Performance evaluation of the BD SARS-CoV-2 reagents for the BD MAX™ system.

Background Nucleic acid amplification testing (NAAT) for SARS-CoV-2 is the standard approach for confirming COVID-19 cases. This study compared results between two Emergency Use Authorization (EUA) NAATs, with two additional EUA NAATs utilized for discrepant testing. Methods The limits of detection (LOD) for the BD SARS-CoV-2 Reagents for BD MAX™ System ("MAX SARS-CoV-2 assay"), the Biomerieux BioFire® Respiratory Panel 2.1 ("BioFire SARS-CoV-2 assay"), the Roche cobas SARS-CoV-2 assay ("cobas SARS-CoV-2 assay"), and the Hologic Aptima® SARS-CoV-2 assay Panther® ("Aptima SARS-CoV-2 assay") NAAT systems were determined using a total of 84 contrived nasopharyngeal specimens with seven target levels for each comparator. The positive and negative percent agreement (PPA and NPA, respectively) of the MAX SARS-CoV-2 assay, compared to the Aptima SARS-CoV-2 assay, was evaluated in a post-market clinical study utilizing 708 nasopharyngeal specimens collected from suspected COVID-19 cases. Discordant testing was achieved using cobas and BioFire SARS-CoV-2 NAATs. Results In this study, the measured LOD for the MAX SARS-CoV-2 assay (251 copies/mL; [95%CI: 186, 427]) was comparable to the cobas SARS-CoV-2 assay (298 copies/mL; [95%CI: 225, 509]) and the BioFire SARS-CoV-2 assay (302 copies/mL; [95%CI: 219, 565]); the Aptima SARS-CoV-2 assay had a LOD of 612 copies/mL; [95%CI: 474, 918]. The MAX SARS-CoV-2 assay had a PPA of 100% (95%CI: [97.3%-100.0%]) and a NPA of 96.7% (95%CI: [94.9%-97.9%]) when compared to the Aptima SARS-CoV-2 assay. Conclusions The clinical performance of the MAX SARS-CoV-2 assay agreed with another sensitive EUA assay.