Test Code CDIFF C. difficile Toxin B PCR
Additional Codes
Epic: LAB253
Specimen Minimum Volume
3mL loose or liquid stool. Stool must take the shape of the container
Report Available
1-2 days
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.
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.
Specimen Stability Information
Room temperature: 24 hours
Refrigerated: 5 days
Frozen: Unacceptable
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
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
Category
Molecular