Abstract
The SARS-CoV-2 pandemic led to an urgent need for rapid diagnostic testing in order to inform timely patients' management. This study aimed to assess the performance of the STANDARD™ M10 SARS-CoV-2 assay as a diagnostic tool for COVID-19. A total of 400 nasopharyngeal or oropharyngeal swabs were tested against a reference real-time RT-PCR, including 200 positive samples spanning the full range of observed Ct values. The sensitivity of the STANDARD™ M10 SARS-CoV-2 assay was 98.00% (95% CI 94.96% to 99.45%, 196/200), while the specificity was also estimated at 97.50% (95% CI 94.26% to 99.18%, 195/200). The assay proved highly efficient for the detection of SARS-CoV-2, even in samples with low viral load (Ct>25), presenting lower Ct values compared to the reference method. We concluded that the STANDARD™ M10 SARS-CoV-2 assay has a similar performance compared to the reference method and other molecular point-of-care assays and can be a valuable tool for rapid and accurate diagnosis.