdansk Mariana Smoluchowskiego 17 street) Person in charge of Statistics and Unit: Pawel Chrzan PhD. Contact number: +48 5858443802022-08-24 09:08:01 CET2786Immuno-AntigenYesYesNoImmunoassayQualitativeSandwich10LOD50TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives14.55AUPrecisionEvaluatedAccuracy97.17%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity85.45%AntigenClinical Specificity100%AntigenType of antigenEnvelop protein3104SARS-CoV-2 (COVID-19) Antigen Rapid Detection Kit (Lateral Flow Method) (Nasal swab)1132Shen Zhen Zi Jian Biotechnology Co. Ltd.Chinahttp://www.szzijian.com/YesCommercialisedNoNoManualAntigenNasal swabSARS-CoV679B.1.1.7Alpha1022B.1.351Beta1471P.1Gamma1213B.1.525Eta1122B.1.427Epsilon1127B.1.429Epsilon1495P.3Theta3116B.1.6161310B.1.617.1Kappa1311B.1.617.2Delta1312B.1.617.31313B.1.621Mu15A.23.12016C.37Lambda1430C.3660AT.11214B.1.526IotaB.1.526.1B.1.526.2668B.1.1.529Omicron1494P.2Zetanucleocapsid proteinhttp://www.szzijian.com/2022-08-24 09:08:01 CET2810Immuno-AntigenYesYesNoImmunochromatographyQualitative15LOD32600TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.06AUFalse negatives0AUPrecisionEvaluatedAccuracy98.5%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94%AntigenClinical Specificity100%AntigenType of antigenNucleocapsid protein3125COVID-19 Antigen Rapid Test1383Shenzhen Everbest Machinery lndustry Co. Ltd.Chinawww.cem-instruments.comYesCommercialisedNoNoManualAntigenNasal swab1311B.1.617.2Delta668B.1.1.529Omicronnucleocapsid proteinThe COVID-19 Antigen Rapid Test is a lateral flow chromatographic immunoassay test for detection of the Nucleocapsid (N) Protein of SARS-CoV-2 virus and used for in vitro qualitative detection of SARS-CoV-2 antigen in human anterior nasal swab specimens.2022-08-24 09:08:01 CET2833Immuno-AntigenYesYesN.A.ImmunochromatographyQualitative15LOD494TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positivesSARS-coronavirus shows 90.52% homology across 100% of the nucleocapsid sequence.False negativesNegative test results are not intended to rule in other non-SARS viral or bacterial infections.PrecisionEvaluatedAccuracy98.62%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.73%Clinical Specificity100%Type of antigenNucleocapsid protein3356SARS-CoV-2 Antigen Test Kit (Colloidal Gold)1106Shenzhen Huian Biosci Technology Co. Ltd.Chinawww.huiantech.comYesCommercialisedNoNoNear POC / POCOtherAntigenAnterior nasal swabSARS-CoV15A.23.160AT.1668B.1.1.529Omicron679B.1.1.7Alpha1022B.1.351Beta1122B.1.427Epsilon1213B.1.525EtaB.1.526.1B.1.526.23116B.1.6161310B.1.617.1Kappa1311B.1.617.2Delta1312B.1.617.31430C.362016C.37Lambda1471P.1Gamma1494P.2Zeta1495P.3Thetanucleocapsid protein2022-08-24 09:08:01 CET3096Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD150TCID50/mlAnalytical Sensitivity84%Analytical Specificity100%False positives0%False negatives17.95%Accuracy93%Clinical Sensitivity82.05%Clinical Specificity100%5738SARS-CoV-2 Antigen Rapid Self-test Kit (Colloidal Gold)3204SHENZHEN REETOO BIOTECHNOLOGY CO. LTDChinahttp://www.reetoo.com.cn/YesCommercialisedNoNoManualAntigenAnterior nasal swabAdenovirusAlpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Coronaviruses (HCoV)Cytomegalovirus (CMV)Epstein-Barr Virus (EBV)Human Metapneumovirus (HMPV)Influenza AInfluenza A H1N1Influenza A H3N2Influenza A H5N1Influenza BInfluenza B VictoriaInfluenza B YamagataMumps Virus (MuV)Respiratory Syncytial V (RSV)Rhinovirus668B.1.1.529Omicron679B.1.1.7Alphanucleocapsid protein2022-10-31 09:11:51 CET5252Immuno-AntigenYesYesNoImmunoassayQualitativeSandwichColloidal gold15LOD200TCID50/mlCalibrationNot evaluatedAnalytical Sensitivity90%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives0.25%False negatives3.96%PrecisionEvaluatedAccuracy99%RobustnessEvaluatedClinical Sensitivity96.04%Clinical Specificity99.75%3999 2019-nCoV Antigen Rapid Test (Immunochromatography Assay)1367Shenzhen Superbio Technology Co. Ltd.Chinahttp://superbiodx.com/YesCommercialisedNoNoNear POC / POCOtherAntigenNasal swabAdenovirusAdenovirus 3Adenovirus 7Adenovirus