Prospective, multi-site evaluation of the Cepheid Xpert Xpress CoV-2 <i>plus</i> test on nasal and nasopharyngeal swabs
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continues to cause millions of infections and tens of thousands of deaths per year in the United States. While the FDA authorized hundreds of SARS-CoV-2 tests during the public health emergency, significantly fewer have made the transition to being cleared or approved. There continues to be a need for FDA-authorized point-of-care SARS-CoV-2 testing that can be performed by untrained users. We conducted a large prospective study of the Cepheid Xpert Xpress CoV-2 <i>plus</i> test for detection of SARS-CoV-2 in both nasal and nasopharyngeal swabs by trained and untrained users. The assay demonstrated excellent clinical performance characteristics and, as a result of this study, was cleared by the FDA.
Authors
- Brian Webster
- Yannis Amador (ORCID: https://orcid.org/0000-0002-4217-5453)
- Ronald Ackerman
- Matthew L. Faron
- Aarthi Raman
- Christina Ulen
- Kelly R. Bergmann (ORCID: https://orcid.org/0000-0002-0975-4218)
- D. Green
- William P. Stewart (ORCID: https://orcid.org/0000-0001-5819-9540)
- Dana King (ORCID: https://orcid.org/0000-0003-4635-5272)
- Erin McElvania (ORCID: https://orcid.org/0009-0007-3959-2583)
- Mary Allen Staat (ORCID: https://orcid.org/0000-0003-1788-8037)
- Dharmesh Patel (ORCID: https://orcid.org/0000-0002-8474-6453)
- Imad Jandali
- Laura Slade (ORCID: https://orcid.org/0000-0001-8425-9359)
- Alexander L. Greninger (ORCID: https://orcid.org/0000-0002-7443-0527)
- Deepa B. Rao (ORCID: https://orcid.org/0000-0002-8149-6401)
- Jennifer Killion
- Glenn Harnett
- Jane Whitney Gibson (ORCID: https://orcid.org/0000-0002-0973-8285)
- Rajasekaran Annamalai
- Megan Washington (ORCID: https://orcid.org/0000-0002-9883-2408)
- Xiaohong Liu (ORCID: https://orcid.org/0000-0002-6050-9592)
- Rahul S. Patel (ORCID: https://orcid.org/0000-0002-0345-4679)
- Amrish Patel
- Jibran Atwi
- Allan Larcena
Institutions
- Simpson University (US)
- Cincinnati Children's Hospital Medical Center (US)
- Froedtert Hospital (US)
- Cape Town HVTN Immunology Laboratory / Hutchinson Centre Research Institute of South Africa (ZA)
- National Federation of the Blind (US)
- Orlando Health (US)
- Santa Clara University (US)
- University of Washington (US)
- Medical College of Wisconsin (US)
- University of Iowa Hospitals and Clinics (US)
- Innovate UK (GB)
- University of Chicago (US)
- EES Research (United Kingdom) (GB)
- Endeavor Charter School (US)
- Fred Hutch Cancer Center (US)
- McFarland Clinic - Jefferson (US)
- Patients First (US)
- Iscare I.V.F (CZ)
- Evanston Hospital (US)
- Cancer Research Center (US)
- Children's Minnesota (US)
- Quidel Corporation (United States) (US)
- Meridian Clinical Research (US)
- Children's Hospital & Medical Center (US)
- Piedmont HealthCare (US)
- MedPharm (United Kingdom) (GB)
- Department of Health Services (US)
- Comprehensive Clinical Research (US)
- HealthPartners (US)
- Rockwell Automation (United States) (US)
- PA Consulting Group (GB)
- National Patient Safety Foundation (US)
Publication Details
- Journal
- Journal of Clinical Microbiology
- Published
- 2024-11-06
- DOI
- https://doi.org/10.1128/jcm.01219-24
- Citations
- 1
- Primary Topic
- SARS-CoV-2 detection and testing
- Type
- article
- Field-Weighted Citation Impact
- 0.39