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

Yanson, K.; LaViers, W.; Neely, L.; Lockamy, E.; Castillo-Hernandez, L. C.; Oldfied, C.; Ackerman, R.; Ackerman, J.; Ortiz, D.; Pacheco, S.; Simner, P.; Young, S.; McElvania, E.; Lin, Y.-C.; Cooper, C.

Background The RT-qPCR assay for detecting SARS-CoV-2 virus is the favorable approach to test suspected COVID-19 cases. However, discordant results can occur when two or more assays are compared. Variability in analytical sensitivities between assays, among other factors, may account for these differences in reporting. Methods The limits of detection (LOD) for the BD SARS-CoV-2 Reagents for BD MAXTM System ('MAX SARS-CoV-2 assay'), the Biomerieux BioFire(R) 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(R) SARS-CoV-2 assay Panther(R) ('Aptima SARS-CoV-2 assay') RT-qPCR 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) for the MAX SARS-CoV-2 assay were compared to the Aptima SARS-CoV-2 assay in a post-market clinical study utilizing 708 paired nasopharyngeal specimens collected from suspected COVID-19 cases. Discordant results were further tested by the cobas and BioFire SARS-CoV-2 assays. Results The measured LOD for the MAX SARS-CoV-2 assay (251 copies/mL) was comparable to the cobas SARS-CoV-2 assay (298 copies/mL) and the BioFire SARS-CoV-2 assay (302 copies/mL); the Aptima SARS-CoV-2 assay had a LOD of 612 copies/mL. 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 MAX SARS-CoV-2 assay exhibited a high analytical sensitivity and specificity for SARS-CoV-2 detection. The clinical performance of the MAX SARS-CoV-2 assay agreed with another sensitive EUA cleared assay.