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Test ID CDIFS Clostridioides difficile Culture with Antimicrobial Susceptibilities, Varies


Ordering Guidance


Culture is not the preferred diagnostic test for Clostridioides difficile. For routine diagnostic testing, order CDPCR / Clostridioides difficile Toxin, PCR, Feces



Shipping Instructions


 



Necessary Information


Specimen source is required.



Specimen Required


Submit only 1 of the following specimens:

 

Patient Preparation: Patient should not use antacids, barium, bismuth, antidiarrheal medication, zinc oxide paste, Vagisil cream or oily laxatives prior to specimen collection.

 

Preferred:

Specimen Type: Preserved feces

Supplies: Culture and Sensitivity Stool Transport Vial (T058); Stool Collection Kit, Random (T635)

Container/Tube: Commercially available transport system specific for recovery of enteric pathogens from fecal specimens (15 mL of non-nutritive transport medium containing phenol red as a pH indicator, either Cary-Blair or Para-Pak C and S [T058])

Specimen Volume: Representative portion of feces; 5 mL

Collection Instructions:

1. Collect 1 gram or 5 mL fresh fecal specimen and submit in container with transport medium.

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

Additional Information: Only diarrheal (ie., unformed) feces should be tested. Testing formed feces for C difficile is not clinically indicated.

Specimen Stability Information: Ambient (preferred) 96 hours/Refrigerated 96 hours/Frozen 7 days

 

Acceptable:

Specimen Type: Unpreserved feces

Supplies: Stool container, Small (Random), 4 oz (T288); Stool Collection Kit, Random (T635)

Specimen Volume: Representative portion of stool

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

Specimen Stability Information: Ambient (preferred) 72 hours/Frozen 7 days

Additional Information: Only diarrheal (i.e., unformed) stool should be tested. Testing formed stool for C difficile is not clinically indicated.

Specimen Stability Information: Ambient (preferred) 72 hours/Frozen 7 days

 

Specimen Type: Fresh tissue or biopsy

Sources: Colon

Supplies: Anaerobe Transport Tube (T588)

Specimen Volume: Entire collection, 1-2 cm(3)

Collection Instructions: Aseptically collect a 1-2 cm(3) piece of tissue whenever possible. In general, a larger piece of tissue is preferred. Submit in an anaerobic transport tube.

Specimen Stability Information: Ambient 72 hours


Useful For

Providing an isolate suitable for antimicrobial susceptibility testing to direct antimicrobial therapy of extraluminal infections and in cases of treatment failure

Highlights

Culture provides definitive evidence of the presence of the bacterium Clostridioides (Clostridium) difficile in feces, providing an isolate for antimicrobial susceptibility testing.

 

Susceptibility testing of C difficile isolates may be warranted in cases of treatment failure, or when used to guide therapy of extraluminal infections.

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
ANAID Anaerobe Ident No, (Bill Only) No
RMALA Id MALDI-TOF Mass Spec Anaerobe No, (Bill Only) No
ISAN Anaerobe Ident by Sequencing No, (Bill Only) No
SANA Anaerobe Suscep per agent No, (Bill Only) No
BATTA Anaerobe Suscep Battery No, (Bill Only) No

Testing Algorithm

When this test is ordered, the reflex tests may be performed and charged separately. Isolates of Clostridioides (Clostridium) difficile (1,2) will automatically have susceptibility testing performed and billed as appropriate. Antimicrobial agents appropriate to the organism and specimen source will be tested according to Mayo’s practice and the laboratory’s standard operating procedures.

 

See Anaerobic Bacteria Antimicrobials in Special Instructions to review the table which provides a listing of the antimicrobials routinely tested in our laboratory as well as antimicrobials that may be tested upon request. If the antimicrobial of interest is not listed in this table, contact Mayo Clinic Laboratories at 800-533-1710 and ask to speak to the Bacteriology Anaerobe Laboratory.

 

Anaerobe susceptibilities battery will routinely be performed at an additional charge. If fewer than 3 antibiotics will be reported, then anaerobe susceptibilities battery will be canceled and anaerobe susceptibilities per agent will be charged per antibiotic tested. Based on susceptibility criteria, anaerobe susceptibilities per agent may be performed at an additional charge.

Method Name

Conventional Culture Technique with Minimum Inhibitory Concentration (MIC) by Agar Dilution

Reporting Name

C. difficile Culture + Susc

Specimen Type

Varies

Specimen Minimum Volume

Stool: 1 gram or 5 mL
Tissue: 5 mm(3)

Specimen Stability Information

Specimen Type Temperature Time Special Container
Varies Varies

Reject Due To

Fecal swab
Specimen in Ecofix
Reject
  All specimens will be evaluated at Mayo Clinic Laboratories for test suitability.

Clinical Information

Clostridioides difficile can cause diarrhea and may cause pseudomembranous colitis. Overgrowth of toxin-producing C difficile in the colon leads to the production of toxins A and/or B by the organism, and subsequent diarrhea. C difficile infection should be suspected in patients with symptoms of diarrhea with risk factors such as current or recent use of antibiotics, history of C difficile infection, current or recent hospitalization or placement in a nursing home or long-term care facility, over 65 years of age, and gastric acid suppression. C difficile infection is the most common cause of diarrhea in hospitalized patients and may lead to serious complications, including sepsis, bowel perforation, and increased overall mortality (especially in elderly patients). The incidence of C difficile infection has risen in the community and in healthcare settings. While culture is not the preferred means to diagnose C difficile-associated diarrhea, culture for C difficile provides an isolate suitable for antimicrobial susceptibility testing.

