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BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel

The FDA-cleared BIOFIRE GI Panel tests for 22 of the most common pathogens associated with gastroenteritis—all from one patient sample and one easy to use reagent, with results available in about one hour.

Product Overview

22 Targets. 1 Test. ~1 Hour.

With overlapping symptoms, distinguishing possible causes of gastroenteritis can be challenging for any clinician. To further complicate diagnosis, traditional testing methods are slow, labor intensive, and fail to reveal the etiology of a patient’s gastrointestinal symptoms.1 Fortunately, syndromic testing from the BIOFIRE GI Panel eliminates limitations from conventional methods by providing faster, more accurate, and comprehensive results.

See "Technical Details" tab for full product menu.

 

A New Option for C. difficile Reporting

A new pouch module option called C. difficile Select* gives users running the BIOFIRE GI Panel on either the BIOFIRE® FILMARRAY® TORCH or the BIOFIRE® FILMARRAY® 2.0 System the choice to either always report or never report C. difficile results.

*C. difficile Select is available only to customers in the US.

REQUEST NEW MODULE HERE
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Clinical Benefits

Because traditional stool testing methods are slow and lack sensitivity, clinicians often have to make patient management decisions without a laboratory result. Syndromic testing from the BIOFIRE GI Panel offers fast sample-to-answer turnaround and accurate results, which can:

  • Reduce antibiotic use2
  • Reduce time to antimicrobial therapy3
  • Lead to more targeted therapy3
  • Reduce downstream procedures such as endoscopies and abdominal imaging2
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Workflow Benefits

The BIOFIRE GI Panel can streamline workflow by providing faster and more comprehensive test results. Compared to traditional diagnostic methods, syndromic testing from the BIOFIRE GI Panel can:

  • Increase diagnostic yield by an average of 31.5%.7
  • Reduce the number of laboratory tests on average from 3 to 14
  • Potentially reduce the number of send-out tests
  • Reduce the average time to result by 84%4

 

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Who Should Be Tested?

Guidelines from American College of Gastroenterology and Infectious Disease Society of America:

  • Individuals at high risk of spreading disease to others and during known or suspected outbreaks.1
  • Individuals presenting with:1,6
  • Dysentery
  • Diarrhea with fever, severe abdominal cramps, or signs of sepsis
  • Moderate to severe disease
  • Symptoms lasting more than seven days
  • Immunocompromised patients with diarrhea
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Don’t Guess. Know.

We take a molecular approach to in vitro diagnostic testing. The BIOFIRE GI Panel uses multiplex PCR technology to quickly and accurately identify infectious agents that produce similar symptoms in patients. It’s more sensitive than culture and more efficient than individual and send-out tests.

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Technical Details

  • Overall 98.5% Sensitivity and 99.2% Specificity8
  • Sample Type: Stool in Cary Blair medium

Panel Menu:

BACTERIA:

  • Campylobacter (C. jejuni / C. coli / C. upsaliensis)
  • Clostridioides (Clostridium) difficile (toxin A/B)
  • Plesiomonas shigelloides
  • Salmonella
  • Yersinia enterocolitica
  • Vibrio (V. parahaemolyticus / V. vulnificus / V. cholerae)
    • Vibrio cholerae
  • 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

 

Service & Support

With the urgent nature of patient and community care, we take pride in addressing all concerns quickly and accurately. bioMérieux is dedicated to providing world class customer support 24 hours a day, 7 days a week, 365 days a year.

For assistance please contact our customer technical support team at:

To order, contact your regional sales representative or use the following contact information:

Product availability varies by country. Consult your bioMérieux representative.

 

References:

  1. Riddle MS, DuPont HL, Connor BA. 2016. ACG Clinical Guideline: Diagnosis, Treatment, and Prevention of Acute Diarrheal Infections in Adults. Am J Gastroenterol. 111:602–622.
  2. Axelrad JE, Freedberg DE, Whittier S, Greendyke W, Lebwohl B, Green DA. Impact of Gastrointestinal Panel Implementation on Healthcare Utilization and Outcomes. J of Clin. Microbiology. 2019; 27;57(3). e01775-18.
  3. Cybulski R, Bateman A, Bourassa L, Bryan A, Beail B, Matsumoto J, Cookson B, Fang FC; Clinical impact of a Multiplex Gastrointestinal PCR Panel in Patients with Acute Gastroenteritis. 2018. Clinical Infectious Diseases, ciy357, https://doi.org/10.1093/cid/ciy357.
  4. Beal S., Tremblay E., Toffel S., Velez L., Rand K. A gastronintestinal PCR panel improves clinical management and lowers healthcare costs. J. Clin. Microbiol. January 2018 56:1 e01457-17.
  5. Beard K, et al. The impact of routine molecular point-of-care testing for gastrointestinal pathogens in adults hospitalised with suspected gastroenteritis: interim results of a pragmatic randomised controlled trial (GastroPOC). ECCMID 2019.
  6. Shane A, Rajal M, Crump J, Tarr P, Steiner T, Kotloff K, Langley J, Wanke C, Warren C, Cheng A, Cantey J, Pickering L. 2017. Infectious Diseases Society of America clinical practice guidelines for the diagnosis and management of infectious diarrhea. Clin Infect Dis. 65(12):e45–e80.
  7. Meyer J, et al. Scand J Gastroenterol. 2020, 55(12):1405-1410.
  8. Stated sensitivity and specificity is the aggregate performance from the prospective clinical study data presented in the BioFire Gastrointestinal Panel Instruction Booklet.