|Alternate:||C diff by PCR|
|Includes:||PCR testing for toxigenic C. Difficile|
|Available:||Orderable daily, 24 hours. Specimens received before 1 PM resulted the same day or next day.|
|Turnaround:||1 -2 days.|
|Volume:||1 mg of stool (equivalent to the size of a pea), 1 mL liquid stool, or a swab heavily coated with stool.|
|Container:||Clean container or culturette|
|Temperature:||Room temperature. Refrigerate if transport is delayed more than one hour.|
|Rejection:||Formed stool should not be tested.|
|Normal:||Negative for C. difficile by PCR.|
|Uses:||Detects the presence of cytotoxin producing C. difficile.|
|Limitations:||The C. difficile PCR assay is a highly sensitive test that detects the Toxin B gene. This test has been approved by the Food and drug Administration for testing unformed stool specimens from patients suspected of having C. difficile infection and has been validated by the Childrens Medical Center Virology Laboratory. this test detects the presence of DNA encoding this gene and does not detect viable organisms or the presence of the protien toxin. As a result, PCR is not to be used as a test of cure and repeat testing on POSITIVE patients will only be accepted for new episodes after 7 days from the previous test.
Also due to the sensitivity of the PCR test the negative predictive value in our population is very good. Repeat testing to confirm NEGATIVE results is not necessary and will only be accepted for new episodes of diarrhea that occur after 7 days from the previous test.
In certain age groups the sole determination of C. difficile toxin positivity in stool is not conclusive evidence that the patient has C. difficile infection (CDI). Asymptomatic carriage of toxigenic C. difficile is common in young children (<2 years of age) and laboratory findings should be interpreted in conjunction with patient history to establish a diagnosis of CDI.
|Method:||Polymerase Chain Reaction (PCR)|
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