Montoya JJ, Rubio JM, Ouahid Y, Lopez A, Madejon A, Gil-Garcia AI, Hannam RJ, Butler HRE and Castan P
Background and aims: Quick, user-friendly, and sensitive diagnostic tools are the keys to controlling the spread of the SARS-CoV-2 pandemic in the new epidemiologic landscape. The aim of this work is to characterize a new COVID-19 antigen test that uses an innovative chromatographic Affimer®-based technology designed for the qualitative detection of SARS-CoV-2 antigen. As rapid technology to detect COVID-19, the test was extensively characterized in vitro. Once the analytical parameters of performance were set, the test system was challenged in a test field study. The aim of this study was to evaluate its diagnostic accuracy, as compared by the gold standard RT-PCR and other existing lateral flow tests.