Cited by 554Viral gastroenteritis research and epidemiologyBacterial Identification and Susceptibility TestingSalmonella and Campylobacter epidemiology

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Multicenter Evaluation of the BioFire FilmArray Gastrointestinal Panel for Etiologic Diagnosis of Infectious Gastroenteritis

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Buss, Sarah N., Leber, Amy, Chapin, Kimberle, Fey, Paul D., Bankowski, Matthew J., Jones, Matthew K., Rogatcheva, Margarita, Kanack, Kristen J., Bourzac, Kevin M.·2015·Journal of Clinical Microbiology

DOI 10.1128/jcm.02674-14PMC PMC4390666

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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 ( 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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Lee, H. W., Han, S. B., & Rhim, J. W. (2021) · Children · doi:10.3390/children8070538 · Cited by 1
Norovirus infection in renal transplant patients with chronic diarrhea: A report of four cases and review of the literature
Parameswaran, S., Rao, B., Balasubramaniam, S., Parameswaran, A., & Tarigopula, A. (2021) · Gastroenterology Hepatology and Endoscopy Practice · doi:10.4103/ghep.ghep_14_20 · Cited by 2
Evaluation of Giardia intestinalis, Entamoeba histolytica and Cryptosporidium hominis/Cryptosporidium parvum in human stool samples by the BD MAXTM Enteric Parasite Panel.
Akgun, S., & Çelik, T. (2020) · Folia Parasitologica · doi:10.14411/fp.2020.020 · Cited by 2
“As demonstrated in other studies, molecular tests can increase the detection of pathogens while lowering both the hands-on time and the time to results (Patel et al. 2014, Buss et al. 2015).”
Result
Vibrio cholera and V. parahaemolyticus coinfection in an oncology patient with gastroenteritis.
Cintrón, M., O'Sullivan, B., Babady, N., & Tang, Y.-W. (2019) · Diagnostic microbiology and infectious disease · doi:10.1016/j.diagmicrobio.2019.114927 · Cited by 2
High-throughput multi-parallel enteropathogen quantification via nano-liter qPCR
Grembi, J., Mayer-Blackwell, K., Luby, S., & Spormann, A. (2019) · bioRxiv · doi:10.1101/746446 · Cited by 2
Entamoeba histolytica liver abscess case: could stool PCR avoid it?
Bernet-Sánchez, A., Bellés-Bellés, A., Arnuelos, J. A., Sanz, A. J., Abizanda, E. S., Vallverdú-Vidal, M., & García-González, M. (2019) · Diagnosis · doi:10.1515/dx-2019-0006 · Cited by 2
Interpretation and Relevance of Advanced Technique Results
Stratton, C. W., & Tang, Y. (2018) · Springer eBooks · doi:10.1007/978-3-319-95111-9_31 · Cited by 3
“This means that a multiplex PCR such as the Luminex bead method or the FilmArray real-time PCR assay must be used [146, 147, 149, 150].”
Method
Evaluation of alternate parasite transport systems for the BD MAX™ enteric parasite panel.
DeBurger, B., Hanna, S., & Mortensen, J. (2018) · Diagnostic microbiology and infectious disease · doi:10.1016/j.diagmicrobio.2018.06.003 · Cited by 2
Diagnostic Interpretation Guidance for Pediatric Enteric Pathogens: A Modified Delphi Consensus Process
Stang, A. S., Trudeau, M. S., Vanderkooi, O. G., Lee, B. E., Chui, L., Pang, X.-L., Allen, V. G., Burnham, C. D., Goldfarb, D. A., MacDonald, J. C., et al. (2018) · Canadian Journal of Infectious Diseases and Medical Microbiology · doi:10.1155/2018/2589826 · Cited by 7
“difficile test represents the classic challenge clinicians face in multianalyte arrays as its presence may represent colonization and not pathogenic infection, particularly in infancy [11, 13, 28, 29].”
Background
Oral typhoid vaccine and culture independent testing for travelers' diarrhea.
Connor, B., Rogova, M., & Whyte, O. (2017) · Journal of Travel Medicine · doi:10.1093/jtm/tax071 · Cited by 2
“A FilmArray GI panel, which is high throughput multiplex deoxyribonucleic acid (DNA) extraction PCR, revealed the presence of Salmonella.2 As the patient was suffering with worsening diarrhea, she was prescribed azithromycin 500mg daily for a 3-day course.”
