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

Amy L Leber,Kristen Holmberg,Kathleen Mckinley,Amanda Harrington,Kathy Everhart,Paul Schreckenberger,Aubrey Hopper,Bart Kensinger,Judy A Daly,Matthew Jones,Yi-Wei Tang

doi:10.1128/jcm.01945-17

Amy L Leber, Kristen Holmberg + Show 9 more

Open Access

https://doi.org/10.1128/jcm.01945-17

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Abstract

ABSTRACTThe FilmArray Respiratory Panel 2 (RP2) is a multiplex in vitro diagnostic test for the simultaneous and rapid (∼45-min) 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 virus A, influenza virus A H1, influenza virus A H1-2009, influenza virus A H3, influenza virus 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 1,612 prospectively collected NPS samples, with performance compared to that of the FilmArray RP or PCR and sequencing. The overall percent agreement between the 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 the FilmArray RP, with a substantially shorter run time that could aid in the diagnosis of respiratory infections in a variety of clinical scenarios.

Highlights

The FilmArray Respiratory Panel 2 (RP2) is a multiplex in vitro diagnostic test for the simultaneous and rapid (ϳ45-min) detection of 22 pathogens directly from nasopharyngeal swab (NPS) samples
The organisms detected by the FilmArray RP2 include all of those identified by the FilmArray RP: adenovirus, coronavirus 229E (CoV-229E), coronavirus HKU1 (CoV-HKU1), coronavirus NL63 (CoV-NL63), coronavirus OC43 (CoV-OC43), human metapneumovirus, human rhinovirus/ enterovirus (HRV/EV), influenza virus A (FluA), influenza virus A H1 (FluA H1), influenza virus A H1-2009 (FluA H1-2009), influenza virus A H3 (FluA H3), influenza virus B (FluB), parainfluenza virus 1 (PIV1), parainfluenza virus 2 (PIV2), parainfluenza virus 3 (PIV3), parainfluenza virus 4 (PIV4), respiratory syncytial virus (RSV), Bordetella pertussis, Chlamydia pneumoniae, and Mycoplasma pneumoniae
This analyte is reported in the FilmArray Respiratory Panel 2plus (RP2plus) product, which is sold outside the U.S for testing individuals demonstrating signs/symptoms of respiratory infection and has been cleared by the U.S FDA, with a modified intended use to aid in the differential diagnosis of MERS-CoV infections only in cases meeting MERS-CoV clinical and/or epidemiological criteria

Summary

Introduction

The FilmArray Respiratory Panel 2 (RP2) is a multiplex in vitro diagnostic test for the simultaneous and rapid (ϳ45-min) 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. In order to ensure that a molecular diagnostic assay remains clinically relevant, and for syndromic assays, it is important to periodically update the test to incorporate new sequence information and to accommodate emerging or previously unrecognized strains or pathogens To this end, BioFire Diagnostics has updated the FilmArray RP product again by adding new assays to broaden the test’s detection capabilities ( for adenoviruses), modifying a subset of assays to reflect newly available genetic sequences of currently included analytes, improving chemistry to enhance sensitivity overall, and for the inclusion of new analytes. MERS-CoV was not circulating in the United States during the time of the study; all specimens were assumed to be negative, and no comparator testing was performed for this analyte

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