Retrospective and prospective studies evaluating the performance of the SARS-Cov-2 "AQ+ COVID-19 Ag Rapid Test" from InTec on symptomatic and non-symptomatic patients.

For the last two years, the SARS-CoV-2 virus spread all around the world and led to the COVID-19 pandemic. The need of methods to control the pandemic and to propose rapid and efficient diagnostic tools has emerged. In this perspective, SARS-CoV-2 rapid antigen detection tests (RADT) have been developed. We performed a retrospective study on 638 collected nasopharyngeal samples used for reference RT-qPCR diagnosis to compare the AQ + COVID-19 Ag Rapid Test" from InTec (AQ + InTec test) performance with other commercially available RADT (Abbott Panbio, Roche SDBiosensor and Siemens Clinitest). We analysed the sensitivity and specificity of the different tests and showed a better overall performance of the AQ + InTec test, which was confirmed on the SARS-Cov-2 Omicron variant. We then conducted a prospective study on 844patients, to evaluate the sensitivity and specificity of the AQ + InTec test on nasal and nasopharyngeal samples in a point of care setting. We showed that sensitivity and specificity reach acceptable criteria (respectively 94.4% and 99.6% on nasal samples) regarding the official recommendations of the MDCG 2021-21 in both symptomatic and asymptomatic patients. Overall, the results of these two studies confirm that the AQ + InTec test is a valuable tool for testing in a pandemic context with a high proportion of asymptomatic patients who are potential carriers for the SARS-CoV-2 virus and is performant on the most current circulating variant Omicron.