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Clostridium difficile Toxin/GDH with Reflex to PCR
Test Code91664
CPT Codes
87449, 87324
Includes
If GDH Antigen is detected and Toxin A and B are not detected, then Clostridium difficile Toxin B, Qualitative, Real-Time PCR will be performed at an additional charge (CPT code(s): 87493).
or
If GDH Antigen is not detected and Toxin A and B are detected, then Clostridium difficile Toxin B, Qualitative, Real-Time PCR will be performed at an additional charge (CPT code(s): 87493).
or
If GDH Antigen is not detected and Toxin A and B are detected, then Clostridium difficile Toxin B, Qualitative, Real-Time PCR will be performed at an additional charge (CPT code(s): 87493).
Preferred Specimen
5 grams or 5 mL unformed stool submitted in a sterile, leak-proof container
Minimum Volume
1 gram or 1 mL
Instructions
Collect fresh stool in sterile, leak-proof container without media, preservative, or metal ion. Cap securely. Do not use any preservative, media or additive.
For patients requiring the use of diapers, first line the diaper with clean plastic to prevent absorption. Then transfer 5 grams or 5 mL of the stool specimen from the plastic lined diaper to the sterile container. Do not submit the diaper itself.
For patients requiring the use of diapers, first line the diaper with clean plastic to prevent absorption. Then transfer 5 grams or 5 mL of the stool specimen from the plastic lined diaper to the sterile container. Do not submit the diaper itself.
Transport Temperature
Frozen
Specimen Stability
Room temperature: Unacceptable
Refrigerated: 72 hours
Frozen: 30 days
Refrigerated: 72 hours
Frozen: 30 days
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Formed stool • Stool submitted in transport media or swab • Rectal swab • Unfrozen stool >72 hours old • Received room temperature
Methodology
Immunoassay (IA)
Setup Schedule
Set up: Sun-Fri; Report available: Next day
Reference Range
Not detected
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.
Performing Laboratory
Quest Diagnostics Nichols Institute
14225 Newbrook Drive
Chantilly, VA 20153