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BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panels

1 Test. 11 or 22 Targets. ~1 Hour

BIOFIRE FILMARRAY GI Panels are fast and sensitive molecular stool testing methods for infectious gastrointestinal disease.

BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel tests for 22 targets from one patient sample. Its comprehensive menu includes 13 bacteria, 5 viruses and 4 parasites commonly associated with infectious gastroenteritis.

BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel Mid tests for 11 targets and offers clinicians another GI testing option. Its menu includes 7 bacteria, 1 virus and 3 parasites associated with infectious gastroenteritis.

  

Disclaimer: Product availability varies by country. Please consult your local bioMérieux representative for product availability in your country. 

BIOFIRE GI Panel

Overview

Despite advances in food safety, sanitation, and medical treatment, infectious gastroenteritis remains a significant problem in industrialized countries among all age groups. It is particularly challenging in healthcare environments, due to risk of spreading healthcare-associated infections.

 

  • In the United States, there are an estimated 179 million cases of AGE (Acute Gastroenteritis) each year, including 900 000 hospitalizations and and 2-3 millions of ambulatory visits.1,2
  • In developing countries, diarrheal diseases are estimated to claim 1.4 to 2.5 million lives annually, and are a leading cause of childhood death.3

 

With overlapping symptoms, distinguishing possible causes of gastroenteritis can be challenging for any clinician. The final diagnosis might be delayed, considering that traditional testing methods are slow, labour-intensive, and do not always reveal the aetiology of infectious gastroenteritis.4

 

  

Syndromic Infectious Disease Testing for Gastrointestinal Infections

The BIOFIRE GI Panels test for the most commons gastrointestinal pathogens, including viruses, bacteria, and parasites that cause infectious diarrhea and other gastrointestinal symptoms. They are designed for use on the integrated BIOFIRE® FILMARRAY® TORCH System, an FDA, CE-IVD, and TGA certified multiplex PCR testing instrument. The system seamlessly integrates sample preparation, amplification, detection, and analysis.

Our suite of BIOFIRE® FILMARRAY® Gastrointestinal Panels provides rapid and accurate results that empower clinicians to make timely and informed decisions which may improve patient outcomes and streamline laboratory workflows.

With fast and accurate diagnosis of important pathogens, the BIOFIRE GI Panel provides clinicians with the information necessary to make the most appropriate treatment decisions for improved patient outcomes and decreased healthcare costs.5

The BIOFIRE GI Panel Mid brings clinicians an additional option in diagnosing infectious gastroenteritis.

BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel

  • Simple: 2 minutes hands-on time
  • Fast: Turnaround time of about an hour
  • Comprehensive: Simultaneously tests for 22 targets
  • Accurate: 98.7% sensitivity and 99.2% specificity6

BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel Mid

  • Simple: 2 minutes hands-on time
  • Fast: Turnaround time of about an hour
  • Comprehensive: Simultaneously tests for 11 targets
  • Accurate: 98.5% sensitivity and 99.2% specificity6
References

1. Grytdal, Scott P et al. “Incidence of Norovirus and Other Viral Pathogens That Cause Acute Gastroenteritis (AGE) among Kaiser Permanente Member Populations in the United States, 2012-2013.” PloS one vol. 11,4 e0148395. 26 Apr. 2016, doi:10.1371/journal.pone.0148395

2. Schmidt, Mark A et al. “Incidence, Etiology, and Healthcare Utilization for Acute Gastroenteritis in the Community, United States.” Emerging infectious diseases vol. 28,11 (2022): 2234-2242. doi:10.3201/eid2811.220247

3. "Diarrhoeal Disease". World Health Organization Fact sheets, http://www.who.int/news-room/fact-sheets/detail/diarrhoeal-disease (Accessed 13 February 2025)

4. Riddle, Mark S et al. “ACG Clinical Guideline: Diagnosis, Treatment, and Prevention of Acute Diarrheal Infections in Adults.” The American journal of gastroenterology vol. 111,5 (2016): 602-22. doi:10.1038/ajg.2016.126

5. Moon, Rena C et al. “Relationship between Diagnostic Method and Pathogen Detection, Healthcare Resource Use, and Cost in U.S. Adult Outpatients Treated for Acute Infectious Gastroenteritis.” Journal of clinical microbiology vol. 61,2 (2023): e0162822. doi:10.1128/jcm.01628-22

6. Data on file, BioFire Diagnostics. The stated performance is the overall aggregate performance of the prospective clinical study data presented in the IFU

 

Panel Menu

BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel Menu

1 Test. 22 Targets. ~1 Hour.

Bacteria

  • Campylobacter (C. jejuni/C. coli/C. upsaliensis)
  • Clostridioides (Clostridium) difficile (toxin A/B)*
  • Plesiomonas shigelloides
  • Salmonella
  • Vibrio (V. parahaemolyticus/V. vulnificus/V. cholerae)
    • Vibrio cholerae
  • Yersinia enterocolitica
  • Diarrheagenic Escherichia coli/Shigella
    • Enteroaggregative E. coli (EAEC)
    • Enteropathogenic E. coli (EPEC)
    • Enterotoxigenic E. coli (ETEC) lt/st
    • Shiga-like toxin-producing E. coli (STEC) stx1/stx2
      • E. coli O157
    • Shigella/Enteroinvasive E. coli (EIEC)

Viruses

  • Adenovirus F40/41
  • Astrovirus
  • Norovirus GI/GII
  • Rotavirus A
  • Sapovirus (I, II, IV, and V) 

Parasites

  • Cryptosporidium
  • Cyclospora cayetanensis
  • Entamoeba histolytica
  • Giardia lamblia

*Selective reporting available for C.diff

FDA Cleared

BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel Mid

1 Test. 11 Targets. ~1 Hour.

Bacteria

  • Campylobacter (C. jejuni/C. coli/C. upsaliensis)
  • Clostridioides (Clostridium) difficile (toxin A/B)*
  • Salmonella
  • Vibrio (V. parahaemolyticus/V. vulnificus/V. cholerae)
  • Yersinia enterocolitica
  • Shiga-like toxin-producing E. coli (STEC) stx1/stx2
  • Shigella/Enteroinvasive E. coli (EIEC)

Viruses

  • Norovirus GI/GII

Parasites

  • Cryptosporidium 
  • Cyclospora cayetanensis 
  • Giardia lamblia

*Selective reporting available for C.diff

FDA Cleared

Product availability varies by country, please consult your bioMérieux representative

Services & Support

Customer Support: bioMérieux offers the best possible support with dedicated BIOFIRE® technical experts.

Application Specialists: bioMérieux offers dedicated support teams who are available to help set up equipment and troubleshoot any issues.

For assistance: please contact our customer technical support team at biofiresupport@biomerieux.com

Specs & Resources

Technical Panel Specifications

Sample HandlingPerformance Parameters
Sample Type: Stool in Cary Blair Transport Media Hands-on Time: Approx. 2 Minutes
Sample Volume: 0.2 mLRun Time: ~ 1 Hour
Product NamePart NumberQuantity
BIOFIRE® FILMARRAY® GI Panel Reagent KitRFIT-ASY-0116 
30 Pouches
RFIT-ASY-0104 6 Pouches
Product NamePart NumberQuantity
BIOFIRE® FILMARRAY® GI Panel Mid Reagent Kit424898
30 Pouches
4250896 Pouches

Resources

BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel Information Sheet

Download

Clinical Impact of the BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel

Download

BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel Mid Information Sheet

Download

BIOFIRE® All Panels Information Sheet

Download

BIOFIRE® All Panels Information Sheet - plus version

Download

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