Method
Pediatric Healthcare Epidemiology
Siegel, J. D., & Guzman‐Cottrill, J. A. (2017) · Elsevier eBooks · doi:10.1016/b978-0-323-40181-4.00002-5 · Cited by 2
“As more respiratory viruses and gastrointestinal pathogens are identified by using highly sensitive molecular methods, epidemiologic studies will be required to define further the risk of transmission in healthcare facilities and the clinical significance of positive antigen detection test results.(40,41) Healthcareas…”
Background
Evaluation of an Assay Based On Multiple Detection Temperature Technique for Simultaneous Detection of Viral Gastroenteritis-Causing Pathogens
Han, J., Kim, S.-H., & Paik, S. (2017) · doi:10.5812/jjm.43548 · Cited by 2
Application of Alternative Nucleic Acid Extraction Protocols to ProGastro SSCS Assay for Detection of Bacterial Enteric Pathogens
Munson, E., Napierala, M., Munson, K., Bilbo, D., & Schulte, M. A. (2016) · Journal of Clinical Microbiology · doi:10.1128/jcm.00271-16 · Cited by 2
Emerging Diagnostics for Transplant Infectious Diseases
Azar, M. M., Gaston, D. C., & Malinis, M. F. (2020) · Springer eBooks · doi:10.1007/978-3-030-01751-4_69-1 · Cited by 4
Pathogenic Intestinal Parasites in Transplant Recipients
Rosser, J., & Blackburn, B. (2020) · Emerging Transplant Infections · doi:10.1007/978-3-030-01751-4_57-1 · Cited by 2
Diagnostics: The Role of the Laboratory
Afzal, A., Kaplan, H. M., Motazedi, T., Qureshi, T. M., & Woc-Colburn, L. E. (2020) · Springer eBooks · doi:10.1007/978-3-030-33803-9_4 · Cited by 4
Campylobacter jejuni and Campylobacter coli
Yi, J., & Anderson, E. J. (2017) · Elsevier eBooks · doi:10.1016/b978-0-323-40181-4.00163-8 · Cited by 1
Human Microbiome: Implications on Health and Disease
Hira, P., Sood, U., Gupta, V., Nayyar, N., Mahato, N. K., Singh, Y. P., Lal, R., & Shakarad, M. (2017) · Springer eBooks · doi:10.1007/978-981-10-4298-0_8 · Cited by 4
Multiplex PCR to Diagnose Gastrointestinal Infections: Key Limitations in Interpretation
Tansarli, G. S., & Fang, F. C. (2026) · United European Gastroenterology Journal · doi:10.1002/ueg2.70272 · Cited by 1
“…conventional stool culture, microscopy, and antigen‐based testing, these assays provide markedly higher analytic sensitivity, enabling more reliable detection of enteric pathogens, including organisms present at low abundance or that are difficult to recover by traditional methods [8, 16, 18, 24].”
Influential
Effect of Diagnostic Test Type on Detection of Salmonella Infections — Foodborne Diseases Active Surveillance Network, 2004–2024
Tierney, R., Louis, R. P., Boxrud, D. J., Lamas, K. H., Angelo, K. M., & Weller, D. L. (2026) · MMWR. Morbidity and mortality weekly report · doi:10.15585/mmwr.mm7529a2 · Cited by 1
“Bayesian splines regression §§ was used to model trends in culture-diagnosed and culture-confirmed infections during 2004–2024 and in CIDT-diagnosed and unconfirmed infections during 2011–2024 ¶¶ ( 8 , 9 ).”
West Nile Virus and Other Nationally Notifiable Arboviral Diseases — United States, 2024
Mace, K. E., Jacobs, D., Gould, C. V., Staples, J., & Lyons, S. (2026) · MMWR. Morbidity and mortality weekly report · doi:10.15585/mmwr.mm7529a1 · Cited by 1
Impact of GI PCR Versus Stool Culture on Clinical Outcomes in Hospitalized Patients: A Retrospective Cohort Study.
