Clinical evaluation of the BioFire® Respiratory Panel 2.1 and detection of SARS-CoV-2
Hannah M. Creager, Barbara Cabrera, Andy Schnaubelt, Jesse L. Cox, Allison M. Cushman‐Vokoun, Salika M. Shakir, Keith D. Tardif, Meei‐Li Huang, Keith R. Jerome, Alexander L. Greninger, Daria Drobysheva, Usha Spaulding, Margarita B. Rogatcheva, Kevin M. Bourzac, S. H. Hinrichs, M. Jana Broadhurst, Paul D. Fey
Abstract
We evaluated the performance of the BioFire® Respiratory Panel 2.1 (RP2.1) in the detection of SARS CoV-2 in comparison against three other SARS CoV-2 EUA assays. In these studies, the RP2.1 panel had 98 % positive percent agreement (48/49) and 100 % negative percent agreement (49/49). Since 30 % of nasopharyngeal swab specimens have a SARS CoV-2 Ct >30 and thus detection of virus in low titers is clinically relevant, a sample with a high titer was diluted and each 10 fold dilution was tested in triplicate and compared against 6 other EUA approved SARS CoV-2 assays. These data suggested that the BioFire® RP2.1 panel, along with four other SARS CoV-2 assays (Roche cobas, Cepheid Xpert Xpress, BioFire® Defense COVID19, and NECoV19), consistently detected viral RNA at the 10-7 dilution. Overall, these studies suggest that the BioFire® RP2.1 assay can be used to detect acute cases of SARS CoV2 in addition to patients with low viral titer later in disease presentation.