Utility of the BioFire® FilmArray® Pneumonia Panel plus assay for syndromic testing of lower respiratory tract infections in a low/middle-income setting

Abstract

Background Determining lower respiratory tract infection (LRTI) aetiology is complex. Culture-based methods are laborious with poor sensitivity. Molecular assays improve detection of potential pathogens, but incorrect interpretation of results may lead to inappropriate antimicrobial therapy. Methods The utility of the BioFire® FilmArray® Pneumonia Panel plus (FA-PP) to detect LRTI pathogens, and the potential impact on antimicrobial stewardship in a low-resource setting, were assessed. Routine LRT samples were included from adult patients with clinically suspected LRTI or with a concomitant blood culture at Groote Schuur Hospital and referring facilities. Culture and FA-PP results were compared, and pharmacy data analysed to determine appropriateness of antibiotic therapy. Results There was an 80% correlation between cultured LRTI pathogens and the FA-PP bin ≥107 results. Compared with culture, the FA-PP detected substantially more pathogens (86.6% versus 17.9%) and produced a combined 100% positive percent agreement, and 88% negative percent agreement. The FA-PP detected bacterial/viral coinfections in 27% of samples. Correlation of FA-PP results with pharmacy data (n = 69) indicated a potential antibiotic change in 75% of cases, but this is difficult to accurately characterize without a ‘gold standard’ for treatment or complete clinical data. Conclusions The FA-PP increased the number of positive samples with typical bacteria, but the semi-quantitative reporting algorithm does not describe the correlation between the different bin values and colonization versus infection. This complicates result interpretation and may lead to inappropriate antimicrobial treatment. This study highlights the potential positive impact of rapid molecular assays for routine care in lower-income settings, but also underscores the interpretive challenges associated with these tests.

Development and validation of multiplex real-time PCR for simultaneous detection of six bacterial pathogens causing lower respiratory tract infections and antimicrobial resistance genes

“…The specificity for all targets was 87.2% [ 14 ]. Despite its high diagnostic yield, the direct cost of FilmArray Pneumonia Panel was estimated to be around €155/test [ 17 ] and its clinical utility in LMIC required further evaluation [ 15 ]. Our assays are simple and inexpensive with a turnaround time of around 6 h, offering a useful tool to potentially guide optimal antibiotic therapy.…”

“…The BioFire FilmArray Pneumonia Plus Panel can detect 18 bacteria (11 Gram-negative, 4 Gram-positive and 3 atypical) , 7 AMR markers, and 9 viruses that cause pneumonia [ 14 ]. However, the FilmArray assay is expensive and may not be affordable for routine diagnostics, particularly in low- and middle-income (LMIC) settings [ 15 ]. Currently, a variety of traditional diagnostic methods are used to detect respiratory pathogens, including microscopic examination, bacterial culture and antigen detection [ 11 ].…”

“…The BioFire FilmArray Pneumonia Plus Panel can detect 18 bacteria (11 Gram-negative, 4 Gram-positive and 3 atypical) , 7 AMR markers, and 9 viruses that cause pneumonia [ 14 ]. However, the FilmArray assay is expensive and may not be affordable for routine diagnostics, particularly in low- and middle-income (LMIC) settings [ 15 ].…”

The development and validation of multiplex real-time PCRs with fluorescent melting curve analysis for simultaneous detection of six bacterial pathogens of lower respiratory tract infections and antimicrobial resistance genes

“…The BioFire FilmArray Pneumonia Panel and Pneumonia Plus Panel can detect 18 bacteria (11 Gram negative, 4 Gram positive and 3 atypical), 7 AMR markers, and 9 viruses that cause pneumonia 12 . However, the BioFire FilmArray assays are expensive and may not be adopted for routine diagnostics, particularly in low-and middleincome (LMIC) settings 13 . Alternatively, multiplex real-time PCR with either fluorescent probe or fluorescent dye targeting key locally relevant bacterial-AMR gene combinations can provide a pragmatic and inexpensive diagnostic method for clinical utility.…”

Supporting Clinical Decisions with Rapid Molecular Diagnostic Pneumonia Panel in Pediatric Intensive Care Unit: Single Center Experience in Turkiye

“…There is a total of 15 distinct bacteria (semiquantitative data provided), 3 atypical bacteria, 9 viruses, and 7 distinct antibiotic-resistance genes [9,10]. Although there is evidence of the efficacy of the FA-PP in the adult setting for rapidly diagnosing the complicated microbiological etiologies of pneumonia infections, there are limited data in the PICU situation [3,[9][10][11][12][13][14][15][16][17]. The purpose of this research was to evaluate the performance of a rapid molecular diagnostic pneumonia panel, the FA-PP, for use with children in the PICU who have lower respiratory tract infections.…”