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.
“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]
The low percentage of failures indicates there was not a significant amount of inhibition of PCR in the samples.
“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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“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).”
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“In the last decade, aEPEC has become more frequent in high-income and also in developing countries [36, 37].”
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Performance of the QIAstat-Dx Gastrointestinal Panel for Diagnosing Infectious Gastroenteritis
Boers, S. A., Peters, C. J. A., Wessels, E., Melchers, W., & Claas, E. (2020) · Journal of Clinical Microbiology · doi:10.1128/jcm.01737-19 · Cited by 38
“coli pathotypes detected were detected as coinfection or colonization with at least one (other) established enteropathogen, which is consistent with results from previous studies (28, 30, 31) and which complicates studies toward the clinical relevance and pathogenicity of E.”
ResultPotgieter, N., Lee, H.-N., Ngandu, J. K., Ledwaba, S. E., Zitha, T., Mudau, L. S., Becker, P., Traoré, A., & Barnard, T. (2023) · Pathogens · doi:10.3390/pathogens12020315 · Cited by 37
“Further complicating the interpretation of results obtained by utilisation of the BioFire® Film Array® GI Panel (BioFire Diagnostics, Salt Lake City, UT, USA) is that several enteric pathogens are shed over a prolonged period by patients who have already recovered from an episode of diarrhoea and are asymptomatic at t…”
ResultThe GenMark ePlex®: another weapon in the syndromic arsenal for infection diagnosis.
Schmitz, J. E., & Tang, Y.-W. (2018) · Future Microbiology · doi:10.2217/fmb-2018-0258 · Cited by 37
Gonzalez, M. D., Langley, L., Buchan, B., Faron, M., Maier, M., Templeton, K., Walker, K., Popowitch, E., Miller, M. B., Rao, A., et al. (2015) · Journal of Clinical Microbiology · doi:10.1128/jcm.02361-15 · Cited by 37
“Two recent studies (14, 15) evaluated the FilmArray GI panel, using a CDC-based assay as the reference method for norovirus detection (31), and reported sensitivities of 91.”
MethodUse of a multiplex DNA extraction PCR in the identification of pathogens in travelers’ diarrhea
Connor, B. A., Rogova, M., & Whyte, O. (2017) · Journal of Travel Medicine · doi:10.1093/jtm/tax087 · Cited by 44 · see citing works
Teh, R., Tee, W. D., Tan, E. X. X., Fan, K. H., Koh, C. J., Tambyah, P. A., Oon, J. E. L., Tee, N. W. S., Soh, A. Y. S., & Siah, K. T. H. (2021) · Journal of Gastroenterology and Hepatology · doi:10.1111/jgh.15581 · Cited by 42 · see citing works
Beganovic, M., McCreary, E. K., Mahoney, M. V. G., Dionne, B., Green, D. A., & Timbrook, T. T. (2018) · The Journal of Applied Laboratory Medicine · doi:10.1373/jalm.2018.026450 · Cited by 34 · see citing works
“1%, GI panels can be instrumental in deescalation efforts for ASPs (73).”
BackgroundGallardo, P., Izquierdo, M., Vidal, R. M., Chamorro-Veloso, N., Rossello-Mora, R. A., O’Ryan, M., & Farfán, M. J. (2017) · Frontiers in Cellular and Infection Microbiology · doi:10.3389/fcimb.2017.00424 · Cited by 39 · see citing works
“Implementation of molecular techniques allowing simultaneous detection of multiple enteric pathogens, including DEC pathotypes, have shown that the prevalence of these pathotypes in diarrheal infections is higher than previously thought (Buss et al., 2015; Farfán et al., 2016).”
