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 a performed using a simple sample to answer platform with results available in approximately 69 minutes. The pathogens identified are adenovirus, coronavirus 229E, coronavirus HKU1, coronavirus NL63, coronavirus OC43, human metapneumovirus A+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+B, Bordetella pertussis, Chlamydophila pneumoniae and Mycoplasma pneumoniae This multicenter evaluation provides data obtained from 1994 prospectively collected and 310 retrospectively collected (archived) NPS specimens with performance compared to 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 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.Copyright © 2020 Leber et al.

authors

• Baker, Amy
• Bareta, Joseph
• Granato, Paul A
• Hannet, Irene
• Hansen, Ellen
• Lisby, Jan Gorm
• Relich, Ryan F
• Schneider, Uffe Vest
• Young, Stephen

publication date

• March 2020

published in

• Journal of clinical microbiology  Journal

Digital Object Identifier (DOI)

• https://doi.org/10.1128/jcm.00155-20

PubMed ID

• 32132186

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