Clinical evaluation of the molecular-based BD SARS-CoV-2/Flu for the BD MAX™ System

Objectives Establish the diagnostic performance related to SARS-CoV-2 and Flu A/B detection for the BD SARS-CoV-2/Flu for BD MAX™ System (“MAX SARS-CoV-2/Flu”) multiplex assay. Methods and Materials Two hundred and thirty-five (235) retrospective nasopharyngeal specimens were obtained from external vendors. The BD BioGx SARS-CoV-2 Reagents for BD MAX™ System (“BioGx SARS-CoV-2”) and the Cepheid Xpert® Xpress Flu/RSV (“Xpert Flu”) were utilized as reference methods. Results By reference methods, 52 specimens were SARS-CoV-2-positive, 59 were Flu A-positive, and 60 were Flu B-positive. MAX SARS-CoV-2/Flu had positive percent agreement (PPA) and negative percent agreement (NPA) values for SARS-CoV-2 detection of 96.2% ([95%CI]:87.0-98.9) and 100% [95%CI:88.7-100], respectively; PPA values for Flu A and Flu B of 100% [95%CI:93.9-100] and 98.3% [95%CI:91.1-99.7], respectively, and NPA values for Flu A and Flu B of 98.9% [95%CI:94.0-99.8] and 100% [95%CI:95.9-100], respectively. Discussion The MAX SARS-CoV-2/Flu assays met FDA-EUA performance criteria for SARS-CoV-2 (≥95% for PPA and NPA) and FDA clearance criteria for Flu A/B (PPA ≥90%; lower bound of the 95%CI ≥80%) and (NPA ≥95%; lower bound of the 95%CI ≥90%). ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial This research was conducted by using materials obtained from pre-selected frozen remnants, received after routine care. ### Funding Statement This study was funded by Becton, Dickinson and Company; BD Life Sciences, Integrated Diagnostics Solutions. Non-BD employee authors received research funds to support their work for 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: New York Biologics holds two IRB approvals for residual specimen collection: one from Western IRB (WIRB) and the other from Ethical & Independent Review Services (EIRS). Trans-Hit Bio partners with academic and hospital-based biobanks and other clinical collection sites. These samples were collected under their biobank umbrella protocol (approved by the Valleywise Health Institutional Review Board) that allows for the collection of various biospecimens including NP swabs. Under this protocol, ICF is waived for diagnostic remnants (as was the case with the NP swabs) 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 All data are available upon request.