Test ID F5DNA Factor V Leiden (R506Q) Mutation, Blood
Ordering Guidance
This assay will only detect the F5 c.1601G>A; p.Arg534Gln (rs6025) variant associated with factor V Leiden thrombophilia. To detect other pathogenic alterations in the F5 gene of a patient with a laboratory diagnosis of coagulation factor V deficiency, order F5NGS / F5 Gene Next Generation Sequencing, Varies.
This assay will not will not detect alterations in individuals with activated protein C (APC)-resistance caused by mechanisms other than the F5:c.1601G>A, p.Arg534Gln variant. Coagulation-based activated protein C (APC)-resistance ratio (mixing with factor V-deficient plasma) is recommended as the initial screening assay for APC-resistance. Depending on the assay system, the APC-resistance ratio may be indeterminate for patients with a lupus anticoagulant or extremely high heparin levels. For more information, see APCRV / Activated Protein C Resistance V (APCRV), Plasma or APCRR / Activated Protein C Resistance V (APCRV), with Reflex to Factor V Leiden, Blood and Plasma.
Specimen Required
Patient Preparation: A previous bone marrow transplant from an allogenic donor will interfere with testing. Call 800-533-1710 for instructions for testing patients who have received a bone marrow transplant.
Container/Tube:
Preferred: Lavender top (EDTA)
Acceptable: Yellow top (ACD solution B), light-blue top (sodium citrate)
Specimen Volume: 3 mL
Collection Instructions:
1. Invert several times to mix blood.
2. Send specimen in original tube. Do not aliquot.
Forms
1. New York Clients-Informed consent is required. Document on the request form or electronic order that a copy is on file. The following documents are available in Special Instructions:
-Informed Consent for Genetic Testing (T576)
-Informed Consent for Genetic Testing-Spanish (T826)
2. Coagulation Patient Information (T675) in Special Instructions
Useful For
Patients with clinically suspected thrombophilia and:
1. Activated protein C (APC)-resistance either proven or suspected by a low or borderline APC-resistance ratio
or
2. A family history of factor V Leiden
Genetics Test Information
This test detects the F5 c.1601G>A; p.Arg534Gln variant (legacy R506Q).
Disease States
- Factor V Leiden
Special Instructions
Method Name
Direct Variant Analysis
Reporting Name
Factor V Leiden (R506Q) Mutation, BSpecimen Type
Whole bloodSpecimen Minimum Volume
1 mL
Specimen Stability Information
Specimen Type | Temperature | Time | Special Container |
---|---|---|---|
Whole blood | Ambient (preferred) | 14 days | |
Frozen | 14 days | ||
Refrigerated | 14 days |
Reference Values
Negative
Day(s) Performed
Weekly
Report Available
3 to 5 daysPerforming Laboratory
Mayo Clinic Laboratories in RochesterTest Classification
This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.CPT Code Information
81241
LOINC Code Information
Test ID | Test Order Name | Order LOINC Value |
---|---|---|
F5DNA | Factor V Leiden (R506Q) Mutation, B | 21668-9 |
Result ID | Test Result Name | Result LOINC Value |
---|---|---|
21838 | Factor V Leiden (R506Q) Mutation, B | 21668-9 |
21839 | F5DNA Interpretation | 69049-5 |
21841 | F5DNA Reviewed By | 18771-6 |