Test Details
Methodology
Polymerase chain reaction (PCR) and gel electrophoresis
Result Turnaround Time
3 - 5 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Test Includes
Factor II G20210A DNA analysis (F2 gene - c.*97G>A); Factor V Leiden DNA analysis (F5 gene - c.1691G>A, p.Arg534Gln; Factor II G20210A DNA analysis (F2 gene - c.*97G>A); Factor V Leiden DNA analysis (F5 gene - c.1691G>A, p.Arg534Gln)
Use
Evaluation of patients with venous thrombosis. See Related Information for individual components of this profile.
Limitations
Variants analyzed: F5 gene - c.1691G>A (p.Arg534Gln), also known as Factor V Leiden; F2 gene -c.*97G>A, also known 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.
Specimen Requirements
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 or refrigerate.
Causes for Rejection
Frozen specimen; hemolysis; quantity not sufficient for analysis; improper container; one buccal swab; wet buccal swab
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 511403 | Thrombotic Risk Profile | 511559 | Factor V Leiden Mutation | 21667-1 | ||
| 511403 | Thrombotic Risk Profile | 512258 | Reviewed by: | 56850-1 | ||
| 511403 | Thrombotic Risk Profile | 511218 | Factor II, DNA Analysis | 24476-4 | ||
| 511403 | Thrombotic Risk Profile | 512253 | Reviewed by: | 56850-1 | ||
| Order Code | 511403 | |||||
| Order Code Name | Thrombotic Risk Profile | |||||
| Order Loinc | ||||||
| Result Code | 511559 | |||||
| Result Code Name | Factor V Leiden Mutation | |||||
| UofM | ||||||
| Result LOINC | 21667-1 | |||||
| Order Code | 511403 | |||||
| Order Code Name | Thrombotic Risk Profile | |||||
| Order Loinc | ||||||
| Result Code | 512258 | |||||
| Result Code Name | Reviewed by: | |||||
| UofM | ||||||
| Result LOINC | 56850-1 | |||||
| Order Code | 511403 | |||||
| Order Code Name | Thrombotic Risk Profile | |||||
| Order Loinc | ||||||
| Result Code | 511218 | |||||
| Result Code Name | Factor II, DNA Analysis | |||||
| UofM | ||||||
| Result LOINC | 24476-4 | |||||
| Order Code | 511403 | |||||
| Order Code Name | Thrombotic Risk Profile | |||||
| Order Loinc | ||||||
| Result Code | 512253 | |||||
| Result Code Name | Reviewed by: | |||||
| UofM | ||||||
| Result LOINC | 56850-1 |