Factor V (Leiden) Mutation Analysis with Reflex to HR2 Mutation Analysis

Test Code

17904

CPT Codes
81241

Includes

If Factor V Leiden is Heterozygous for the R506Q mutation, then HR2 testing will be performed at an additional charge (CPT code: 81400).

Preferred Specimen

5 mL whole blood collected in an EDTA (lavender-top) tube

Minimum Volume

3 mL

Other Acceptable Specimens

Whole blood collected in: acid citrate dextrose ACD (yellow-top) tube, or sodium heparin or lithium heparin (green-top) tube

Instructions

Extracted DNA: Please call 1-866-GENE-INFO additional information.

Transport Temperature

Room temperature

Specimen Stability

Room temperature: 8 days
Refrigerated: 8 days
Frozen: 30 days

Methodology
Screen: Polymerase Chain Reaction and Detection
Reflex: Fluorescent Microspheres • Oligonucleotide Ligation Assay • Polymerase Chain Reaction (PCR)

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. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule

Set up: Daily; Report available: 4-5 days

Reference Range

See Laboratory Report

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.