Test Overview
Test Methodology

FilmArray multiplex Polymerase Chain Reaction (PCR)

Test Usage

The Gastrointestinal Panel (GIPAN) is a multiplexed nucleic acid test intended for qualitative detection of multiple gastrointestinal bacteria, viruses and parasites. This test is intended for use in patients with diarrhea that began prior to or within three days of hospitalization and there is concern for other etiologies aside from C. difficile. The GIPAN should not be used as the primary test for the detection of C. difficile infection. If indicated, order PCRCD test code.

Reference Range *

Negative

Test Limitations

Specimens that are positive for the C. difficile toxin A/B gene by FilmArray Gastrointestinal Panel are immediately reflexed to a C. difficile Toxin A/B EIA assay to assess the specimen for the presence of detectable levels of Toxin A or B. Consult pediatric ID for assistance on interpretation of positive results for C. difficile in children <1 year of age.
This test does not detect Aeromonas spp. Call laboratory if culture for this organism is indicated.
The performance of the FilmArray™ GI Panel has not been established in individuals who received Rotavirus A vaccine. Recent oral administration of a Rotavirus A vaccine may cause positive results for Rotavirus A if the virus is passed in the stool.
The E. coli O157 result is only reported in association with STEC stx1/stx2.
Target genes associated with the diarrheagenic E. coli/Shigella pathotypes are capable of horizontal transfer between strains, thus detected results for multiple diarrheagenic E.coli/Shigella may be due to co-infection with multiple pathotypes or, less frequently, may be due to the presence of a single organism containing genes characteristic of multiple pathotypes. An example of the latter is the 2011 E. coli O104:H4 outbreak strain that contains determinants of both STEC and EAEC.
The FilmArray™ GI Panel detects Enteropathogenic E. coli (EPEC) through targeting of the eae gene, and some Shiga-like toxin-producing E. coli (STEC) also carry eae. The FilmArray™ GI Panel cannot distinguish between STEC containing eae and a co-infection of EPEC and STEC. Therefore, the EPEC result is not applicable (N/A) and not reported for specimens in which STEC has also been detected. Rare instances of other organisms carrying eae have been documented; e.g., Aeromonas spp., Citrobacter spp., Escherichia albertii, and Shigella boydii.
Shigella dysenteriae possess a shiga toxin gene (stx) that is identical to the stx1 gene of STEC. The detection of both Shigella/Enteroinvasive E. coli (EIEC) and STEC stx1/stx2 analytes in the same specimen may indicate the presence of S. dysenteriae.

Test Details
Days Set Up
Daily
Analytic Time

1 day

Soft Order Code
GIPAN
MiChart Code
Gastrointestinal Panel, PCR
Synonyms
  • GI Pathogen Panel
  • Vibrio
  • Yersinia enterocolitica
  • Enteroaggregative E.coli (EAEC)
  • Enteropathogenic E.coli (EPEC)
  • Enterotoxigenic E.coli (ETEC)
  • Shiga-like toxin-producing E.coli (STEC)
  • Shigella/Enteroinvasive E.coli (EIEC)
  • Cryptosporidium
  • Cyclospora cayetanensis
  • Vibrio cholera
  • Salmonella
  • Rotavirus A and Sapovirus
  • Norovirus GI/GII
  • Astrovirus
  • Adenovirus F40/41
  • Giardia lamblia
  • Campylobacter
  • Clostridium difficile toxin A/B
  • Plesiomonas shigelloides
  • Entamoeba histolytica
Laboratory
Microbiology
Section
Microbiology
Specimen Requirements
Collection Instructions

Collect fresh random stool specimen. Add stool specimen to transport vial until liquid reaches fill line. Emulsify specimen thoroughly in transport fluid. If necessary, place a urine bag on the patient to prevent urine contamination. Acceptable specimens are stool sent in Stool Culture transport (orange cap - Cary Blair) stored at room temperatture or refrigerated up to 4 days. If an unacceptable specimen is received, the client will be notified before disposal of the original specimen. See MLabs Stool Specimen Collection Instructions available online at http://mlabs.umich.edu/files/pdfs/GL-Stool_Collection_Guidelines.pdf for patient instructions.

Rejection Criteria
Specimens not received in Cary-Blair transport
Minimum Volume
5 grams of stool
Storage Temperature
Specimens should be processed and tested as soon as possible. Specimen may be stored at room temperature (18-30 C) or refrigerated (2-8 C) for up to four days.
Additional Information

Panel includes: Campylobacter, Clostridium difficile toxin A/B, Plesiomonas shigelloides, Salmonella, Vibrio, Vibrio cholera, Yersinia enterocolitica, Enteroaggregative E.coli (EAEC), Enteropathogenic E.coli (EPEC), Enterotoxigenic E.coli (ETEC), Shiga-like toxin-producing E.coli (STEC), Shigella/Enteroinvasive E.coli (EIEC), Cryptosporidium, Cyclospora cayetanensis, Entamoeba histolytica, Giardia lamblia, Adenovirus F40/41, Astrovirus, Norovirus GI/GII, Rotavirus A and Sapovirus.
For guidance on use of the GI panel, please copy and paste the following link into a new browser window:
http://tinyurl.com/j4ua3pw

Billing
CPT Code
0097U
Fee Code
LA023
LOINC
82195-9
NY State Approved
No