CERTIFICATIONS AND RECOGNITIONS

The coronavirus disease 2019 (COVID-19) pandemic continues to spread across the world. Hence, there is an urgent need for rapid, simple, and accurate tests to diagnose severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. While currently recommended nucleic acid amplification tests (NAAT), such as real-time reverse transcription polymerase chain reaction (rtRT-PCR) assays, remain the gold standard cornerstone for the diagnosis of SARS-CoV-2 infection (Smithgall et al., 2020, Rai et al., 2021), immunological methods can also be used to detect viral antigens (Dinnes et al., 2020, Li and Li, 2020, Rai et al., 2021). Indeed, performing rtRT-PCR is expensive, time consuming, and requires special equipment and qualified operators. Faster, cheaper, and easier to use alternative tools could be represented by novel point-of-care antigen-detecting rapid diagnostic tests (Ag-RDT) (Dinnes et al., 2020). Ag-RDT relies on direct detection of SARS-CoV-2 viral proteins produced by replicating virus in nasal swabs and other respiratory secretions, often the virus N nucleocapsid protein, preferred because of its relative abundance and conserved structure, or other viral proteins such as the spike protein (Li and Li, 2020). Most Ag-RDTs use sandwich catching by anti-SARS-CoV-2 monoclonal antibodies to detect viral antigens in the simple-to-use lateral flow immunoassay format allowing results in <30 min. Around 150 Ag-RDTs for SARS-CoV-2 infection are now commercially available or in development (Finddx, 2021). However, there is significant variability reported with respect to their diagnostic performances and a lack of external validation for many of the available tests, which still require clinical validation (Dinnes et al., 2020, Mattiuzzi et al., 2020, Favresse et al., 2021, Fitzpatrick et al., 2021, Schildgen et al., 2021).The aim of our study was to evaluate the Ag-RDT SIENNA™ COVID-19 Antigen Rapid Test Cassette (Nasopharyngeal Swab) (Salofa Oy, Salo, Finland; manufactured under license of T&D Diagnostics Canada Pvt. Ltd., Halifax, Canada), for the diagnosis of COVID-19 in hospitalized patients with suspect SARS-CoV-2 infection during the second wave of the COVID-19 epidemic in Paris, France. The results of this test were compared with qualitative and quantitative results obtained in parallel using rtRT-PCR as reference test.