Ayinde, B., Louis, M., Akhtar, A., Grabill, N., Tucker, A., Slaton, J., & Gross, P. (2026) · Journal of Clinical Gastroenterology · doi:10.1097/mcg.0000000000002419 · Cited by 1
Twenty-Two Months of Syndromic Multiplex-PCR Testing for Acute Infections in a Southern Italian Hospital: Pathogen Epidemiology, Diagnostic Appropriateness and the Cost of Negative Results
Chirizzi, D., Spedicato, A., Bianco, G., Lupo, L. I., Serafini, I., Pisanò, D., Orsi, M. R., Moschettini, G., Sorge, A., Bruno, R., et al. (2026) · Microorganisms · doi:10.3390/microorganisms14071574 · Cited by 1
“Second, C. difficile toxin-gene detection identifies carriage as well as infection and must be read against the clinical criteria for C. difficile infection rather than acted on in isolation [1,10,18].”
Influential
Contributions of whole-genome sequencing to the epidemiological monitoring of Campylobacter spp. in France
Jehanne, Q., Aptel, J., Ducournau, A., Bénejat, L., Martin, M., Rodriguez, C., & Lehours, P. (2026) · Antimicrobial Agents and Chemotherapy · doi:10.1128/aac.00193-26 · Cited by 1
Repeat multiplex PCR gastrointestinal panel testing within 14 days yields minimal additional diagnostic information: a multicenter cohort study
Shu, J. H., Wang, H., Misra, A., Rhoads, D. D., Nowacki, A. S., Dalton, J. E., & Deshpande, A. (2026) · Infection Control and Hospital Epidemiology · doi:10.1017/ice.2026.10464 · Cited by 1
Systematic review of point-of-need molecular diagnostics for rotavirus and enteric adenoviruses F40/F41
Top, F. K., Diagne, C., Touré, C. T., Gonfouli, J.-M., Faye, O., Dièye, Y., Reboud, J., Sow, A., Cooper, J. M., & Faye, M. (2026) · BMC Infectious Diseases · doi:10.1186/s12879-026-13081-4 · Cited by 1
“Among the molecular diagnostic assays included in this review, three PCR assays [28, 33, 41] and three LAMP assays [36, 38, 39] meet the point-of-care criteria with satisfactory performances, especially the LAMP assays [55], which are potentially applicable as a bedside diagnostic method, requiring…”
Diagnostic Accuracy of Multiplex NAAT/PCR and Culture Against Salmonella spp.: A Comparison of Meta-Analytical Methods
Rousou, X., Furuya‐Kanamori, L., Meletis, E., Lioupi, O., Σολωμάκος, Ν., Kostoulas, P., & Doi, S. A. R. (2025) · Pathogens · doi:10.3390/pathogens15010045 · Cited by 1
Epidemiological characterization and clinical utility of the multiplex PCR FilmArray™ Gastrointestinal Panel at a tertiary university hospital in Japan, 2024.
Asagai, Y., Yamaguchi, H., Yamamura, T., Kusuki, M., Ohnuma, K., Horinouchi, T., Bo, R., Yamamoto, N., Yano, Y., Nagase, H., et al. (2025) · Pediatrics and Neonatology · doi:10.1016/j.pedneo.2025.11.009 · Cited by 1
Meeting report of the eight annual Tri-Service Microbiome Consortium Symposium
Kardish, M. R., Agans, R., Barbato, R. A., Doherty, S. J., Goodson, M. S., Karl, J. P., Kokoska, R. J., Liechty, Z., McNeal, N. D., Racicot, K., et al. (2025) · BMC Proceedings · doi:10.1186/s12919-025-00355-z · Cited by 1
“A limitation of traditional screening using certified panels is a reliance on the BioFire PCR diagnostic instrument that performs directed PCR for specific disease targets [9].”
Evaluation of the Hologic Panther Fusion investigational use only assays for gastrointestinal bacterial pathogens
Yakubu, R. R., Merwede, J., Viglione, B., Patel, V., & Peaper, D. R. (2025) · Journal of Clinical Microbiology · doi:10.1128/jcm.00730-25 · Cited by 1
Performance evaluation of the Biosynex AMPLIQUICK Fecal Bacteriology PCR kit
Beaufils, Q., Bénéjat, L., Ducournau, A., Aptel, J., Chevalier, A., Jauvain, M., & Lehours, P. (2025) · BMC Microbiology · doi:10.1186/s12866-025-04118-w · Cited by 1
FilmArray® Effectively Detects All Clades of F41 but Encounters Challenges with Other Adenovirus Species.
