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

Young, S.; Taylor, S.; Cammarata, C.; Roger-Dalbert, C.; Montano, A.; Griego-Fullbright, C.; Burgard, C.; Fernandez, C.; Eckert, K.; Andrews, J. C.; Ren, H.; Allen, J.; Ackerman, R.; Gary, D.; Cooper, C.

Objectives The clinical performance of the BD Veritor System for Rapid Detection of SARS-CoV-2 antigen (Veritor test), a chromatographic immunoassay that detects the SARS-CoV-2 nucleocapsid antigen, was evaluated on nasal specimens from patients with suspected symptoms of COVID-19. Methods and Materials Two studies were employed. In study 1, 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 the Veritor test to the Lyra SARS-CoV-2 PCR Assay (Lyra assay). In study 2, nasal specimens from 361 participants with COVID-19 symptoms (<=5 DSO), >=18 years of age, were utilized to compare performance of the Veritor test to that of the Sofia SARS Antigen FIA test (Sofia test). Positive, negative, and overall percent agreement (PPA, NPA, and OPA, respectively) were the primary outcomes Results In study 1, the Veritor test had a PPA with the Lyra assay ranging from 81.8%-87.5% for the 0-1 through the 0-6 DSO ranges. In study 2, the Veritor test had a PPA, NPA, and OPA of 97.4%, 98.1%, and 98.1%, respectively with the Sofia test. Discordant testing showed one Lyra positive missed by the Veritor test and five Lyra positives missed by Sofia; one Veritor positive result was negative by Lyra. Conclusions The Veritor test met FDA-EUA acceptance criteria for SARS-CoV-2 antigen testing (>=80% PPA point estimate) for the 0-5 and 0-6 DSO ranges. In addition, the Veritor and Sofia tests showed a high degree of agreement for detection of SARS-CoV-2. The Veritor test should facilitate rapid and reliable results for COVID-19 diagnosis.