2024-03-29 10:28:24 CET1363COVID-19 Antigen Rapid Test413Hangzhou Clongene Biotech Co. Ltd.Chinahttp://en.clongene.com/YesCommercialisedYesYesNear POC / POCAntigenNasal swabNasopharyngeal swab679B.1.1.7Alpha1022B.1.351Beta1471P.1Gamma1213B.1.525Eta1122B.1.427Epsilon1127B.1.429Epsilon1495P.3Theta3116B.1.6161310B.1.617.1Kappa1311B.1.617.2Delta1312B.1.617.31313B.1.621Mu15A.23.12016C.37Lambda1430C.3660AT.11214B.1.526IotaB.1.526.1B.1.526.2668B.1.1.529Omicron1494P.2Zetanucleocapsid proteinA prospective clinical study conducted in Greece from Nov. 2021 to Feb. 2022, the performance of COVID-19 Antigen Rapid Test was evaluated by detection of 626 nasopharyngeal swab specimens, setting a RT-PCR detection of nasopharyngeal specimens as comparator. The test showed a sensitivity of 95.5% (n=150/157, 95%CI: 91.1%-97.8%) and a specificity of 100% (n=469/469, 95%CI: 99.2%-100%). A genotyping analysis on unselected 88 PCR-positive specimens identified 31 cases of Omicron infection, those comparator PCR Ct values ranged from 10.5 to 31.1 (7/31 at Ct >25) and all of which were positive by COVID-19 Antigen Rapid Test. Thus, the test performance is not affected by Omicron variant.2022-08-24 09:08:01 CET1122Immuno-AntigenYesNoNoImmunochromatographyQualitative15antigen_epi AA95-175LODTCID50/ml570 TCID50/mLAnalysis of cross reactivityEvaluatedFalse positives%0%False negatives%4%PrecisionEvaluatedAccuracy99.1%Nasopharyngeal swabAccuracy99.1%Nasal swabReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96%Nasopharyngeal swabClinical Sensitivity95.5%Nasal swabClinical Specificity100%Nasopharyngeal swabClinical Specificity100%Nasal swabType of antigenNucleocapsid protein