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Alphabetical Index
Clostridioides (Clostridium) difficile toxin (8000100147)
Test Mnemonic:

V CDT
Specimen Requirements:

Pseudomembranous colitis; Detection of toxigenic Clostridioides (Clostridium) difficile from "watery" fecal samples.
Collection:

Submit specimen in a sterile, spillproof container. Only specimens of soft, loose, or watery consistency are tested. 
Container:

Sterile, spillproof container. 
Minimum Volume:

2.0 mL
Storage/Transport:

Store/transport specimen refrigerated, 2-8°C.  
Stability:

For optimal results, specimens must be refrigerated and tested within 72 hours of collection.
Causes for Rejection:

Formed stool specimens, insufficient quantity, sample on culturette, stool in preservatives, specimen container unlabeled or mislabeled, no date and time of collection on form.

Testing is not repeated within 7 days. Duplicate requests (negative or positive) rejected if collected within 7 days. 

Children <24 months old will only be performed with Pediatric ID or Pediatric GI approval.

Fecal specimens received in formalin-based or alcohol-based fixatives.
Specimen Preparation:

Transfer feces to a clean, spillproof container 
Methodology:

EIA membrane assay, PCR (for reflex tests only)

Discordant results will be reflexed to PCR for confirmatory testing
Performed:
Lab:

Clinical Microbiology
Turnaround Time:

Specimens are batch tested three times within a day.
Reference Range:

Negative
CPT 4 Code:

87449, 87324, 87493 (if reflexed to PCR)
Synonyms:

Pseudomembranous colitis test; C. difficile toxin assay; C. difficile toxigenic assay; Clostridioides (Clostridium)difficile test; Clostridioides (Clostridium) difficile toxin test; Clostridioides (Clostridium) difficile cytotoxin assay.
Patient Preparation :

This test is performed on patients with diarrhea.
Clinical Indication:

Aid in the diagnosis of Clostridioides (Clostridium) difficile related disease
Effective Date: 03/12/2024
Reviewed By/Date: Williams-Bouyer, Natalie - 03/25/2019
Approved By/Date: Williams-Bouyer, Natalie - 03/22/2024
When ordering tests for which Medicare or Medicaid reimbursement will be sought, physicians should only order tests that are medically necessary for the diagnosis or treatment of the patient. Components of the organ or disease panels may be ordered individually. The diagnostic information must substantiate all tests ordered and must be in the form of an ICD-10 code or its verbal equivalent.

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