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

The ability to provide timely identification of the causative agent of lower respiratory tract infections can promote better patient outcomes and support antimicrobial stewardship efforts. Current diagnostic testing options can 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 turn-around-times. This study assessed the performance of the BioFire® FilmArray® Pneumonia (PN)/Pneumonia plus (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)). Semi-quantitative results are also provided for the bacterial targets. This manuscript describes select analytical and clinical studies that were conducted to evaluate performance of the panel for regulatory clearance. Prospectively collected respiratory specimens (846 BAL, 836 sputum) 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 10/24 for sputum specimens. All other targets had sensitivities of ≥75% or were unable to be calculated due to low prevalence in the study population. Specificity of 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.