C. difficile Toxin B PCR with reflex to C. difficile Antigen and Toxins A/B EIA

Abbrev Code:CDBPCR   
Order Code:LAB8261Order Name:C. difficile Toxin B PCR with reflex to C. difficile Antigen and Toxins A/B EIA
Synonyms:Clostridioides difficile; Clostridium difficile; Cdiff; Stool; C Diff; Cdiff Toxin
Methodology:Real-time polymerase chain reaction (PCR) with reflex to an Enzyme Immunoassay
CPT Codes: 87493 x1, 87493 x1, 87324 x1, 87324 x1
Turnaround Time:Performed daily; results are reported within 24 hours.
Associated Links:

IDDL Stool Collection Container Guidelines, C. difficile Reflex Testing Results Information and Interpretation

Collection Instructions

Specimen:Feces, liquid/pourable/unformed/conforms to shape of container
Optimal Volume:3 mL
Minimum\Peds Volume:1 mL
Container:Plastic Leakproof Container or Sterile Stool Transport Vial
Causes for Rejection:Formed and semi-formed stools are not acceptable. Stool samples must be liquid/pourable and unformed in consistency. Rectal swabs are not acceptable. Feces collected in preservative are not acceptable. Specimens in formalin-based or alcohol-based fixative; Rectal swabs.
Exception: Formed and semi-formed stools received from Rebiotix and from Adult and Pediatric BMT patients from 5A, 5B, 5C, and Peds BMT URU4 from admission screening are acceptable for testing.

Processing and Shipping

Specimen Processing:Store in refrigerator.
Shipping Instructions:Ship at refrigerated temperature <24 hours. Ship frozen >24 hours. Must arrive within 3 days. Ideal specimens are <24 hours old.
Stability:24 hours at refrigerated temperature; 3 days frozen.
Test Performed at or Referral Lab Infectious Diseases Diagnostic Laboratory   (Grand Itasca, Range, UMMC East Bank)


Reference Range:
Negative for C. difficile toxin B by PCR  
Limitations:Per assay package insert: Inhibition of the C. difficile assay has been observed in the presence of the following substances: zinc oxide paste and Vagisil cream. Performance characteristics were not established for patients less than 2 years of age with this assay. The effects of urine contamination in stool specimens submitted for C. difficile PCR testing are unknown. Therefore, it is advisable to avoid urine contamination.
Use:C. difficile Toxin B PCR utilizes real-time PCR to detect toxin B gene sequences associated with toxin producing C. difficile in stool specimens collected from patients suspected of having Clostridioides difficile infection. The C. difficile enzyme immunoassay detects a C. difficile antigen, glutamate dehydrogenase (GDH), as a screen for the presence of C. difficile. It also confirms the presence of toxigenic C. difficile by detecting toxins A and B in fecal specimens from persons suspected of having C. difficile infection.  These tests are used to aid in the diagnosis of C. difficile disease in patients experiencing loose, watery stools with risk factors (e.g. recent antibiotic use, immunosuppression, hospital stay) and should be used in conjunction with patient history and clinical findings.

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