Factor V Leiden

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Coagulation factor activity measurement.

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Factor V Leiden Test Information Guide

Why is it done?
- Detects a genetic mutation in the Factor V gene that increases blood clotting risk and predisposes individuals to thrombosis (abnormal blood clots)
- Evaluates personal or family history of unexplained blood clots (deep vein thrombosis, pulmonary embolism, or stroke)
- Assesses thrombotic risk before initiating hormone therapy, oral contraceptives, or hormone replacement therapy
- Evaluates women with recurrent pregnancy losses or adverse pregnancy outcomes
- Screens family members when Factor V Leiden is identified in a relative
- Determines need for anticoagulation therapy or thrombosis prevention strategies
Normal Range
- Normal Result (Negative): Absence of Factor V Leiden mutation; homozygous wild-type (GG genotype). Indicates normal Factor V gene with no increased clotting risk from this genetic factor.
- Heterozygous (Carrier): One copy of the Factor V Leiden mutation (GA genotype). Increases thrombotic risk approximately 3-8 fold compared to non-carriers.
- Homozygous: Two copies of the Factor V Leiden mutation (AA genotype). Significantly increases thrombotic risk approximately 50-100 fold compared to non-carriers.
- Units of Measurement: Qualitative result reported as presence or absence of mutation; genotype typically expressed as GA or AA
Interpretation
- Negative Result (Wild-type): No Factor V Leiden mutation detected. Patient has normal clotting risk from this genetic factor. However, other thrombotic disorders may still exist.
- Heterozygous Positive Result: One mutated Factor V gene present. Carries elevated thrombotic risk, particularly when combined with other risk factors (pregnancy, surgery, immobility, oral contraceptives, smoking). Most common form of inherited thrombophilia.
- Homozygous Positive Result: Two mutated Factor V genes present. High risk for thrombosis, even without additional risk factors. Anticoagulation prophylaxis typically recommended.
- Factors Affecting Results: Genetic mutation is lifelong and not affected by medications, diet, or lifestyle. Test should not be performed during acute thrombotic event or within 2 weeks of stopping anticoagulation therapy.
- Clinical Significance: Most carriers (85%) never develop thrombosis; presence does not guarantee clot formation but indicates predisposition. Approximately 5% of Caucasian population are heterozygous carriers. Lifetime thrombotic risk for carriers is approximately 10%, increasing significantly with additional risk factors.
Associated Organs
- Primary Organ Systems: Hematologic system (blood and coagulation); vascular system (arteries and veins throughout body)
- Associated Conditions with Abnormal Results: Deep vein thrombosis (DVT), pulmonary embolism (PE), arterial thrombosis, stroke, myocardial infarction, recurrent miscarriage, thrombophilia-related pregnancy complications
- Commonly Associated Diseases: Inherited thrombophilia, antiphospholipid syndrome (when combined with other markers), pregnancy-related thrombosis
- Potential Complications: Unprovoked thrombosis, recurrent thromboembolism, limb ischemia, organ infarction, cerebral venous sinus thrombosis, mesenteric vein thrombosis, adverse pregnancy outcomes including preeclampsia, intrauterine growth restriction, and placental abruption
Follow-up Tests
- Recommended Screening Tests When Factor V Leiden is Positive: Prothrombin time (PT), activated partial thromboplastin time (aPTT), thrombin time, platelet count to assess basic coagulation function
- Additional Thrombophilia Screening: Prothrombin G20210A mutation, protein C activity and antigen, protein S activity and antigen, antithrombin activity, lupus anticoagulant, anticardiolipin antibodies
- Imaging Studies if Thrombosis Suspected: Compression ultrasound (lower extremity DVT), CT pulmonary angiography (PE), brain CT or MRI (stroke), abdominal imaging (visceral thrombosis)
- Genetic Counseling: Recommended for positive results to discuss inheritance patterns and family screening
- Family Screening: Consider testing first-degree relatives (parents, siblings, children), especially those with personal or family history of thrombosis
- Monitoring and Follow-up Frequency: No routine re-testing needed (mutation is permanent); annual or biennial assessment recommended if on anticoagulation therapy; increased monitoring during high-risk periods (pregnancy, surgery, immobilization, hormone therapy initiation)
Fasting Required?
- Fasting Required: No. Factor V Leiden DNA testing does not require fasting as it is a genetic test.
- Patient Preparation: No special preparation required; patient may eat and drink normally before test
- Timing Considerations: Test should ideally be performed when patient is not in acute thrombotic state (if testing for first episode). If obtaining concurrent coagulation studies (PT, aPTT), those may require fasting.
- Medications: No medications need to be held or avoided for DNA testing. Anticoagulants do not interfere with genetic testing results.
- Sample Collection: Blood draw (typically 5-10 mL in EDTA tube) or saliva collection, depending on laboratory methodology

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