Multicenter Evaluation of the QIAstat-Dx Respiratory Panel for Detection of Viruses and Bacteria in Nasopharyngeal Swab Specimens

作者：Amy L. Leber, Jan Gorm Lisby, Glen T. Hansen, Ryan F. Relich, Uffe Vest Schneider, Paul A. Granato, Stephen A. Young, Josep Pareja, Irene Hannet · 发表于：Journal of Clinical Microbiology · 年份：2020 · DOI：10.1128/jcm.00155-20 · 被引用次数：60 · 研究领域：Respiratory viral infections research、Influenza Virus Research Studies、Viral gastroenteritis research and epidemiology

This multicenter evaluation provides data obtained from 1,994 prospectively collected and 310 retrospectively collected (archived) NPS specimens with performance compared to that of the BioFire FilmArray Respiratory Panel, version 1.7. The overall percent agreement between QIAstat-Dx RP and the comparator testing was 99.5%. In the prospective cohort, the QIAstat-Dx RP demonstrated a positive percent agreement of 94.0% or greater for the detection of all but four analytes: coronaviruses 229E, NL63, and OC43 and rhinovirus/enterovirus. The test also demonstrated a negative percent agreement of ≥97.9% for all analytes. The QIAstat-Dx RP is a robust and accurate assay for rapid, comprehensive testing for respiratory pathogens.