Evaluation of the BioFire(R) FilmArray(R) Pneumonia Panel for rapid detection of respiratory bacterial pathogens and antibiotic resistance genes in sputum and endotracheal aspirate specimens.

OBJECTIVES: The performance of the investigational-use-only version of the BioFire(R) FilmArray(R) Pneumonia Panel (FA-Pneumo), a high-order nested multiplex PCR, was evaluated for detection of typical respiratory bacterial pathogens and antibiotic resistance genes in sputa and endotracheal aspirate (ETA) specimens. METHODS: Thirty-one sputa and 69 ETA specimens were analyzed. The diagnostic performance of FA-Pneumo was assessed using routine microbiological methods as the reference standard. RESULTS: Overall sensitivity and specificity for organism detection using FA-Pneumo were 98.5% and 76.5%, respectively. The sensitivities for each pathogen were 100%, except for Klebsiella aerogenes, and the range of specificity was 83.3 - 99.0%. FA-Pneumo detected antimicrobial resistance genes in 17 out of 18 specimens (94.4%) that were resistant by antimicrobial susceptibility testing. FA-Pneumo additionally detected 25 resistance genes in 22 specimens, and sequencing for the presence of resistance genes confirmed the majority of these results (20/25, 80%). Semi-quantitative analysis of bacterial nucleic acid amounts by FA-Pneumo revealed that 88.2% of the identified bacteria (67/76) with >/= 10(6) copies/mL also gave culture-positive results with significant amounts of bacteria. CONCLUSION: FA-Pneumo is a rapid test with high sensitivity for detection of bacteria and antimicrobial resistance genes from sputum and ETA specimens and could aid in determining antibiotic therapy.