Lower respiratory tract infections (LRTI) are clinical conditions that arise throughout the population. Appropriate adoption of this test could provide actionable diagnostic information that is anticipated to impact patient care and antimicrobial stewardship decisions. Specificity for all targets was ≥87.2%, with many false-positive results compared to culture that were confirmed by alternative molecular methods. All other targets had sensitivities of ≥75% or were unable to be calculated due to low prevalence in the study population. The PN panel showed a sensitivity of 100% for 15/22 etiologic targets using BAL specimens and for 10/24 using sputum specimens. 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. This paper describes selected analytical and clinical studies that were conducted to evaluate performance of the panel for regulatory clearance. Semiquantitative results are also provided for the bacterial targets.
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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 fluid). These methods may require collection of various specimens, involve extensive sample treatment, and can suffer from low sensitivity and long turnaround times. Current diagnostic testing options include culture, molecular testing, and antigen detection. 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.
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