Journal of Clinical Trials
Open Access
ISSN: 2167-0870
ISSN: 2167-0870
Department of Microbiology, National Center for Microbiology, Carlos III Health Institute, Ctra. De Pozuelo, Majadahonda, Madrid, Spain
Research Article
In vitro Characterisation and Clinical Evaluation of the Diagnostic Accuracy of a New Antigen Test for SARS-CoV-2 Detection
Author(s): 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... View More»