Prospective, multi-site evaluation of the Cepheid Xpert Xpress CoV-2 <i>plus</i> test on nasal and nasopharyngeal swabs.

ABSTRACT: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continues its largely aseasonal spread with millions of cases per year. Highly sensitive, point-of-care testing is critical for rapid detection of coronavirus disease 2019 (COVID-19) cases and initiation of antiviral therapy to avert adverse health outcomes and reduce onward transmission of the virus. While hundreds of COVID-19 diagnostics received emergency use authorization from the FDA during the pandemic, significantly fewer have navigated the course to FDA clearance or approval. Here, we determined the clinical performance of the Cepheid Xpert Xpress CoV-2 plus for detection of SARS-CoV-2 in 3,750 anterior nasal swab (NS) specimens and nasopharyngeal swab (NPS) from 32 sites in comparison to the FDA-authorized BioFire

SUBMITTER: Greninger AL 

PROVIDER: S-EPMC11633094 | biostudies-literature | 2024 Dec

REPOSITORIES: biostudies-literature