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Test Code LAB5736 Clostridium difficile Toxin B PCR

Performing Section

Microbiology

Purpose/Principle

Diagnostic test for rapid detection of the toxin B gene by real-time PCR in unformed (liquid or soft) stool specimens collected from patients with a suspected CDI. This test detects but does not differentiate the hypervirulent strain from other toxigenic strains of C. difficile. This test targets the tcdB gene for Toxin B production. It does not detect strains of C. difficile that do not contain the tcdB gene.

Special Collection Notes

Collect fresh stool specimen in a sterile screw capped container.
Specimens will be rejected:
If formed stool unless toxic megacolon is suspected.
If patient has a previous positive less than two weeks prior

Specimen Type

Stool:
Sterile Container

  • A sterile container is not required. Specimens collected at home may be placed in a container that has been cleaned in a household dishwasher.

Specimen Volume

Preferred: 3.0 grams
Minimum: 1.0 grams ( or 1mL liquid or semi-formed stool)

Processing Instructions

Store refrigerated and send specimen on wet ice via courier.

Temperature

Refrigerated

Test Components

C.DIFFICILE TOXIN B PCR

Reference Range

Not Detected

TAT

3 Hours

Sample Stability

Refrigerated: 5 days

Additional Notes

Unacceptable Specimens:
I. Formed stools, rectal swabs, stool on cotton balls or diapers and specimens submitted too soon after
prior testing are not appropriate for this test. Guidelines for repeat testing are:
A. Repeat testing may be performed within two days after of an initially negative result.
B. Repeat testing within two weeks of a previous-positive result is not acceptable due

Aliases

CDT PCT
C. Difficile PCR

CPT

87493