Jornal de Ensaios Clínicos
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Abstrato

In vitro Characterisation and Clinical Evaluation of the Diagnostic Accuracy of a New Antigen Test for SARS-CoV-2 Detection

Juan José Montoya Miñano, José M Rubio, Ouahid Y, Lopez A, Madejon A, Gil-Garcia AI, Ryan Hannam, Butler HRE, Pablo Castan

Quick, user-friendly and sensitive diagnostic tools are the key 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.