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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Amjad, M. (2020) · International Journal of Microbiology · doi:10.1155/2020/8135724 · Cited by 70
“For the remaining 3 targets, sensitivity could not be calculated due to the low prevalence of the pathogens in the study [30].”
Background
Comparison of three multiplex gastrointestinal platforms for the detection of gastroenteritis viruses
Chhabra, P., Gregoricus, N., Weinberg, G. A., Halasa, N., Chappell, J., Hassan, F., Selvarangan, R., Mijatovic-Rustempasic, S., Ward, M., Bowen, M., et al. (2017) · Journal of Clinical Virology · doi:10.1016/j.jcv.2017.08.012 · Cited by 55
“High rates of false positivity for norovirus detection using this platform was recently reported by others [2].”
BackgroundResultInfluential
Evaluation of the BioFire FilmArray® GastrointestinalPanel in a Midwestern Academic Hospital
Murphy, C., Fowler, R., Iwen, P., & Fey, P. (2017) · European Journal of Clinical Microbiology and Infectious Diseases · doi:10.1007/s10096-016-2858-7 · Cited by 54
“Many studies have been performed that demonstrate the improved sensitivity of syndromic panels in the detection of GI pathogens compared with traditional stool methods [2, 12, 23].”
BackgroundSelf-citation
Multicenter Evaluation of BD Max Enteric Parasite Real-Time PCR Assay for Detection of Giardia duodenalis, Cryptosporidium hominis, Cryptosporidium parvum, and Entamoeba histolytica
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Comparative Evaluation of Enteric Bacterial Culture and a Molecular Multiplex Syndromic Panel in Children with Acute Gastroenteritis
Kellner, T., Parsons, B., Chui, L., Berenger, B., Xie, J.-L., Burnham, C., Tarr, P., Lee, B. E., Nettel-Aguirre, A., Szelewicki, J., et al. (2019) · Journal of Clinical Microbiology · doi:10.1128/jcm.00205-19 · Cited by 52
“In contrast, nucleic acid amplification techniques (NAAT) can detect multiple pathogens within hours (4).”
Background
Low Yield of FilmArray GI Panel in Hospitalized Patients with Diarrhea: an Opportunity for Diagnostic Stewardship Intervention
Hitchcock, M., Gomez, C. A., & Banaei, N. (2017) · Journal of Clinical Microbiology · doi:10.1128/jcm.01558-17 · Cited by 50
“7) Norovirus (3) Rotavirus (1) Preceding positive ( 72 h and 72 h) 9 (9.”
BackgroundInfluential
A review on urinary tract infections diagnostic methods: Laboratory-based and point-of-care approaches
Santos, M., Mariz, M., Tiago, I., Martins, J., Alarico, S., & Ferreira, P. C. N. (2022) · Journal of Pharmaceutical and Biomedical Analysis · doi:10.1016/j.jpba.2022.114889 · Cited by 44
“FilmArray, developed by bioMérieux, is an integrated PCR platform that identifies the pathogen and its antibiotic susceptibility in 1 h, using a whole-sample, and is feasible to adapt to UTIs detection [38,39].”
Method
Diagnosis of Febrile Illnesses Other Than Ebola Virus Disease at an Ebola Treatment Unit in Sierra Leone: Table 1.
O’Shea, M. K., Clay, K. A., Craig, D. G. N., Matthews, S., Kao, R. L. C., Fletcher, T. E., Bailey, M. S., & Hutley, E. J. (2015) · Clinical Infectious Diseases · doi:10.1093/cid/civ399 · Cited by 45
“The BioFire FilmArray is perhaps the easiest to use with minimal hands-on processing, rapid generation of results and the inclusion of an extensive and diverse spectrum of pathogenic targets [10] . High sensitivities and specificities have been reported; however, the FilmArray assay has low-throughput as only one test…”
Background
Multicenter evaluation of the new QIAstat Gastrointestinal Panel for the rapid syndromic testing of acute gastroenteritis
Hannet, I., Engsbro, A. L., Pareja, J., Schneider, U. V., Lisby, J. G., Pružinec-Popović, B., Hoerauf, A. M., & Parčina, M. (2019) · European Journal of Clinical Microbiology & Infectious Diseases · doi:10.1007/s10096-019-03646-4 · Cited by 60
Propagation of Astrovirus VA1, a Neurotropic Human Astrovirus, in Cell Culture
Janowski, A. B., Bauer, I. K., Holtz, L. R., & Wang, D. (2017) · Journal of Virology · doi:10.1128/jvi.00740-17 · Cited by 45
Accuracy and comparison of two rapid multiplex PCR tests for gastroenteritis pathogens: a systematic review and meta-analysis
Chang, L., Hsiao, C.-J., Chen, B., Liu, T.-Y., Ding, J. H., Hsu, W., Su-Ortiz, V. A., Chen, S., Su, K., Wu, H., et al. (2021) · BMJ Open Gastroenterology · doi:10.1136/bmjgast-2020-000553 · Cited by 52
HIV and diarrhoea: what is new?
