Clostridioides difficile Toxin Gene, NAA, With Reflex to Clostridioides difficile Toxins A+B, EIA

Clinical Use

Order Test

Use

Two-step algorithm to aid in the determination of C. difficile infection versus C. difficile colonization

Special Instructions

Not provided.

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.

Test Details

Methodology

PCR-based (Real-time PCR)

Biomarkers

C difficile toxin gene

Microorganism

NAA

Other • Binary (Detected / Not Detected)

C difficile Toxins A+B

Microorganism

EIA

Other • Binary (Detected / Not Detected)

LOINC Codes

Order Codes

54067-4 - C diff Tox gens Stl Ql NAA+probe

Result Codes

54067-4 - C diff Tox gens Stl Ql NAA+probe
34468-9 - C diff Tox A+B Stl Ql IA

Result Turnaround Time

1-2 days

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.