Test Code F5DNA Factor V Leiden (R506Q) Mutation, Blood
Reporting Name
Factor V Leiden (R506Q) Mutation, BPerforming Laboratory
Mayo Clinic Laboratories in RochesterUseful 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
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.
Specimen Minimum Volume
1 mL
Specimen Type
Whole bloodSpecimen 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 daysForms
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
Special Instructions
Method Name
Direct Variant Analysis
Test 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 |