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Test Code LAB9501A Gastrointestinal Pathogen Panel, PCR, Full, (Inpatient, Acute Illness/Immunocompromised)

Intended Use

The Film Array GI Panel is a multiplexed nucleic acid test capable of simultaneous qualitative detection and identification of nucleic acids from multiple bacteria, viruses, and parasites directly from stool samples obtained from individuals with sign and/or symptoms of gastrointestinal infection.

Results are meant to be used in conjunction with other clinical, laboratory, and epidemiological data. Positive results do not rule out co-infection with organisms not included in the
Film Array GI Panel.  The agent detected may not be the definite cause of the disease.

 

Reflex testing: Stools positive for Clostridium difficile with reflex to C. difficile Toxin A/B EIA test to help distinguish between active infection and colonization. Stool Culture is performed if Salmonella or Shigella is detected.

 

Methodology

Multiplex Polymerase Chain reaction (PCR)

 

 

Bacteria Diarrheagenic E. coli/Shigella
Campylobacter (C. jejuni/C. coli/C. upsaliensis) Enteroaggregative E. coli
Clostridium difficile (Toxin A/B) Enteropathogenic E. coli
Plesiomonas shigelloides Enterotoxigenic E. coli lt/st
Salmonella Shiga-like toxin-producing E. coli stx1/stx2
Vibrio cholerae E. coli O157
Vibrio (V. parahaemolyticus/V, vulnificus/V. cholerae) Shigella/Enteroinvasive E. coli
Yersinia enterocolitica  
Viruses Parasites
Adenovirus F 40/41 Cryptosporidium
Astrovirus  
Norovirus GI/GII Entamoeba histolytica

Sapovirus (Genogroups I, II, IV and V)

Giardia lamblia
Rotavirus  

 

Performing Laboratory

RCH-SPH

Specimen Requirements

Specimen Requirements:

Specimen Type: Both raw stool and stool in Cary Blair transport medium (FecalSwab or C&S Medium) should be submitted. 

Container:  Stool specimen container and FecalSwab or C&S Medium

Transport temperature: Refrigerated (2-8°C) up to 4 days.

Collection Instructions:  link to FecalSwab collection instructions

1. Collect fresh stool and place in a clean preservative-free container.

2. Following the manufacture's instructions, place a portion of stool in Cary-Blair transport     medium.  Stool must be placed in transportr medium within 2 hours of collection.

 

Submit both raw stool in a clean container and Cary-Blair transport media.

 

Specimen Stability

Must be refrigerated: 2-8°C for up to 4 days

Day(s) Test Set Up

Monday through Sunday 24 hours a day

 

Test Classification and CPT Coding

87507-GI Pathogen Panel

87324-C. difficile Toxin A/B EIA

87045, 87186-Stool culture and susceptibility for Salmonella or Shigella

 

** ABN/Procedure Not Covered, may be applicable**