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

• DOI: 10.1016/j.ijid.2020.03.024
• Publication Date: 2020-03-13T22:41:17Z
• Authors: In Young Yoo; Kyungmin Huh; Hyang Jin Shim; Sun Ae Yun; Yoo Na Chung; On Kyun Kang; Hee Jae Huh; Nam Yong Lee
• Keywords: 0301 basic medicine; FilmArray Pneumonia Panel plus; Bacterial respiratory pathogen; Bacteria; Antibiotic resistance; Sputum; Drug Resistance, Microbial; Infectious and parasitic diseases; RC109-216; Sensitivity and Specificity; Anti-Bacterial Agents; 3. Good health; 03 medical and health sciences; PCR; Molecular Diagnostic Techniques; Genes, Bacterial; Pneumonia, Bacterial; Humans; Semi-quantitative result; Multiplex Polymerase Chain Reaction; Retrospective Studies

The performance of the investigational-use-only version of the BioFire FilmArray Pneumonia Panel (FA-Pneumo), a high-order nested multiplex PCR, was evaluated for the detection of typical respiratory bacterial pathogens and antibiotic resistance genes in sputa and endotracheal aspirate (ETA) specimens.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.Overall sensitivity and specificity for organism detection using FA-Pneumo were 98.5% and 76.5%, respectively. The sensitivity for each pathogen was 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 ≥106 copies/ml also gave culture-positive results with significant amounts of bacteria.FA-Pneumo is a rapid test with high sensitivity for the detection of bacteria and antimicrobial resistance genes in sputum and ETA specimens and could aid in determining antibiotic therapy.