BackgroundFreeman, K., Tsertsvadze, A., Taylor‐Phillips, S., McCarthy, N. D., Mistry, H., Manuel, R. J., & Mason, J. M. (2017) · PLoS ONE · doi:10.1371/journal.pone.0173196 · Cited by 36 · see citing works
Multani, A., Allard, L. S., Wangjam, T., Sica, R. A., Epstein, D. J., Rezvani, A. R., & Ho, D. Y. (2019) · Blood Advances · doi:10.1182/bloodadvances.2019000634 · Cited by 35 · see citing works
“However, clinicians should be familiar with the multiplex syndromic PCRs used at their institution because some of these assays may not detect all adenovirus serotypes known to cause disease in HCT recipients.(35-38) In the setting of high clinical suspicion for adenoviral disease, clinicians may hesitate to administe…”
BackgroundPaulos, S., Saugar, J. M., de Lucio, A., Fuentes, I., Mateo, M., & Carmena, D. (2019) · PLoS ONE · doi:10.1371/journal.pone.0215068 · Cited by 43 · see citing works
Calderaro, A., Martinelli, M., Buttrini, M., Montecchini, S., Covan, S., Rossi, S., Ferraglia, F., Montagna, P., Pinardi, F., Larini, S., et al. (2018) · International Journal of Medical Microbiology · doi:10.1016/j.ijmm.2018.04.007 · Cited by 34 · see citing works
Beyond the Gastrointestinal Tract: The Emerging and Diverse Tissue Tropisms of Astroviruses
Janowski, A. B. (2021) · Viruses · doi:10.3390/v13050732 · Cited by 35 · see citing works
Zhang, L. T., Westblade, L., Iqbal, F., Taylor, M. R., Chung, A., Satlin, M., Magruder, M., Edusei, E., Albakry, S., Botticelli, B., et al. (2021) · Clinical Transplantation · doi:10.1111/ctr.14260 · Cited by 32
Advances in Cyclosporiasis Diagnosis and Therapeutic Intervention
Li, J.-Q., Cui, Z., Qi, M., & Zhang, L. (2020) · Frontiers in Cellular and Infection Microbiology · doi:10.3389/fcimb.2020.00043 · Cited by 32
Integrated LAMP and immunoassay platform for diarrheal disease detection
Phaneuf, C., Mangadu, B., Tran, H. M., Light, Y. K., Sinha, A., Charbonier, F. W., Eckles, T. P., Singh, A. K., & Koh, C.-Y. (2018) · Biosensors & bioelectronics · doi:10.1016/j.bios.2018.08.005 · Cited by 32
Knabl, L., Grutsch, I., & Orth‐Höller, D. (2015) · European Journal of Clinical Microbiology & Infectious Diseases · doi:10.1007/s10096-015-2517-4 · Cited by 33 · see citing works
Foster, M. A., Iqbal, J., Zhang, C., McHenry, R. E., Cleveland, B. E., Romero, Y., Fonnesbeck, C., Payne, D. C., Chappell, J. D., Halasa, N., et al. (2015) · Diagnostic Microbiology and Infectious Disease · doi:10.1016/j.diagmicrobio.2015.07.016 · Cited by 32 · see citing works
“As new multipanel systems for DEC detection become available, more accurate epidemiological data on DEC in the United States will be reported (Buss et al., 2015).”
Leli, C., di Matteo, L., Gotta, F., Vay, D., Cavallo, V., Mazzeo, R., Busso, S., Carrabba, L., & Rocchetti, A. (2019) · Infectious Diseases · doi:10.1080/23744235.2019.1688861 · Cited by 31
“[10], nevertheless, in that study, the 86.”
BackgroundResultIs Follow-Up Testing with the FilmArray Gastrointestinal Multiplex PCR Panel Necessary?
Park, S., Hitchcock, M. M., Gómez, C. A., & Banaei, N. (2017) · Journal of Clinical Microbiology · doi:10.1128/jcm.02354-16 · Cited by 38 · see citing works
“The FilmArray gastrointestinal (GI) panel (BioFire Diagnostics, Salt Lake City, UT) is a novel sample-to-answer, on-demand, multiplex, real-time PCR assay for the syndromic diagnosis of infectious gastroenteritis (1).”
BackgroundLiesman, R. M., & Binnicker, M. J. (2016) · Current Opinion in Infectious Diseases · doi:10.1097/qco.0000000000000276 · Cited by 34 · see citing works
Laszkowska, M., Kim, J., Faye, A. S., Joelson, A. M., Ingram, M. A., Truong, H., Silver, E. R., May, B. L., Greendyke, W. G., Zucker, J. E., et al. (2021) · Digestive Diseases and Sciences · doi:10.1007/s10620-020-06760-y · Cited by 39 · see citing works
Bridging Systemic Immunity with Gastrointestinal Immune Responses via Oil‐in‐Polymer Capsules
Xia, Y.-F., Wu, J., Du, Y.-Q., Miao, C., Su, Z., & Ma, G. (2018) · Advances in Materials · doi:10.1002/adma.201801067 · Cited by 30
Future potential of metagenomics in microbiology laboratories
Schuele, L., Cassidy, H., Peker, N., Rossen, J. W. A., & Couto, N. (2021) · Expert Review of Molecular Diagnostics · doi:10.1080/14737159.2021.2001329 · Cited by 35 · see citing works
Riddle, M. S., Savarino, S. J., & Sanders, J. W. (2015) · American Journal of Tropical Medicine and Hygiene · doi:10.4269/ajtmh.15-0200 · Cited by 37 · see citing works
Chao, A., Bhatti, M. M., DuPont, H., Nataro, J., Carlin, L., & Okhuysen, P. (2017) · Diagnostic microbiology and infectious disease · doi:10.1016/j.diagmicrobio.2017.08.004 · Cited by 28
“…(NAATs) that can simultaneously detect the presence of multiple enteropathogens in stools of patients in a cost efficient manner is increasing our ability to define the epidemiology, clinical implications and outcomes of infectious diarrhea in pediatric and adult populations(Buss et al., 2015).”
BackgroundMoon, R. C., Bleak, T. C., Rosenthal, N. A., Couturier, B. A., Hemmert, R. B., Timbrook, T. T., Brown, H., & Fang, F. C. (2023) · Journal of Clinical Microbiology · doi:10.1128/jcm.01628-22 · Cited by 22 · see citing works
“We hypothesized that the outcomes would be different for smaller panels (PCR , 12) and larger panels (PCR $ 12) since one of the benefits of multiplex PCR test is testing simultaneously for many different pathogens (23).”
Background
- 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 · 2014: 1
- 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
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Clinical Biochemistry › 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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