Factor II (Prothrombin) G20210A Mutation Analysis

CPT 81240
Synonyms
  • Prothrombin DNA
  • Prothrombin Gene Analysis
  • Prothrombin Gene Mutation

Test Details

Use

Contributes to the risk assessment for venous thromboembolis thromboembolism (VTE) to better inform decisions regarding treatment and clinical management decisions of patients with relevant personal history of VTE and potential preventative care for patients with significant family history of VTE.

Limitations

Variant analyzed: c.*97G>A, previously referred to as G20210A. Results must be combined with clinical information for the most accurate interpretation. Molecular-based testing is highly accurate, but as in any laboratory test, diagnostic errors may occur. False positive or false negative results may occur for reasons that include genetic variants, blood transfusions, bone marrow transplantation, somatic or tissue-specific mosaicism, mislabeled samples, or erroneous representation of family relationships.

This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration.

Methodology

Polymerase chain reaction (PCR); restriction enzyme digestion

Related Documents

For more information, please view the literature below.

Procedures for Hemostasis and Thrombosis: A Clinical Test Compendium

Specimen Requirements

Information on collection, storage, and volume

Specimen

Whole blood or LabCorp buccal swab kit (buccal swab collection kit contains instructions for use of a buccal swab)

Volume

7 mL whole blood or LabCorp buccal swab kit

Minimum Volume

3 mL whole blood or two buccal swabs

Container

Lavender-top (EDTA) tube, yellow-top (ACD) tube, or LabCorp buccal swab kit

Storage Instructions

Maintain specimen at room temperature.

Causes for Rejection

Frozen specimen; hemolysis; quantity not sufficient for analysis; improper container; one buccal swab; wet buccal swab