How do you screen for factor V Leiden (factor 5 Leiden) mutation?

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From the Guidelines

Screening for factor V Leiden mutation is typically done through genetic testing of a blood sample, using a DNA-based test called polymerase chain reaction (PCR), which specifically identifies the genetic mutation responsible for factor V Leiden, as recommended by the American College of Medical Genetics consensus statement 1. The primary method of screening is a DNA-based test, which can determine if a person is heterozygous (one copy of the mutation) or homozygous (two copies), affecting the degree of thrombosis risk. Before genetic testing, doctors may first perform a functional screening test called activated protein C resistance (APCR) assay, which measures how well a patient's blood responds to activated protein C, as noted in the study by 1. An abnormal APCR result suggests factor V Leiden but requires confirmation with the DNA test. Testing is typically recommended for individuals with:

  • Unexplained venous thromboembolism (especially at a young age)
  • A strong family history of blood clots
  • Thrombosis in unusual locations
  • Recurrent pregnancy loss The test requires a standard blood draw and results are usually available within a few days to weeks. No special preparation is needed before the test, though patients should inform their healthcare provider about any blood-thinning medications they're taking, as these won't affect genetic test results but are relevant to overall care, as stated in the guidelines by 1. It's also important to consider the patient's age, with testing recommended for those under 50 with any venous thrombosis, and for those with a strong family history of thrombotic disease, as recommended by 1. Additionally, testing may be considered for women with recurrent pregnancy loss or unexplained severe preeclampsia, placental abruption, intrauterine fetal growth retardation, or stillbirth, as noted in the study by 1. Random screening of the general population for factor V Leiden is not recommended, as stated in the guidelines by 1. Overall, the decision to screen for factor V Leiden mutation should be based on individual patient risk factors and medical history, as recommended by the American College of Medical Genetics consensus statement 1.

From the Research

Screening Methods for Factor V Leiden

To screen for Factor V Leiden mutation, several methods can be employed, including:

  • Activated Protein C resistance assay, a coagulation screening test 2
  • DNA analysis of the F5 gene, which encodes the Factor V protein 2
  • Russell viper venom time-based assay, which can be performed on whole blood or platelet-poor plasma 3
  • Polymerase chain reaction (PCR) for the FV Leiden defect, followed by detection with lanthanide-labeled probes 4
  • Modified activated partial thromboplastin time (APTT) using FV-deficient plasma 3

Recommendations for Screening

The decision to screen for Factor V Leiden should be made on an individual basis, taking into account the patient's family history and personal risk factors for thrombosis 5, 2.

  • Patients with a family history of thrombosis may be at increased risk of carrying the Factor V Leiden mutation, but a family history is not a reliable criterion for detecting carriers 5
  • Screening may be worthwhile even if the advantages of oral contraception are higher than the thrombotic risk 5
  • Asymptomatic Factor V Leiden heterozygotes do not require long-term anticoagulation, but prophylactic anticoagulation may be considered in high-risk clinical settings 2

Laboratory Testing Methods

The preferred laboratory testing methods for Factor V Leiden include:

  • PCR and DNA analysis 2, 4
  • Activated Protein C resistance assay 2
  • Russell viper venom time-based assay 3 Expert consensus recommendations suggest that these methods should be used to guide diagnostic, prognostic, and management decisions for patients with thromboembolic disorders 6

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

Factor V Leiden thrombophilia.

Genetics in medicine : official journal of the American College of Medical Genetics, 2011

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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