In vitro characterisation and clinical evaluation of the diagnostic accuracy of a new antigen test for SARS-CoV-2 detection

Author:

Montoya J.J.,Rubio J.M.,Ouahid Y.,Lopez A.,Madejon A.,Gil-Garcia A.I.,Hannam R.J.,Butler H.R.E.,Castan P.

Abstract

AbstractBackground and aimsQuick, 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 characterise 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 characterised 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.

Publisher

Cold Spring Harbor Laboratory

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5. Promise versus Reality: Optimism Bias in Package Inserts for Tuberculosis Diagnostics

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