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. 2020 Aug:129:104538.
doi: 10.1016/j.jcv.2020.104538. Epub 2020 Jul 6.

Clinical evaluation of the BioFire® Respiratory Panel 2.1 and detection of SARS-CoV-2

Hannah M Creager  1 , Barbara Cabrera  1 , Andy Schnaubelt  1 , Jesse L Cox  1 , Allison M Cushman-Vokoun  1 , Salika M Shakir  2 , Keith D Tardif  2 , Meei-Li Huang  3 , Keith R Jerome  4 , Alexander L Greninger  3 , Daria Drobysheva  5 , Usha Spaulding  5 , Margarita Rogatcheva  5 , Kevin M Bourzac  5 , S H Hinrichs  1 , M J Broadhurst  1 , P D Fey  6
Affiliations

Clinical evaluation of the BioFire® Respiratory Panel 2.1 and detection of SARS-CoV-2

Hannah M Creager et al. J Clin Virol. 2020 Aug.

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.

Keywords: COVID19; Diagnostics; SARS CoV-2.

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Conflict of interest statement

Declaration of Competing Interest The Corresponding author has acted as a consultant and received grant funding from BioFire Diagnostics.

Figures

Fig. 1
Fig. 1
Ct distribution of specimens tested in clinical study. Ct values are shown for each assay used for characterizing clinical specimens, as indicated on the X axis. Horizontal bars represent Ct median values for each assay.
See this image and copyright information in PMC

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