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Test Code EIACD Clostridioides difficile Toxin, EIA, Feces


Ordering Guidance


This test is validated for unformed (liquid or soft) fecal specimens collected from patients suspected of having Clostridioides difficile infection.



Specimen Required


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. Within 2 hours of collection place feces in preservative.

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

 

Acceptable:

Specimen Type: Unpreserved feces

Supplies:

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


Useful For

Diagnosing the presence of toxigenic Clostridioides difficile

Method Name

Enzyme Immunoassay (EIA)

Reporting Name

C. difficile Toxin Antigen, Feces

Specimen Type

Fecal

Specimen Minimum Volume

See Specimen Required

Specimen Stability Information

Specimen Type Temperature Time
Fecal Varies 7 days

Reject Due To

Formed stool
Fecal ESwabs
Feces in gel transport medium
ECOFIX preservative
Formalin or polyvinyl acetate (PVA) fixative
Preserved feces received frozen		 Reject

Clinical Information

In the United States, toxigenic Clostridioides difficile (TCD) accounts for 15% to 25% of all episodes of antibiotic-associated diarrhea. TCD is also associated with a spectrum of disease states, ranging from asymptomatic colonization to pseudomembranous colitis, toxic megacolon, sepsis, and death. Pathogenic C difficile produces one or both of 2 toxins, toxin A and toxin B. While toxin A is produced by most disease-causing strains of C difficile, it has been shown that some disease-causing strains of C difficile produce only toxin B. C difficile strains that do not produce toxins A or B are thought to be avirulent.

 

Toxin A and B enzyme immunoassays (EIA) have low sensitivity and moderate specificity for C difficile infection. The suboptimal performance of EIA sparked the development of molecular tests (eg, polymerase chain reaction) that have high sensitivity. EIA may be useful as part of a multi-step algorithm if patients do not meet preanalytic criteria for stool submission (unexplained and new onset diarrhea with at least 3 unformed stools/day and no recent laxative use).

Reference Values

Negative

Day(s) Performed

Monday through Sunday

Report Available

Same day/1 day

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test has been modified from the manufacturer's instructions. Its performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information

87324