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Test Code CDPCR Clostridioides difficile Toxin, PCR, Feces


Ordering Guidance


This test is validated for unformed (liquid or soft) fecal specimens collected from patients suspected of having Clostridioides difficile infection.



Specimen Required


The high sensitivity of amplification by polymerase chain reaction requires the specimen to be processed in an environment in which contamination of the specimen by Clostridioides difficile toxin DNA is unlikely.

 

Submit only 1 of the following specimens:

 

Preferred:

Specimen Type: Preserved feces

Supplies: Culture and Sensitivity Stool Transport Vial (T058)

Container/Tube: Commercially available transport system specific for recovery of enteric pathogens from fecal specimens (15 mL of nonnutritive transport medium containing phenol red as a pH indicator, either Cary-Blair or Para-Pak C and S)

Specimen Volume: Representative portion of feces; 5 mL

Collection Instructions:

1. Collect fresh fecal specimen and submit in container with transport medium.

2. Place feces in preservative within 2 hours of collection.

Specimen Stability Information: Ambient (preferred) <5 days/Refrigerated <5 days

 

Acceptable:

Specimen Type: Unpreserved feces

Supplies:

-Stool container, Small (Random), 4 oz Random (T288)

-Stool Collection Kit, Random (T635)

Container/Tube: Fecal container

Specimen Volume: Representative portion of feces

Collection Instructions: Collect fresh fecal specimen and submit representative sample in fecal container.

Specimen Stability Information: Refrigerated (preferred) <5 days/Frozen <5 days


Useful For

Sensitive, specific, and rapid diagnosis of Clostridioides (Clostridium) difficile-associated diarrhea and pseudomembranous colitis

 

The test is not recommended as a test of cure.

Testing Algorithm

For more information see Laboratory Testing for Infectious Causes of Diarrhea.

Method Name

Real-Time Polymerase Chain Reaction (PCR)/Reverse Transcription-(RT) PCR

Reporting Name

C. difficile Toxin, PCR, F

Specimen Type

Fecal

Specimen Minimum Volume

See Specimen Required

Specimen Stability Information

Specimen Type Temperature Time Special Container
Fecal Varies 5 days

Reference Values

Negative

Interpretation

Positive: Toxin producing Clostridioides (Clostridium) difficile target nucleic acid is detected.

 

Negative: C difficile target nucleic acid is not detected.

Clinical Reference

1. Aichinger E, Schleck CD, Harmsen WS, Nyre LM, Patel R. Nonutility of repeat laboratory testing for detection of Clostridium difficile by use of PCR or enzyme immunoassay. J Clin Microbiol. 2008;46(11):3795-3797

2. Sloan LM, Duresko BJ, Gustafson DR, Rosenblatt JE. Comparison of real-time PCR for detection of the tcdC gene with four toxin immunoassays and culture in diagnosis of Clostridium difficile infection. J Clin Microbiol. 2008;46(6):1996-2001

3. Verdoorn BP, Orenstein R, Rosenblatt JE, et al. High prevalence of tcdC deletion-carrying Clostridium difficile and lack of association with disease severity. Diagn Microbiol Infect Dis. 2010;66(1):24-28

4. Karre T, Sloan L, Patel R, Mandrekar J, Rosenblatt J. Comparison of two commercial molecular assays to a laboratory-developed molecular assay for diagnosis of Clostridium difficile infection. J Clin Microbiol. 2011;49(2):725-727

5. Lawson PA, Citron DM, Tyrrell KL, Finegold SM. Reclassification of Clostridium difficile as Clostridioides difficile (Hall and O'Toole 1935) Prevot 1938. Anaerobe. 2016;40:95-99. doi:10.1016/j.anaerobe.2016.06.008

Day(s) Performed

Monday through Sunday

Report Available

Same day/1 day

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information

87493

LOINC Code Information

Test ID Test Order Name Order LOINC Value
CDPCR C. difficile Toxin, PCR, F 54067-4

 

Result ID Test Result Name Result LOINC Value
TCDRR C. difficile Toxin, PCR 54067-4

Forms

If not ordering electronically, complete, print, and send 1 of the following with the specimen:

-Microbiology Test Request (T244)

-Gastroenterology and Hepatology Test Request (T728)