Subtype BAdenovirus Subtype CAlpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Bordetella PertussisCoronaviruses (HCoV)Cytomegalovirus (CMV)Hemophilus InfluenzaeInfluenza AInfluenza A H1N1Influenza A H3N2Influenza BInfluenza B VictoriaInfluenza B YamagataMERS-CoVMumps Virus (MuV)Mycoplasma PneumoniaeParainfluenza Virus Type 2Respiratory Syncytial V (RSV)RhinovirusVaricella Zoster Virus (VZV)668B.1.1.529Omicron679B.1.1.7Alpha1022B.1.351Beta1122B.1.427Epsilon1127B.1.429Epsilon1213B.1.525Eta1214B.1.526Iota1310B.1.617.1Kappa1311B.1.617.2Deltanucleocapsid protein2022-08-24 09:08:01 CET3664Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, DoubleOther15LOD80testsAnalytical Sensitivity80%Analytical Specificity100%False positives0.01%False negatives7.58%Accuracy97.69%Clinical Sensitivity92.42%Clinical Specificity100%57662019-nCOV Antigen Rapid Test1367Shenzhen Superbio Technology Co. Ltd.Chinahttp://superbiodx.com/YesCommercialisedNoNoNear POC / POCAntigenNasal swabAlpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Beta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)SARS-CoV-2668B.1.1.529Omicron1311B.1.617.2Deltanucleocapsid protein2022-11-17 10:03:50 CET5321Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwichColloidal gold15LOD80TCID50/mlCalibrationNot evaluatedAnalytical Sensitivity92%Analytical Specificity99%Analysis of cross reactivityEvaluatedFalse positivessamples122 Positive and 0 falseFalse negatives10samples300 Negative and 10 falsePrecisionNot evaluatedAccuracy97%RobustnessNot evaluatedClinical Sensitivity100%Clinical Specificity100%3270COVID-19 Ag+Flu A/Flu B Rapid Test (Immunochromatography Assay)1405Shenzhen Superbio Technology Co.,Ltd.Chinahttp://superbiodx.com/YesCommercialisedNoNoManualAntigenNasal swabNasopharyngeal swabOropharyngeal swabInfluenza AInfluenza BSARS-CoV668B.1.1.529Omicron1022B.1.351Beta1311B.1.617.2Delta1312B.1.617.3nucleocapsid protein2022-08-24 09:08:01 CET3034Immuno-AntigenYesYesYesImmunochromatographyQualitativeSandwich, DoubleOther152999SARS-CoV-2 Antigen Test Kit (Colloidal Gold)1327Shenzhen Uni-medica Technology Co. Ltd.Chinawww.uni-medica.comYesNoNoManualAntigenAnterior nasal swabSARS-CoVUnknownnone2022-08-24 09:08:01 CET2705Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwichColloidal gold15CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.45%False negatives1.74%PrecisionEvaluatedAccuracy99.29%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.26%Clinical Specificity99.56%3042SARS-CoV-2 Ag Self-test Kit (Saliva)1353Shenzhen Watmind Medical Co. Ltd.Chinahttp://www.watmind.comYesCommercialisedNoNoNear POC / POCAntigenSalivaCoronaviruses (HCoV)679B.1.1.7Alpha1022B.1.351Beta1471P.1Gamma1213B.1.525Eta1122B.1.427Epsilon1127B.1.429Epsilon1495P.3Theta1310B.1.617.1Kappa1311B.1.617.2Delta1313B.1.621Mu2016C.37Lambda1214B.1.526Iota668B.1.1.529Omicron1494P.2Zetanucleocapsid proteinThis kit is used for in vitro qualitative detection of Nucleocapsid(N) Protein antigen from SARS-CoV-2 in human saliva samples.2022-08-24 09:08:01 CET2748Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, Double15LOD150TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1%False negatives9%PrecisionEvaluatedAccuracy95.5%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90.79%95%CI:85.13%-94.43%for CT values ≤36Clinical Specificity99.01%95%CI: 96.48%-99.73%Type of antigenNucleocapsid protein2054TODA Autotest Nasal Covid-19681TODA PHARMAFrancehttps://www.todapharma.com/YesCommercialisedNoNoNear POC / POCAntigenAnterior nasal swabNasal swab679B.1.1.7Alpha1022B.1.351Beta1471P.1Gamma3116B.1.6161310B.1.617.1Kappa1311B.1.617.2Delta1312B.1.617.3nucleocapsid proteinPlease kindly note that the above mentioned performance rates are based on nasal swab.2022-08-24 09:08:01 CET1734Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, Double15LOD0AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives3.38%On 59 negative samples confirmed by RT-PCR, 57 were also negative with our test : 2 false positivesFalse negatives0%On 34 positive samples confirmed by RT-PCR, 34 were