Evaluation of the BioFire Gastrointestinal Panel to Detect Diarrheal Pathogens in Pediatric Patients

Abstract

Infectious diarrhea is a global pediatric health concern; therefore, rapid and accurate detection of enteropathogens is vital. We evaluated the BioFire® FilmArray® Gastrointestinal (GI) Panel with that of comparator laboratory tests. Stool samples of pediatric patients with diarrhea were prospectively collected and tested. As a comparator method for bacteria, culture, conventional PCR for diarrheagenic E. coli, and Allplex GI-Bacteria(I) Assay were tested. For discrepancy analysis, BD MAX Enteric Bacterial Panel was used. As a comparator method for virus, BD MAX Enteric Virus Panel and immunochromatography was used and Allplex GI-Virus Assay was used for discrepancy analysis. The “true positive” was defined as culture-positive and/or positive results from more than two molecular tests. Of the 184 stool samples tested, 93 (50.5%) were true positive for 128 pathogens, and 31 (16.9%) were positive for multiple pathogens. The BioFire GI Panel detected 123 pathogens in 90 of samples. The BioFire GI Panel demonstrated a sensitivity of 100% for 12 targets and a specificity of >95% for 16 targets. The overall positive rate and multiple pathogen rate among patients in the group without underlying diseases were significantly higher than those in the group with hematologic disease (57.0% vs. 28.6% (p = 0.001) and 20.4% vs. 4.8% (p = 0.02), respectively). The BioFire GI Panel provides comprehensive results within 2 h and may be useful for the rapid identification of enteropathogens.

Comparison of a Rapid Multiplex Gastrointestinal Panel with Standard Laboratory Testing in the Management of Children with Hematochezia in a Pediatric Emergency Department: Randomized Controlled Trial

“…The BioFire FilmArray gastrointestinal panel (bioMérieux Canada Inc., Quebec, Canada) is a multiplexed nucleic acid (NA) amplification assay that simultaneously identifies 22 enteric pathogens, including targets for E. coli O157:H7 and the Shiga toxin ( stx 1 and stx 2 ) genes ( 8 ). It provides results with a 1-h run time and has excellent diagnostic sensitivity and specificity ( 9 ), and its usage has been demonstrated to reduce antibiotic use among hospitalized children with acute diarrhea ( 10 ). As such, it has the potential to rapidly identify STEC-infected children at risk for HUS while simultaneously ruling out such infections in the majority of children, thereby reducing the need for close monitoring while awaiting culture results ( 11 ).…”

A pilot study using hospital surveillance and a birth cohort to investigate enteric pathogens and malnutrition in children, Dili, Timor-Leste

“…Multiplex PCR testing is very sensitive and detects presence of pathogen nucleic acid but not necessarily viable pathogen. The Biofire® GI PCR panel has shown high sensitivity and specificity in detection of diarrhoeal pathogens [ 63 ]. We intended to culture all human clinical Salmonella , Campylobacter and Shigella samples at NHL, however due to a lack of available resources this was not completed in most cases.…”

A pilot investigation of enteric pathogens and stunting and malnutrition using a combination of hospital surveillance and a birth cohort of children in Dili, Timor-Leste

“…In addition, multiplex PCR testing is very sensitive and detects presence of pathogen nucleic acid but not necessarily viable pathogen. The Biofire GI PCR panel has shown high sensitivity and specificity in detection of diarrhoeal pathogens (49). We intended to culture all human clinical Salmonella, Campylobacter and Shigella samples at NHL, however due to a lack of available resources this was not completed in most cases.…”