Evaluation of Cepheid Xpert Xpress CoV-2/Flu/RSV plus for nasal and nasopharyngeal specimens tested in CLIA-accredited and CLIA-waived settings

Erin McElvania; Deepa Rao; Alexander L. Greninger; Glenn Harnett; Allan Larcena; Amrish Patel; Brian Webster; Christina Ulen; Dallas F. Green; Dana King; Deepesh Rubin Patel; Imad Jandali; Jane Gibson; Jennifer Killion; Jibran Atwi; Kelly R. Bergmann; Lance Slade; Mary Allen Staat; Matthew Faron; Megan Washington; Rahul Patel; Rajasekaran Annamalai; Ronald Ackerman; William P. Stewart; Yuliet Mora Amador; Aarthi Raman; Xiaohong Liu

doi:10.1016/j.jcv.2025.105851

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Evaluation of Cepheid Xpert Xpress CoV-2/Flu/RSV plus for nasal and nasopharyngeal specimens tested in CLIA-accredited and CLIA-waived settings

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Evaluation of Cepheid Xpert Xpress CoV-2/Flu/RSV plus for nasal and nasopharyngeal specimens tested in CLIA-accredited and CLIA-waived settings

Erin McElvania, Deepa Rao, Alexander L. Greninger, Glenn Harnett, Allan Larcena, Amrish Patel, Brian Webster, Christina Ulen, Dallas F. Green, Dana King, …

Journal of clinical virology, Vol.180, 105851

10/2025

DOI: 10.1016/j.jcv.2025.105851

PMID: 40818320

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Abstract

Respiratory viruses are responsible for millions of health care visits annually. The unpredictable periodicity of Coronavirus disease 2019 and seasonal patterns of influenza and respiratory syncytial virus result in concurrent circulation of these viruses with non-specific and overlapping clinical symptoms. This study evaluated the Cepheid Xpert Xpress CoV-2/Flu/RSV plus test using 3,011 nasopharyngeal swab (NPS) and 2,943 anterior nasal (NS) specimens. The assay was evaluated in CLIA-accredited (CA) laboratories with laboratory trained operators and CLIA-waived (CW) settings with non-laboratory personnel. Results were compared to the BioFire Respiratory Panel 2.1 for SARS-CoV-2 and Hologic Panther Fusion Flu A/B/RSV for influenza A, influenza B, and RSV. Cepheid Xpert Xpress CoV-2/Flu/RSV plus testing of NPS and NS specimens had high positive and negative agreement with reference testing. Overall agreement for NPS was 98.8%, 99.1%, 99.9%, and 100% for SARS-CoV-2, influenza A, influenza B, and RSV, respectively. For NS, overall agreement was 98.7%, 99.3%, 99.9%, and 99.9% for SARS-CoV-2, influenza A, influenza B, and RSV, respectively. Specimen testing performed at CA and CW locations also had high positive and negative agreement with reference testing. Overall agreement for CA testing was 97.7%, 99.6%, 100%, and 100% for SARS-CoV-2, influenza A, influenza B, and RSV, respectively. For CW testing, overall agreement was 98.8%, 99.0%, 99.9%, and 99.9% for SARS-CoV-2, influenza A, influenza B, and RSV, respectively. This study demonstrates that Xpert Xpress CoV-2/Flu/RSV plus provides rapid and accurate results from NPS and NS specimens in CA and CW testing facilities regardless of staff experience with molecular testing. •COVID-19, influenza A, influenza B, and RSV cause upper respiratory infections.•Historically testing is performed on nasopharyngeal swabs in CLIA-accredited labs.•Xpert Xpress CoV-2/Flu/RSV RT-PCR rapidly detects these respiratory viruses.•This is the first evaluation of Xpert Xpress CoV-2/Flu/RSV plus using nasal swabs.•Testing was accurate when performed in CLIA-waived and CLIA-accredited settings.

molecular

nasal

nasopharyngeal

respiratory virus

RT-PCR

SARS-CoV-2

Details

Title: Subtitle: Evaluation of Cepheid Xpert Xpress CoV-2/Flu/RSV plus for nasal and nasopharyngeal specimens tested in CLIA-accredited and CLIA-waived settings
Creators: Erin McElvania - NorthShore University HealthSystem
Deepa Rao - Cepheid
Alexander L. Greninger - University of Washington
Glenn Harnett - No Resistance Consulting Group, Birmingham, AL, USA
Allan Larcena - Slidell Internal Medicine Clinic, Slidell, LA, USA
Amrish Patel - Piedmont HealthCare
Brian Webster - Innovo Research - Wilmington Health, Wilmington, NC, USA
Christina Ulen - Advanced Pediatrics, Vienna, VA, USA
Dallas F. Green - AHF-The Kinder Medical Group, Miami, FL, USA
Dana King - University of Iowa
Deepesh Rubin Patel - Patient Plus South Downs, Baton Rouge, LA, USA
Imad Jandali - ASCLEPES Research Centers, FL, USA
Jane Gibson - University of Central Florida
Jennifer Killion - McFarland Clinic - Jefferson
Jibran Atwi - MedPharmics LLC, Lafayette, LA, USA
Kelly R. Bergmann - Children's Minnesota
Lance Slade - Meridian Clinical Research
Mary Allen Staat - Cincinnati Children's Hospital Medical Center
Matthew Faron - Medical College of Wisconsin
Megan Washington - MemorialCare Health System
Rahul Patel - Meridian Clinical Research
Rajasekaran Annamalai - PCP for Life-Tidwell, Houston, TX, USA
Ronald Ackerman - Comprehensive Clinical Research
William P. Stewart - Atrium Health Wake Forest Baptist
Yuliet Mora Amador - Santa Clara Family Clinic, Houston, TX, USA
Aarthi Raman - Cepheid
Xiaohong Liu - Cepheid
Resource Type: Journal article
Publication Details: Journal of clinical virology, Vol.180, 105851
DOI: 10.1016/j.jcv.2025.105851
PMID: 40818320
NLM abbreviation: J Clin Virol
ISSN: 1386-6532
eISSN: 1873-5967
Publisher: Elsevier B.V
Grant note: Cepheid
This research study was funded by Cepheid. The data presented in his manuscript was generated as part of the United States FDA sub-mission for Cepheid Xpert Xpress CoV-2/Flu/RSVplus.
Language: English
Electronic publication date: 08/07/2025
Date published: 10/2025
Academic Unit: Emergency Medicine
Record Identifier: 9984946702802771

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