also negative with our test : 0 false negativePrecisionEvaluatedAccuracy97%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94%Clinical Specificity99%Type of antigenNucleocapsid protein2522Unibioscience Covid-19 Rapid Antigen Saliva Test1150Unibioscience ASTurkeywww.unibioscience.comYesCommercialisedNoNoManualNear POC / POCAntigenSalivaSputum679B.1.1.7Alpha1022B.1.351Beta1471P.1Gamma1122B.1.427Epsilon1127B.1.429Epsilon1495P.3Theta1310B.1.617.1Kappa1311B.1.617.2Delta668B.1.1.529Omicron1494P.2Zetanucleocapsid proteinSaliva tests are self-administered; this means that after you are shown how to perform the test, you’ll do it by yourself. You will spit several times into a funnel attached to a tube, and then screw on a cap to complete the sample collection. Saliva tests are more comfortable than nasal swabs and just as accurate.2022-08-24 09:08:01 CET2226Immuno-AntigenYesYesNoImmunoassayQualitativeSandwich, Double20LOD2870TCID50/mlAnalysis of cross reactivityEvaluatedFalse positives1.33%4/300False negatives0.33%1/300PrecisionEvaluatedAccuracy99.17%ReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity98.67%Clinical Specificity99.67%Type of antigenNucleocapsid proteinType of antigenNucleocapsid protein1956COVID19-CHECK1 ANTIGEN574VEDALABFrancewww.vedalab.comYesCommercialisedNoNoManualAntigenNasal swabNasopharyngeal swab679B.1.1.7Alpha1022B.1.351Beta1471P.1Gamma1311B.1.617.2Delta668B.1.1.529Omicronnucleocapsid proteinProfessional version is also CE marked and available2022-08-24 09:08:01 CET1632Immuno-AntigenYesYesNoImmunochromatographyQualitative20LOD0.05ng/mLrecombinant nucleoproteinAnalysis of cross reactivityEvaluatedFalse positives0.33%specificity 99.67%False negatives0.92%sensitivity 99.08% (Ct value <=25)PrecisionEvaluatedAccuracy99.51%95% IC [98.14 - 100.00] (overall agreement)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.08%95% IC [94.67 - 100.00] for Ct<=25 (109 tested samples)Clinical Specificity99.67%95% IC [98.03 - 100.00] (300 tested samples)Type of antigenNucleoproteinType of antigenNucleocapsid protein3147PerkinElmer® COVID-19 Antigen Test1392Viola Diagnostics Systems-Tulip DiagnosticsIndiahttp://www.tulipgroup.com/YesCommercialisedNoNoAntigenNasal swab679B.1.1.7Alpha1022B.1.351Beta1471P.1Gamma1213B.1.525Eta1122B.1.427Epsilon1127B.1.429Epsilon1495P.3Theta3116B.1.6161310B.1.617.1Kappa1311B.1.617.2Delta1312B.1.617.31313B.1.621Mu15A.23.12016C.37Lambda1430C.3660AT.11214B.1.526IotaB.1.526.1B.1.526.2668B.1.1.529Omicron1494P.2Zetaspike proteinN/A2022-08-24 09:08:01 CET2855Immuno-AntigenYesYesNoImmunoassayQualitativeSandwich, Double15All Known VoCs detected CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity86.11%Clinical Specificity99%Type of antigenNucleocapsid protein5829Vision Biyoteknoloji Araştırma Geliştirme Laboratuvar Sistemleri Sanayi ve Ticaret Limited Şirketi 957Vision Biyoteknoloji AraÅŸtırma GeliÅŸtirme Laboratuvar Sistemleri Sanayi ve Ticaret Limited ÅžirketiTurkeywww.visionbiotechnology.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabAdenovirusAdenovirus 3Adenovirus 7Adenovirus Subtype BAdenovirus Subtype CAlpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Anti-Nuclear AntibodyBeta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Bordetella PertussisChlamydia PneumoniaeCoronaviruses (HCoV)Cytomegalovirus (CMV)Enterovirus A71 (EV-A71)Epstein-Barr Virus (EBV)Hemophilus InfluenzaeHepatitis A Virus (HAV)Hepatitis B Virus (HBV)Hepatitis C Virus (HCV)Herpes Simplex (HSV)Human Immunodeficiency Virus (HIV)Human Metapneumovirus (HMPV)Influenza AInfluenza A H1N1Influenza A H3N2Influenza A H5N1Influenza BInfluenza B VictoriaInfluenza B YamagataMERS-CoVMumps Virus (MuV)Mycobacterium TuberculosisMycoplasma PneumoniaeOtherParainfluenza Virus TypeParainfluenza Virus Type 1Parainfluenza Virus Type 2Parainfluenza Virus Type 3Parainfluenza Virus Type 4Respiratory Syncytial V (RSV)Respiratory Syncytial V (RSV) Type ARespiratory Syncytial V (RSV) Type BRhinovirusRhinovirus ARhinovirus BSARS-CoVSARS-CoV-2Varicella Zoster Virus (VZV)15A.23.160AT.1668B.1.1.529Omicron679B.1.1.7Alpha1022B.1.351Beta1122B.1.427Epsilon1127B.1.429Epsilon1213B.1.525Eta1214B.1.526IotaB.1.526.1B.1.526.23116B.1.6161310B.1.617.1Kappa1311B.1.617.2Delta1312B.1.617.31313B.1.621Mu1430C.362016C.37LambdaOther1471P.1Gamma1494P.2Zeta1495P.3Thetanucleocapsid protein2023-01-10 11:20:00 CET5434Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD3200TCID50/ml(for Covid19)CalibrationEvaluatedAnalytical Sensitivity100%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives0.32%1 out of 306False negatives0.49%2 out of 407PrecisionEvaluatedAccuracy99.25%ADENORobustnessEvaluatedClinical Sensitivity99.26%ADENOClinical Specificity99.06%ADENO5831VISION COVID-INF A/B- RSV- ADENO MULTI RAPID TEST KIT957Vision Biyoteknoloji AraÅŸtırma GeliÅŸtirme Laboratuvar Sistemleri Sanayi ve Ticaret Limited ÅžirketiTurkeywww.visionbiotechnology.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabAdenovirusAdenovirus 3Adenovirus 7Adenovirus Subtype BAdenovirus Subtype CAlpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Anti-Nuclear AntibodyBeta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Bordetella PertussisChlamydia PneumoniaeCoronaviruses (HCoV)Cytomegalovirus (CMV)Enterovirus A71 (EV-A71)Epstein-Barr Virus (EBV)Hemophilus InfluenzaeHepatitis A Virus (HAV)Hepatitis B Virus (HBV)Hepatitis C Virus (HCV)Herpes Simplex (HSV)Human Immunodeficiency Virus (HIV)Human Metapneumovirus (HMPV)Influenza AInfluenza A H1N1Influenza A H3N2Influenza A H5N1Influenza BInfluenza B VictoriaInfluenza B YamagataMERS-CoVMumps Virus (MuV)Mycobacterium TuberculosisMycoplasma PneumoniaeOtherParainfluenza Virus TypeParainfluenza Virus Type 1Parainfluenza Virus Type 2Parainfluenza Virus Type 3Parainfluenza Virus Type 4Respiratory Syncytial V (RSV)Respiratory Syncytial V (RSV) Type ARespiratory Syncytial V (RSV) Type BRhinovirusRhinovirus ARhinovirus BSARS-CoVSARS-CoV-2Varicella Zoster Virus (VZV)15A.23.160AT.1668B.1.1.529Omicron679B.1.1.7Alpha1022B.1.351Beta1122B.1.427Epsilon1127B.1.429Epsilon1213B.1.525Eta1214B.1.526IotaB.1.526.1B.1.526.23116B.1.6161310B.1.617.1Kappa1311B.1.617.2Delta1312B.1.617.31313B.1.621Mu1430C.362016C.37LambdaOther1471P.1Gamma1494P.2Zeta1495P.3Thetanucleocapsid protein2023-01-10 11:26:28 CET5435Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD3200TCID50/ml(for Covid19)CalibrationEvaluatedAnalytical Sensitivity100%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives4samples4 out of 205False negatives2samples2 out of 200PrecisionEvaluatedAccuracy98.98%rsvAccuracy98.09%ınfaAccuracy98.18%ınfbAccuracy98.98%covid19RobustnessEvaluatedClinical Sensitivity98.13%ınfbClinical Sensitivity98.04%ınfaClinical Sensitivity99.03%covid19Clinical Sensitivity99.03%rsvClinical Specificity99.04%ınfbClinical Specificity98.04%covid19Clinical Specificity99.01%ınfaClinical Specificity98.04%rsv3611RapidFor SARS-CoV-2 Rapid Antigen Test Kit (Nasal)1016Vitrosens Biotechnology Co. Ltd.Turkeywww.vitrosens.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabSARS-CoV668B.1.1.529Omicron679B.1.1.7Alpha1022B.1.351Beta1213B.1.525Eta1311B.1.617.2Delta1471P.1Gammanucleocapsid protein2022-08-24 09:08:01 CET3327Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD100TCID50/mlAnalytical Sensitivity100%Analytical Specificity100%False positives0.65%False negatives2.94%Accuracy98.64%Clinical Sensitivity97.06%Clinical Specificity99.35%5804RapidFor™ SARS-CoV-2 + FLU A/B + RSV Combo Test Kit678Vitrosens Biotechnology Co. Ltd.Turkeywww.vitrosens.comYesCommercialisedNoNoManualNear POC / POCAntigenAnterior nasal swabNasal swabNasopharyngeal swabOropharyngeal swabThroat swabOther15A.23.160AT.1668B.1.1.529Omicron679B.1.1.7Alpha1022B.1.351Beta1122B.1.427Epsilon1127B.1.429Epsilon1213B.1.525Eta1214B.1.526IotaB.1.526.1B.1.526.23116B.1.6161310B.1.617.1Kappa1311B.1.617.2Delta1312B.1.617.31313B.1.621Mu1430C.362016C.37Lambda1471P.1Gamma1494P.2Zeta1495P.3Thetanucleocapsid protein1. Twin test of this product was evaluated and approved by Paul-Ehrlich-Institute in Germany in March 2021 and Therapeutic Goods Administration (TGA) in Australia at 2022 for SARS-CoV-2.
