2026-07-14 05:53:53 CET12162019-nCoV Ag Rapid Detection Kit (Immuno-Chromatography)569Guangdong Longsee Biomedical Co. Ltd.Chinawww.longseemed.comYesCommercialisedYesYesNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabSARS-CoV-220A.23.1678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1223B.1.525Eta1224B.1.526IotaB.1.526.1B.1.526.23939B.1.6161320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu2041C.37LambdaOther1495P.1Gamma1518P.2Zeta1519P.3Thetanucleocapsid proteinThis update is mainly for vaviants detected.2022-10-12 09:45:49 CET3966Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwich, DoubleColloidal gold15LOD600TCID50/mlOropharyngeal swabLOD600TCID50/mlNasal swabLOD600TCID50/mlNasopharyngeal swabAnalysis of cross reactivityEvaluatedFalse positives0.28%Nasopharyngeal swabFalse positives0.32%Nasal swabFalse positives0.28%Oropharyngeal swabFalse negatives4.49%Nasopharyngeal swabFalse negatives5.85%Nasal swabFalse negatives4.78%Oropharyngeal swabPrecisionEvaluatedAccuracy97.64%Nasopharyngeal swabAccuracy97.6%Nasal swabAccuracy97.5%Oropharyngeal swabReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.51%Nasopharyngeal swabClinical Sensitivity95.22%Oropharyngeal swabClinical Sensitivity94.15%Nasal swabClinical Specificity99.72%Nasopharyngeal swabClinical Specificity99.72%Oropharyngeal swabClinical Specificity99.68%Nasal swabType of antigenNucleocapsid protein25042019-nCoV Ag Rapid Detection Kit (Immuno-Chromatography) (Nasopharyngeal Swab)1141Guangdong Longsee Biomedical Co. Ltd.Chinahttp://www.longseemed.com/YesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta1320B.1.617.1Kappa1321B.1.617.2Delta1224B.1.526Iota1518P.2Zeta1. Type if Antigen: Nucleocapsid protein (N protein); 2. PEI test is positive; 3. Approved and registered in Germany, Italy, Austria, Peru and so on.2022-08-24 09:08:01 CET2208Immuno-AntigenYesImmunoassaySandwich, Double15LOD600TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives1AUFalse negatives17AUPrecisionEvaluatedAccuracy97.49%(Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.22%Antigen)Clinical Specificity99.72%(Antigen)25092019-nCoV Ag Rapid Detection Kit (Immuno-Chromatography) (Oropharyngeal swab)1141Guangdong Longsee Biomedical Co. Ltd.Chinahttp://www.longseemed.com/YesCommercialisedNoNoNear POC / POCAntigenOropharyngeal swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1223B.1.525Eta1132B.1.427Epsilon1137B.1.429Epsilon1519P.3Theta1320B.1.617.1Kappa1321B.1.617.2Delta1224B.1.526Iota1518P.2Zetanucleocapsid protein1. Type of Antigen: Nucleocapsid protein (N protein); 2. PEI test is positive; 3. Approved and registered in Germany, Italy, Belgium, Autria, Peru, and so on.2022-08-24 09:08:01 CET2213Immuno-AntigenYesImmunoassaySandwich, Double15LOD600TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives1AUFalse negatives19AUPrecisionEvaluatedAccuracy97.21%(Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.66%(Antigen)Clinical Specificity99.72%(Antigen)Type of antigenNucleocapsid protein (N protein)