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. ### Competing Interest Statement KC, HR, SC, and CC are employees of Becton, Dickinson and Company. The individuals acknowledged here have no additional funding or additional compensation to disclose. ### Clinical Trial retrospective study ### Funding Statement Becton, Dickinson and Company; BD Life Sciences - Integrated Diagnostic Solutions provided funding to both BD and non-BD employee authors to support this study. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The study protocol was approved by the Advarra Institutional Review Board (IRB). All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes The data will be available upon request.