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FilmArray^® GI Panel

Gastrointestinal (GI) panel for use on FilmArray®

The 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 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 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 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

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

22 target pathogens at once

FilmArray^® GI Panel targets:

Bacteria	Diarrheagenic E. coli/Shigella
Campylobacter (jejuni, coli & upsaliensis) Clostridium difficile (Toxin A/B) Plesiomonas shigelloides Salmonella Yersinia enterocolitica Vibrio (parahaemolyticus, vulnificus, & cholerae) Vibrio cholerae	E. coli O157 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 F 40/41 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 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