2024-03-29 11:54:46 CET933COVID-9 IgG/IgM Rapid Test Kit (Colloidal Gold)516JOYSBIO (Tianjin) Biotechnology Co. Ltd.Chinaen.joysbio.com/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgM2022-08-24 09:08:01 CET753Immuno-AntibodyYesImmunoassayColorimetry1764SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold)516JOYSBIO (Tianjin) Biotechnology Co. Ltd.Chinaen.joysbio.com/YesCommercialisedYesYesNear POC / POCAntigenNasal swab2022-08-24 09:08:01 CET1442Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD160AUAnalytical Sensitivity98.13%Analysis of cross reactivity0AUFalse positives3AUFalse negatives2AUAccuracy98.98%1766SARS-CoV-2 Antigen Rapid Test Kit - Saliva (Colloidal Gold)516JOYSBIO (Tianjin) Biotechnology Co. Ltd.Chinaen.joysbio.com/YesCommercialisedNoNoNear POC / POCAntigenSalivanucleocapsid protein2022-08-24 09:08:01 CET1445Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD320U/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0%0 out of 260 RT-PCR negative specimensFalse negatives4.9%5 out of 102 RT-PCR positive specimensPrecisionEvaluatedAccuracy98.62%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.1%Type of antigenNucleoprotein2813SARS-CoV-2 Antigen Rapid Test Kit-PRO (Colloidal Gold)1258JOYSBIO (Tianjin) Biotechnology Co. Ltd.Chinahttps://en.joysbio.com/YesCommercialisedNoNoNear POC / POCAntigenNasal 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.1.526.21494P.2Zetathis test is evaluated by PEI in Germany and marked as passed evaluation. It is listed as "Joysbio SARS-CoV-2 Antigen rapid test kit - PRO (Colloidal Gold)" in the PEI evaluation list. 2022-08-24 09:08:01 CET2518Immuno-AntigenNoImmunochromatographyQualitativeMembrane-basedColloidal gold15LOD120TCID50/mlCalibrationEvaluatedAnalysis of cross reactivityEvaluatedFalse positives0.44%1 out of 224 RT-PCR negative specimensFalse negatives1.81%2 out of 110 RT-PCR positive specimensPrecisionEvaluatedAccuracy99.1%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.18%Clinical Specificity99.55%Type of antigenNucleocapsid protein