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

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

2021-10-29 infectious diseases
10.1101/2021.10.28.21265544 medRxiv
Show abstract

Background 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(R)-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.

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