LAB3716
CDIFF PCR

Test not performed on patients less than 2 years of age. Specimens from patients under the age of 2 are referred to Children’s Hospital Anschutz lab for testing (Minimum volume: 100 µL of fresh, unformed stool).

• Formed stool.
• Sample with preservative.
• Stool contaminated with urine.
• Stool in diapers, tissue paper, or homemade containers.
• Samples sent on adult patients (≥18 years) previously tested as negative less than 7 days ago or previously tested as positive less than 14 days ago.
• Children <2 years of age.
• Sample not properly identified, incorrect container, insufficient volume, or past stability.

Internal: Deliver to lab immediately at ambient temperature.
Offsite: Refrigerate and deliver fresh stool to lab within 24 hours (preferred).

Room Temp: 24 hours
Refrigerated: 5 days
Frozen: 6 months (fresh preferred)

The results of this test should be coupled with clinical indicators for diagnosis, as Toxin B may be detected for an extended period after successful treatment. A negative CDIFF PCR result does not exclude C. difficile involvement in a disease process.
This assay will identify non-027/NAP/BI isolates representing toxinotype XIV and occasionally toxinotypes IV, V and X as presumptive positives for 027/NAP/BI.

For Inpatients Only: A "Detected" stand-alone C. difficile Toxin PCR test will reflex to Toxin EIA (TOXINEIACDIF).

Inpatient and ED ordering must occur through the GI Wizard. Restrictions apply to adults ≥18 years. Ensure stool documentation is accurate.

For C. difficile PCR ordering questions please refer to the link at the top of the GI Wizard or Amion under (UCH) Infection Control.

For GI PCR Panel ordering questions please refer to the link at the top of the GI Wizard or Amion under (UCH) Clinical Laboratory.

Same day for C. difficile Toxin PCR

Inpatient and ED ordering must occur through the GI Wizard. Restrictions apply to adults ≥18 years. Ensure stool documentation is accurate.

Samples for previously negative patients may only be submitted seven days or more after the previous sample collection date. Samples for previously positive patients may only be submitted 14 days or more after the previous sample collection date.

The reflex C. diff Toxin EIA test is not available as a standalone order.

To request approval for a C. difficile PCR only please contact Infection Prevention between 7 A.M–9 P.M.

To request approval for a GI PCR Panel please contact the Clinical Lab Molecular Diagnostics department (86892) for Medical Director contact information.

LAB3716
CDIFF PCR

Toxin PCR
Testing Note:
Test is not performed on children less than 2 years of age, as method has not been validated by the manufacturer for this age group.  Diarrheal stools should be sent because asymptomatic colonization with toxigenic strains can occur in hospital environments.

Interpretation:
Toxigenic C. difficile Negative = no toxigenic C. difficile detected
Toxigenic C. Difficile Positive = toxigenic C. difficile detected

027 NAP1 BI Presumptive Negative for NAP-1 = NAP-1 not detected
027 NAP1 BI Presumptive Positive for NAP-1 = NAP-1 detected

Methodology:
This test employs PCR amplification using C. difficile Toxin B-specific primers and probes. A positive result should be coupled with clinical indicators for diagnosis as Toxin B may be detected for an extended period after successful treatment.  A negative result for this assay does not exclude C. difficile involvement in a disease process. This test has been approved by the U.S. Food and Drug Administration.   This laboratory is certified under the Clinical Laboratory Improvement Amendment of 1988 ("CLIA") as qualified to perform high complexity clinical testing.

87493 – CDIFF PCR
And if indicated:
87324 – TOXIN EIA (CDIF)