Multicenter evaluation of the cepheid xpert xpress SARS-CoV-2/Flu/RSV test

Heba H. Mostafa, Karen C. Carroll, Rachel Hicken, Gregory J. Berry, Ryhana Manji, Elizabeth Smith, Jennifer L. Rakeman, Randal C. Fowler, Mindy Leelawong, Susan M. Butler-Wu, David Quintero, Minette Umali-Wilcox, Robert W. Kwiatkowski, David H. Persing, Fred Weir, Michael J. Loeffelholz

Research output: Contribution to journalArticlepeer-review


With the approach of respiratory virus season in the Northern Hemisphere, clinical microbiology and public health laboratories will need rapid diagnostic assays to distinguish severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) from influenza virus and respiratory syncytial virus (RSV) infections for diagnosis and surveillance. In this study, the clinical performance of the Xpert Xpress SARS-CoV-2/Flu/RSV test (Cepheid, Sunnyvale, CA, USA) for nasopharyngeal swab specimens was evaluated in four centers: Johns Hopkins Medical Microbiology Laboratory, Northwell Health Laboratories, NYC Public Health Laboratory, and Los Angeles County/University of Southern California (LAC1USC) Medical Center. A total of 319 nasopharyngeal swab specimens, positive for SARS-CoV-2 (n = 75), influenza A virus (n = 65), influenza B virus (n = 50), or RSV (n = 38) or negative (n = 91) by the standard-of-care nucleic acid amplification tests at each site, were tested using the Cepheid panel test. The overall positive percent agreement for the SARS-CoV-2 target was 98.7% (n = 74/75), and the negative agreement was 100% (n = 91), with all other analytes showing 100% total agreement (n = 153). Standard-of-care tests to which the Cepheid panel was compared included the Cepheid Xpert Xpress SARS-CoV-2, Cepheid Xpert Xpress Flu/RSV, GenMark ePlex respiratory panel, BioFire respiratory panel 2.1 and v1.7, DiaSorin Simplexa COVID-19 Direct, and Hologic Panther Fusion SARS-CoV-2 assays. The Xpert Xpress SARS-CoV-2/Flu/RSV test showed high sensitivity and accuracy for all analytes included in the test. This test will provide a valuable clinical diagnostic and public health solution for detecting and differentiating SARS-CoV-2, influenza A and B virus, and RSV infections during the current respiratory virus season.

Original languageEnglish (US)
Article numbere02955-20
JournalJournal of clinical microbiology
Issue number3
StatePublished - Mar 2021


  • 4-plex
  • Cepheid
  • Flu
  • Influenza
  • RSV
  • SARS-CoV-2

ASJC Scopus subject areas

  • Microbiology (medical)


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