1 Multicenter Evaluation of the BioFire FilmArray Respiratory Panel 2 for the Detection of 2 Viruses and Bacteria in Nasopharyngeal Swab Samples 3

The FilmArray ® Respiratory Panel 2 (RP2) is a multiplex in vitro diagnostic test 20 for the simultaneous and rapid (~45 minutes) detection of 22 pathogens directly from 21 nasopharyngeal swab (NPS) samples. It contains updated (and in some instances redesigned) 22 assays that improve upon the FilmArray ® Respiratory Panel (RP; version 1.7), with a faster run 23 time. The organisms identified are adenovirus, coronavirus 229E, coronavirus HKU1, 24 coronavirus NL63, coronavirus OC43, human metapneumovirus, human rhinovirus/enterovirus, 25 influenza A, influenza A H1, influenza A H1-2009, influenza A H3, influenza B, parainfluenza 26 virus 1, parainfluenza virus 2, parainfluenza virus 3, parainfluenza virus 4, respiratory syncytial 27 virus, Bordetella pertussis , Chlamydia pneumoniae , and Mycoplasma pneumoniae. Two new 28 targets are included in the FilmArray RP2: Middle East respiratory syndrome coronavirus, and 29 Bordetella parapertussis . This study provides data from a multicenter evaluation of 1612 30 prospectively collected NPS samples with performance compared to FilmArray RP or PCR and 31 sequencing. The overall percent agreement between FilmArray RP2 and the comparator testing 32 was 99.2%. The RP2 demonstrated a positive percent agreement of 91.7% or greater for 33 detection of all but three analytes: coronavirus OC43, B. parapertussis , and B. pertussis . The 34 FilmArray RP2 also demonstrated a negative percent agreement of ≥93.8% for all analytes. Of 35 note, the adenovirus assay detects all genotypes with a demonstrated increase in sensitivity. The 36 FilmArray RP2 represents a significant improvement over FilmArray RP with a substantially 37 shorter run time that could aid in diagnosis of respiratory infections in a variety of clinical 38 scenarios.