Clostridioides difficile Toxin Antigen, Feces

Test Code
18305


CPT Codes
87324<br>Restricted Client Code

Preferred Specimen
5 mL representative portion of feces: stool collected in 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)


Other Acceptable Specimens
Representative portion of feces collected in fecal container


Instructions

Preserved feces:
1. Collect fresh fecal specimen and submit in container with transport medium.
2. Within 2 hours of collection place feces in preservative.

Unpreserved feces:
Collect fresh fecal specimen and submit representative sample in fecal container.



Transport Temperature
Preserved: Room temperature
Unpreserved: Refrigerated (cold packs)


Specimen Stability
Preserved
Room temperature: 7 days
Refrigerated: 7 days
Frozen: Unacceptable

Unpreserved
Room temperature: Unacceptable
Refrigerated: 7 days
Frozen: 7 days


Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Formed stool • Fecal ESwabs • Feces in gel transport medium • ECOFIX preservative • Formalin or polyvinyl acetate (PVA) fixative • Preserved feces received frozen


Methodology
Enzyme Immunoassay (EIA)

FDA Status
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.

Setup Schedule
Set up: Mon-Sun; Report available: 1 day


Reference Range
Negative


Clinical Significance
Diagnosing the presence of toxigenic Clostridioides difficile.




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.