Clinical evaluation of BD Veritor™ SARS-CoV-2 and Flu A+B Assay for point-of-care (POC) System

Differential diagnosis of COVID-19 and/or influenza (flu) at point of care is critical for efficient patient management and treatment for either of these diseases. Clinical performance of the BD Veritor™ System for Rapid Detection of SARS-CoV-2 & FluA+B (Veritor SARS-CoV-2/Flu) triplex assay was characterized. The performance for SARS-CoV-2 detection was determined using two hundred and ninety-eight (298) specimens from patients reporting COVID-19 symptoms within 7 days from symptom onset (DSO) in comparison with Lyra® SARS-CoV-2 RT-PCR Assay (Lyra SARS-CoV-2). The Veritor SARS-CoV-2/Flu Assay met the FDA EUA acceptance criterion with 95% overall agreement for SARS-CoV-2 test when compared to Lyra SARS-CoV-2. The performance for Flu A and Flu B detection was determined using 75 influenza-positive and 40 influenza-negative retrospective specimens in comparison with the previously FDA cleared BD Veritor™ System for Rapid Detection of Flu A+B (Veritor Flu). The Veritor SARS-CoV-2/Flu also demonstrated 100% agreement with the Veritor Flu.