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

Efficient and accurate assays for the differential diagnosis of COVID-19 and/or influenza (flu) could facilitate optimal treatment for both diseases. Diagnostic performance related to SARS-CoV-2 and Flu A/B detection was characterized for the BD SARS-CoV-2/Flu for BD MAX System ("MAX SARS-CoV-2/Flu") multiplex assay in comparison with BD BioGx SARS-CoV-2 Reagents for BD MAX System ("BioGx SARS-CoV-2") and the Cepheid Xpert(R) Xpress Flu/RSV ("Xpert Flu"). Two hundred and thirty-five nasopharyngeal specimens were obtained from external vendors. MAX SARS-CoV-2/Flu had positive percent agreement (PPA) and negative percent agreement (NPA) values for SARS-CoV-2 and Flu A/B that met FDA-EUA acceptance criteria of >95%.