Multicenter Evaluation of the BioFire FilmArray Pneumonia/Pneumonia Plus Panel for Detection and Quantification of Agents of Lower Respiratory Tract Infection
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Open Access
- 30 June 2020
- journal article
- research article
- Published by American Society for Microbiology in Journal of Clinical Microbiology
- Vol. 58 (7)
- https://doi.org/10.1128/JCM.00128-20
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.Funding Information
- BioFire Diagnostics
This publication has 36 references indexed in Scilit:
- Evaluation and Implementation of FilmArray Version 1.7 for Improved Detection of Adenovirus Respiratory Tract InfectionJournal of Clinical Microbiology, 2013
- Can an etiologic agent be identified in adults who are hospitalized for community-acquired pneumonia: Results of a one-year studyJournal of Infection, 2013
- Comparison of Three Different Methods for Detection of Shiga Toxin-Producing Escherichia coli in a Tertiary Pediatric Care CenterJournal of Clinical Microbiology, 2013
- Management of Community-Acquired Pneumonia in Infants and Children Older Than 3 MonthsClinical Infectious Diseases, 2012
- CTX-M Enzymes: Origin and DiffusionFrontiers in Microbiology, 2012
- Quantitative detection of Streptococcus pneumoniae from sputum samples with real-time quantitative polymerase chain reaction for etiologic diagnosis of community-acquired pneumoniaDiagnostic Microbiology and Infectious Disease, 2008
- First Report of the Emergence of CTX-M-Type Extended-Spectrum β-Lactamases (ESBLs) as the Predominant ESBL Isolated in a U.S. Health Care SystemAntimicrobial Agents and Chemotherapy, 2007
- Infectious Diseases Society of America/American Thoracic Society Consensus Guidelines on the Management of Community-Acquired Pneumonia in AdultsClinical Infectious Diseases, 2007
- CTX-M: changing the face of ESBLs in EuropeJournal of Antimicrobial Chemotherapy, 2006
- A 3-year prospective study of a urinary antigen-detection test for Streptococcus pneumoniae in community-acquired pneumonia: utility and clinical impact on the reported etiologyJournal of Infection and Chemotherapy, 2004