Laboratory evaluation of the BioFire FilmArray Pneumonia plus panel compared to conventional methods for the identification of bacteria in lower respiratory tract specimens: a prospective cross-sectional study from South Africa

Abstract

Lower respiratory tract infections are important causes of morbidity and mortality. The global increase in antimicrobial resistance necessitates rapid diagnostic assays. The BioFire FilmArray Pneumonia plus (FAPP) panel is an FDA approved multiplex polymerase chain reaction assay that detects the most important etiological agents of pneumonia, and associated antibiotic resistance genes, in approximately one hour. This study assessed the diagnostic performance of this assay by comparing it to conventional culture methods in the analysis of 59 lower respiratory tract specimens. The sensitivity and specificity of the FAPP panel for bacterial detection were 92.0% (95% CI, 80.8% - 97.8%) and 93.8% (95% CI, 91.1% - 95.3%) respectively. For detecting antibiotic resistance, the positive- and negative percent agreement were 100% (95% CI, 81.5% - 100.0%) and 98.5% (95% CI, 216 96.7% - 99.4%) respectively. The FAPP panel was found to be highly accurate in evaluating tracheal aspirate specimens from hospitalised patients.

Impact of rapid multiplex PCR on management of antibiotic therapy in COVID-19-positive patients hospitalized in intensive care unit

“…We observed that the main species identified by mPCR, in our population composed exclusively by ICU patients, were Gram-negative bacilli, especially P. aeruginosa , E. coli , and Klebsiella spp. which is consistent with other studies that have evaluated the same kit in ICU patients [ 8 – 10 ] .…”

“…In our study, the mPCR provided good overall performance for bacteria, with a PPV of 85.6% which is above what has been found in previous studies (between 46.9 and 79.6%) and an NPV of 99.5% which is consistent with previous studies [ 10 – 13 ]. Other studies showed positive and negative percentage agreement of mPCR compared to culture between 90 and 98.4% and 96 and 97% respectively [ 9 , 12 , 14 ].…”

“…Our study is one of the first to analyze the impact of mPCR on the management of antibiotic therapy in COVID-19 patients suspected of bacterial pneumonia [ 16 ]. Only 33% of mPCR were positive, lower than in other studies, in which it ranged between 58.5 and 74.6%, confirming the difficulty of diagnosing bacterial superinfection in COVID-19 ICU patients [ 9 , 10 , 12 , 14 ].…”

Multinational evaluation of the BioFire® FilmArray® Pneumonia plus Panel as compared to standard of care testing

“…Our rate of bacteria detection (95.77%) as compared to culture was consistent with Mitton et al (92.0%) [ 21 ] and Yoo et al (99.3%) [ 22 ]. A study by Webber et al demonstrated that the BioFire PN plus Panel identified most bacteria (98.4%) detected by SOC and additionally 92 bacteria including more S. aureus (23.9%) and H. influenza (27.2%) [ 23 ].…”

Clinical decision making is improved by BioFire Pneumonia Plus in suspected lower respiratory tract infection after lung transplantation: Results of the prospective DBATE‐IT* study

“…17 Recent studies demonstrate that BFPPp and the earlier BioFire Pneumonia panel (BFPP) perform well in both sputum and BAL samples in a variety of settings outside the context of LTx. [16][17][18][19][20][21][22][23][24][25][26][27][28][29][30] Furthermore, the older BFPP was recently shown to allow for faster clinical decisions while retaining good overall concordance with conventional diagnostics in LTx recipients. 31 Notably, the majority of patients in this study underwent bronchoscopy for routine surveillance, not due to suspected LRTI.…”