Journal of Clinical Trials
Open Access

Abstract

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 A.I, Ryan Hannam, Butler H.R.E and 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.

Published Date: 2021-11-24; Received Date: 2021-11-03