Multicenter Evaluation of the BioFire FilmArray Pneumonia/Pneumonia Plus Panel for Detection and Quantification of Agents of Lower Respiratory Tract Infection

Caitlin N Murphy, Randal Fowler, Joan Miquel Balada-Llasat, Amanda Carroll, Hanna Stone, Oluseun Akerele, Blake Buchan, Sam Windham, Amanda Hopp, Shira Ronen, Ryan F Relich, Rebecca Buckner, Del A Warren, Romney Humphries, Shelly Campeau, Holly Huse, Suki Chandrasekaran, Amy Leber, Kathy Everhart, Amanda Harrington, Christina Kwong, Andrew Bonwit, Jennifer Dien Bard, Samia Naccache, Cynthia Zimmerman, Barbara Jones, Cory Rindlisbacher, Maggie Buccambuso, Angela Clark, Margarita Rogatcheva, Corrin Graue, Kevin M Bourzac, Caitlin N Murphy, Randal Fowler, Joan Miquel Balada-Llasat, Amanda Carroll, Hanna Stone, Oluseun Akerele, Blake Buchan, Sam Windham, Amanda Hopp, Shira Ronen, Ryan F Relich, Rebecca Buckner, Del A Warren, Romney Humphries, Shelly Campeau, Holly Huse, Suki Chandrasekaran, Amy Leber, Kathy Everhart, Amanda Harrington, Christina Kwong, Andrew Bonwit, Jennifer Dien Bard, Samia Naccache, Cynthia Zimmerman, Barbara Jones, Cory Rindlisbacher, Maggie Buccambuso, Angela Clark, Margarita Rogatcheva, Corrin Graue, Kevin M Bourzac

Abstract

The ability to provide timely identification of the causative agents of lower respiratory tract infections can promote better patient outcomes and support antimicrobial stewardship efforts. Current diagnostic testing options include culture, molecular testing, and antigen detection. These methods may require collection of various specimens, involve extensive sample treatment, and can suffer from low sensitivity and long turnaround times. This study assessed the performance of the BioFire FilmArray Pneumonia Panel (PN panel) and Pneumonia Plus Panel (PNplus panel), an FDA-cleared sample-to-answer assay that enables the detection of viruses, atypical bacteria, bacteria, and antimicrobial resistance marker genes from lower respiratory tract specimens (sputum and bronchoalveolar lavage [BAL] fluid). Semiquantitative results are also provided for the bacterial targets. This paper describes selected analytical and clinical studies that were conducted to evaluate performance of the panel for regulatory clearance. Prospectively collected respiratory specimens (846 BAL and 836 sputum specimens) evaluated with the PN panel were also tested by quantitative reference culture and molecular methods for comparison. The PN panel showed a sensitivity of 100% for 15/22 etiologic targets using BAL specimens and for 10/24 using sputum specimens. All other targets had sensitivities of ≥75% or were unable to be calculated due to low prevalence in the study population. Specificity for all targets was ≥87.2%, with many false-positive results compared to culture that were confirmed by alternative molecular methods. Appropriate adoption of this test could provide actionable diagnostic information that is anticipated to impact patient care and antimicrobial stewardship decisions.

Keywords: respiratory pathogens; respiratory viruses; syndromic panel.

Copyright © 2020 Murphy et al.

Figures

FIG 1
FIG 1
BioFire PN panel bin result linearity and accuracy. Contrived BAL samples containing S. aureus (a) or K. aerogenes (b) were quantified by dPCR and spiked at 1-log serial dilutions spanning the range of BioFire PN panel bin reporting. The reported percent (of 90 replicates) is graphed as a bar in each bin at each dilution tested.

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