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. 2021 Jun;1(1):100014.
doi: 10.1016/j.jcvp.2021.100014. Epub 2021 Apr 12.

Clinical evaluation of the GeneXpert® Xpert® Xpress SARS-CoV-2/Flu/RSV combination test

Grant Johnson  1   2 , Arek Zubrzycki  1 , Michele Henry  3 , Charlene Ranadheera  4 , Cindi Corbett  4   5 , Adrienne F A Meyers  5   6 , Paul A Sandstrom  5   6 , Michael G Becker  6
Affiliations

Clinical evaluation of the GeneXpert® Xpert® Xpress SARS-CoV-2/Flu/RSV combination test

Grant Johnson et al. J Clin Virol Plus. 2021 Jun.

Abstract

The Cepheid Xpert Xpress SARS-CoV-2/Flu/RSV combination test received emergency use authorization approval by the United States Food and Drug Administration in December 2020, and Health Canada approval in January 2021. The performance characteristics of the GeneXpert Xpert Xpress SARS-CoV-2/Flu/RSV combination test were assessed at Lakeridge Health Oshawa and the National Microbiology Laboratory of Canada. The combination test was compared to the Xpert SARS-CoV-2 and Xpert Flu/RSV assays, and the BioFire FilmArray Respiratory Panel 2.1 (RP2.1) test kit. Materials evaluated were serial dilutions of chemically-inactivated SARS-CoV-2 and remnant clinical specimens (nasal or nasopharyngeal swabs) collected from patients. The limit of detection (LOD) for the SARS-CoV-2 component of the Xpert SARS-CoV-2/Flu/RSV combination test was determined to be <100 viral copies/mL when using chemically-inactivated SARS-CoV-2. In total, 86 clinical positive and 51 clinical negative samples were used for this study, with mixtures of clinical positives being used to mimic coinfection and screen for competitive inhibition. The combination test showed a high percent agreement with the Xpert SARS-CoV-2 and Xpert Flu/RSV tests, as well as the BioFire FilmArray RP2.1. Based on the findings from this study and a growing body of research, the Xpert SARS-CoV-2/Flu/RSV combination test will serve as an effective replacement for the Xpert SARS-CoV-2 and Xpert Flu/RSV assays.

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Conflict of interest statement

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Fig 1
Fig. 1
Ct value comparisons between different Xpert assays using clinical specimens. Overall, reported Ct values are lower on the Xpert SARS-CoV-2/Flu/RSV combination test as compared to others. The Xpert SARS-CoV-2/Flu/RSV assay detected one high Ct Influenza A clinical sample and one high Ct Influenza B clinical that were not detected by the Flu/RSV test.
Fig 2
Fig. 2
Average assay run time across the different GeneXpert Xpress assays evaluated in this study. Because the SARS-CoV-2 (SCV-2) assay can terminate early during positive tests, average time is displayed as both the run time for either positive (+) or negative (-) tests.
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