2.The LOD for this product is 50 TCID50/mL.
2022-12-22 08:49:09 CET20282Immuno-AntigenYesYesNoImmunochromatographyQualitativeMembrane-basedColorimetry-15LOD50%for SARS-CoV-2CalibrationEvaluatedAnalytical Sensitivity100%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives0.95%5 out of 525 (NP Swab for SARS-CoV-2)False positives0.87%2 out of 231(NP Swab for RSV)False positives0.79%3 out of 379 (NP Swab for InfB)False positives0.53%2 out of 375 (NP Swab for InfA)False negatives2.7%17 out of 630 (NP Swab for SARS-CoV-2)False negatives2.24%5 out of 223 (NP Swab for RSV)False negatives3.03%5 out of 165 (NP Swab for InfB)False negatives2.56%4 out of 156 (NP Swab for InfA)PrecisionEvaluatedAccuracy98.09%NP swab:(SARS-CoV-2)Accuracy98.87%NP swab:(Inf A)Accuracy98.53%NP swab:(Inf B)Accuracy98.46%NP swab:(RSV)RobustnessEvaluatedClinical Sensitivity97.3%NP swab:(SARS-CoV-2)Clinical Sensitivity97.44%NP swab:(Inf A)Clinical Sensitivity96.97%NP swab:(Inf B)Clinical Sensitivity97.76%NP swab:(RSV)Clinical Specificity99.05%NP swab:(SARS-CoV-2)Clinical Specificity99.47%NP swab:(Inf A)Clinical Specificity99.21%NP swab:(Inf B)Clinical Specificity99.13%NP swab:(RSV)5816RapidFor™ SARS-CoV-2 + FLU A/B + RSV+ADV Combo Test Kit678Vitrosens Biotechnology Co. Ltd.Turkeywww.vitrosens.comYesCommercialisedNoNoManualNear POC / POCAntigenAnterior nasal swabNasal swabNasopharyngeal swabOropharyngeal swabThroat swabOther15A.23.160AT.1668B.1.1.529Omicron679B.1.1.7Alpha1022B.1.351Beta1122B.1.427Epsilon1127B.1.429Epsilon1213B.1.525Eta1214B.1.526IotaB.1.526.1B.1.526.23116B.1.6161310B.1.617.1Kappa1311B.1.617.2Delta1312B.1.617.31313B.1.621Mu1430C.362016C.37Lambda1471P.1Gamma1494P.2Zeta1495P.3Thetanucleocapsid protein1. Twin test of this product was evaluated and approved by Paul-Ehrlich-Institute in Germany in March 2021 and Therapeutic Goods Administration (TGA) in Australia at 2022 for SARS-CoV-2.
2.The LOD for this product is 50 TCID50/mL.
