Test Catalog

Test Id : EIACD

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Clostridioides difficile Toxin, EIA, Feces

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Overview

Test Catalog

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

Diagnosing the presence of toxigenic Clostridioides difficile

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

Enzyme Immunoassay (EIA)

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 Antigen, Feces

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

Antibiotic Associated Diarrhea

Antibiotic Associated Pseudomembranous Colitis

Enzyme immunoassay

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

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. Within 2 hours of collection place feces in preservative.

Specimen Stability Information: Ambient (preferred) <7 days/Refrigerated <7 days

 

Acceptable:

Specimen Type: Unpreserved feces

Supplies:

-Stool container, Small (Random), 4 oz (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) <7 days/Frozen <7 days

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

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

Formed stool
Fecal ESwabs
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 7 days

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

Diagnosing the presence of toxigenic Clostridioides difficile

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

In the United States, toxigenic Clostridioides difficile (TCD) accounts for 15% to 25% of all episodes of antibiotic-associated diarrhea. TCD is also associated with a spectrum of disease states, ranging from asymptomatic colonization to pseudomembranous colitis, toxic megacolon, sepsis, and death. Pathogenic C difficile produces one or both of 2 toxins, toxin A and toxin B. While toxin A is produced by most disease-causing strains of C difficile, it has been shown that some disease-causing strains of C difficile produce only toxin B. C difficile strains that do not produce toxins A or B are thought to be avirulent.

 

Toxin A and B enzyme immunoassays (EIA) have low sensitivity and moderate specificity for C difficile infection. The suboptimal performance of EIA sparked the development of molecular tests (eg, polymerase chain reaction) that have high sensitivity. EIA may be useful as part of a multi-step algorithm if patients do not meet preanalytic criteria for stool submission (unexplained and new onset diarrhea with at least 3 unformed stools/day and no recent laxative use).

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:

 C difficile toxin detected by enzyme immunoassay (EIA).

 

Negative:

C difficile toxin not detected by enzyme immunoassay (EIA).

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

Results should be interpreted in conjunction with other laboratory and clinical data available to the clinician.

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

1. Johnson S, Lavergne V, Skinner AM, et al. Clinical Practice Guideline by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA): 2021 Focused Update Guidelines on Management of Clostridioides difficile Infection in Adults. Clin Infect Dis. 2021;73(5):e1029-e1044. doi:10.1093/cid/ciab549

2. McDonald LC, Gerding DN, Johnson S, et al. Clinical practice guidelines for Clostridium difficile infection in adults and children: 2017 update by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA). Clin Infect Dis. 2018;66(7):987-994

3. Miller R, Morillas JA, Brizendine KD, Fraser TG. Predictors of Clostridioides difficile infection -related complications and treatment patterns among nucleic acid amplification test -positive/toxin enzyme immunoassay-negative patients. J Clin Microbiol. 2020;58(3):e01764-19

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

The C. DIFF QUIK CHEK COMPLETE test uses antibodies specific for  toxins A and B of C difficile. The device contains a Reaction Window with three vertical lines of immobilized antibodies. The Conjugate consists of antibodies to toxins A and B coupled to horseradish peroxidase. To perform the test, the sample is added to a tube containing a mixture of Diluent and Conjugate. The diluted sample-conjugate mixture is added to the Sample Well and the device is allowed to incubate at room temperature for 15 minutes. During the incubation, any toxins A and B in the sample bind to the antibody-peroxidase conjugates. The antigen-antibody-conjugate complexes migrate through a filter pad to a membrane where they are captured by the immobilized toxins A and B-specific antibodies in the lines. The Reaction Window is subsequently washed with Wash Buffer, followed by the addition of Substrate. This test will detect levels of toxin A at greater or equal to 0.63 ng/mL and toxin B at greater than or equal to 0.16 ng/mL.(Package insert: C. Diff Quik Chek Complete IFU. RMS 91-525C-03-TL, TechLab; 06/2021)

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 modified from the manufacturer's instructions. Its performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.

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.

87324

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
EIACD C. difficile Toxin Antigen, Feces 79177-2
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.
EIACD C. difficile Toxin Antigen, Feces 79177-2

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

Test Update Resources

Change Type Effective Date
New Test 2025-06-05