Logan, C., Beadsworth, M., & Beeching, N. J. (2016) · Current Opinion in Infectious Diseases · doi:10.1097/qco.0000000000000305 · Cited by 57
Gastrointestinal Infections
Alby, K., & Nachamkin, I. (2016) · Microbiology Spectrum · doi:10.1128/microbiolspec.dmih2-0005-2015 · Cited by 15
“Clinical studies with the FilmArray panel have shown positivity rates in excess of 50% (94).”
Background
Comparative Evaluation of Seegene Allplex Gastrointestinal, Luminex xTAG Gastrointestinal Pathogen Panel, and BD MAX Enteric Assays for Detection of Gastrointestinal Pathogens in Clinical Stool Specimens
Yoo, J., Park, J., Lee, H. K., Yu, J. K., Lee, D., Park, K. G., Oak, H. C., & Park, Y.-J. (2019) · Archives of Pathology & Laboratory Medicine · doi:10.5858/arpa.2018-0002-oa · Cited by 49
Astrovirus Diagnostics
Pérot, P., Lecuit, M., & Eloit, M. (2017) · Viruses · doi:10.3390/v9010010 · Cited by 43
“9%, respectively, for the detection of MAstV 1 (but not MAstV 6 and 9), and a turnaround time of around one hour [108].”
Background
Advances in Diagnostic Approaches for Viral Etiologies of Diarrhea: From the Lab to the Field
Malik, Y. S., Verma, A., Kumar, N., Touil, N., Karthik, K., Tiwari, R., Bora, D. P., Dhama, K., Ghosh, S., Hemida, M. G., et al. (2019) · Frontiers in Microbiology · doi:10.3389/fmicb.2019.01957 · Cited by 48
Molecular characteristics
Zhang, L.-X., Wang, R.-J., Zhao, G., & Li, J.-Q. (2021) · Cyclospora and Cyclosporiasis · doi:10.1016/b978-0-12-821616-3.00008-4 · Cited by 41
Enteric Infection in Relapse of Inflammatory Bowel Disease: The Utility of Stool Microbial PCR Testing
Axelrad, J., Joelson, A., Nobel, Y., Lawlor, G., Green, P., Lichtiger, S., & Lebwohl, B. (2017) · Inflammatory Bowel Diseases · doi:10.1097/mib.0000000000001097 · Cited by 40
Diagnosis of Clostridium difficile Infections in Children
Antonara, S., & Leber, A. L. (2016) · Journal of Clinical Microbiology · doi:10.1128/jcm.03014-15 · Cited by 49
“(2015) (49) tcdA and tcdB PCR 1556 (<1 - >65 yrs) (62%) 98.”
BackgroundSelf-citation
Prevalence, phylogeny, and antimicrobial resistance of Escherichia coli pathotypes isolated from children less than 5 years old with community acquired- diarrhea in Upper Egypt
Khairy, R. M. M., Fathy, Z. A., Mahrous, D. M., Mohamed, E. S., & Abdelrahim, S. S. (2020) · BMC Infectious Diseases · doi:10.1186/s12879-020-05664-6 · Cited by 50
“In the last decade, aEPEC has become more frequent in high-income and also in developing countries [36, 37].”
