2026-06-13 11:06:51 CET1970COVID-19 IgG/IgM Rapid Test Cassette887Hangzhou Sejoy Electronics & Instruments Co. Ltd.Chinasejoy.com/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood with anti-coagulantsWe have evulated the relative interference substances.2022-08-24 09:08:01 CET1646Immuno-AntibodyNoImmunoassayQualitativeSandwich15LOD40AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0% IgGFalse positives2% IgMFalse negatives0AUFalse negatives9% IgMPrecisionEvaluatedAccuracy100% IgGAccuracy93.33% IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100% IgGClinical Sensitivity88.61% IgMClinical Specificity100% IgGClinical Specificity97.67% IgMType of antigenOther3146GENnasal SARS-CoV.2 Antigen Rapid Test1391Hangzhou Sejoy Electronics & Instruments Co. Ltd.ChinaYesCommercialisedNoNoManualAntigenNasal swabSARS-CoV689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1321B.1.617.2Delta678B.1.1.529Omicronnucleocapsid proteinSensitivity, specificity and accuracy are from the newest performance evaluation - including false-positives and false-negatives. German Paul-Ehrlich-Institut (PEI) evaluated this test under test-ID AT 1269/212022-08-24 09:08:01 CET2854Immuno-AntigenYesYesNoImmunochromatographyQualitativeMembrane-based10LOD400TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1%False negatives6%PrecisionEvaluatedAccuracy98.5%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.5%Clinical Specificity99.9%Type of antigenNucleocapsid protein2063SARS-CoV-2 & Influenza A+B Antigen Combo Rapid Test Cassette887Hangzhou Sejoy Electronics & Instruments Co. Ltd.Chinasejoy.com/YesCommercialisedYesYesNear POC / POCAntigenNasopharyngeal swabOropharyngeal swab1518P.2ZetaWe have also evaluated the interference substances.2022-10-05 14:06:10 CET3934Immuno-AntigenNoImmunoassayQualitativeSandwich20LOD40050AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives2AUFalse negatives3AUPrecisionEvaluatedAccuracy98.5%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.4%Clinical Specificity99.1%Type of antigenNucleoprotein1945SARS-CoV-2 Antigen Rapid Test Cassette887Hangzhou Sejoy Electronics & Instruments Co. Ltd.Chinasejoy.com/YesCommercialisedYesYesNear POC / POCAntigenNasal swabnucleocapsid proteinThe cross substances and interference substance are also evaluated.2022-08-24 09:08:01 CET1621Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich20LOD400AUCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives2AUFalse negatives3AUPrecisionEvaluatedAccuracy98.5%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.4%Clinical Specificity99.1%Type of antigenNucleoprotein2671SARS-CoV-2 Antigen Rapid Test Cassette887Hangzhou Sejoy Electronics & Instruments Co. Ltd.Chinasejoy.com/YesCommercialisedYesYesNear POC / POCAntigenNasopharyngeal swabOropharyngeal swabSARS-CoV-2689B.1.1.7Alphanucleocapsid proteinWe have also evaluated interference substance as following:Whole Blood,Ibuprofen,Tetracycline,Mucin,Erythromycin,Tobramycin,Menthol,Afrin, Compound Benzoin Gel,Cromolyn glycate , Chloramphenicol ,Mupirocin,Oseltamivir,Naphazoline Hydrochlo-ride Nasal Drops,Fluticasone propionate spray,Deoxyepinephrine hydro-chloride2023-03-02 11:30:05 CET21058Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwichOther10LOD400TCID50/mlCalibrationNot evaluatedAnalytical Sensitivity87%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives%False negatives13%PrecisionEvaluatedAccuracy97.79%RobustnessEvaluatedClinical Sensitivity87%Clinical Specificity100%1952SARS-CoV-2 Antigen Rapid Test Cassette (nasal, nasopharyngeal, oropharyngeal, saliva)887Hangzhou Sejoy Electronics & Instruments Co. Ltd.Chinasejoy.com/YesCommercialisedYesYesNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabSalivaSARS-CoV-2689B.1.1.7Alphanucleocapsid proteinWe have also evulated the interference substance.2023-02-23 18:20:31 CET20251Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwichImmunofluorescence20LOD400AUCalibrationNot evaluatedAnalytical Sensitivity97.4%Analytical Specificity99.1%Analysis of cross reactivityEvaluatedFalse positives2tests2(Nasal swab),3(Oropharyngeal swabs),2(Nasopharyngeal swabs),3(Saliva)False negatives3tests3(Nasal swab),5(Oropharyngeal swabs),3(Nasopharyngeal swabs),5(Saliva)PrecisionEvaluatedAccuracy98.5%98.48%(Nasal swab),98.67%(Oropharyngeal swabs),98.48%(Nasopharyngeal swabs),98.46%(Saliva)RobustnessEvaluatedClinical Sensitivity97.4%97.4%(Nasal swab),95.76%(Oropharyngeal swabs),97.4%(Nasopharyngeal swabs),95.65%(Saliva)Clinical Specificity99.1%99.1%(Nasal swab),99.38%(Oropharyngeal swabs),99.1%(Nasopharyngeal swabs),99.26%(Saliva)2740SARS-CoV-2 Antigen Saliva Lolly Test952Hangzhou Sejoy Electronics & Instruments Co. Ltd.Chinahttp://www.sejoy.com.cn/YesCommercialisedNoNoNear POC / POCAntigenSalivaAbout interference,we also have evaluated.2022-08-24 09:08:01 CET2445Immuno-AntigenNoImmunochromatographyQualitativeSandwich10LOD400000TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives1AUFalse negatives7AUPrecisionEvaluatedAccuracy96.55%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.91%Clinical Specificity99.15%Type of antigenNucleocapsid protein2062SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette952Hangzhou Sejoy Electronics & Instruments Co. Ltd.Chinahttp://www.sejoy.com.cn/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood1518P.2ZetaWe have also evaluated the cross reactivity and interference substances.2022-08-24 09:08:01 CET1742Immuno-AntibodyNoImmunoassayQualitativeSandwich15neutralizing antibodyLOD5050AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives3AUFalse negatives2AUPrecisionEvaluatedAccuracy98.97%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.4%Clinical Specificity99.2%Type of antigenOther