 

Susceptibility testing routinely includes metronidazole and vancomycin. Routine antimicrobial susceptibility testing of C difficile isolates associated with intestinal infection is not suggested.(4,5) Recent Infectious Diseases Society of America and Society for Healthcare Epidemiology of America guidelines provide treatment guidance for C difficile infection based on clinical course and history rather than measured minimal inhibitory concentrations of isolates.(6) Susceptibility testing of C difficile isolates may be warranted in cases of treatment failure, or when used to guide therapy of extraluminal infections.

 

Note that this test does not differentiate between toxin-producing and nontoxigenic strains of C difficile.

Reference Values

No growth of Clostridioides difficile.

 

Susceptibility results are reported as minimal inhibitory concentration (MIC) in mcg/mL. Breakpoints (also known as clinical breakpoints) are used to categorize an organism as susceptible, susceptible-dose dependent, intermediate, resistant, or nonsusceptible according to breakpoint setting organizations, either the Clinical and Laboratory Standards Institute (CLSI) or the European Committee on Antimicrobial Susceptibility Testing (EUCAST), as applicable.

 

In some instances, an interpretive category cannot be provided based on available data; therefore, the following comment will be included on the report: There are no established interpretive guidelines for agents reported without interpretations.

 

For information regarding CLSI and EUCAST susceptibility interpretations, see Susceptibility Interpretative Category Definitions.

Interpretation

A positive result indicates the presence of viable Clostridioides difficile in stool.

 

A positive culture may be found with asymptomatic C difficile colonization with a toxin-producing or non-toxin-producing strain, or with C difficile-associated diarrhea.

 

A negative result indicates the absence of C difficile growth in culture.

 

Isolation of C difficile does not differentiate between toxin-producing and non-toxin-producing strains.

 

Refer to the Reference Values section for interpretation of various antimicrobial categories.

Cautions

The assay must be performed on fresh feces, fresh-frozen feces, or feces in transport medium. Only diarrheal (ie, unformed) feces should be tested.

 

Submission of more than 1 specimen for testing is not recommended.

 

Repeated testing during a single episode of diarrhea is not recommended.

 

Testing of asymptomatic patients (ie, without diarrhea) or for test of cure is not recommended.

 

Patients may asymptomatically carry C difficile.

 

Testing of specimens collected by colostomy, ileostomy, or colonoscopy has not been validated.

 

When antimicrobial susceptibilities are performed, in vitro susceptibility does not guarantee clinical response. Therefore, the decision to treat with a particular agent should not be based solely on the antimicrobial susceptibility testing result.

Clinical Reference

1. 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

2. Oren A, Garrity GM. List of new names and new combinations previously effectively, but not validly, published. Int J Syst Evol Microbiol, 2016;66(7):2463-2466. doi:10.1099/ijsem.0.001149

3. CLSI: Performance Standards for Antimicrobial Susceptibility Testing. 32nd edition. CLSI Supplement M100. Wayne, PA. Clinical and Laboratory Standards Institute. 2023

4. 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)

5. Schuetz AN, Carpenter DE: Susceptibility test methods: anaerobic bacteria. In: Carroll KC, Pfaller MA, eds. Manual of Clinical Microbiology. 12th ed. ASM Press; 2019:1377-1397

6. Johnson S, Lavergne V, Skinner AM, et al. Clinical practice guidelines 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

7. Snydman DR, McDermott LA, Jacobus NV, et al. U.S.-Based National Sentinel Surveillance Study for the epidemiology of clostridium difficile-associated diarrheal isolates and their susceptibility to fidaxomicin. Antimicrob Agents Chemother. 2015;59(10):6437-6443. doi:10.1128/AAC.00845-15

8. Goldstein EJ, Citron DM, Tyrrell KL, Merriam CV. Comparative in vitro activities of SMT19969, a new antimicrobial agent, against clostridium difficile and 350 gram-positive and gram-negative aerobic and anaerobic intestinal flora isolates. Antimicrob Agents Chemother. 2013;57(10):4872-4876. doi:10.1128/AAC.01136-13

6. Johnson S, Lavergne V, Skinner AM, et al. Clinical practice guidelines 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

Method Description

Specimens are directly inoculated onto a chromogenic C difficile plate which is incubated anaerobically at 35 to 37° C for 24 hours. Plates are observed for characteristic fluorescence using ultraviolet light at 365 nm. Fluorescent colonies are identified by MALDI-TOF MS or 16S ribosomal RNA gene sequencing.(Instruction manual: CHROMagar C. difficile, NT-EXT-077, Version 9, Available at www.CHROMagar.com)

 

The agar dilution method is used for routine susceptibility testing. The antimicrobial is added to agar in various concentrations depending upon levels attainable in serum. A standardized suspension of the organism is applied to the agar plates, which are incubated anaerobically for 42 to 48 hours at 35 to 37° C. The end point is that in which a marked reduction occurs in the appearance of growth on the test plate as compared to that of growth on the control plate. Examples of marked change include a change from confluent growth to a haze, less than 10 tiny colonies, or 1 to 3 normal-sized colonies.(CLSI. Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria. 9th ed. CLSI standard M11. Wayne PA, CLSI, 2018)

Day(s) Performed

Monday through Sunday

Report Available

2 to 9 days

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

87081-C. difficile Culture

87076-Anaerobe Ident (if appropriate)

87076-Id MALDI-TOF Mass Spec Anaerobe (if appropriate)

87153-Anaerobe Ident by Sequencing (if appropriate)

87181-Anaerobe Susceptibility per agent (if appropriate)

87181 x 3-Antimicrobial Susceptibility, Anaerobic Bacteria, MIC (if appropriate)

NY State Approved

Yes