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 Rogatcheva; Kevin M. Bourzac; S. H. Hinrichs; M. J. Broadhurst; P. D. Fey

doi:10.1016/j.jcv.2020.104538

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 Rogatcheva, Kevin M. Bourzac, S. H. Hinrichs, M. J. Broadhurst, P. D. Fey

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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.

Original language	English (US)
Article number	104538
Journal	Journal of Clinical Virology
Volume	129
DOIs	https://doi.org/10.1016/j.jcv.2020.104538
State	Published - Aug 2020

Keywords

COVID19
Diagnostics
SARS CoV-2

ASJC Scopus subject areas

Virology
Infectious Diseases

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Creager, H. M., Cabrera, B., Schnaubelt, A., Cox, J. L., Cushman-Vokoun, A. M., Shakir, S. M., Tardif, K. D., Huang, M. L., Jerome, K. R., Greninger, A. L., Drobysheva, D., Spaulding, U., Rogatcheva, M., Bourzac, K. M., Hinrichs, S. H., Broadhurst, M. J., & Fey, P. D. (2020). Clinical evaluation of the BioFire® Respiratory Panel 2.1 and detection of SARS-CoV-2. Journal of Clinical Virology, 129, Article 104538. https://doi.org/10.1016/j.jcv.2020.104538

Creager, HM, Cabrera, B, Schnaubelt, A, Cox, JL , Cushman-Vokoun, AM, Shakir, SM, Tardif, KD, Huang, ML, Jerome, KR, Greninger, AL, Drobysheva, D, Spaulding, U, Rogatcheva, M, Bourzac, KM, Hinrichs, SH , Broadhurst, MJ & Fey, PD 2020, 'Clinical evaluation of the BioFire® Respiratory Panel 2.1 and detection of SARS-CoV-2', Journal of Clinical Virology, vol. 129, 104538. https://doi.org/10.1016/j.jcv.2020.104538

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abstract = "We evaluated the performance of the BioFire{\textregistered} 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{\textregistered} RP2.1 panel, along with four other SARS CoV-2 assays (Roche cobas, Cepheid Xpert Xpress, BioFire{\textregistered} Defense COVID19, and NECoV19), consistently detected viral RNA at the 10−7 dilution. Overall, these studies suggest that the BioFire{\textregistered} 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.",

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AU - Schnaubelt, Andy

AU - Cox, Jesse L.

AU - Cushman-Vokoun, Allison M.

AU - Shakir, Salika M.

AU - Tardif, Keith D.

AU - Huang, Meei Li

AU - Jerome, Keith R.

AU - Greninger, Alexander L.

AU - Drobysheva, Daria

AU - Spaulding, Usha

AU - Rogatcheva, Margarita

AU - Bourzac, Kevin M.

AU - Hinrichs, S. H.

AU - Broadhurst, M. J.

AU - Fey, P. D.

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AB - 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.

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

Abstract

Keywords

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