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Respiratory infections: what to expect from molecular tools?

Multinational Performance Evaluation of the BIOFIRE® FILMARRAY® Pneumonia plus Panel

April 21 • P4389

C. C. Ginocchio1, C. García2, B. Mauerhoff2, C. Rindlisbacher1, and the EMEA Evaluation Program Collaborative

1) BioFire Diagnostics, LLC, Salt Lake City, UT, USA
2) bioMérieux, Marcy l’Étoile, France

Introduction: Identification of pathogens causing community acquired, heath-care and ventilated associated pneumonia can be problematic. The BIOFIRE® FILMARRAY® Pneumonia plus Panel detects 15 bacteria (with semi-quantification), three atypical bacteria, eight viral classes and seven antibiotic resistance markers (mecA/C/MREJ, CTX-M, KPC, VIM, IMP, NDM, OXA-48 like) directly from sputum-like specimens (induced or expectorated sputum; endotracheal aspirates), and bronchoalveolar lavage (BAL)-like specimens with results in about one hour. 

Methods: 52 laboratories from 13 countries across Europe and Israel compared the BIOFIRE® Pneumonia plus Panel results to standard of care (SOC) test results. SOC tests varied by site and included various combinations of culture, urinary antigen, molecular assays, and direct fluorescent antibody assays. A total of 2,501 samples (1,252 sputum-like and 1,249 BAL-like) were tested. Comparison of semi-quantification results for BIOFIRE® Pneumonia plus Panel and SOC bacterial pathogens were compared for 1,297 matched detections.

Results: A total of 3,278 bacterial analytes included on BIOFIRE® Pneumonia plus Panel were detected by at least one method. The BIOFIRE® Pneumonia plus Panel identified 3,128 (95%) compared to 1,878 (54%) for SOC. The BIOFIRE® Pneumonia plus Panel detected 93 atypical bacteria and 618 viruses compared to 73 atypical bacteria and 135 viruses for SOC.  Semi-quantitative values for the BIOFIRE® Pneumonia plus Panel were less than SOC values, equal to SOC values or greater than SOC values in 5.09%, 25.91% and 69.01% of the results, respectively. On average, BIOFIRE® Pneumonia plus Panel values were 1.06 log higher than SOC values (57.75% 1-2 log; 11.26% 3-4 log). All resistance markers were detected at least once by the BIOFIRE® Pneumonia plus Panel and in various combinations, with mecA/C/MREJ the most prevalent in Staphylococcus aureus (20.35%), followed by CTM-X (8.0%) and KPC (4.3%) in applicable gram-negative bacteria.

Conclusions: Despite variations in laboratory testing methodologies across sites, the BIOFIRE® Pneumonia plus Panel performed consistently with enhanced detection of all types of respiratory pathogens. In particular, limited SOC testing for viral pathogens was shown to be a missed opportunity to define the potential cause of respiratory infection. The identification of the potential cause of pneumonia and associated resistance markers in approximately 1 hour could dramatically change antimicrobial selection and enhance patient outcomes.

filmarray

Pneumonia Panel

Paper poster