Test Catalog

Test Id : CDPCR

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Clostridioides difficile Toxin, PCR, Feces

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Overview

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

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
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Method Name
A short description of the method used to perform the test

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

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

C. difficile Toxin, PCR, F

Aliases
Lists additional common names for a test, as an aid in searching

Antibiotic Associated Diarrhea

Antibiotic Associated Pseudomembranous Colitis

C diff

C difficile Toxin

C difficile, Stool

C. diff

C. difficile Toxin

C. difficile, Stool

Clostridioides

Clostridioides (Clostridium) difficile

Clostridioides difficile

Clostridium

Clostridium difficile, Feces

Clostridium difficile, Stool

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Specimen Type
Describes the specimen type validated for testing

Fecal

Ordering Guidance

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

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

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

Special Instructions
Library of PDFs including pertinent information and forms related to the test

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)

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.

See Specimen Required

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Feces in gel transport medium
ECOFIX preservative
Formalin or polyvinyl acetate (PVA) fixative
Preserved feces received frozen 		Reject

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Fecal Varies 5 days

Useful For
Suggests clinical disorders or settings where the test may be helpful

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
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Clostridioides difficile (formerly Clostridium difficile) is the cause of C difficile-associated diarrhea (CDAD), an antibiotic-associated diarrhea, and pseudomembranous colitis (PMC). In these disorders bacterial overgrowth of C difficile develops in the colon, typically as a consequence of antibiotic usage. Clindamycin and broad-spectrum cephalosporins have most frequently been associated with CDAD and PMC, but almost all antimicrobials may be responsible. Disease is related to production of toxin A and B.

 

Treatment typically involves withdrawal of the associated antimicrobials and, if symptoms persist, orally administered and intraluminally active metronidazole, vancomycin, or fidaxomicin. Intravenous metronidazole may be used if an oral agent cannot be administered. In recent years, a more severe form of CDAD with increased morbidity and mortality has been recognized as being caused by an epidemic toxin-hyperproducing strain of C difficile (NAP1 strain). Many toxin-hyperproducing isolates also contain the binary toxin gene and are resistant to quinolones. This test does not differentiate between toxin-hyperproducing and non-toxin-hyperproducing strains.

 

Traditionally, diagnosis relied upon:

1. Clinical and epidemiologic features

2. Culture, which is labor intensive and time consuming

3. Cytotoxicity assays, which are labor intensive and time consuming

4. Toxin detection immunoassays, which are insensitive

This test uses a polymerase chain reaction assay that detects the regulatory gene (tcdC) responsible for production of toxins A and B. This test is used for rapid diagnosis of CDAD and PMC, enabling prompt treatment that may reduce hospital stays for inpatients with CDAD.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

Negative

Interpretation
Provides information to assist in interpretation of the test results

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

 

Negative: C difficile target nucleic acid is not detected.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

The assay must be performed on fresh feces, fresh-frozen feces, or feces in transport medium.

 

The assay has not been validated as a test of cure. Since nucleic acid may persist after effective treatment, follow-up testing of a positive result is not recommended.

 

Interfering substances in the feces may affect the accuracy of the assay; results should always be interpreted in conjunction with clinical and epidemiologic findings.

 

Submission of more than one specimen for testing is not recommended.

 

Testing has not been validated for colostomy-, ileostomy-, or colonoscopically-collected specimens.

 

Patients may asymptomatically carry Clostridioides difficile; clinical correlation is needed when deciding how to manage patients with a positive test result.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

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

Method Description
Describes how the test is performed and provides a method-specific reference

Test is performed on the Cepheid GeneXpert Dx System, which automates and integrates sample purification, nucleic acid amplification, and detection of the target sequence in simple or complex samples using real-time polymerase chain reaction (PCR) and reverse transcription PCR assays. The system requires the use of single-use disposable cartridges that hold the PCR reagents and host the PCR process. Because the cartridges are self-contained, cross-contamination between samples is eliminated.

 

The Cepheid Xpert C difficile/Epi Assay is a qualitative in vitro diagnostic test for rapid detection of toxin B gene sequences and for presumptive identification of 027/NAP1/BI strains of toxigenic Clostridioides (Clostridium) difficile from patients suspected of having C difficile infection (CDI). Presumptive identification of 027/NAP1/BI strains of C difficile is by detection of binary toxin gene sequences and the single base pair deletion at nucleotide 117 in the tcdC gene. The tcdC gene encodes for a negative regulator in C difficile toxin production.

 

The Xpert C difficile/Epi Assay is intended as an aid in the diagnosis of CDI. Detection of 027/NAP1/BI strains of C difficile by the Xpert C difficile/Epi Assay is presumptive and is solely for epidemiological purposes and is not intended to guide or monitor treatment for C difficile infections. Concomitant culture is necessary only if further typing or organism recovery is required.(Package insert: Xpert C difficile /Epi. Cepheid; Rev. J, 04/2020)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Sunday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

Same day/1 day

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

7 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their account representative. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

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
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

87493

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
CDPCR C. difficile Toxin, PCR, F 54067-4
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
TCDRR C. difficile Toxin, PCR 54067-4

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports