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Test ID: GIP Gastrointestinal Pathogen Panel, PCR, Feces

Useful For

Rapid detection of gastrointestinal infections caused by:

-Campylobacter species (Campylobacter jejuni/Campylobacter coli/Campylobacter upsaliensis)

-Clostridioides difficile toxin A/B

-Plesiomonas shigelloides

-Salmonella species

-Vibrio species (Vibrio parahaemolyticus, Vibrio vulnificus, Vibrio cholerae)

-Vibrio cholerae-Yersinia species

-Enteroaggregative Escherichia coli (EAEC)

-Enteropathogenic E coli (EPEC)

-Enterotoxigenic E coli (ETEC)

-Shiga toxin

-E coli O157

-Shigella/Enteroinvasive E coli (EIEC)

-Cryptosporidium species

-Cyclospora cayetanensis

-Entamoeba histolytica

-Giardia

-Adenovirus F 40/41

-Astrovirus

-Norovirus GI/GII

-Rotavirus A

-Sapovirus

 

This test is not recommended as a test of cure.

Method Name

Multiplex Polymerase Chain Reaction (PCR)

Reporting Name

GI Pathogen Panel, PCR, F

Specimen Type

Fecal


Advisory Information


It is not recommended that the following tests be concomitantly ordered if this test is ordered:

-VIBC / Vibrio Culture, Feces

-ROTA / Rotavirus Antigen, Feces

-LADV / Adenovirus, Molecular Detection, PCR, Varies

-GIAR / Giardia Antigen, Feces

-CRYPS / Cryptosporidium Antigen, Feces

-CYCL / Cyclospora Stain, Feces

-STL / Enteric Pathogens Culture, Feces

-CAMPC / Campylobacter Culture, Feces

-SHIGC / Shigella Culture, Feces

-SALMC / Salmonella Culture, Feces

-YERSC / Yersinia Culture, Feces

-E157C / Escherichia coli O157:H7 Culture, Feces

-STFRP / Shiga Toxin, Molecular Detection, PCR, Feces

-CDFRP / Clostridioides (Clostridium) difficile Toxin, Molecular Detection, PCR, Feces

-LNORO / Norovirus PCR, Molecular Detection, Feces



Additional Testing Requirements


In some cases, there may be local public health requirements that impact Mayo Clinic Laboratories (MCL) clients and require additional testing on specimens with positive results from this panel. Clients should familiarize themselves with local requirements. MCL recommends clients retain an aliquot of each specimen submitted for this test to perform additional testing themselves, as needed. If necessary, see Interpretation for detailed information about how to obtain this testing.



Shipping Instructions


Specimen must arrive within 96 hours of collection. 



Necessary Information


 



Specimen Required


Supplies: C and S Vial (T058)

Container/Tube: Cary-Blair transport system is required.

 

Specific for recovery of enteric pathogens from fecal specimens (15 mL of non-nutritive transport medium containing phenol red as a pH indicator; Cary Blair media: Remel Cary Blair, Protocol Cary Blair, Para Pak C and S [modified Cary Blair]). Submit sample in original Cary Blair medium container (not an aliquot).

Specimen Volume: Representative portion of feces; 1 gram or 5 mL

Collection Instructions:

1. Collect fresh fecal specimen and submit in container with transport medium.

2. Place feces in preservative within 2 hours of collection.


Specimen Minimum Volume

1 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Fecal Ambient (preferred) 4 days
  Refrigerated  4 days

Clinical Information

Acute diarrheal syndromes are usually self-limiting but may be complicated by dehydration, vomiting, and fever. Diagnostic testing and treatment may be required in some instances. Many bacterial enteric infections in the United States originate within the food supply chain. According to the CDC, in 2012 there were 19,531 laboratory-confirmed cases of infection with pathogens potentially transmitted through food in the United States. The numbers of infections, by pathogen, were as follows: Salmonella species (7800), Campylobacter species (6793), Shigella species (2138), Cryptosporidium species (1234), Shiga toxin-producing Escherichia coli non-O157 (551), Shiga toxin-producing E coli O157 (531), Vibrio species (193), Yersinia species (155), and Cyclospora cayetanensis (15). Giardia may also be transmitted through ingestion of contaminated food and water. There were 15,178 cases of giardiasis reported to the CDC in 2012. Since the clinical presentation may be very similar to many of these bacterial, viral, and parasitic pathogens, laboratory testing is required for definitive identification of the causative agent.

 

Rapid multiplex panel detection of the most common agents of bacterial, viral, and parasitic enteric infections directly from stool specimens is sensitive, specific, and provides same-day results, obviating the need for culture, antigen testing, microscopy, or individual nucleic acid amplification tests.

 

For other diagnostic tests that may be of value in evaluating patients with diarrhea the following are available in Special Instructions:

-Parasitic Investigation of Stool Specimens Algorithm

-Laboratory Testing for Infectious Causes of Diarrhea

Reference Values

Negative (for all targets)

Interpretation

A negative result should not rule-out infection in patients with a high pretest probability for gastrointestinal infection. The assay does not test for all potential infectious agents of diarrheal disease.

 

Positive results do not distinguish between a viable or replicating organism and the presence of a nonviable organism or nucleic acid, nor do they exclude the potential for coinfection by organisms not contained within the panel.

