Evaluation of Three Covid-19 Antigen Assay Versus PCR Detection in Routine Practice

Abstract

According to WHO, molecular testing is the "Gold Standard" for the diagnosis of SARS-CoV-2 infection. However, these tests have some limitations in practice (well trained staff, specific equipment requirements, organization of area and time frame for reporting results). Thus, rapid antigen test (RAT) for the detection of one or several SARS-CoV-2 antigens have emerged. We evaluated the analytical performance of 3 RAT used in our laboratory : FREND® Ag COVID-19 (NanoEntek) (FA), STANDARD Q COVID-19 Ag (SD Biosensor) (BA), PANBIO™ COVID-19 Ag RAPID TEST DEVICE (Abbott) (PA) in comparaison to rRT-PCR results. Our study indicates that PA and SA antigen tests have a very good sensitivity to identify infected patients with COVID-19 specifically between in the 0-5 days time-window post onset of symptoms. Nevertheless, one out of three antigen tests (FA) showed very poor clinical performance.