2023-01-09 10:06:31 CET5418Immuno-AntigenYesYesNoChromatographyQualitativeMembrane-basedColorimetry-15LOD50TCID50/mlfor SARS-CoV-2CalibrationEvaluatedAnalytical Sensitivity100%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives0.95%5 out of 525 (NP Swab for SARS-CoV-2)False positives0.82%2 out of 223 (NP Swab for ADV)False positives0.53%2 out of 375 (NP Swab for InfA)False positives0.79%3 out of 379 (NP Swab for InfB)False positives0.87%2 out of 231(NP Swab for RSV)False negatives2.7%17 out of 630 (NP Swab for SARS-CoV-2)False negatives1.78%4 out of 225 (NP Swab for ADV)False negatives2.24%5 out of 223 (NP Swab for RSV)False negatives3.03%5 out of 165 (NP Swab for InfB)False negatives2.56%4 out of 156 (NP Swab for InfA)PrecisionEvaluatedAccuracy98.09%NP swab:(SARS-CoV-2)RobustnessEvaluatedClinical Sensitivity97.3%NP swab:(SARS-CoV-2)Clinical Sensitivity97.44%NP swab:(Inf A)Clinical Sensitivity96.97%NP swab:(Inf B)Clinical Sensitivity97.76%NP swab:(RSV)Clinical Sensitivity98.22%NP swab:(ADV)Clinical Specificity99.05%NP swab:(SARS-CoV-2)Clinical Specificity99.47%NP swab:(Inf A)Clinical Specificity99.21%NP swab:(Inf B)Clinical Specificity99.13%NP swab:(RSV)Clinical Specificity99.18%NP swab:(ADV)5834RapidFor™ SARS-CoV-2 +FLUA/B + RSV + ADV + M. Pneumoniae Combo Test Kit678Vitrosens Biotechnology Co. Ltd.Turkeywww.vitrosens.comYesCommercialisedNoNoManualNear POC / POCAntigenAnterior nasal swabNasal swabNasopharyngeal swabOropharyngeal swabThroat swabOther15A.23.160AT.1668B.1.1.529Omicron679B.1.1.7Alpha1022B.1.351Beta1122B.1.427Epsilon1127B.1.429Epsilon1213B.1.525Eta1214B.1.526IotaB.1.526.1B.1.526.23116B.1.6161310B.1.617.1Kappa1311B.1.617.2Delta1312B.1.617.31313B.1.621Mu1430C.362016C.37Lambda1471P.1Gamma1494P.2Zeta1495P.3Thetanucleocapsid protein1. Twin test of this product was evaluated and approved by Paul-Ehrlich-Institute in Germany in March 2021 and Therapeutic Goods Administration (TGA) in Australia at 2022 for SARS-CoV-2.
2.The LOD for this product is 50 TCID50/mL.
2023-01-13 13:46:41 CET5441Immuno-AntigenYesYesNoChromatographyQualitativeMembrane-basedColorimetry-15LOD50%for SARS-CoV-2CalibrationEvaluatedAnalytical Sensitivity100%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives0.95%5 out of 525 (NP Swab for SARS-CoV-2)False positives1.19%3 out of 108 (NP Swab for M. Pneumoniae )False positives2.24%5 out of 223 (NP Swab for RSV)False positives0.53%2 out of 375 (NP Swab for InfA)False positives0.79%3 out of 379 (NP Swab for InfB)False positives0.87%2 out of 231(NP Swab for RSV)False positives0.82%2 out of 223 (NP Swab for ADV)False negatives2.7%17 out of 630 (NP Swab for SARS-CoV-2)False negatives2.78%3 out of 108 (NP Swab for M. Pneumoniae )False negatives1.78%4 out of 225 (NP Swab for ADV)False negatives3.03%5 out of 165 (NP Swab for InfB)False negatives2.56%4 out of 156 (NP Swab for InfA)PrecisionEvaluatedAccuracy98.09%NP swab:(SARS-CoV-2)RobustnessEvaluatedClinical Sensitivity97.3%NP swab:(SARS-CoV-2)Clinical Sensitivity97.22%NP Swab for M. Pneumoniae Clinical Specificity99.05%NP swab:(SARS-CoV-2)Clinical Specificity98.81%NP Swab for M. Pneumoniae 5810RapidFor™ SARS-CoV-2+RSV Combo Test Kit678Vitrosens Biotechnology Co. Ltd.Turkeywww.vitrosens.comYesCommercialisedNoNoManualNear POC / POCAntigenAnterior nasal swabNasal swabNasopharyngeal swabOropharyngeal swabThroat swabOther15A.23.160AT.1668B.1.1.529Omicron679B.1.1.7Alpha1022B.1.351Beta1122B.1.427Epsilon1127B.1.429Epsilon1213B.1.525Eta1214B.1.526IotaB.1.526.1B.1.526.23116B.1.6161310B.1.617.1Kappa1311B.1.617.2Delta1312B.1.617.31313B.1.621Mu1430C.362016C.37Lambda1471P.1Gamma1494P.2Zeta1495P.3Thetanucleocapsid protein1. Twin test of this product was evaluated and approved by Paul-Ehrlich-Institute in Germany in March 2021 and Therapeutic Goods Administration (TGA) in Australia at 2022 for SARS-CoV-2.