Background
The other Campylobacters: Not innocent bystanders in endemic diarrhea and dysentery in children in low-income settings
François, R., Yori, P., Rouhani, S., Salas, M. S., Olórtegui, M. P., Trigoso, D. R., Pisanic, N., Burga, R., Meza, R., Sánchez, G. M., et al. (2018) · PLoS Neglected Tropical Diseases · doi:10.1371/journal.pntd.0006200 · Cited by 39
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.”
Result
High Burden of Co-Infection with Multiple Enteric Pathogens in Children Suffering with Diarrhoea from Rural and Peri-Urban Communities in South Africa
Potgieter, N., Heine, L., Kabue, J. P., Ledwaba, S. E., Zitha, T., Mudau, L. S., Becker, P., Traoré, A. N., & Barnard, T. G. (2023) · Pathogens · doi:10.3390/pathogens12020315 · Cited by 46
“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…”
Result
The 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
Multicenter Evaluation of the Xpert Norovirus Assay for Detection of Norovirus Genogroups I and II in Fecal Specimens
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.”
Method
Use 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
Review of the role of gastrointestinal multiplex polymerase chain reaction in the management of diarrheal illness
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
Interplay between Rapid Diagnostic Tests and Antimicrobial Stewardship Programs among Patients with Bloodstream and Other Severe Infections
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
“1%, GI panels can be instrumental in deescalation efforts for ASPs (73).”
Background
Distinctive Gut Microbiota Is Associated with Diarrheagenic Escherichia coli Infections in Chilean Children
Gallardo, 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 40
“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).”
Background
Agreement between gastrointestinal panel testing and standard microbiology methods for detecting pathogens in suspected infectious gastroenteritis: Test evaluation and meta-analysis in the absence of a reference standard
Freeman, 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 38
Missed diagnosis and misdiagnosis of infectious diseases in hematopoietic cell transplant recipients: an autopsy study
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
“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…”
Background
Comparative performance evaluation of four commercial multiplex real-time PCR assays for the detection of the diarrhoea-causing protozoa Cryptosporidium hominis/parvum, Giardia duodenalis and Entamoeba histolytica
Paulos, 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
Contribution of the FilmArray® Gastrointestinal Panel in the laboratory diagnosis of gastroenteritis in a cohort of children: a two-year prospective study.
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
Beyond the Gastrointestinal Tract: The Emerging and Diverse Tissue Tropisms of Astroviruses
Janowski, A. B. (2021) · Viruses · doi:10.3390/v13050732 · Cited by 35
Gut microbiota profiles and fecal beta‐glucuronidase activity in kidney transplant recipients with and without post‐transplant diarrhea
Zhang, L. T., Westblade, L. F., Iqbal, F., Taylor, M. R., Chung, A. P., Satlin, M. J., Magruder, M. L., Edusei, E., Albakry, S., Botticelli, B., et al. (2021) · Clinical Transplantation · doi:10.1111/ctr.14260 · Cited by 35
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
Comparison of the BD MAX® Enteric Bacterial Panel assay with conventional diagnostic procedures in diarrheal stool samples
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
Enteropathogenic and enteroaggregative E. coli in stools of children with acute gastroenteritis in Davidson County, Tennessee
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
“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).”
Evaluation of a multiplex gastrointestinal PCR panel for the aetiological diagnosis of infectious diarrhoea
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.”
BackgroundResult
Is 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
“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).”
Background
The role of multiplex molecular panels for the diagnosis of gastrointestinal infections in immunocompromised patients
Liesman, R. M., & Binnicker, M. J. (2016) · Current Opinion in Infectious Diseases · doi:10.1097/qco.0000000000000276 · Cited by 34
Prevalence of Clostridioides difficile and Other Gastrointestinal Pathogens in Patients with COVID-19
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
Bridging Systemic Immunity with Gastrointestinal Immune Responses via Oil‐in‐Polymer Capsules
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Clinical features and molecular epidemiology of diarrheagenic Escherichia coli pathotypes identified by fecal gastrointestinal multiplex nucleic acid amplification in patients with cancer and diarrhea
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“…(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).”
Background
Relationship between Diagnostic Method and Pathogen Detection, Healthcare Resource Use, and Cost in U.S. Adult Outpatients Treated for Acute Infectious Gastroenteritis
Moon, 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
“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)
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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