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Test Code STFRP Shiga Toxin, Molecular Detection, PCR, Feces

Reporting Name

Shiga Toxin PCR, F

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Useful For

Sensitive, specific, and rapid detection of the presence of Shiga toxin-producing organisms such as Escherichia coli O157:H7 and Shigella dysenteriae type 1 in stool

 

This test is not recommended as a test of cure.

Method Name

Real-Time Polymerase Chain Reaction (PCR) using Fluorescent Resonance Energy Transfer (FRET)


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 for this test. MCL recommends that clients retain an aliquot of each specimen submitted for testing to perform such additional testing, if needed. Alternatively (not preferred), clients who want their specimen returned from MCL should call MCL 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 their specimens to appropriate public health departments.



Necessary Information


Specimen source is required.



Specimen Required


The high sensitivity of amplification by polymerase chain reaction requires the specimen to be processed in an environment in which contamination of the specimen by shiga toxin DNA is unlikely.

 

Submit only 1 of the following specimens:

 

Preferred:

Specimen Type: Preserved feces

Supplies: Culture and Sensitivity Stool Transport Vial (T058)

Container/Tube: Commercially available transport system specific for recovery of enteric pathogens from fecal specimens (15 mL of nonnutritive transport medium containing phenol red as a pH indicator, either Cary-Blair or Para-Pak C and S)

Specimen Volume: Representative portion of feces; 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 Stability Information: Ambient (preferred) <7 days/Refrigerated <7 days

 

Acceptable:

Specimen Type: Unpreserved feces

Supplies:

-Stool container, Small (Random), 4 oz Random (T288)

-Stool Collection Kit, Random (T635)

Container/Tube: Fecal container

Specimen Volume: Representative portion of feces

Collection Instructions: Collect fresh fecal specimen and submit representative sample in fecal container.

Specimen Stability Information: Refrigerated (preferred) <7 days/Frozen <7 days


Specimen Type

Fecal

Specimen Minimum Volume

1 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Fecal Varies 7 days

Reject Due To

Formed feces or feces in gel transport medium
EcoFix preservative; formalin or PVA fixative
Preserved feces received frozen
Reject

Reference Values

Not applicable

Interpretation

A positive polymerase chain reaction (PCR) result indicates the likely presence of Shiga toxin-producing Escherichia coli in the specimen. Although Shigella dysenteriae serotype 1 may produce a positive result, it is extremely rare in the United States.

 

A negative result indicates the absence of detectable Shiga toxin DNA in the specimen, but does not rule out the presence of Shiga toxin-producing E coli and may occur due to inhibition of PCR, sequence variability underlying primers or probes, or the presence of Shiga toxin DNA in quantities less than the limit of detection of the assay. Shiga toxins are encoded on mobile genetic elements and can theoretically be lost by their bacterial host.

Day(s) Performed

Monday through Sunday

Report Available

1 to 2 days

Test Classification

This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information

87798

LOINC Code Information

Test ID Test Order Name Order LOINC Value
STFRP Shiga Toxin PCR, F 80679-4

 

Result ID Test Result Name Result LOINC Value
SRC59 Specimen Source 31208-2
56052 Result 80679-4

Forms

If not ordering electronically, complete, print, and send 1 of the following forms with the specimen:

-Microbiology Test Request (T244)

-Gastroenterology and Hepatology Test Request (T728)

-Renal Diagnostics Test Request (T830)

-Coagulation Test Request (T753)

Testing Algorithm

For more information see Laboratory Testing for Infectious Causes of Diarrhea.