Cepheid Xpert Xpress Flu/RSV evaluation performed by minimally trained non-laboratory operators in a CLIA-waived environment

Bashar S. Shihabuddin; Matthew L. Faron; Ryan F. Relich; Paul Van Heukelom; Donna Mayne; Mary Allen Staat; Rangaraj Selvarangan; Leslie A. Hueschen; Donna M. Wolk; Stacey House; Glenn Harnett; Kevin McGann; Mark T. Steele; Jose R. Romero; Joe Arms; Owen Lander; Michael Loeffelholz; Fiona Strouts; Daniel Cohen

doi:10.1016/j.diagmicrobio.2022.115764

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Cepheid Xpert Xpress Flu/RSV evaluation performed by minimally trained non-laboratory operators in a CLIA-waived environment

Journal article

Open access

Peer reviewed

Cepheid Xpert Xpress Flu/RSV evaluation performed by minimally trained non-laboratory operators in a CLIA-waived environment

Bashar S. Shihabuddin, Matthew L. Faron, Ryan F. Relich, Paul Van Heukelom, Donna Mayne, Mary Allen Staat, Rangaraj Selvarangan, Leslie A. Hueschen, Donna M. Wolk, Stacey House, …

Diagnostic microbiology and infectious disease, Vol.104(2), pp.115764-115764

10/2022

DOI: 10.1016/j.diagmicrobio.2022.115764

PMCID: PMC9271353

PMID: 35917666

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https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9271353View

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Abstract

The COVID-19 pandemic highlighted the significance of readily available and easily performed viral testing for surveillance during future infectious pandemics. The objectives of this study were: to assess the performance of the Xpert Xpress Flu and/or RSV test, a multiplex PCR assay for detecting influenza A and B virus and respiratory syncytial virus nucleic acids in respiratory tract specimens, relative to the Quidel Lyra Influenza A+B assay and the Prodesse ProFlu+ assay, and the system's ease of use by minimally trained operators. Overall, the Xpert Xpress Flu/RSV test demonstrated a high positive and negative percent agreement with the comparator assays, and was easy to use and interpret results, based on the operators’ feedback. We concluded that the Xpert Xpress Flu/RSV test is sensitive, specific, and easy to use for the diagnosis of influenza and RSV by minimally trained operators and can be a valuable tool in future infectious clusters or pandemics.

Influenza

CLIA-Waved Environment

Multiplex real-time PCR test

RSV

Details

Title: Subtitle: Cepheid Xpert Xpress Flu/RSV evaluation performed by minimally trained non-laboratory operators in a CLIA-waived environment
Creators: Bashar S. Shihabuddin - Nationwide Children's Hospital
Matthew L. Faron - Medical College of Wisconsin
Ryan F. Relich - Indiana University
Paul Van Heukelom - University of Iowa
Donna Mayne - Ascension Sacred Heart Hospital, Pensacola, FL, USA
Mary Allen Staat - Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA
Rangaraj Selvarangan - Sisters of Mercy Health System
Leslie A. Hueschen - University of Missouri–Kansas City
Donna M. Wolk - Geisinger, Diagnostic Medicine Institute, Danville, PA, USA
Stacey House - Department of Emergency Medicine, Washington University School of Medicine, St. Louis, MO, USA
Glenn Harnett
Kevin McGann - Healthplex Family Clinic, Shreveport, LA, USA
Mark T. Steele - University of Missouri–Kansas City
Jose R. Romero - Arkansas Children's Hospital
Joe Arms - Children's Hospital of Minnesota, Minneapolis, MN, USA
Owen Lander - West Virginia School of Medicine, Morgantown, WV, USA
Michael Loeffelholz - Cepheid, Sunnyvale, CA, USA
Fiona Strouts - Cepheid, Sunnyvale, CA, USA
Daniel Cohen - Nationwide Children's Hospital
Resource Type: Journal article
Publication Details: Diagnostic microbiology and infectious disease, Vol.104(2), pp.115764-115764
Publisher: Elsevier Inc
DOI: 10.1016/j.diagmicrobio.2022.115764
PMID: 35917666
PMCID: PMC9271353
ISSN: 0732-8893
eISSN: 1879-0070
Language: English
Date published: 10/2022
Academic Unit: Emergency Medicine
Record Identifier: 9984297148802771

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