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Multicenter Evaluation of the BioFire FilmArray Gastrointestinal Panel for Etiologic Diagnosis of Infectious Gastroenteritis
Open accessAbstract
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 ( stx 1 and stx 2 ) (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.
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“The low percentage of failures (6/1,577 [0.38%]) is consistent with other published data on different FilmArray panels and indicates there was not a significant amount of inhibition of PCR in the samples (15).”
From Multicenter Evaluation of BioFire FilmArray Meningitis/Encephalitis Panel for Detection of Bacteria, Viruses, and Yeast in Cerebrospinal Fluid Specimens (2016) · cites this paper as [15]
In the citing paper
“The low percentage of failures (6/1,577 [0.38%]) is consistent with other published data on different FilmArray panels and indicates there was not a significant amount of inhibition of PCR in the samples (15).”
From Multicenter Evaluation of BioFire FilmArray Meningitis/Encephalitis Panel for Detection of Bacteria, Viruses, and Yeast in Cerebrospinal Fluid Specimens (2016) · cites this paper as [15]
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Cited by
Sorted by citations
Liu, J., Platts-Mills, J. A., Juma, J., Kabir, F., Nkeze, J., Okoi, C., Operario, D. J., Uddin, M. J., Ahmed, S., Alonso, P. L., et al. (2016) · The Lancet · doi:10.1016/s0140-6736(16)31529-x · Cited by 869
Leber, A. L., Everhart, K., Balada-Llasat, J.-M., Cullison, J., Daly, J., Holt, S., Lephart, P., Salimnia, H., Schreckenberger, P. C., DesJarlais, S., et al. (2016) · Journal of Clinical Microbiology · doi:10.1128/jcm.00730-16 · Cited by 609
“38%]) is consistent with other published data on different FilmArray panels and indicates there was not a significant amount of inhibition of PCR in the samples (15).”
ResultSelf-citationSyndromic Panel-Based Testing in Clinical Microbiology
Ramanan, P., Bryson, A. L., Binnicker, M. J., Pritt, B. S., & Patel, R. (2018) · Clinical Microbiology Reviews · doi:10.1128/cmr.00024-17 · Cited by 308
“The overall specificity of the BioFire GIP was 97% (58).”
BackgroundResultMetagenomics: The Next Culture-Independent Game Changer
Forbes, J. D., Knox, N., Ronholm, J., Pagotto, F., & Reimer, A. R. (2017) · Frontiers in Microbiology · doi:10.3389/fmicb.2017.01069 · Cited by 340
“Lastly, multiplex panels are highly sensitive (90–100%) and specific (98%) (Buchan et al., 2013; Navidad et al., 2013; Onori et al., 2014; Buss et al., 2015; Harrington et al., 2015).”
BackgroundMessacar, K., Parker, S. K., Todd, J. K., & Dominguez, S. R. (2016) · Journal of Clinical Microbiology · doi:10.1128/jcm.02264-16 · Cited by 329
Metadata
- Authors
- Buss, S. N., Leber, A., Chapin, K., Fey, P. D., Bankowski, M. J., Jones, M. K., Rogatcheva, M., Kanack, K. J., & Bourzac, K. M.
- Affiliations
- University of Nebraska Medical Center (US)
- Nationwide Children's Hospital (US)
- Lifespan (US)
- University of Hawaiʻi at Mānoa (US)
- BioFire Diagnostics (United States) (US)
- Venue
- Journal of Clinical Microbiology
- Publisher
- American Society for Microbiology
- Published
- 2015-03
- Volume
- 53
- Issue
- 3
- Pages
- 915-925
- ISSN
- 0095-1137 (ISSN-L)
- 1098-660X
- PMC
- PMC4390666
- OpenAlex
- W2169792847
- Cited by
- 554
- References
- 0
- Citations by year
- 2026: 43 · 2025: 46 · 2024: 42 · 2023: 62 · 2022: 43 · 2021: 51 · 2020: 61 · 2019: 41 · 2018: 58 · 2017: 48 · 2016: 39 · 2015: 18
- FWCI
- 42.22
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Journal of Clinical Microbiology (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- BioFire Diagnostics
- National Institutes of Health
- National Institute of Allergy and Infectious Diseases (R01AI104593, R01AI089489)
- Topics
- Health Sciences › Medicine › Infectious Diseases › Viral gastroenteritis research and epidemiology
- Health Sciences › Medicine › Microbiology (medical) › Bacterial Identification and Susceptibility Testing
- Life Sciences › Agricultural and Biological Sciences › Food Science › Salmonella and Campylobacter epidemiology
- Keywords
- infectious gastroenteritis, enteric pathogens, multiplex PCR, sensitivity and specificity, diarrheagenic Escherichia coli, norovirus, rotavirus, sapovirus, Cryptosporidium, Giardia lamblia, Shiga toxin-producing Escherichia coli, rapid molecular diagnostics
- MeSH terms
- Adolescent, Adult, Aged, Aged, 80 and over, Animals, Bacteria, Child, Child, Preschool, Feces, Female, Gastroenteritis, Humans, Infant, Infant, Newborn, Male, Microbiological Techniques, Middle Aged, Parasites, Prospective Studies, Sensitivity and Specificity, Time Factors, Viruses, Molecular Diagnostic Techniques, Young Adult
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