 

Results of the panel are intended to aid in the diagnosis of illness and are meant to be used in conjunction with other clinical and epidemiological findings.

 

In some cases, there may be local public health requirements that impact Mayo Clinic Laboratories (MCL) clients and require additional testing on specimens with positive results from this panel. Clients should familiarize themselves with local requirements. MCL recommends clients retain an aliquot of each specimen submitted for this test to perform additional testing themselves, as needed. If necessary, selected add-on tests can be performed by MCL at an additional charge, as detailed below. Call 800-533-1710 within 96 hours of specimen collection to request supplemental testing for positive test results:

 

Gastrointestinal Pathogen Panel Positive for

Client Action

Campylobacter species

Request add on test: CAMPC / Campylobacter Culture, Feces

Salmonella species

Request add on test: SALMC / Salmonella Culture, Feces

Shigella/Enteroinvasive E coli

Request add on test: SHIGC / Shigella Culture, Feces (for the Shigella/Enteroinvasive E coli target, the culture will assess for Shigella species only)

Yersinia species

Request add on test: YERSC / Yersinia Culture, Feces

Vibrio species

Request add on test: VIBC / Vibrio Culture, Feces

Shiga toxin-producing E coli

E coli O157

Request add on test: E157C / Escherichia coli O157:H7 Culture, Feces

 

MCL will report results to the client for additional cultures when ordered. If cultures are positive and the client is in need of the isolated organism (eg, Campylobacter, Salmonella, Shigella, Yersinia or Vibrio species, or E coli O157:H7) for submission to a public health laboratory, the client needs to call MCL and request that the isolates be returned to them (the client). The client will be responsible for submitting the isolates to the appropriate public health department. Positive culture results will also be reported via the Electronic Clinical Laboratory Reporting System (ECLRS).

 

Alternatively (not preferred), clients who want a patient specimen returned from MCL should call 800-533-1710 as soon as possible, at the latest within 96 hours of specimen collection, to request that MCL return an aliquot of the submitted specimen to them. Clients will be responsible for submitting specimens to appropriate public health departments.

Clinical Reference

1. Khare R, Espy MJ, Cebelinski E, et al: Comparative evaluation of two commercial multiplex panels for detection of gastrointestinal pathogens by use of clinical stool specimens. J Clin Microbiol. 2014 Oct;52(10):3667-3673

2. Centers for Disease Control and Prevention: Incidence and trends of infection with pathogens transmitted commonly through food-foodborne diseases active surveillance network, 10 U.S. sites, 1996-2012. MMWR Morb Mortal Wkly Rep. 2013;62(15):283-287

3. Centers for Disease Control and Prevention: Summary of notifiable diseases-United States, 2012. MMWR Morb Mortal Wkly Rep. 2014;61(53):1-121

4. DuPont HL: Persistent diarrhea: A clinical review. JAMA. 2016;315(24):2712-2723 doi: 10.1001/jama.2016.7833

5. Lawson PA, Citron DM, Tyrrell KL, Finegold SM: Reclassification of Clostridium difficile as Clostridioides difficile (Hall and O'Toole 1935) Prevot 1938. Anaerobe 2016 Aug;40:95-99.doi: 10.1016/j.anaerobe.2016.06.008

6. Oren A, Garrity GM: List of new names and new combinations previously effectively, but not validly, published. IJSEM 2016;66:3761-3764. doi: 10.1099/ijsem.0.001321

Test Classification

This test has been cleared, approved or is exempt by the U.S. Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information

0097U

LOINC Code Information

Test ID Test Order Name Order LOINC Value
GIP GI Pathogen Panel, PCR, F 82195-9

 

Result ID Test Result Name Result LOINC Value
SRCGI Specimen Source 31208-2
37081 Campylobacter species 82196-7
37082 C. difficile toxin 82197-5
37083 Plesiomonas shigelloides 82198-3
37084 Salmonella species 82199-1
37085 Vibrio species 82200-7
37086 Vibrio cholerae 82201-5
37087 Yersinia species 82202-3
37088 Enteroaggregative E. coli (EAEC) 80349-4
37089 Enteropathogenic E. coli (EPEC) 80348-6
37090 Enterotoxigenic E. coli (ETEC) 80351-0
37091 Shiga toxin producing E. coli 82203-1
37092 Escherichia coli O157 serotype 82204-9
37093 Shigella/Enteroinvasive E. coli 80350-2
37094 Cryptosporidium species 82205-6
37095 Cyclospora cayetanensis 82206-4
37096 Entamoeba histolytica 82207-2
37097 Giardia 82208-0
37098 Adenovirus F40/41 82209-8
37099 Astrovirus 82210-6
37100 Norovirus GI/GII 82211-4
37101 Rotavirus 82212-2
37103 Sapovirus 82213-0
37262 Interpretation 59464-8

Testing Algorithm

The following algorithms are available in Special Instructions:

-Parasitic Investigation of Stool Specimens Algorithm

-Laboratory Testing for Infectious Causes of Diarrhea

Mayo Clinic Laboratories | Gastroenterology Catalog Additional Information:

mml-gi-id, mml-gi-intestinal-infections, mml-gi-intestinal-infections-pathogens