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HelpTest Code LAB2535 Clostridium difficile Antigen and Toxin by EIA, plus Reflex PCR
Infectious
Clinical System Name
Clostridium difficile Ag+Toxin Reflx PCR
Synonyms
C diff Toxin PCR
C. diff Toxin
Clostridium difficile Toxin A
CDIF TOX
Colitis Toxin
Clostridioides difficile
LAB2535
Sample Requirements
Specimen: Unformed Stool that conforms to the shape of the container
Container: Sterile (or clean) Container
Preferred Vol: 0.5 grams or mL
Minimum Vol: 0.2 grams or mL
A minimum of 7 days is required before repeat testing can be performed.
* Fixed stool specimens or rectal swabs are not acceptable and will be rejected.
* Formed stool samples are accepted from Heme/Onc patients where demonstration of clearance of the organism may be necessary.
* Samples collected in diapers should be transferred to a clean airtight container, and submitted as listed below.
Processing Instructions
CPA: Send sample to Microbiology for processing. If sample is shared and only one tube, or other container is received, affix shared sample label and send entire sample plus requisition to Microbiology.
Off-site collection: Off-site Children's Lab locations should send to SCH Main Campus for testing. Refrigerate sample before and during courier transport.
Other off-site locations, refrigerate sample prior to and during transport to SCH.
Stability
| Temp | Time |
|---|---|
| Room temp | <1 hour |
| Refrigerated | <72 hours |
| Frozen* | >72 hours |
*Stool specimens that are received frozen are not acceptable for the reflex PCR test, they will be tested by EIA only.
Availability
| Procedure | Performed | Turn Around Time (TAT) |
|---|---|---|
| EIA | 24/7 | 1 hour |
| PCR | 24/7 |
3 hours |
Performing Laboratory
Seattle Children's Laboratory
Department
Microbiology Laboratory
CPT Codes
87324
87493
Description
Stool is analyzed for Clostridum difficile (Clostridioides difficile) antigen and toxin by EIA. Samples that are Antigen positive and Toxin negative by EIA screen, will be analyzed by the more sensitive PCR assay to detect C. difficile toxin.
Note: Stool specimens that are received frozen are not acceptable for the reflex PCR test, they will be tested by EIA only.
A minimum of 7 days is required before repeat testing can be performed.
Note: Testing for C. difficile toxin in infants is often inappropriate because of the frequency of asymptomatic colonization:
<1 month old: 37% of infants are colonized with toxin-producing C difficile.
1-6 month old: 30% of infants are colonized with toxin-producing C difficile.
6-12 month old: 14% of infants are colonized with toxin-producing C difficile.
Results of tests in these age groups may not be indicative of disease caused by this organism.
With the exception of patients from Hematology/Oncology service (where demonstration of clearance of the organism is required before patient can be removed from isolation), this test is only performed on unformed stools that conform to the shape of the container.
Reporting Information
Final Report: 1-3 hours
Notifiable Result
See Link below for Notifiable Conditions for WA state labs:
https://doh.wa.gov/public-health-healthcare-providers/notifiable-conditions
See Link below for PDF of phone numbers for Local Health jurisdictions (by County) in WA State:
https://www.doh.wa.gov/Portals/1/Documents/1200/LHJCommunicableDiseaseReporting.pdf