2.The LOD for this product is 50 TCID50/mL.
2023-01-09 10:03:07 CET5413Immuno-AntigenYesYesNoImmunochromatographyQualitativeMembrane-basedColorimetry-15LOD50%for SARS-CoV-2CalibrationEvaluatedAnalytical Sensitivity100%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives0.95%5 out of 525 (NP Swab for SARS-CoV-2)False negatives2.7%17 out of 630 (NP Swab for SARS-CoV-2)False negatives0.87%2 out of 231(NP Swab for RSV)PrecisionEvaluatedAccuracy98.09%NP swab:(SARS-CoV-2)Accuracy98.46%NP swab:(RSV)RobustnessEvaluatedClinical Sensitivity97.3%NP swab:(SARS-CoV-2)Clinical Sensitivity97.76%NP swab:(RSV)Clinical Specificity99.05%NP swab:(SARS-CoV-2)Clinical Specificity99.13%NP swab:(RSV)2100Verino Pro SARS CoV 2 Ag Rapid Test1006VivaChek Biotech (Hangzhou) Co. Ltd.Chinawww.vivachek.comYesCommercialisedYesYesManualNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabSARS-CoV679B.1.1.7Alpha1022B.1.351Beta1471P.1Gamma1122B.1.427Epsilon1127B.1.429Epsilon1311B.1.617.2Delta1313B.1.621Mu2016C.37Lambda668B.1.1.529Omicronnucleocapsid proteinVerino® Pro SARS-CoV-2 Ag Rapid Test is for the rapid, qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in human nasal swab, oropharyngeal swab or nasopharyngeal swab specimen . The test is for in vitro diagnostic use only. It provides only an initial screening test result. More specific alternative diagnosis methods (molecular diagnostic and / or CT) should be performed in order to obtain the confirmation of SARS-CoV-2 infection.2022-08-24 09:08:01 CET1783Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich15LOD75.5TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.01%False negatives2.58%PrecisionEvaluatedAccuracy99.32%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity97.42%Clinical Specificity99.99%Type of antigenNucleocapsid protein2759Verino Pro SARS CoV 2 Ag Rapid Test (self test)175VivaChek Biotech (Hangzhou) Co. Ltd.Chinawww.vivachek.comYesCommercialisedNoNoManualNear POC / POCAntigenAnterior nasal swabSARS-CoV679B.1.1.7Alpha1471P.1Gamma1310B.1.617.1Kappa1311B.1.617.2Delta1312B.1.617.31022B.1.351Beta668B.1.1.529Omicronnucleocapsid proteinself test and home test2022-08-24 09:08:01 CET2464Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich15LOD75.5AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0.97%PrecisionEvaluatedAccuracy99.83%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity99.13%Clinical Specificity99.99%Type of antigenNucleocapsid protein2099VivaDiag Pro SARS CoV 2 Ag Rapid Test (self test)1006VivaChek Biotech (Hangzhou) Co. Ltd.Chinawww.vivachek.comYesCommercialisedNoNoManualNear POC / POCAntigenAnterior nasal swab679B.1.1.7Alpha1022B.1.351Beta1471P.1Gamma1122B.1.427Epsilon1127B.1.429Epsilon1311B.1.617.2Delta1313B.1.621Mu2016C.37Lambda668B.1.1.529Omicronnucleocapsid proteinVivaDiag Pro SARS CoV 2 Ag Rapid Test (self test) is for self test and home test.2022-08-24 09:08:01 CET1782Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich15LOD75.5AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0.97%PrecisionEvaluatedAccuracy99.83%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity99.13%Clinical Specificity99.99%Type of antigenNucleocapsid protein2991SARS-CoV-2 Antigen Rapid Test Kit ( Colloidal Gold )1324Wuhan J.H. Bio-Tech. Co. Ltd.ChinaYesCommercialisedNoNoNear POC / POCAntigenNasal swabOropharyngeal swab679B.1.1.7Alpha1022B.1.351Beta1471P.1Gamma1213B.1.525Eta1310B.1.617.1Kappa1311B.1.617.2Delta1312B.1.617.32016C.37Lambda1214B.1.526Iota668B.1.1.529Omicron1494P.2Zetanucleocapsid proteinN/A2022-08-24 09:08:01 CET2697Immuno-AntigenYesYesImmunochromatographyQualitativeOtherColloidal gold10LOD100TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%Based on the