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

Author:

Loeffelholz Michael J.1,Alland David2,Butler-Wu Susan M.3,Pandey Utsav4,Perno Carlo Frederico5,Nava Alice5,Carroll Karen C.6,Mostafa Heba6,Davies Emma7,McEwan Ashley7,Rakeman Jennifer L.8,Fowler Randal C.8,Pawlotsky Jean-Michel9,Fourati Slim9ORCID,Banik Sukalyani2,Banada Padmapriya P.2ORCID,Swaminathan Shobha2,Chakravorty Soumitesh1,Kwiatkowski Robert W.1,Chu Victor C.1,Kop JoAnn1,Gaur Rajiv1,Sin Mandy L. Y.1,Nguyen Duy1,Singh Simranjit1,Zhang Na1,Persing David H.1

Affiliation:

1. Cepheid, Sunnyvale, California, USA

2. Center for Emerging Pathogens, Department of Medicine, Rutgers-New Jersey Medical School, Newark New Jersey, USA

3. Keck School of Medicine of USC, Department of Pathology, Los Angeles, California, USA

4. Children’s Hospital Los Angeles, Los Angeles, California, USA

5. Niguarda Hospital, Ospedale Niguarda Ca’ Granda, Milan, Italy

6. The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA

7. Department of Virology, Manchester University NHS Foundation Trust, Manchester, United Kingdom

8. NYC Public Health Laboratory, Department of Health and Mental Hygiene, New York, New York, USA

9. Bacteriology-Virology, Henri Mondor Hospital, Creteil, France

Abstract

Nucleic acid amplification tests (NAATs) are the primary means of identifying acute infections caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Accurate and fast test results may permit more efficient use of protective and isolation resources and allow rapid therapeutic interventions. We evaluated the analytical and clinical performance characteristics of the Xpert Xpress SARS-CoV-2 (Xpert) test, a rapid, automated molecular test for SARS-CoV-2. Analytical sensitivity and specificity/interference were assessed with infectious SARS-CoV-2; other infectious coronavirus species, including SARS-CoV; and 85 nasopharyngeal swab specimens positive for other respiratory viruses, including endemic human coronaviruses (hCoVs).

Publisher

American Society for Microbiology

Subject

Microbiology (medical)

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