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Test Code LAB4605 C DIFFICILE BY PCR

Infectious

Specimen Type

Fresh stool without preservative, liquid, or soft stool (must conform to collection container)

Collection Instructions

Collect liquid or unformed stool in a container with a tight fitting lid
Label collection container with patient’s name, source, date and time of collection

Specimen Volume

Preferred: 5mL

Min volume: 10uL

Turnaround Time

4 hours

Test Schedule

Daily from 0500 to 2300

Sample Stability

Room Temp: 2 days
Refrigerated: 5 days

Method

Cepheid GeneXpert Real-time PCR assay

Reference Ranges

Not Detected

Detected*

 

*A positive C.diff result will automatically reflex to toxin EIA testing.

Synonyms

C diff, Clostridium difficile Toxins A/B, C diff PCR.

Test Components

Clostridium difficile, toxin gene(s), amplified probe technique

CPT Codes

87493

Interfering Substances

Potentially interfering substances include, but are not limited to, Vagisil cream and zinc oxide paste.

Rejection Criteria

Solid or formed stool (does not conform to specimen cup)

Stool in transport media

Stool mixed with toliet water or urine

Limitations

  • Detection of C. difficile nucleic acid in stools confirms the presence of these organisms in diarrheal patients but may not indicate that C. difficile are the etiologic agents of the diarrhea.
  • Results from the Xpert C. difficile/Epi Assay should be interpreted in conjunction with other laboratory and clinical data available to the clinician.
  • Positive results observed with immunocompromised pediatric patients may reflect asymptomatic carriage of C. difficile/Epi.
  • False-negative results may occur when the infecting organism has genomic mutations, insertions, deletions, or rearrangements or when performed very early in the course of illness.