2026-05-11 14:18:51 CET1446COVID-19 Antigen Test Kit (Colloidal Gold)1191Hangzhou Singclean Medical Products Co. Ltd.Chinawww.singclean.netYesCommercialisedYesYesNear POC / POCAntigenNasal swabSARS-CoV678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1224B.1.526Iota1320B.1.617.1Kappa1321B.1.617.2Delta2041C.37Lambda1495P.1Gammanucleocapsid proteinThe specimen is Nasal swab2022-10-05 14:05:17 CET3933Immuno-AntigenYesNoYesImmunochromatographyQualitativeSandwichColorimetry15LOD9.75AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives1%False negatives2.78%PrecisionNot evaluatedAccuracy98.63%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.22%Clinical Specificity99%Type of antigenNucleocapsid protein2210COVID-19 Test Kit (Colloidal Gold Method)1191Hangzhou Singclean Medical Products Co. Ltd.Chinawww.singclean.netYesCommercialisedNoNoManualAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1321B.1.617.2Deltanucleocapsid proteinThe specimen was Nasal swab.2023-07-27 10:45:35 CET21090Immuno-AntigenYesNoImmunochromatographyQualitativeSandwichColloidal gold15LOD9.75AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives1%False negatives2.78%PrecisionNot evaluatedAccuracy98.63%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.22%Clinical Specificity99%Type of antigenNucleocapsid protein2609COVID-19 Test Kit (Colloidal Gold Method)(Nasal Swab)1191Hangzhou Singclean Medical Products Co. Ltd.Chinawww.singclean.netYesCommercialisedNoNoAntigenNasal swab689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1321B.1.617.2Deltanucleocapsid proteinBfarm list AT 1013/21 The specimen was Nasal swab.2022-08-24 09:08:01 CET2314Immuno-AntigenYesNoImmunochromatographyQualitativeSandwichColloidal gold15LOD9.75AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives1%False negatives2.78%PrecisionNot evaluatedAccuracy98.63%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.22%Clinical Specificity99%Type of antigenNucleocapsid protein