Multicenter evaluation of the QIAstat-Dx respiratory panel for detection of viruses and bacteria in nasopharyngeal swab specimens

Amy L. Leber, Jan Gorm Lisby, Glen Hansen, Ryan F. Relich, Uffe Vest Schneider, Paul Granato, Stephen Young, Josep Pareja, Irene Hannet

Research output: Contribution to journalArticle

2 Scopus citations

Abstract

The QIAstat-Dx Respiratory Panel (QIAstat-Dx RP) is a multiplex in vitro diagnostic test for the qualitative detection of 20 pathogens directly from nasopharyngeal swab (NPS) specimens. The assay is performed using a simple sample-toanswer platform with results available in approximately 69 min. The pathogens identified are adenovirus, coronavirus 229E, coronavirus HKU1, coronavirus NL63, coronavirus OC43, human metapneumovirus A and B, influenza A, influenza A H1, influenza A H3, influenza A H1N1/2009, influenza B, parainfluenza virus 1, parainfluenza virus 2, parainfluenza virus 3, parainfluenza virus 4, rhinovirus/enterovirus, respiratory syncytial virus A and B, Bordetella pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae. 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.

Original languageEnglish (US)
Article numbere00155-20
JournalJournal of clinical microbiology
Volume58
Issue number5
DOIs
StatePublished - May 2020

Keywords

  • Multiplex
  • PCR
  • Respiratory

ASJC Scopus subject areas

  • Microbiology (medical)

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