2024-03-28 19:38:17 CET2426AffiDX SARS-CoV-2 Antigen Lateral Flow Test1109Avacta Life Sciences Ltd.United Kingdomwww.avacta.comYesCommercialisedNoNoAntigenNasal swab679B.1.1.7Alpha1022B.1.351Beta1311B.1.617.2Deltaspike protein antigen2022-08-24 09:08:01 CET2129Immuno-AntigenYesNoQualitative20LOD600AUCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives%1 out of 102 confirmed negativesFalse negatives%2 out of 98 confirmed positives (PCR Ct values up to 31)PrecisionEvaluatedAccuracy98.5%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98%Clinical Specificity99%Type of antigenOther