19911A>G Mutation Analysis

Test Code

16533X

CPT Codes
81400

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

ACD solution A or B (yellow-top) tube • Lithium heparin (green-top) tube • Sodium heparin (green-top) tube

Instructions

Whole blood: Normal phlebotomy procedure. Specimen stability is crucial. Store and ship ambient immediately. Do not freeze.

Transport Temperature

Room temperature

Specimen Stability

Room temperature: 8 days
Refrigerated: 8 days
Frozen: Unacceptable

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

Blood samples received frozen

Methodology
Capillary Electrophoresis • Fluorescence Detection • Polymerase Chain Reaction Amplification • Single Nucleotide Extension

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.

This test is performed pursuant to a license agreement with Orchid Biosciences, Inc.

Setup Schedule

A.M. Sets up 1 day a week.

Clinical Significance

This test can be used to detect the 19911A→G polymorphism in the prothrombin (Factor II) gene which may modulate the risk of deep vein thrombosis in patients with the G20210A mutation.

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.