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

Autor: Creager HM; University of Nebraska Medical Center, Omaha, NE, USA., Cabrera B; University of Nebraska Medical Center, Omaha, NE, USA., Schnaubelt A; University of Nebraska Medical Center, Omaha, NE, USA., Cox JL; University of Nebraska Medical Center, Omaha, NE, USA., Cushman-Vokoun AM; University of Nebraska Medical Center, Omaha, NE, USA., Shakir SM; ARUP Institute for Clinical and Experimental Pathology, Salt Lake City, UT, USA., Tardif KD; ARUP Institute for Clinical and Experimental Pathology, Salt Lake City, UT, USA., Huang ML; Department of Laboratory Medicine, University of Washington, Seattle, WA, USA., Jerome KR; Department of Laboratory Medicine, University of Washington, Seattle, WA, USA; Fred Hutchinson Cancer Research Center, Seattle, WA, USA., Greninger AL; Department of Laboratory Medicine, University of Washington, Seattle, WA, USA., Drobysheva D; BioFire Diagnostics LLC, Salt Lake City, UT, USA., Spaulding U; BioFire Diagnostics LLC, Salt Lake City, UT, USA., Rogatcheva M; BioFire Diagnostics LLC, Salt Lake City, UT, USA., Bourzac KM; BioFire Diagnostics LLC, Salt Lake City, UT, USA., Hinrichs SH; University of Nebraska Medical Center, Omaha, NE, USA., Broadhurst MJ; University of Nebraska Medical Center, Omaha, NE, USA., Fey PD; University of Nebraska Medical Center, Omaha, NE, USA. Electronic address: pfey@unmc.edu.
Jazyk: angličtina
Zdroj: Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology [J Clin Virol] 2020 Aug; Vol. 129, pp. 104538. Date of Electronic Publication: 2020 Jul 06.
DOI: 10.1016/j.jcv.2020.104538
Abstrakt: 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.
Competing Interests: Declaration of Competing Interest The Corresponding author has acted as a consultant and received grant funding from BioFire Diagnostics.
(Copyright © 2020 The Authors. Published by Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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