2026-06-10 08:41:29 CET1454COVID-19/Flu A/B Antigen Combo Rapid Test340GenSure Biotech Inc.Chinawww.gensbio.com/YesCommercialisedNoNoNear POC / POCAntigenNasal swabnucleocapsid protein2022-08-24 09:08:01 CET1204Immuno-AntigenYesNoImmunoassayQualitative15Accuracy: 97.5 (Influenza A); 96.9 (Influenza B). Clinical sensitivity: 91.7 (Influenza A); 86.2 (Influenza B)LOD50AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positivesThe samples collected were contaminated, do not follow the instructions manual, etc. False negativesSamples collected contained low levels of the virus, do not follow the instructions manual, etc. PrecisionEvaluatedAccuracy98.9%(COVID-19)ReproducibilityNot evaluatedRobustnessNot evaluatedClinical Sensitivity96.9%(COVID-19)Type of antigennucleoprotein1253GenSure COVID-19 Antigen Rapid Kit340GenSure Biotech Inc.Chinawww.gensbio.com/YesCommercialisedYesYesNear POC / POCAntigenNasal swabNasopharyngeal swabSARS-CoV-2678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1223B.1.525Eta1224B.1.526Iota1320B.1.617.1Kappa1321B.1.617.2Delta1323B.1.621Mu2041C.37Lambda1495P.1Gammanucleocapsid proteinGenSure COVID-19 Antigen Rapid Test Kit (REF: P2004)2022-11-28 10:30:56 CET5343Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwichNot found15LOD50TCID50/mlCalibrationNot evaluatedAnalytical Sensitivity96.86%Analytical Specificity100%Analysis of cross reactivityEvaluatedFalse positives%False negatives3.14%PrecisionEvaluatedAccuracy98.91%ReproducibilityEvaluatedRobustnessEvaluatedType of antigenNucleocapsid protein2853GenSure COVID-19 Antigen Rapid Test Kit340GenSure Biotech Inc.Chinawww.gensbio.com/YesCommercialisedYesYesManualAntigenNasal swabSaliva689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu2041C.37Lambda2022-08-24 09:08:01 CET2558Immuno-AntigenYesNoImmunoassayQualitative15LOD50TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positivesThere is a very small possibility of false positives.False negativesThere is a very small possibility of false negatives.PrecisionEvaluatedAccuracy98.68%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.73%Clinical Specificity100%Type of antigenNucleocapsid protein565GenSure COVID-19 IgG/IgM Rapid Test (REF: P2002)340GenSure Biotech Inc.Chinawww.gensbio.com/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2022-08-24 09:08:01 CET450Immuno-AntibodyYesNoImmunoassayQualitative15566GenSure COVID-19 IgM Rapid Test (REF: P2001)340GenSure Biotech Inc.Chinawww.gensbio.com/YesCommercialisedNoNoNear POC / POCAntibodyIgMWhole blood2022-08-24 09:08:01 CET452Immuno-AntibodyYesNoImmunoassayQualitative15Clinical Sensitivity95%Clinical Specificity95%1826GenSure COVID-19 Neutralizing Antibody Test (Fluorescence)340GenSure Biotech Inc.Chinawww.gensbio.com/YesCommercialisedNoNoManualAntibody2022-08-24 09:08:01 CET1503Immuno-AntibodyImmunoassayNeutralization Antibody (NAb)15LODEvaluatedCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedPrecisionEvaluatedReproducibilityNot evaluatedRobustnessNot evaluated2112GenSure COVID-19 Neutralizing Antibody Test (Latex)979GenSure Biotech Inc.Chinahttp://www.gensbio.comYesCommercialisedNoNoAntibody689B.1.1.7Alpha1032B.1.351Beta2022-08-24 09:08:01 CET1802Immuno-AntibodyImmunoassayNeutralization Antibody (NAb)15LOD0AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positivesThere is a very small possibility of false positives.False negativesThere is a very small possibility of false negatives.PrecisionEvaluatedAccuracy98.1%ReproducibilityNot evaluatedRobustnessNot evaluatedClinical Sensitivity94.6%Clinical Specificity100%