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Multicenter Evaluation of the BioFire FilmArray Respiratory Panel 2 for the Detection of Viruses and Bacteria in Nasopharyngeal Swab Samples

tetano

Editor, Senior Moderator
J Clin Microbiol. 2018 Mar 28. pii: JCM.01945-17. doi: 10.1128/JCM.01945-17. [Epub ahead of print]
[h=1]Multicenter Evaluation of the BioFire FilmArray Respiratory Panel 2 for the Detection of Viruses and Bacteria in Nasopharyngeal Swab Samples.[/h] Leber AL[SUP]1[/SUP], Everhart K[SUP]2[/SUP], Daly JA[SUP]3[/SUP], Hopper A[SUP]3[/SUP], Harrington A[SUP]4[/SUP], Schreckenberger P[SUP]4[/SUP], McKinley K[SUP]4[/SUP], Jones M[SUP]5[/SUP], Holmberg K[SUP]5[/SUP], Kensinger B[SUP]5[/SUP].
[h=3]Author information[/h]

[h=3]Abstract[/h] The FilmArray? Respiratory Panel 2 (RP2) is a multiplex in vitro diagnostic test for the simultaneous and rapid (∼45 minutes) detection of 22 pathogens directly from nasopharyngeal swab (NPS) samples. It contains updated (and in some instances redesigned) assays that improve upon the FilmArray? Respiratory Panel (RP; version 1.7), with a faster run time. The organisms identified are adenovirus, coronavirus 229E, coronavirus HKU1, coronavirus NL63, coronavirus OC43, human metapneumovirus, human rhinovirus/enterovirus, influenza A, influenza A H1, influenza A H1-2009, influenza A H3, influenza B, parainfluenza virus 1, parainfluenza virus 2, parainfluenza virus 3, parainfluenza virus 4, respiratory syncytial virus, Bordetella pertussis, Chlamydia pneumoniae, and Mycoplasma pneumoniae. Two new targets are included in the FilmArray RP2: Middle East respiratory syndrome coronavirus, and Bordetella parapertussis This study provides data from a multicenter evaluation of 1612 prospectively collected NPS samples with performance compared to FilmArray RP or PCR and sequencing. The overall percent agreement between FilmArray RP2 and the comparator testing was 99.2%. The RP2 demonstrated a positive percent agreement of 91.7% or greater for detection of all but three analytes: coronavirus OC43, B. parapertussis, and B. pertussis The FilmArray RP2 also demonstrated a negative percent agreement of ≥93.8% for all analytes. Of note, the adenovirus assay detects all genotypes with a demonstrated increase in sensitivity. The FilmArray RP2 represents a significant improvement over FilmArray RP with a substantially shorter run time that could aid in diagnosis of respiratory infections in a variety of clinical scenarios.


PMID: 29593057 DOI: 10.1128/JCM.01945-17
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