Toxigenic Clostridioides difficile by LFA with Reflex to PCR, Stool

Casandra

Casandra Test Code AR15564Version 1 (DRAFT)

Performing Lab

Lab ARUP LaboratoriesLab Test ID 3001801CPT Codes 87324, 87493, 87899

Toxigenic Clostridioides difficile by LFA with Reflex to PCR, Stool

Also known as: CDIFF LFA

Clinical Use

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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

Specimens preserved in Cary Blair/C&S media, formalin-based fixative, or alcohol-based fixative are not acceptable for testing. Formed stool samples are also not acceptable. Patient preparation includes the collection of liquid or soft stool samples.

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.

Test Details

FDA Approved