UGT1A1 Gene Polymorphism (TA Repeat)
Order Code:
UGT
Test Summary
This test is intended to identify patients who may have Gilbert syndrome and those who are at increased risk for Irinotecan toxicity.
Aliases
- N/A
Specimen Collection
Special Instructions
N/A
Preferred Specimen
5 mL whole blood collected in an EDTA (lavender-top) tube
Minimum Volume
3 mL
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.
Patient Preparation
N/A
Storage
N/A
Transport Temperature
Room temperature
Specimen Stability
- Room temperature: 8 days
- Refrigerated: 8 days
- Frozen: Unacceptable
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.
Other Acceptable Specimens
Whole blood collected in: EDTA (royal blue-top), sodium heparin (green-top) or lithium heparin (green-top)
Unacceptable Specimens
Received frozen, gross hemolysis, clotted blood
Order Code
UGT
EPIC (Premier) Code
LAB3298
Includes
N/A
CPT Code
- 81350
Billing Code
- 670858
CPT Statement
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 the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
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.
Testing Laboratory
Quest Diagnostics Nichols Institute
33608 Ortega Highway
San Juan Capistrano CA, 92675
33608 Ortega Highway
San Juan Capistrano CA, 92675
Department
Reference Testing
Reference Range
See Laboratory Report
Setup Schedule / Expected Turnaround Time
Monday, Thursday; Report available: 6 days after set up
Specimen Collection
Special Instructions
N/A
Preferred Specimen
5 mL whole blood collected in an EDTA (lavender-top) tube
Minimum Volume
3 mL
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.
Patient Preparation
N/A
Storage
N/A
Transport Temperature
Room temperature
Specimen Stability
- Room temperature: 8 days
- Refrigerated: 8 days
- Frozen: Unacceptable
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.
Other Acceptable Specimens
Whole blood collected in: EDTA (royal blue-top), sodium heparin (green-top) or lithium heparin (green-top)
Unacceptable Specimens
Received frozen, gross hemolysis, clotted blood
Result Information
Methodology
Fluorescent Polymerase Chain Reaction
Testing Laboratory
N/A
Reference Range
See Laboratory Report
Setup Schedule / Expected Turnaround Time
Monday, Thursday; Report available: 6 days after set up