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Multicenter Study
. 2021 Feb 18;59(3):e02955-20.
doi: 10.1128/JCM.02955-20. Print 2021 Feb 18.

Multicenter Evaluation of the Cepheid Xpert Xpress SARS-CoV-2/Flu/RSV Test

Heba H Mostafa #  1 , Karen C Carroll #  1 , Rachel Hicken  1 , Gregory J Berry  2 , Ryhana Manji  2 , Elizabeth Smith  2 , Jennifer L Rakeman  3 , Randal C Fowler  3 , Mindy Leelawong  3 , Susan M Butler-Wu  4 , David Quintero  4 , Minette Umali-Wilcox  4 , Robert W Kwiatkowski  5 , David H Persing  5 , Fred Weir  5 , Michael J Loeffelholz  6
Affiliations
Multicenter Study

Multicenter Evaluation of the Cepheid Xpert Xpress SARS-CoV-2/Flu/RSV Test

Heba H Mostafa et al. J Clin Microbiol. .

Abstract

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 (LAC+USC) 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.

Keywords: 4-plex; Cepheid; RSV; SARS-CoV-2; flu; influenza.

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Figures

FIG 1
FIG 1
Correlation of the Cepheid Xpert Xpress SARS-CoV-2/Flu/RSV test cycle threshold (CT) values with the standard-of-care test CT values for SARS-CoV-2 (A and B), influenza A virus (C), and influenza B virus (D). Notably, The Cepheid Xpert Xpress SARS-CoV-2/Flu/RSV test detects SARS-CoV-2 genes E and N2, similar to the Xpert Xpress SARS-CoV-2 test, but in contrast, the two targets are not differentiated (A and B).
See this image and copyright information in PMC

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