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Products > Life Therapeutics > Factor V Leiden Assay

GradiLeiden V
A simple functional Screening Test for Factor V (Leiden)

Factor V Leiden and APC resistance

The Factor V (Leiden) mutation has been identified as the most important underlying cause of hereditary thrombophilia. This mutation in clotting factor V confers resistance to normal proteolytic cleavage by activated protein C (APC), resulting in impaired function of an important regulatory mechanism in the clotting process.

Factor V Leiden has traditionally been first detected by screening tests using addition of exogenous APC to patient plasma in an APTT test, where the clotting time for normal patients is prolonged, while individuals with a mutation in Factor V exhibit shorter clotting time results.

However the mutation can also be detected by a Dilute-Russell's Viper Venom Time (DRVVT) based test. The DRVVT method avoids limitations inherent in the APTT based method, which requires a normal baseline APTT and may be affected by high concentrations of Factor VIII, Lupus Anticoagulant and anticoagulant therapy. The use of a DRVVT test also eliminates the requirement to pre-dilute patient samples with Factor V deficient plasma.

GradiLeiden V

GradiLeiden V is a simple alternative to the APTT based procedure for detecting resistance to Activated Protein C caused by the Factor V (Leiden) defect. This system is based on the activation of the patients endogenous Protein C by pre-incubation with Agkistodon contortrix venom reagent (VACL). A Phospholipid Rich Russell's Viper Venom reagent (PR3V) is then used to perform a Dilute Russell's Viper Venom Time (DRVVT) test on the plasma.

This DRVVT based assay is very sensitive to prolongation in the presence of APC. In normal individuals, activation of their own Protein C prolongs the result 2 to 3 fold, while in individuals with Factor V (Leiden) defect, only marginal prolongation is achieved due to resistance in their Factor V to APC.

GradiLeiden V

  • Can be used directly for testing patients stabilized on oral anticoagulant therapy
  • Provides enhanced discrimination between normal individuals and those with the Factor V (Leiden) defect compared to APTT based methods
  • Is unaffected by variations in levels of Factors VIII, IX, XI, contact factors or heparin and normal variation in Proteins C and S
  • Is resistant to all but the strongest Lupus anticoagulants


Product Code
FVLK-1 GradiLeiden V (100 test) 5 x 2ml VACL, 5 x 4ml PR3V
PCPP-1 Gradiplasma PCP/FVL Control 5 x 1ml Normal, 5 x 1ml Abnormal


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