Factor V (Leiden) Mutation Analysis

Factor V (Leiden) Mutation Analysis

Test Code

17900
81241
CPT Code is subject to a Medicare Limited Coverage Policy and may require a signed ABN when ordering.
17900
81241
CPT Code is subject to a Medicare Limited Coverage Policy and may require a signed ABN when ordering.
Not offered in Quest Diagnostics Nichols Institute (IFD) – San Juan Capistrano. Please provide SERVICE AREA INFORMATION to find available tests you can order.
In-home collection is not available in your area through Quest Mobile.

Clinical Significance

Factor V (Leiden) Mutation Analysis -

This test detects the factor V Leiden variant, the most common cause of inherited thrombophilia; it may be used to evaluate individuals with a strong personal or family history of venous thromboembolism (VTE) and inform treatment or preventive decisions [1].

Factor V Leiden refers to the c.1691G>A variant in the FV gene, which encodes coagulation factor V. This variant results in resistance to factor V protein degradation by activated protein C and increases the risk of VTE 6 to 8 fold in heterozygous carriers and 80 fold in homozygous carriers [1]. The mean age of symptom onset ...

Test Resources

Test Details

Methodology

Polymerase Chain Reaction and Detection

Assay Category

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.

Reference Range(s)

See Laboratory Report

LOINC® Codes, Performing Laboratory

Methodology

Polymerase Chain Reaction and Detection
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.

Reference Range(s)

See Laboratory Report

Preferred Specimen(s)

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

Alternative Specimen(s)

Whole blood collected in: EDTA (royal blue-top), sodium heparin (green-top), ACD solution A or B (yellow-top), or lithium heparin (green-top)

Minimum Volume

3 mL

Collection Instructions

Extracted DNA: Please call 1-(866)-GENE-INFO or 1-866-436-3463 for additional information.

Frozen shipping is acceptable.

Transport Container

EDTA (lavender-top) tube

Transport Temperature

Room temperature

Specimen Stability

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

Setup Schedule

4 mL whole blood collected in an EDTA (lavender-top) tube
Whole blood collected in: EDTA (royal blue-top), sodium heparin (green-top), ACD solution A or B (yellow-top), or lithium heparin (green-top)
3 mL
Extracted DNA: Please call 1-(866)-GENE-INFO or 1-866-436-3463 for additional information.

Frozen shipping is acceptable.
EDTA (lavender-top) tube
Room temperature
Room temperature: 8 days
Refrigerated: 8 days 
Frozen: 30 days
Not offered in Quest Diagnostics Nichols Institute (IFD) – San Juan Capistrano. Please provide SERVICE AREA INFORMATION to find available tests you can order.
In-home collection is not available in your area through Quest Mobile.
Test Details

Clinical Significance

Test Resources

Reference ranges are provided as general guidance only. To interpret test results use the reference range in the laboratory report.

The CPT codes provided are based on AMA guidance and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

This material contains content from LOINC® (http://loinc.org). The LOINC Table, LOINC Table Core are copyright © 1995-2019, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee and is available at no cost under the license at http://loinc.org/license.

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