Clinical assessment of the Roche SARS-CoV-2 rapid antigen test

Abstract Objectives Novel point-of-care antigen assays present a promising opportunity for rapid screening of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections. The purpose this study was the clinical assessment new Roche SARS-CoV-2 Rapid Antigen Test. Methods performance Test evaluated vs. reverse transcription polymerase chain reaction (RT-PCR) laboratory-based assay (Seegene AllplexTM2019-nCoV) in nasopharyngeal swabs collected from series consecutive patients referred diagnostics to Pederzoli Hospital (Peschiera del Garda, Verona, Italy) over 2-week period. Results final population consisted 321 (mean age, 46 years and IQR, 32–56 years; 181 women, 56.4%), with 149/321 (46.4%) positive RNA via Seegene AllplexTM2019-nCoV Assay, 109/321 (34.0%) Test, respectively. overall accuracy compared molecular testing 86.9%, 72.5% sensitivity 99.4% specificity. Progressive decline observed as cycle threshold (Ct) values different gene targets increased. found range between 97–100% samples Ct <25, 50–81% those 25 <30, but low 12–18% 30 <37. Conclusions is excellent which makes it reliable test high viral load. However, mass community would require use more sensitive techniques.