Accurate and rapid laboratory tests are essential for the prompt diagnosis of COVID-19, which is important to patients and infection control. The Xpert Xpress SARS-CoV-2 test is a real-time RT-PCR intended for the qualitative detection of nucleic acid from SARS-CoV-2 in upper respiratory specimens. In this study, we assessed the analytical performance characteristics of this rapid test for SARS-CoV-2 in 60 bronchoalveolar lavage (BAL) specimens. BAL is a specimen type that is not authorized under EUA for the Xpert Xpress SARS-CoV-2 test. The limit of detection of the Xpert Xpress SARS-CoV-2 test was 500 copies/ml. The overall agreement of the Xpert Xpress SARS-CoV-2 test was 100%. The Xpert Xpress SARS-CoV-2 test is sensitive and specific to aid in diagnosis of COVID-19 using bronchoalveolar lavage.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8856763 | PMC |
http://dx.doi.org/10.1016/j.jcvp.2022.100067 | DOI Listing |
Background: Early confirmation of infections with influenza virus and/or respiratory syncytial virus (RSV) is beneficial for prompt treatment and outbreak management. This study aimed to assess the Cepheid Xpert Xpress Flu/ RSV assay in Central China, using Sanger sequencing as the reference method.
Methods: Nasopharyngeal swab (NP) samples from pediatric and adult patients with influenza-like illnesses were collected by the Hubei Province Disease Control and Prevention Center.
PLoS One
November 2024
Cepheid, Sunnyvale, California, United States of America.
While molecular testing is recommended for symptomatic patients suspected of having coronavirus disease 2019 (COVID-19), limited data are available examining real-world use of tests for severe acute respiratory syndrome coronavirus (SARS-CoV-2) and the impact of SARS-CoV-2 testing on patient outcomes. In this retrospective cohort study using de-identified administrative claims data in the Optum Labs Data Warehouse, we identified 2 groups of patients with ≥1 outpatient claims with a procedure code for SARS-CoV-2 testing between January 2021 and September 2022. Group 1 had ≥1 claims with CPT code 0240U or 0241U ("Xpert Xpress") (N = 51,602); Group 2 had ≥1 claims for laboratory-based molecular testing (N = 317,192).
View Article and Find Full Text PDFJ Clin Microbiol
December 2024
Cepheid, Sunnyvale, California, USA.
Unlabelled: 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.
View Article and Find Full Text PDFDiagnostics (Basel)
October 2024
Division of Clinical Pathology, Department of Pathology, National Defense Medical Center, Tri-Service General Hospital, Taipei 114, Taiwan.
J Virol Methods
January 2025
Ndlovu Research Centre, Ndlovu Laboratories, Elandsdoorn, Dennilton, Limpopo, South Africa. Electronic address:
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