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Prothrombin (Factor II) 20210G>A Mutation Analysis
Test Code17909
CPT Codes
81240
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), lithium heparin (green-top), or ACD (yellow-top) tube
Instructions
Extracted DNA: Please call 1-(866)-GENE-INFO or 1-(866)-436-3463 for additional information.
Frozen shipping is acceptable
Frozen shipping is acceptable
Transport Temperature
Room temperature
Specimen Stability
Room temperature: 8 days
Refrigerated: 8 days
Frozen: 30 days
Refrigerated: 8 days
Frozen: 30 days
Methodology
Polymerase Chain Reaction and Detection
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
Limitations
If this mutation is not found by the testing procedure, it does not mean that the risk of carrying or developing deep vein thrombosis is not present. It simply means that this specific mutation has not been found, although other mutations may be present. It is also possible that such a patient may have secondary deep vein thrombosis due to non-genetic causes that would not be detected by this test. A person with one copy of the mutation has an approximate 3-fold increase in risk for venous thrombosis. The increase in risk for a person with two copies of the mutation is not known.
Reference Range
See Laboratory Report
Clinical Significance
Factor II Mutation (G20210A) is one of the most common causes of venous thrombosis. 2.3% of the general population is heterozygous in contrast with 6.2% of patients with venous thrombosis and 18% with familial venous thrombosis. Other risk factors compound the risk for venous thrombosis.
Performing Laboratory
Quest Diagnostics Nichols Institute-San Juan Capistrano, CA |
33608 Ortega Highway |
San Juan Capistrano, CA 92675-2042 |