title: Multicenter evaluation of the BioFire FilmArray gastrointestinal panel for etiologic diagnosis of infectious gastroenteritis.
abstract: The appropriate treatment and control of infectious gastroenteritis depend on the ability to rapidly detect the wide range of etiologic agents associated with the disease. Clinical laboratories currently utilize an array of different methodologies to test for bacterial, parasitic, and viral causes of gastroenteritis, a strategy that suffers from poor sensitivity, potentially long turnaround times, and complicated ordering practices and workflows. Additionally, there are limited or no testing methods routinely available for most diarrheagenic Escherichia coli strains, astroviruses, and sapoviruses. This study assessed the performance of the FilmArray Gastrointestinal (GI) Panel for the simultaneous detection of 22 different enteric pathogens directly from stool specimens: Campylobacter spp., Clostridium difficile (toxin A/B), Plesiomonas shigelloides, Salmonella spp., Vibrio spp., Vibrio cholerae, Yersinia enterocolitica, enteroaggregative E. coli, enteropathogenic E. coli, enterotoxigenic E. coli, Shiga-like toxin-producing E. coli (stx1 and stx2) (including specific detection of E. coli O157), Shigella spp./enteroinvasive E. coli, Cryptosporidium spp., Cyclospora cayetanensis, Entamoeba histolytica, Giardia lamblia, adenovirus F 40/41, astrovirus, norovirus GI/GII, rotavirus A, and sapovirus. Prospectively collected stool specimens (n = 1,556) were evaluated using the BioFire FilmArray GI Panel and tested with conventional stool culture and molecular methods for comparison. The FilmArray GI Panel sensitivity was 100% for 12/22 targets and ≥94.5% for an additional 7/22 targets. For the remaining three targets, sensitivity could not be calculated due to the low prevalences in this study. The FilmArray GI Panel specificity was ≥97.1% for all panel targets. The FilmArray GI Panel provides a comprehensive, rapid, and streamlined alternative to conventional methods for the etiologic diagnosis of infectious gastroenteritis in the laboratory setting. The potential advantages include improved performance parameters, a more extensive menu of pathogens, and a turnaround time of as short as 1 h.
authors.affiliation: Department of Pathology and Microbiology, University of Nebraska Medical Center, Omaha, Nebraska, USA sarah.buss@wyo.gov.
authors.forename: Sarah N
authors.initials: SN
authors.lastname: Buss
authors.affiliation: Department of Laboratory Medicine, Nationwide Children's Hospital, Columbus, Ohio, USA.
authors.forename: Amy
authors.initials: A
authors.lastname: Leber
authors.affiliation: Departments of Pathology and Medicine, Lifespan Academic Medical Center, Providence, Rhode Island, USA.
authors.forename: Kimberle
authors.initials: K
authors.lastname: Chapin
authors.affiliation: Department of Pathology and Microbiology, University of Nebraska Medical Center, Omaha, Nebraska, USA.
authors.forename: Paul D
authors.initials: PD
authors.lastname: Fey
authors.affiliation: Diagnostic Laboratory Services, Inc., Aiea, Hawaii, USA Departments of Pathology, Tropical Medicine, Medical Microbiology, and Pharmacology, John A. Burns School of Medicine and the University of Hawaii at Manoa, Honolulu, Hawaii, USA.
authors.forename: Matthew J
authors.initials: MJ
authors.lastname: Bankowski
authors.affiliation: BioFire Diagnostics, LLC, Salt Lake City, Utah, USA.
authors.forename: Matthew K
authors.initials: MK
authors.lastname: Jones
authors.affiliation: BioFire Diagnostics, LLC, Salt Lake City, Utah, USA.
authors.forename: Margarita
authors.initials: M
authors.lastname: Rogatcheva
authors.affiliation: BioFire Diagnostics, LLC, Salt Lake City, Utah, USA.
authors.forename: Kristen J
authors.initials: KJ
authors.lastname: Kanack
authors.affiliation: BioFire Diagnostics, LLC, Salt Lake City, Utah, USA.
authors.forename: Kevin M
authors.initials: KM
authors.lastname: Bourzac
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000818:Animals; D001419:Bacteria / Q000145:classification / Q000302:isolation & purification*; D002648:Child; D002675:Child, Preschool; D005243:Feces / Q000382:microbiology / Q000469:parasitology / Q000821:virology; D005260:Female; D005759:Gastroenteritis / Q000175:diagnosis*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D008828:Microbiological Techniques / Q000379:methods*; D008875:Middle Aged; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D010271:Parasites / Q000145:classification / Q000302:isolation & purification*; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D013997:Time Factors; D014780:Viruses / Q000145:classification / Q000302:isolation & purification*; D055815:Young Adult