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.
Highlights
Infectious diarrhea is associated with childhood morbidity and mortality [1]
Microbiological testing of stool specimens using cultures, enzyme immunoassays (EIA), multiplex molecular assays, and parasite examinations is recommended for the detection of a wide range of causative enteropathogens [4]
Stool culture indicated a sensitivity of 85.0% for Campylobacter spp., 100% for Salmonella spp., 60.0% for Y. enterocolitica, and 0% for P. shigelloides
Summary
Infectious diarrhea is associated with childhood morbidity and mortality [1]. Viruses, and parasites act on the gastrointestinal tract via various mechanisms, appropriate management of these pathogens requires timely identification of the causative agents [2,3]. Microbiological testing of stool specimens using cultures, enzyme immunoassays (EIA), multiplex molecular assays, and parasite examinations is recommended for the detection of a wide range of causative enteropathogens [4]. Conventional diagnostic methods such as stool culture can only detect a limited number of pathogens and require long turnaround times, and those including EIAs are not highly sensitive [2,5,6]. Rapid multiplex molecular assays have a rapid turnaround time and high sensitivity [6]. There are several studies which evaluated BF-GI, to our knowledge, none of them evaluated all the pathogens with another molecular assay and discrepancy analysis with third party molecular assay in pediatric patients
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