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. 2022 Apr 27;10(2):e0180721.
doi: 10.1128/spectrum.01807-21. Epub 2022 Apr 12.

Clinical Evaluation of BD Veritor SARS-CoV-2 and Flu A+B Assay for Point-Of-Care System

Katherine Christensen  1 , Huimiao Ren  2 , Shirley Chen  2 , Charles K Cooper  1 , Stephen Young  3
Affiliations

Clinical Evaluation of BD Veritor SARS-CoV-2 and Flu A+B Assay for Point-Of-Care System

Katherine Christensen et al. Microbiol Spectr. .

Abstract

Differential diagnosis of COVID-19 and/or influenza (flu) at point of care is critical for efficient patient management and treatment of both these diseases. The study presented here characterizes the BD Veritor System for Rapid Detection of SARS-CoV-2 and Flu A+B ("Veritor SARS-CoV-2/Flu") triplex assay. The performance for SARS-CoV-2 detection was determined using 298 specimens from patients reporting COVID-19 symptoms within 7 days from symptom onset (DSO) in comparison with the Lyra SARS-CoV-2 RT-PCR (reverse transcriptase PCR) assay ("Lyra SARS-CoV-2") as the reference. 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 assay ("Veritor Flu") as the reference. The Veritor SARS-CoV-2/Flu assay met the FDA EUA acceptance criteria (86.7%; 95% confidence interval [95% CI]: 75.8 to 93.1) for SARS-CoV-2 testing compared to Lyra SARS-CoV-2. The Veritor SARS-CoV-2/Flu assay also demonstrated 100% agreement with the Veritor Flu for Flu A+B assay. For flu A detection, the lower bound of the 95% CI was 91.2%; for flu B detection, the lower bound was 90.0%. The dual detection capability of Veritor SARS-CoV-2/Flu for the etiologic agents causing COVID-19 and flu will allow efficient differentiation between the two illnesses, inform disease management, and facilitate optimal treatment. IMPORTANCE COVID-19 and flu are two respiratory illnesses which share similar clinical symptoms. The BD Veritor SARS-CoV-2/Flu assay has high sensitivity and specificity for detecting the SARS-CoV-2 and influenza A/B, the two etiologic agents causing COVID-19 and flu, respectively. This dual detection capability is critical when overlap occurs between the COVID-19 pandemic and the flu season. This triplex assay will allow efficient differentiation between the two respiratory illnesses and support a point-of-care physician diagnosis to facilitate the proper treatment and disease management for patients exhibiting overlapping symptoms.

Keywords: BD Veritor; COVID-19; SARS-CoV-2; flu; influenza; triplex antigen assay.

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Conflict of interest statement

The authors declare a conflict of interest. K.C., H.R., S.C., and C.K.C. are current and previous employees of Becton, Dickinson and Company. The individuals acknowledged here have no additional funding or additional compensation to disclose.

Becton, Dickinson and Company; BD Life Sciences-Integrated Diagnostic Solutions provided funding to both BD and non-BD employee authors to support this study. K.C., H.R., S.C., and C.K.C. are current and previous employees of Becton, Dickinson and Company. The individuals acknowledged here have no additional funding or additional compensation to disclose. S.Y. reports personal fees from Becton, Dickinson and Company; Quidel, Inc.; and Safeguard Biosystems.

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