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

Background and aims: 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 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. The study was approved by MiRNAX corporate review board to ensure i) that the test complied with all the ethical requirements, ii) that the rights of participants were protected, and iii) that donors were fully informed about the likelihood that they would not personally benefit from the research. The tests were completed under the frame of Project SENSORNAS RTC-20176501 in collaboration with MiRNAX Biosens Ltd. and Hospital Carlos III and are currently under submission and review from the Ethics Committee of Universidad Autonoma de Madrid. Keywords: respiratory disease COVID-19; SARS-CoV-2; ELISA; RT-PCR; antigen lateral flow test.