Ito, S., Takano, C., Hoque, S., Shimizu-Onda, Y., Okitsu, S., Komoto, S., Hayakawa, S., Komine-Aizawa, S., Khamrin, P., Hanaoka, N., et al. (2025) · Journal of Infection and Chemotherapy · doi:10.1016/j.jiac.2025.102626 · Cited by 1
Is the repeat worth it? Optimizing syndromic panel pathogen detection protocols
Cerqueira, F. M., Do, L., Enderle, J. L., & Ren, P. (2024) · Laboratory Medicine · doi:10.1093/labmed/lmae100 · Cited by 1
Detection of Gastrointestinal Pathogens with Zoonotic Potential in Horses Used in Free-Riding Activities during a Countrywide Study in Greece
Tyrnenopoulou, P., Tsilipounidaki, K., Florou, Z., Gkountinoudis, C.-G., Tyropoli, K., Starras, A., Peleki, C., Marneris, D., Arseniou, N., Lianou, D. T., et al. (2024) · Animals · doi:10.3390/ani14172566 · Cited by 1
“In major validation studies, performed in samples of human origin, the overall specificity of the assay was found to be >97% [19,21,22], while the overall reproducibility and negative percent agreement are considered to be >99% [23].”
Background
Molecular testing for gastrointestinal pathogens in intestinal tissue of infants with necrotizing enterocolitis or spontaneous intestinal perforation
Talavera-Barber, M. M., Sánchez, P. J., Conces, M., Kaptsan, I., Everhart, K., Leber, A. L., Malleske, D., Moallem, M., Panesso-Gómez, S., & Shimamura, M. (2024) · Journal of Perinatology · doi:10.1038/s41372-024-01999-z · Cited by 1
Self-citation
Evaluation of Gastrointestinal Pathogens in Children with Inflammatory Bowel Disease Using Multiplex Polymerase Chain Reaction
Appak, Y. Ç., Appak, Ö., Aksoy, B., Emir, B., Sayıner, A. A., & Baran, M. (2024) · Journal of Pediatric Infectious Diseases · doi:10.1055/s-0044-1800919 · Cited by 1
Detection of Viral Agents Causing Gastroenteritis by Multiplex PCR Method in Patients; Norovirus, Rotavirus, Adenovirus, Astrovirus, Sapovirus
Şahin, E., Bostancı, H., Tunçcan, Ö. G., Yavuz, A., Şahin, C., Fidan, I., Çağlar, K., & Bozdayı, G. (2024) · Molecular Genetics Microbiology and Virology · doi:10.3103/s089141682470006x · Cited by 1
“Norovirus has been found the most prevalent viral agent ( n = 70), followed by sapovirus ( n = 59), adenovirus ( n = 55), rotavirus ( n = 18) and astrovirus ( n = 8), respectively [26].”
Prevalence and antimicrobial resistance of bacterial enteropathogens in Crete, Greece, during 2011–2022
Maraki, S., Mavromanolaki, V. E., Stafylaki, D., Iliaki-Giannakoudaki, E., & Kasimati, A. (2024) · Acta Microbiologica et Immunologica Hungarica · doi:10.1556/030.2024.02214 · Cited by 1
Syndromic testing for increasing diagnostic accuracy in gastrointestinal infection
Dharmawan, A., & Pusparini, P. (2023) · The Journal of Infection in Developing Countries · doi:10.3855/jidc.17038 · Cited by 1
“The timely and comprehensive detection of gastrointestinal pathogens is essential for guiding targeted antimicrobial therapy, preventing transmission of infections, and improving clinical results [1,23].”
