2024-03-29 00:45:32 CET17902019-nCoV Antigen Rapid Test Kit (Colloidal Gold Immunochromatography)319Beijing Lepu Medical Technology Co. Ltd.Chinahttps://www.lepumedical.com/YesCommercialisedNoNoOtherAntigenNasal swabOthernucleocapsid protein2022-08-24 09:08:01 CET1469Immuno-AntigenYesNoImmunochromatographyQualitativeColorimetry15LOD200IU/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.38%False negatives4.94%PrecisionEvaluatedPrecisionEvaluatedAccuracy97.44%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity95.06%Type of antigenNucleoprotein30782019-nCoV antigen, Influenza A virus antigen, Influenza B virus antigen detection kit (colloidal gold immunochromatography)1364Beijing Lepu Medical Technology Co. Ltd.Chinaen.lepumedical.comYesCommercialisedNoNoManualAntigenNasal swabNasopharyngeal swabSARS-CoVInfluenza AInfluenza A H1N1Influenza A H3N2Influenza A H5N1Influenza BInfluenza B Victoria679B.1.1.7Alpha1022B.1.351Beta1471P.1Gamma1311B.1.617.2Delta668B.1.1.529Omicronnucleocapsid protein2022-08-24 09:08:01 CET2784Immuno-AntigenYesNoNoImmunochromatographyQualitativeColloidal gold15CalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy95%19/20ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.44%95%CI: 84.32%-97.42%Clinical Specificity99.38%95%CI: 96.55%-99.89%Type of antigenNucleocapsid protein1857Nucleic Acid Extraction or Purification Kit319Beijing Lepu Medical Technology Co. Ltd.Chinahttps://www.lepumedical.com/YesCommercialisedNoNoAutomatedNucleic acidBronchoalveolar lavage fluidMid-turbinates swabNasal swabNasopharyngeal swabPlasmaSerumThroat swabTissue homogenatesWhole blood2022-08-24 09:08:01 CET1797Nucleic acid-PCROther1858Nucleic Acid Extraction or Purification Kit (Manual method)319Beijing Lepu Medical Technology Co. Ltd.Chinahttps://www.lepumedical.com/YesCommercialisedNoNoManualNucleic acidNO2022-08-24 09:08:01 CET1537OtherN.A.523SARS-CoV-2 Antibody Test (colloidal gold immunochromatography)319Beijing Lepu Medical Technology Co. Ltd.Chinahttps://www.lepumedical.com/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerum2022-08-24 09:08:01 CET423Immuno-AntibodyYesImmunochromatographyColloidal goldLOD3.1U/ml1331SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography)319Beijing Lepu Medical Technology Co. Ltd.Chinahttps://www.lepumedical.com/YesCommercialisedYesYesNear POC / POCAntigenNasal swabNasopharyngeal swab2022-08-24 09:08:01 CET1100Immuno-AntigenYesNoImmunochromatographyQualitativeColloidal gold15Clinical Sensitivity95.06%Clinical Specificity99.62%2881SARS-CoV-2 Antigen Rapid Test Kits for Self-testing (Colloidal Gold Immunochromatography)319Beijing Lepu Medical Technology Co. Ltd.Chinahttps://www.lepumedical.com/YesCommercialisedNoNoManualAntigenNasal swab679B.1.1.7Alpha1022B.1.351Beta1311B.1.617.2Delta668B.1.1.529Omicronnucleocapsid proteinN/A2022-08-24 09:08:01 CET2586Immuno-AntigenYesNoImmunochromatographyQualitativeColloidal gold15LOD200TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0%False negatives0%PrecisionEvaluatedAccuracy97.8%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity95.9%Clinical Specificity100%Type of antigenNucleocapsid protein1859SARS-CoV-2 Nucleic Acid Test Kit (PCR-Fluorescence Probe Method)319Beijing Lepu Medical Technology Co. Ltd.Chinahttps://www.lepumedical.com/YesCommercialisedNoNoManualNucleic acidNasopharyngeal swabOtherNO2022-08-24 09:08:01 CET1538Nucleic acid-PCROtherfluorescence detectionPositive control96.6%Clinical Sensitivity92%Clinical Specificity100%