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Specimen Collection Manual and Test Catalog

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CLOSTRIDIUM DIFFICILE, PCR

Geisinger Epic Procedure Code:  LAB2030    Geisinger Epic ID:  41929

SPECIMEN COLLECTION
Specimen type: 

Fresh undiluted, non-formed stool (1-2 mL). Bristol stool chart 5, 6 and 7 are acceptable consistencies. Formed stool may be accepted only from a Gastroenterology provider.


Preferred collection container: 
Specimen required: 

1-2 mL of non-formed stool


Special notes: 

Stool aspirate specimens (i.e., stool aspirate, colon contents, colon aspirate) are acceptable as long as it is verified that the patient did not have a gastrointestinal preparation. Please contact the laboratory before the collection of stool aspirates for additional instructions.

Any Clostridium difficile PCR (CDIFP) collected =36 hours after admission is automatically cancelled.



SPECIMEN PROCESSING
Transport temperature: 

Transport specimens to laboratory at 2-8°C (2-25°C also acceptable). Protect specimen against freezing or exposure to excessive heat.


Specimen stability: 

Stable at 2-8°C for 5 days. Stable at room temperature (15-25°C) for 24 hours.


Rejection criteria: 

Specimens collected on swabs or in diapers. Specimens collected in formalin, PVA, MF, SAF or ETM. Specimens contaminated with barium. Formed stools, lumen contents, and duodenal aspirates/washes/biopsies are also not acceptable. Improperly labeled/identified specimens. Frozen specimens. Specimens which exceed stability limits. Improper specimen type. Specimen collected in non-sterile container. Diluted samples.



TEST DETAILS
Reference interval: 

Negative. No C. difficile toxin B gene DNA detected by PCR (Amplified Probe)


Critical values/courtesy alerts: 
Positive for C. difficile toxin B gene DNA detected by PCR (Amplified Probe). Presumptive negative for C. diffiicle 027-NAP1-B1 strain by PCR (Amplified Probe) OR Positive for C. difficile Toxin B gene DNA by PCR (Amplified Probe). Presumptive positive for C. difficile 027-NAP1-B1 strain by PCR (Amplified Probe).
CPT code(s):  87493
Note: The billing party has sole responsibility for CPT coding.  Any questions regarding coding should be directed to the payer being billed.
The CPT codes provided by GML are based on AMA guidelines and are for informational purposes only.

Test includes: 

Detection of C. difficile toxin B gene DNA. Presumptive detection of genetic targets associated with hypervirulent (NAP1/027/B2) strain.


Methodology: 
Real-time Polymerase Chain Reaction (PCR)
Synonyms: 

C. difficile assay, Toxin A Assay, Toxin B Assay, Toxin A/B Assay, C. difficile, PCR nucleic acid amplification, Clostridium difficile, CDIFP


Clinical significance: 

C. difficile is a causative agent of a spectrum of diseases ranging from antibiotic-associated diarrhea to toxic megacolon. Overgrowth of the C. difficile bacteria and subsequent toxin production has been associated primarily with antibiotic usage; however, hypervirulent strains may cause disease in people without predisposition.


Doctoral Director(s): 
Donna Wolk PhD, D(ABMM)
Julie Hirschhorn, PhD, HCLD(ABB)
Review Date:  12/31/2024

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