UGT1A1 Gene Polymorphism (TA Repeat)

Test Code

17813

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

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

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.