ABSTRACT
ObjectivesThe clinical performance of the BD Veritor System for Rapid Detection of SARS-CoV-2 antigen (Veritor), a chromatographic immunoassay that detects the SARS-CoV-2 nucleocapsid antigen as a point-of-care test, was evaluated on nasal specimens from individuals with COVID-19 symptoms. Methods and MaterialsTwo studies were completed to determine clinical performance. In the first study, nasal specimens and either nasopharyngeal or oropharyngeal specimens from 251 participants with COVID-19 symptoms ([≤]7 days from symptom onset [DSO]), [≥]18 years of age, were utilized to compare Veritor with the Lyra(R) SARS-CoV-2 PCR Assay (Lyra). In the second study, nasal specimens from 361 participants with COVID-19 symptoms ([≤]5 DSO), [≥]18 years of age, were utilized to compare performance of Veritor to that of the Sofia(R) 2 SARS Antigen FIA test (Sofia 2). Positive, negative, and overall percent agreement (PPA, NPA, and OPA, respectively) were the primary outcomes. ResultsIn study 1, PPA for Veritor, compared to Lyra, ranged from 81.8%-87.5% for 0-1 through 0-6 DSO ranges. In study 2, Veritor had a PPA, NPA, and OPA of 97.4%, 98.1%, and 98.1%, respectively, with Sofia 2. Discordant analysis showed one Lyra positive missed by Veritor and five Lyra positives missed by Sofia 2; one Veritor positive result was negative by Lyra. ConclusionsVeritor met FDA-EUA acceptance criteria for SARS-CoV-2 antigen testing ([≥]80% PPA point estimate) for the 0-5 and 0-6 DSO ranges. Veritor and Sofia 2 showed a high degree of agreement for SARS-CoV-2 detection. The Veritor test should facilitate rapid and reliable results for COVID-19 diagnosis utilizing easy-to-collect nasal swabs. SummaryThe BD Veritor SARS-CoV-2 antigen test met FDA-EUA acceptance criteria for SARS-CoV-2 antigen testing for subjects with COVID-19 symptoms (0-5 days post-onset). BD Veritor and Quidel Sofia 2 antigen tests had good agreement for SARS-CoV-2 detection; discordant analysis favored Veritor.