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

Author:

Johnson Grant12,Gregorchuk Branden S.J.3,Zubrzycki Arek1,Kolsun Kurt34ORCID,Meyers Adrienne F.A.35,Sandstrom Paul A.35,Becker Michael G.34ORCID

Affiliation:

1. Laboratory Medicine and Infection Prevention and Control, Lakeridge Health, Oshawa, ON, Canada

2. Ontario Tech University, Oshawa, ON, Canada

3. National HIV and Retrovirology Laboratories, National Microbiology Laboratory Branch, JC Wilt Infectious Diseases Research Centre, Public Health Agency of Canada, Winnipeg, MB, Canada

4. Department of Microbiology, University of Manitoba, Winnipeg, MB, Canada

5. Department of Medical Microbiology and Infectious Diseases, University of Manitoba, Winnipeg, MB, Canada

Abstract

The GeneXpert® Xpert® Xpress SARS-CoV-2/Flu/RSV PLUS combination test (PLUS assay) received Health Canada approval in January 2022. The PLUS assay is similar to the SARS-CoV-2/Flu/RSV combination test, with modifications to improve assay robustness against circulating and emerging variants. The performance characteristics of the PLUS assay were assessed at the Lakeridge Health Oshawa Hospital Centre and the National Microbiology Laboratory of Canada. The PLUS assay was directly compared to the SARS-CoV-2/Flu/RSV combination test using SARS-CoV-2 culture from five variants and remnant clinical specimens collected across the coronavirus disease 2019 pandemic. This included 50 clinical specimens negative for all pathogens, 110 clinical specimens positive for SARS-CoV-2, influenza A, influenza B, RSVA, and(or) RSVB and an additional 11 mixed samples to screen for target interactions. The PLUS assay showed a high % agreement with the widely used SARS-CoV-2/Flu/RSV combination test. Based on these findings, the PLUS assay and the Xpert SARS-CoV-2/Flu/RSV combination test results are largely consistent with no observed difference in sensitivity, specificity, or time to result when challenged with various SARS-CoV-2 variants. The reported cycle threshold (Ct) values provided by the new PLUS assay were also unchanged, with the exception of a possible 1–2 decrease reported in Ct for RSVA across a limited sample size.

Publisher

Canadian Science Publishing

Subject

Genetics,Molecular Biology,Applied Microbiology and Biotechnology,General Medicine,Immunology,Microbiology

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