Clostridium difficile Toxin/GDH w/o Reflex

Test Code

31693

CPT Codes
87324, 87449<br>Restricted Client Code

Preferred Specimen

5 grams or 5 mL stool collected in a sterile leak-proof container

Minimum Volume

1 g or 1 mL

Instructions

Collect fresh stool in sterile, leak-proof container without media, preservative, or metal ion. For patients requiring the use of diapers, first line the diaper with clean plastic to prevent absorption. Then transfer 5 g or 5 mL of the stool specimen from the plastic lined diaper to the sterile container. Do not submit the diaper itself. Cap securely. Do not use any preservative, media or additive.

Note: New recommendations per the American Society for Microbiology recommend that screening assays for C. difficile toxin be combined with GDH antigen, with discordant results being confirmed by Nucleic Acid Amplification testing

Transport Temperature

Frozen

Specimen Stability

Room temperature: Unacceptable
Refrigerated: 72 hours
Frozen: 30 days

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

Formed stools • Stools submitted in transport media or swab • Rectal swab • Unfrozen stools greater than 72 hours old • Received room temperature

Methodology
Immunoassay

Setup Schedule

Set up: Daily; Report available: Next day

Reference Range

See Laboratory Report

Clinical Significance

After treatment with antibiotics, many patients develop gastrointestinal problems ranging from mild diarrhea to severe pseudomembranous colitis. This organism is an opportunistic anaerobic bacterium that grows in the intestine once the normal flora has been altered by the antibiotic. For diagnosis of toxigenic C. difficile, current practice guidelines from the CDC recommend confirmation by Nucleic Acid Amplification Testing (NAAT) if the glutamate dehydrogenase of C. difficile (GDH) Antigen is positive, and toxin is not detected by Enzyme immunoassay. Additionally, if toxin is detected without the presence of GDH antigen, confirmation by NAAT is also recommended.

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.