cross-reactivity, there is no false positives.False negatives0%There is no false negative.PrecisionEvaluatedAccuracy98.4%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.27AntigenClinical Specificity99.29AntigenType of antigenNucleocapsid protein3853SARS-CoV-2 Antigen Rapid Test Kit (Nasal swab)1435Wuhan Uni-science Biotechnology Co., Ltd.Chinawww.uni-science.comYesCommercialisedNoNoManualAntigenNasal swabAdenovirusAdenovirus 3Adenovirus 7Adenovirus Subtype BAdenovirus Subtype CAlpha Coronavirus 229E (HCoV-229E)Alpha Coronavirus Nl63 (HCoV-Nl63)Anti-Nuclear AntibodyBeta Coronavirus HKU1 (HCoV-HKU1)Beta Coronavirus OC43 (HCoV-OC43)Bordetella PertussisChlamydia PneumoniaeCoronaviruses (HCoV)Cytomegalovirus (CMV)Enterovirus A71 (EV-A71)Epstein-Barr Virus (EBV)Hemophilus InfluenzaeHepatitis A Virus (HAV)Hepatitis B Virus (HBV)Hepatitis C Virus (HCV)Herpes Simplex (HSV)Human Immunodeficiency Virus (HIV)Human Metapneumovirus (HMPV)Influenza AInfluenza A H1N1Influenza A H3N2Influenza A H5N1Influenza BInfluenza B VictoriaInfluenza B YamagataMERS-CoVMumps Virus (MuV)Mycobacterium TuberculosisMycoplasma PneumoniaeOtherParainfluenza Virus TypeParainfluenza Virus Type 1Parainfluenza Virus Type 2Parainfluenza Virus Type 3Parainfluenza Virus Type 4Respiratory Syncytial V (RSV)Respiratory Syncytial V (RSV) Type ARespiratory Syncytial V (RSV) Type BRhinovirusRhinovirus ARhinovirus BSARS-CoVVaricella Zoster Virus (VZV)15A.23.160AT.1668B.1.1.529Omicron679B.1.1.7Alpha1022B.1.351Beta1122B.1.427Epsilon1127B.1.429Epsilon1213B.1.525Eta1214B.1.526IotaB.1.526.1B.1.526.23116B.1.6161310B.1.617.1Kappa1311B.1.617.2Delta1312B.1.617.31313B.1.621Mu1430C.362016C.37LambdaOther1471P.1Gamma1494P.2Zeta1495P.3Thetanucleocapsid protein2022-08-24 09:08:01 CET3525Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD980TCID50/mlAnalytical Sensitivity94.23%Analytical Specificity100%False positives0%False negatives6%Accuracy98.51%Clinical Sensitivity94.23%Clinical Specificity100%5720COVID-19 Ag & Flu A/B Combo Self Test756Xiamen Biotime Biotechnology Co. Ltd.Chinawww.biotime.cn/En_YesCommercialisedNoNoManualAntigenNasal swabInfluenza AInfluenza BSARS-CoV-2679B.1.1.7Alpha1122B.1.427Epsilon1127B.1.429Epsilon1312B.1.617.32016C.37Lambdanucleocapsid protein2022-10-18 08:52:39 CET5211Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwichImmunofluorescence15LOD27900000TCID50/mlCalibrationEvaluatedAnalytical Sensitivity95%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives0samplesFalse negatives0samplesPrecisionEvaluatedAccuracy97.3%RobustnessEvaluatedClinical Sensitivity85.71%Clinical Specificity99.99%5746SARS-CoV-2 Antigen Rapid Qualitative Test756Xiamen Biotime Biotechnology Co. Ltd.Chinawww.biotime.cn/En_YesCommercialisedNoNoManualAntigenNasal swabSARS-CoV-2679B.1.1.7Alpha1122B.1.427Epsilon1127B.1.429Epsilon1312B.1.617.32016C.37Lambdanucleocapsid protein2022-11-03 08:43:19 CET5276Immuno-AntigenYesYesNoImmunochromatographyQualitativeSandwichColloidal gold20LOD1600TCID50/mlCalibrationEvaluatedAnalytical Sensitivity95%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positivessamplesFalse negativessamplesPrecisionEvaluatedAccuracy97.72%RobustnessEvaluatedClinical Sensitivity88.18%Clinical Specificity99.99%3515SOFTEC Covid-19 Antigen Test Kit1419ZET medical textile foreign trade Co LTDTurkeyhttps://www.zetmedikal.com/enYesCommercialisedNoNoNear POC / POCAntigenNasal swabNasopharyngeal swabSARS-CoV668B.1.1.529Omicron679B.1.1.7Alpha1022B.1.351Beta1122B.1.427Epsilon1310B.1.617.1Kappa1311B.1.617.2Delta1313B.1.621Mu2016C.37Lambda1471P.1Gamma1494P.2Zeta1495P.3Thetanucleocapsid protein2022-08-24 09:08:01 CET3234Immuno-AntigenYesYesNoImmunochromatographyQualitativeMembrane-basedColloidal gold15