Clinical Performance of the BD Respiratory Viral Panel for BD MAX™ System in Detecting SARS-CoV-2, Influenza A and B, and Respiratory Syncytial Virus.

Using a nasopharyngeal (NP) or anterior nasal (NS) swab from prospectively collected or retrospective specimens, we assessed the clinical performance of the BD Respiratory Viral Panel (BD RVP) for BD MAX System against FDA-cleared or authorized comparators. Across prospective and retrospective specimens, positive percent agreement (PPA) was ≥ 98.4% for SARS-CoV-2, ≥ 96.7% for influenza (flu) A, ≥ 91.7% for respiratory syncytial virus (RSV), and 100% for flu B (retrospective only) while negative percent agreement (NPA) was ≥ 97.7% across all targets, leading to the assay FDA clearance. A head-to-head comparison of NS versus NP results with BD RVP was also performed; PPA was ≥ 90% and NPA ≥ 98.2% for SARS-CoV-2, flu A and RSV. These findings confirm that the BD MAX RVP assay performs well for detection and differentiation of the three viruses in NP and NS specimens, with strong interrater agreements for NS versus NP comparisons.

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Copyright © 2024. Published by Elsevier Inc.

Déclaration de conflit d'intérêts

Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Becton, Dickinson and Company reports financial support was provided by Biomedical Advanced Research and Development Authority. Nathan Ledeboer reports a relationship with Copan Italy that includes: consulting or advisory. Nathan Ledeboer reports a relationship with Thermo Fisher that includes: consulting or advisory. Barbara Van Der Pol reports a relationship with Abbott that includes: consulting or advisory and funding grants. Barbara Van Der Pol reports a relationship with Becton, Dickinson and Company that includes: consulting or advisory and funding grants. Barbara Van Der Pol reports a relationship with Biofire Diagnostics Inc that includes: consulting or advisory and funding grants. Barbara Van Der Pol reports a relationship with Cue that includes: consulting or advisory and funding grants. Barbara Van Der Pol reports a relationship with Cepheid that includes: consulting or advisory and funding grants. Barbara Van Der Pol reports a relationship with Detect that includes: consulting or advisory and funding grants. Barbara Van Der Pol reports a relationship with Hologic Inc that includes: consulting or advisory and funding grants. Barbara Van Der Pol reports a relationship with Preventx and FIND that includes: consulting or advisory and funding grants. Barbara Van Der Pol reports a relationship with Rheonix that includes: consulting or advisory and funding grants. Barbara Van Der Pol reports a relationship with Roche that includes: consulting or advisory and funding grants. Barbara Van Der Pol reports a relationship with Visby that includes: consulting or advisory and funding grants. Matthew L. Faron reports a relationship with Becton, Dickinson and Company that includes: consulting or advisory. Sonia Paradis reports a relationship with Becton, Dickinson and Company that includes: employment and equity or stocks. William Laviers reports a relationship with Becton, Dickinson and Company that includes: employment and equity or stocks. Elizabeth Lockamy reports a relationship with Becton, Dickinson and Company that includes: employment and equity or stocks. Karen Yanson reports a relationship with Becton, Dickinson and Company that includes: employment and equity or stocks. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.