Clinical evaluation of the BD Veritor™ SARS-CoV-2 point-of-care test

Abstract

BACKGROUND

Whereas COVID-19 is now in the endemic phase, maintaining robust diagnostic capabilities remains critical for ongoing surveillance and timely response to potential infection spikes.

OBJECTIVE

To evaluate the performance of the updated BD Veritor™ System for SARS-CoV-2 (Veritor; Becton Dickinson and Company, BD Life Sciences—Diagnostic Solutions, San Diego, CA ) assay against a comparator, the Panther Fusion (Fusion; Hologic Inc., San Diego, CA) and regulatory performance criteria.

METHODS

This prospective, clinical study enrolled 1,181 SARS-CoV-2 symptomatic individuals across 15 U.S. sites. Healthcare providers collected dual nares samples from participants ≥6 months of age and ≤7 days from symptom onset (DSO) to determine diagnostic accuracy of Veritor compared to Fusion and expected regulatory performance criteria per previously cleared SARS-CoV-2 antigen assays.

RESULTS

Of 1,045 compliant and reportable specimens, Veritor had an overall positive percent agreement (PPA) of 83.4% [95% CI; 76.6, 88.6] and a negative percent agreement (NPA) of 99.7% [95% CI; 99.0, 99.9]. Performance varied by DSO, with higher PPA closer to symptom onset, and by viral load (characterized by Fusion Ct score), with lower Ct scores associated with better Veritor performance. Veritor met the regulatory (FDA 510(k)) acceptance criteria for SARS-CoV-2 antigen testing for the 0-7 DSO range.

CONCLUSION

The Veritor test allows rapid and accurate detection of SARS-CoV-2 antigen testing utilizing easy-to-collect nasal swabs.