Clostridioides difficile Toxin Gene, NAA
Use
Aid in the diagnosis of antibiotic-associated diarrheal disease and pseudomembranous colitis. Toxigenic C difficile is a major cause of antibiotic-associated diarrhea and colitis and is the causative agent for virtually all cases of pseudomembranous colitis. Although about 2% of normal healthy adults are colonized with C difficile, many patients acquire this organism through nosocomial infection. Exposure to most antibiotics is thought to allow proliferation of toxigenic C difficile by disrupting the normal intestinal flora. Two large toxin proteins, toxin A and toxin B, encoded by two separate genes, named tcdA and tcdB, are believed to be the primary virulence factors of C difficile. Together, with three additional genes, they form a 19.6-kb pathogenicity locus called PaLoc, which is found in all known toxigenic strains of C difficile.
Special Instructions
Ensure the test is conducted using unformed stool samples only. This test presumptively differentiates the BI/NAP1/027 strain from other toxigenic strains of C difficile, solely for epidemiological purposes. Proper specimen collection and handling are crucial for accurate detection of bacterial nucleic acid.
Limitations
The test does not differentiate between viable and nonviable organisms. Association with disease in infants under two years is unclear as they can be carriers of toxigenic C difficile without symptoms. The test should be used in conjunction with clinical evaluations and other diagnostic procedures. Detection of BI/NAP1/027 is not intended to guide treatment, and accurate results depend on proper specimen collection, handling, and transportation.
Methodology
PCR-based (Real-time PCR)
Biomarkers
LOINC Codes
- 54067-4
- 54067-4
Result Turnaround Time
1-2 days
Related Documents
For more information, please review the documents below
Specimen
Stool
Volume
5 g
Minimum Volume
0.5 g or 0.5 mL liquid stool
Container
Sterile screw-cap container or stool transport without preservatives (Para-Pak® white clean vial)
Storage Instructions
Specimen should be kept at 2°C to 8°C and transported to the laboratory within 24 hours of collection. Do not freeze.
Causes for Rejection
Unlabeled specimen or name discrepancy; insufficient quantity; formed or frozen stool; stool in preservative; non-stool specimens; improper storage; leaking specimens; specimen older than 24 hours at room temperature or older than five days refrigerated.
Stability Requirements
| Temperature | Period |
|---|---|
| Refrigerated | 5 days (stability provided by manufacturer or literature reference) |
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