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Clostridium difficile/Epi Detection, RT-PCR
MessageSpecimens should be collected before administration of antibiotics or Barium.
Test Code
Lab1043
Alias/See Also
CDIFF
Clostridiodes difficile/Epi, RT-PCR
CPT Codes
87493x2
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.
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.
NOTE: If transport to a Patient service Center is delayed: Refrigerate specimen if delay is greater than 24 hours.
Transport Container
Clean, screw-top container
Transport Temperature
Stable for up to 5 days at 2o-8o C
Alternatively, specimen can be kept at room temperature (20o-30o C) for 24 hours
Alternatively, specimen can be kept at room temperature (20o-30o C) for 24 hours
Specimen Stability
Stable for up to 5 days at 2o-8o C
Alternatively, specimen can be kept at room temperature (20o-30oC) for 24 hours
Alternatively, specimen can be kept at room temperature (20o-30oC) for 24 hours
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
No Cary-Blair
No Ova para-pak
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
No Cary-Blair
No Ova para-pak
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)
Setup Schedule
Daily, all shifts
STAT – 1 hour (from when specimen received in laboratory)
STAT – 1 hour (from when specimen received in laboratory)
Reference Range
Not detected
Clinical Significance
The Cepheid Xpert C.Difficile/Epi test is a rapid, automated in vitro diagnostic test for qualitative detection of toxin-producing Clostridiodes difficile directly from unformed (liquid or soft) stool specimens of patients suspected of having Clostridiodes difficile infection (CDI). The test detects the toxin B gene (tcd B), the binary toxin gene (CDT), and the single-base-pair deletioin at nucleotide 117 within the gene encoding a negative regulator of toxin production (tcdC 117). The combined presence of the genes encoding toxin B and binary toxin and the tcdC 117 deletion have been associated with hypervirulent C. Difficile strain known as 027/NAP/BI, which has been associated with severe disease outbreaks in healthcare facilities worldwide. The test is performed on the Cepheid GeneXpert Instrument Systems.
Performing Laboratory
Meritus Molecular Diagnostics – Microbiology
