Multicenter Evaluation of the Cepheid Xpert Xpress SARS-CoV-2 Test
Michael J. Loeffelholz, David Alland, Susan M. Butler‐Wu, Utsav Pandey, Carlo Federico Perno, Alice Nava, Karen C. Carroll, Heba H. Mostafa, Emma Davies, Ashley McEwan, Jennifer L. Rakeman, Randal C. Fowler, Jean–Michel Pawlotsky, Slim Fourati, Sukalyani Banik, Padmapriya P. Banada, Shobha Swaminathan, Soumitesh Chakravorty, Robert Kwiatkowski, Victor C. Chu, JoAnn Kop, Rajiv L. Gaur, Mandy L.Y. Sin, Duy H. N. Nguyen, Simranjit Singh, Na Zhang, David H. Persing
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).