Toxigenic Clostridioides difficile by LFA with Reflex to PCR, Stool
Also known as: CDIFF LFA
Use
This test is designed for the detection of C. difficile antigen and toxin using a qualitative lateral flow immunoassay (LFA) technique. If the glutamate dehydrogenase (GDH) antigen is detected but the toxin is not, PCR for the tcdB gene is reflexively performed. This serves as an important diagnostic aid in identifying Clostridioides difficile infections, which can cause symptoms ranging from diarrhea to life-threatening inflammation of the colon. Early and accurate diagnosis is critical for effective treatment and control of infection spread.
Special Instructions
Not provided.
Limitations
The test is limited to detecting GDH antigen and toxin A/B, as well as the presence of the tcdB gene in reflex cases. Any interference caused by inhibitors in stool specimens could lead to false-negative results. Moreover, this test does not differentiate between toxigenic and non-toxigenic strains unless the reflex PCR indicates the presence of the tcdB gene. The test results must be interpreted in conjunction with clinical presentation and other diagnostic procedures since colonization by non-toxigenic strains or other pathogens may produce similar symptoms.
FDA ApprovedNew York Approved
Methodology
Immunoassay (Lateral Flow)
Biomarkers
LOINC Codes
- 34712-0 - C diff Stl Ql
Result Turnaround Time
1 day
Related Documents
For more information, please review the documents below
Specimen
Stool
Volume
1.0 mL
Minimum Volume
0.5 mL
Container
Clean, unpreserved transport vial (ARUP Supply# 40910)
Collection Instructions
Collect liquid or soft stool and transfer 1.0 mL to a clean, unpreserved transport vial.
Storage Instructions
Refrigerated preferred; also acceptable: Frozen.
Causes for Rejection
Specimens preserved in Cary Blair/C&S media, formalin-based fixative, or alcohol-based fixative. Formed stool.
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 2 hours |
| Refrigerated | 72 hours |
| Frozen | 1 week |
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