BioFire FilmArray Pneumonia Panel: Multiplex Detection of Respiratory Pathogens with Semiquantitative Bacterial Results
A multicenter study evaluated the BioFire FilmArray Pneumonia and Pneumonia Plus panels across 846 BAL and 836 sputum specimens for detection of viruses, atypical bacteria, typical bacteria, and antimicrobial resistance genes. The panel achieved 100% sensitivity for 15 of 22 targets from BAL specimens, with specificity exceeding 87.2% for all targets. Uniquely, the panel provides semiquantitative bacterial results, and many apparent false positives by culture were confirmed positive by alternative molecular methods, suggesting superior analytical sensitivity.
The original study
Multicenter Evaluation of the BioFire FilmArray Pneumonia/Pneumonia Plus Panel for Detection and Quantification of Agents of Lower Respiratory Tract Infection.
- Authors
- Murphy CN, Fowler R, Balada-Llasat JM, Carroll A, Stone H, Akerele O, et al.
- Journal
- Journal of clinical microbiology
- Type
- Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't
- PMID
- 32350043
Original 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.