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Test Code CDIFF C. difficile Toxin B PCR

Additional Codes

Epic: LAB253

Specimen Required

Sterile Container

 

Specimen Minimum Volume

3mL loose or liquid stool. Stool must take the shape of the container

Clinical Significance

A positive result may indicate infection or colonization with Clostridium difficile harboring the Toxin B gene. The occurrence of Toxin gene A (+)/Toxin B (-) C. difficile is extremely rare and human disease has not been documented.
This assay should not be used as a test of cure and should not be run on formed/solid stool samples. Nucleic acid may persist after effective treatment and could be detected by this assay.

Specimen Stability Information

Specimens can be stored at 2-25°C for a maximum of 24 hours or at 2-8°C for a maximum of 120 hours (5 days) before testing.

Specimen Instructions

1) Submit stool in a dry, sterile, container (ensure that container is closed tightly to prevent leaks).
2) Apply patient identification label.

Note: Stool submitted in Cary Blair media is unacceptable for this assay. Stool that Is not loose enough to take the shape of the container is not acceptable for this assay.

SETUP SCHEDULE

Daily

INCLUDES

Real-time polymerase chain reaction (PCR) for the amplification and detection of C. difficile toxin B gene DNA

TRANSPORT/STORAGE CONDITION

Refrigerated

Method Description

Real-time polymerase chain reaction for the amplification and detection of C. difficile toxin B gene DNA

Analytic Time

1-2 days

Reject Due To

 

The following are situations in which rejection will occur:
Room temperature sample submitted >24 hours from collection time, Formed/Solid stool samples submitted (If in leus due to C. difficile is suspected and only formed stool can be collected, contact the laboratory to request sendout testing on rejected specimen), Repeat order within 7 days (without laboratory approval), Improperly labeled specimen, insufficient volume, specimen not submitted in appropriate transport container

Limitations

This assay detects the presence of a toxin gene. A positive does not indicate that toxin is being produced. This assay does not distinguish between viable and non-viable organisms. Test results are to be used in conjunction with information available from the patient clinical evaluation and other diagnostic procedures.
Colonization at rates up to 50% and higher have been reported in infants and rates up to 32% in cystic fibrosis patients.

Category

Molecular