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

ABSTRACT 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%).