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Clostridium difficile Detection, RT-PCR
MessageSpecimens should be collected before administration of antibiotics or Barium.
Test Code
Lab1043
Alias/See Also
CDT
CDIFF
Clostridium difficile Toxigenic B, real-time PCR
CDIFF
Clostridium difficile Toxigenic B, real-time PCR
CPT Codes
87493
Preferred Specimen
Liquid or unformed (takes shape of container) stool
Minimum Volume
1 mL
Other Acceptable Specimens
None
Instructions
Specimens should be collected before administration of antibiotics or Barium.
Specimen Collection Procedure:
1) Use the bed pan provided to collect the specimen. Do not urinate into the pan.
2) Immediately transfer the specimen to the provided container. Use a disposable plastic spoon to transfer a small scoopful of unformed stool (unformed stool is stool that takes the shape of the container) specimen or 1 teaspoon of liquid specimen into the container.
3) Recap the container and ensure that the cap is on tight.
4) Make sure that your NAME, DOB, DATE and TIME of collection is on the container.
5) Place specimen in 6X9 Biohazard zip lock bag.
6) IMMEDIATELY place the specimen on ICE and drop off the specimen to any Meritus Medical Laboratory Patient Service Center.
1) Use the bed pan provided to collect the specimen. Do not urinate into the pan.
2) Immediately transfer the specimen to the provided container. Use a disposable plastic spoon to transfer a small scoopful of unformed stool (unformed stool is stool that takes the shape of the container) specimen or 1 teaspoon of liquid specimen into the container.
3) Recap the container and ensure that the cap is on tight.
4) Make sure that your NAME, DOB, DATE and TIME of collection is on the container.
5) Place specimen in 6X9 Biohazard zip lock bag.
6) IMMEDIATELY place the specimen on ICE and drop off the specimen to any Meritus Medical Laboratory Patient Service Center.
NOTE: If transport to a Patient Service Center is delayed:
Refrigerate specimen if delay is less than 4 hours
Freeze specimen if delay is between 4 and 24 hours.
Refrigerate specimen if delay is less than 4 hours
Freeze specimen if delay is between 4 and 24 hours.
Transport Container
Clean, screw-top container
Transport Temperature
Transport specimen on ice to laboratory promptly.
If transport delayed less than 4 hours, refrigerate specimen
If transport delayed 4-24 hours, freeze at -20° or below
If transport delayed less than 4 hours, refrigerate specimen
If transport delayed 4-24 hours, freeze at -20° or below
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Solid, formed specimen
Specimens received in leaking containers or containers with obvious gross external contamination
Specimens sent on diapers, toilet paper, or gloves
Specimens containing water or urine
Specimens collected with culture swabs
More than 1 specimen received per day or per order
Improper collection, storage, or transport of specimen
Repeat specimen collected <7 days after initial negative specimen
Repeat specimen collected <21 days after initial positive specimen
NOTE: An Infectious Disease consult is needed to run repeat specimens that meet the above rejection criteria; therefore, the specimens rejected on those criteria are saved for 48 hours.
Specimens received in leaking containers or containers with obvious gross external contamination
Specimens sent on diapers, toilet paper, or gloves
Specimens containing water or urine
Specimens collected with culture swabs
More than 1 specimen received per day or per order
Improper collection, storage, or transport of specimen
Repeat specimen collected <7 days after initial negative specimen
Repeat specimen collected <21 days after initial positive specimen
NOTE: An Infectious Disease consult is needed to run repeat specimens that meet the above rejection criteria; therefore, the specimens rejected on those criteria are saved for 48 hours.
Methodology
Cepheid RT-PCR (Real-time polymerase chain reaction) – inpatient
Cobas® C Dif test, by RT-PCR (Real-time PCR) – outpatient
Setup Schedule
Daily, all shifts
STAT – 1 hour (from when specimen received in laboratory)
Routine – 24 hours
STAT – 1 hour (from when specimen received in laboratory)
Routine – 24 hours
Reference Range
Not detected
Clinical Significance
Clostridium difficile is the major causative agent of antibiotic-associated diarrhea, colitis and pseudomembranous colitis. Only C. difficile strains that produce toxins A and/or B are pathogenic; non-toxin producing strains are not pathogenic. Most pathogenic strains of C. difficile produce both toxins, but some produce only toxin B due to deletions of sequences in the toxin A gene. This real-time PCR assay amplifies and detects sequences in two C. difficile genes that confirm the identity of C. difficile in the specimen and also detect the presence of the toxin B gene in toxigenic strains.
Performing Laboratory
Meritus Molecular Diagnostics – Microbiology
