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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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Elbahr, U., Khairy, A., Reyes, C. S. D., Pastrana, J., Vineeth, C., Ertürk, Z., Öztürk, Ç. P., Şencan, O., Hejres, S., Fadel, E., et al. (2026) · Jundishapur Journal of Microbiology · doi:10.5812/jjm-169803
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“However, this method is not always accurate and may miss some cases [6].”
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“These panels have demonstrated high sensitivity and specificity(19-22).”
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“10,11 The study aimed to investigate the role and utility of FilmArray GIP in the diagnosis of GIs.”
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“5% and 100% (15, 16) The pathogens are: Campylobacter jejuni, Clostridioides difficile (toxin A/B), Plesiomonas shigelloides, Salmonella species, Yersinia enterocolitica, Vibrio parahaemolyticus, Vibrio vulnificus, Vibrio cholerae, enteroaggregative Escherichia coli (EAEC), enteropathogenic E.”
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Infections à « Campylobacter »
Mégraud, F., & Bessède, E. (2022) · EMC - Maladies Infectieuses · doi:10.1016/s1166-8598(21)44820-9
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“Conventional testing methods are increasingly being replaced by multiplex molecular stool testing, which provides an improved detection rate for multiple pathogens simultaneously with a high sensitivity and a rapid turnaround time [7-9].”
MethodTisdale, M. D., Mitra, I., Mccoy, A. J., Simons, M., Reynolds, N. D., Swierczewski, B., Liu, J., Houpt, E., Fraser, J. A., Riddle, M., et al. (2020) · doi:10.21203/rs.3.rs-48924/v1
“The results show a lower than expected PPA of TAC on archival samples and signi cant variability in PPA estimates by pathogen when compared to previously published estimates [4, 5].”
BackgroundResultMcAuliffe, G., Tse, F., Qiao, H., Moore, S., Bissessor, L., Thompson, B., McLaughlin, V., Upton, A., & Taylor, S. (2020) · Pathology (Sydney) · doi:10.1016/j.pathol.2020.02.008
Community acquired Clostridium difficile in an infant without antibiotic exposure
Singh, J., & Vyas, R. (2020) · Journal of Family Medicine and Primary Care · doi:10.4103/jfmpc.jfmpc_702_19
“difficile with PCR assay, a very sensitive and specific finding.[8] So, the possibilities of C.”
BackgroundReplacement of Culture with Molecular Testing for Diagnosis Infectious Diseases
Capraro, G. (2018) · Advances in Molecular Pathology · doi:10.1016/j.yamp.2018.07.002
Nolte, F. S. (2018) · Elsevier eBooks · doi:10.1016/b978-0-12-816061-9.00005-9
“9%.(244) Asymptomatic infections with C.”
The Utility of Multiplex Molecular Tests for Enteric Pathogens: a Micro-Comic Strip
McAdam, A. (2018) · Journal of Clinical Microbiology · doi:10.1128/jcm.01916-17
Leshem, E., & Lopman, B. A. (2017) · Elsevier eBooks · doi:10.1016/b978-0-323-40181-4.00056-6 · Cited by 2
Emerging Technologies in Diagnostic Virology and Antiviral Strategies
Patra, G., & Mukhopadhyay, S. (2021) · Springer eBooks · doi:10.1007/978-3-030-58675-1_97-1
Appendicitis and Infections of the Appendix
Hosseini, M., & Lamps, L. (2019) · Gastrointestinal Diseases and their Associated Infections · doi:10.1016/b978-0-323-54843-4.00008-8
Molecular Diagnosis of Gastrointestinal Infections
Babady, E., & Mead, P. (2019) · Gastrointestinal Diseases and their Associated Infections · doi:10.1016/b978-0-323-54843-4.00013-1
Keddy, K., & Smith, A. (2019) · Gastrointestinal Diseases and their Associated Infections · doi:10.1016/b978-0-323-54843-4.00012-x
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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