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UGT1A1 Gene Polymorphism (TA Repeat)
Test Code17813
CPT Codes
81350
Physician Attestation of Informed Consent
This germline genetic test requires physician attestation that patient consent has been received if ordering medical facility is located in AK, DE, FL, GA, IA, MA, MN, NV, NJ, NY, OR, SD or VT or test is performed in MA.
Preferred Specimen
5 mL whole blood collected in an EDTA (lavender-top) tube
Minimum Volume
3 mL
Other Acceptable Specimens
Whole blood collected in: EDTA (royal blue-top), sodium heparin (green-top) or lithium heparin (green-top)
Instructions
Collect 5 mL of whole blood in a lavender-top (EDTA) tube. Whole blood is shipped at room temperature. Do not freeze whole blood. Record the draw time and date on the tube. Ship immediately to maintain sample stability.
Transport Temperature
Room temperature
Specimen Stability
Room temperature: 8 days
Refrigerated: 8 days
Frozen: Unacceptable
Refrigerated: 8 days
Frozen: Unacceptable
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Gross hemolysis • Clotted blood • Received frozen
Methodology
Fluorescent Polymerase Chain Reaction
FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Setup Schedule
Set up: Mon, Thurs; Report available: 7 days from set up
Limitations
Individuals with two copies of TA7 have a higher risk of side effects such as neutropenia and diarrhea when treated with irinotecan. This assay does not detect other variants or mutations in the UGT1A1 gene which may impair irinotecan metabolism. Neither does it examine other genetic or non-genetic modifiers of irinotecan metabolism.
Reference Range
See Laboratory Report
Clinical Significance
This test is intended to identify patients who may have Gilbert syndrome and those who are at increased risk for Irinotecan toxicity.
Performing Laboratory
Quest Diagnostics Nichols Institute-San Juan Capistrano, CA |
33608 Ortega Highway |
San Juan Capistrano, CA 92675-2042 |