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BIOFIRE® FILMARRAY® GI Panel

BIOFIRE® FILMARRAY® Gastrointestinal Panel

The BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel enables rapid and accurate automated testing for common gastrointestinal pathogens including viruses, bacteria and parasites that cause infectious diarrhea.

  • Simple: 2 minutes of hands-on time
  • Easy: No precise measuring or pipetting required
  • Fast: Turnaround time of about an hour
  • Comprehensive: Simultaneously tests for 22 targets 
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Simple, comprehensive Gastrointestinal Infection testing

The BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel tests for most common gastrointestinal pathogens including viruses, bacteria and parasites that cause infectious diarrhea and other gastrointestinal symptoms. It is designed for use with the integrated BIOFIRE® FILMARRAY® system, an FDA, CE-IVD, and TGA certified multiplex PCR system.  The system integrates sample preparation, amplification, detection and analysis into one simple system that requires just 2 minutes of hands-on time, with a total run time of about an hour.

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, around 73 million cases of foodborne disease – resulting in 1.8 million hospitalizations and 3,100 deaths – are estimated to occur each year1. In developing countries, diarrheal diseases are estimated to claim 1.4 to 2.5 million lives annually and are a leading cause of childhood death2.

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

  • Simple: 2 minutes of hands-on time
  • Easy: No precise measuring or pipetting required
  • Fast: Turnaround time of about an hour
  • Comprehensive: Simultaneously tests for 22 targets

BIOFIRE® FILMARRAY® GI is one of six FDA-cleared and CE-marked panels for use on the BIOFIRE® FILMARRAY®  multiplex PCR system. Taken together, the six BIOFIRE® FILMARRAY® panels comprise the largest infectious disease pathogen menu commercially available. The other available panels are:

22 target pathogens at once

BIOFIRE® FILMARRAY® GI Panel targets:

Bacteria Diarrheagenic E. coli/Shigella
  • 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
 
  • 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 Parasites
  • Adenovirus F40/41
  • Astrovirus
  • Norovirus GI/GII
  • Rotavirus A
  • Sapovirus (I, II, IV, and V)
  • Cryptosporidium
  • Cyclospora cayetanensis
  • Entamoeba histolytica
  • Giardia lamblia
 

 

 

References:

1) Guerrant RL et al. Clin Infect Dis. 2001;32:331-351.

2) World Gastroenterology Organisation practice guideline: Acute diarrhea. 2008.

Panel Specification

Sample Handling Performance Parameters
Sample Type: Stool in Cary-Blair Hands-on time: Approx. 2 minutes
Sample Volume: 200 μL Run turnaround time: About an hour

 

Clinical sensitivity and specificity of the BIOFIRE® FILMARRAY® Gastrointestinal Panel

Analyte Clinical Data
  Sensitivity/PPA

(Range, %)a		 Specificity/NPA

(Range, %)a
Bacteria 97.1–100 97.1–100
Diarrheagenic E. coli/Shigella 95.9–100 97.1–100
Parasites 100 99.5–100
Viruses 94.5–100 99.1–99.9

 

Publications

Spectrum of Enteropathogens detected by the FILMARRAY® GI Pane in a Multicentre Study of Community-acquired Gastroenteritis.

Spina A., Kerr KG., Cormican M., Barbut F., Eigentler A., Zerva L., Tassios P., Popescu GA., Rafila A., Eerola E., Batista J., Maass M., Aschbacher R., Olsen KEP., Allerberger K.

CLINICAL MICROBIOLOGY AND INFECTION 2015;21(8):719-28

Multiplex Gastrointestinal Pathogen Panels: Implications for Infection Control.

Rand K.H., Tremblay E.E., Hoidal M., Fisher L.B., Grau K.R., Karst S.M.

DIAGNOSTIC MICROBIOLOGY AND INFECTIOUS DISEASE 2015;82(2):154-7

How Well Does Physician Selection of Microbiologic Tests Identify Clostridium difficile and other Pathogens in Paediatric Diarrhoea? Insights Using Multiplex PCR-Based Detection.

Stockmann C., Rogatcheva M., Harrel B., Vaughn M., Crisp R., Poritz M., Thatcher S., Korgenski EK., Barney T., Daly J., Pavia A.T.

CLINICAL MICROBIOLOGY AND INFECTIOUS DISEASES 2015;21(2):179

Multicenter Evaluation of the BioFireFILMARRAY® Gastrointestinal Panel for the Etiologic Diagnosis of Infectious Gastroenteritis.

Buss S.N., Leber A., Chapin K., Fey P.D., Bankowski M.J., Jones M.K., Rogatcheva M., Kanack K.J., Bourzac K.M.

JOURNAL OF CLINICAL MICROBIOLOGY 2015;53(3):915-25

Multiplex Detection of Gastrointestinal Pathogens: A Comparative Evaluation of Two Commercial Panels Using Clinical Specimens.

Khare R., Espy M.J., Cebelinski E., Boxrud D., Sloan L.M., Cunningham S.A., Pritt B.S., Patel R., Binnicker M.J.

JOURNAL OF CLINICAL MICROBIOLOGY 2014;52(10):3667-73

 

Technical Notes:

Instructions for Use and Manuals:

Product Support Documents:

EC Declarations of conformity:

 

Please consult your local bioMérieux representative for product availability in your country

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