Clostridioides difficile Toxin Gene, NAA, With Reflex to Clostridioides difficile Toxins A+B, EIA
Use
Two-step algorithm to aid in the determination of C. difficile infection versus C. difficile colonization
Special Instructions
The test is specifically for use with unformed stool samples, i.e., soft or loose stools. If reflex testing is not desired, order Clostridioides difficile Toxin Gene, NAA [183988] instead. Proper specimen collection and handling, including timely transportation, are critical to the accuracy of test results.
Limitations
This assay does not differentiate between viable and non-viable organisms, making it crucial to use in conjunction with other diagnostic procedures and clinical information. It only provides presumptive detection of the BI/NAP1/027 strain for epidemiological tracking, not treatment guidance. The test is not validated for patients under two years old. The accuracy depends on specimen integrity, including handling and storage conditions.
Methodology
PCR-based (Real-time PCR)
Biomarkers
LOINC Codes
- 54067-4
- 54067-4
- 34468-9
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, name discrepancies, insufficient quantity, formed stools, frozen stool, stool in preservative, non-stool specimens, improper storage or transport device, leaking specimens, stool stored at room temperature, or specimen older than 72 hours when refrigerated.
Stability Requirements
| Temperature | Period |
|---|---|
| Refrigerated | 3 days |