Clostridioides difficile Toxin, PCR, Feces
Use
_Clostridioides difficile_ (formerly _Clostridium difficile_) is the cause of _C difficile_-associated diarrhea (CDAD), an antibiotic-associated diarrhea, and pseudomembranous colitis (PMC). In these disorders bacterial overgrowth of _C difficile_ develops in the colon, typically as a consequence of antibiotic usage. Clindamycin and broad-spectrum cephalosporins have most frequently been associated with CDAD and PMC, but almost all antimicrobials may be responsible. Disease is related to production of toxin A and B. The test utilizes automated real-time polymerase chain reaction to detect toxin B gene sequences, enabling prompt treatment that may reduce hospital stays for inpatients with CDAD.
Special Instructions
This test is validated for unformed (liquid or soft) fecal specimens collected from patients suspected of having _Clostridioides difficile_ infection. Do not submit more than one specimen for testing. Testing has not been validated for colostomy-, ileostomy-, or colonoscopically collected specimens. If not ordering electronically, complete, print, and send one of the following with the specimen: Microbiology Test Request (T244), Gastroenterology and Hepatology Test Request (T728).
Limitations
The assay must be performed on fresh feces, fresh-frozen feces, or feces in transport medium. The assay has not been validated as a test of cure. Since nucleic acid may persist after effective treatment, follow-up testing of a positive result is not recommended. Interfering substances in the feces may affect the accuracy of the assay; results should always be interpreted in conjunction with clinical and epidemiologic findings. Patients may asymptomatically carry _Clostridioides difficile_; clinical correlation is needed when deciding how to manage patients with a positive test result. Because of asymptomatic carriage of toxigenic _C difficile_ in infants, treatment for _C difficile_ may not be needed in those 12 months or younger.
New York Approved
Methodology
PCR-based (RT-PCR)
Biomarkers
LOINC Codes
- 54067-4
- 54067-4
Result Turnaround Time
1 day
Related Documents
For more information, please review the documents below
Specimen
Stool
Volume
5 mL
Minimum Volume
Not provided
Container
Commercially available transport system specific for recovery of enteric pathogens from fecal specimens
Collection Instructions
Collect fresh fecal specimen and submit in container with transport medium. Within 2 hours of collection, place feces in preservative.
Causes for Rejection
Feces in gel transport medium, ECOFIX preservative, Formalin or polyvinyl acetate (PVA) fixative, Preserved feces received frozen.
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | <5 days |
| Refrigerated | <5 days |
| Frozen | <5 days |