Clinical evaluation of BD Veritor SARS-CoV-2 point-of-care test performance compared to PCR-based testing and versus the Sofia 2 SARS Antigen point-of-care test

摘要: ABSTRACT The clinical performance of the BD Veritor System for Rapid Detection SARS-CoV-2 nucleocapsid antigen (Veritor), a chromatographic immunoassay used point-of-care testing, was evaluated using nasal specimens from individuals with COVID-19 symptoms. Two studies were completed to determine performance. In first study, and either nasopharyngeal or oropharyngeal 251 participants symptoms (≤7 days symptom onset [DSO], ≥18 years age) utilized compare Lyra PCR assay (Lyra). second 361 (≤5 DSO, that Sofia 2 SARS Antigen FIA test (Sofia 2). positive, negative, overall percent agreement (PPA, NPA, OPA, respectively) primary outcomes. study 1, PPA Veritor, compared Lyra, ranged 81.8 87.5% across 0 1 6 DSO ranges. 2, had PPA, OPA values 97.4, 98.1, 98.1%, respectively, 2. Discordant analysis showed one positive missed by five positives 2; result negative Lyra. met FDA emergency use authorization (EUA) acceptance criteria testing 5 ranges (PPA 83.9% 82.4%, respectively). high degree detection. allows more rapid utilizing easy-to-collect swabs but demonstrated