Background
Evaluación de la diarrea crónica en pacientes con reciente diagnóstico de infección por VIH mediante el panel gastrointestinal FilmArray®
Montalvo-Otivo, R., Vilcapoma, P., Murillo, A., Mathey, C., Olivera, A., Véliz, G., & Estrella, D. (2023) · Revista de Gastroenterología de México · doi:10.1016/j.rgmx.2022.11.002 · Cited by 1
Kryptosporidiose
Reuken, P. (2021) · Zeitschrift für Gastroenterologie - German Journal of Gastroenterology · doi:10.1055/a-1437-6407 · Cited by 1
“Auch in den zunehmend verbreiteten Multiplex-PCR-Assays mit gastrointestinalem Panel sind Kryptosporidien mit enthalten [7].”
Background
No Small Thing: Clinical Implications of Rapid Syndromic Panel-Based Diagnostic Testing in Children
NGUYEN, S., & Same, R. (2021) · Clinical Microbiology Newsletter · doi:10.1016/j.clinmicnews.2021.08.001 · Cited by 1
First case of community acquired giardiasis in Nuuk, Greenland
Thomas, A., Enemark, H., Poulsen, P., & Pedersen, M. L. (2021) · International Journal of Circumpolar Health · doi:10.1080/22423982.2021.1954363 · Cited by 1
“This system has been found to have a sensitivity and specificity of 100 and 99,5, respectively, for Giardia [9].”
Background
The Distribution of Gastrointestinal Pathogens on Stool PCR Prior to the Development of IBD
Varma, S., Green, P., & Krishnareddy, S. (2020) · Journal of Clinical Gastroenterology · doi:10.1097/mcg.0000000000001470 · Cited by 1
“Time to IBD diagnosis, median months (IQR) 6 (2-15) 3 (1.”
Background
Draft genome sequences of concurrent Escherichia coli blood and fecal isolates from a patient with bacteremia and diarrhea belie BioFire-based detection of fecal enteropathogenic E. coli.
Singh, P., Johnston, B., Johnson, J. R., & Donnenberg, M. (2020) · Pathogens and Disease · doi:10.1093/femspd/ftaa058 · Cited by 1
Rapid detection of enteric pathogens in a medical assistance team by real-time multiplex PCR.
Branley, J., Trewin, A., Gray, T., & Polkinghorne, A. (2020) · Pathology (Sydney) · doi:10.1016/j.pathol.2020.06.024 · Cited by 1
Diagnostic tools for bacterial infections in travellers: Current and future options
Baron, S. A., Eldin, C., Gouriet, F., & Dubourg, G. (2020) · Travel Medicine and Infectious Disease · doi:10.1016/j.tmaid.2020.101856 · Cited by 2
Clinical microbiology
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Donut PCR: a rapid, portable, multiplexed, and quantitative DNA detection platform with single-nucleotide specificity
Khodakov, D., Li, J., Zhang, J. X., & Zhang, D. (2020) · bioRxiv · doi:10.1101/2020.04.24.058453 · Cited by 1
Molecular diagnostics in the clinical microbiology laboratory
Obranić, S. (2019) · Molecular and experimental biology in medicine · doi:10.33602/mebm.2.2.1 · Cited by 1
“Buss et al.42 compared the use of a GI multiplex panel that detects 22 different enteric pathogens directly from stool samples with conventional culture testing and other molecular methods.”
Background
Exploring the Less Common Pathogens of Infectious Diarrhea
Toffel, S., Velez, L., Tremblay, E., Shah, K. J., Rand, K., Auerbach, J., Potter, K., & Bea, S. G. (2019) · Journal of Microbiology and Infectious Diseases · doi:10.5799/jmid.537127 · Cited by 1
“This value is lower than the overall positivity rate seen in previous studies [9,39].”
BackgroundMethodResultInfluential
Nonaplex PCR using Cliffhanger primers to identify diarrhoeagenic Escherichia coli from crude lysates of human faecal samples
Schneider, U., Mikkelsen, N. D., Scheutz, F., Friis-møller, A., & Lisby, G. (2018) · PLoS ONE · doi:10.1371/journal.pone.0199766 · Cited by 1

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)
ORCID: Buss, Sarah N.
Leber, Amy
Chapin, Kimberle
Fey, Paul D.
Jones, Matthew K.
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
DOI: 10.1128/jcm.02674-14
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
Licence: journals.asm.org/non-commercial-tdm-license (tdm)
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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Multicenter Evaluation of the BioFire FilmArray Gastrointestinal Panel for Etiologic Diagnosis of Infectious Gastroenteritis

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