FVL (R506Q) Mutation Detection kit

Home Clinical Genetic Disorder FVL (R506Q) Mutation Detection kit


Factor V Leiden (FVL) thrombophiliais a genetic disorder mostly found in 20-25% of patients suffering from venous thromboembolism (VTE). It is characterized by a poor anticoagulant response to activated protein C (APC) and an increased risk of venous thromboembolism. The term “factor V Leiden” refers to the specific G-to-A substitution at nucleotide 1691 in the gene for factor V that predicts a single amino acid replacement (R506Q) at one of three APC cleavage sites in the factor Va molecule. 

The diagnosis of factor V Leiden thrombophilia is suspected in individuals with a history of venous thromboembolism (VTE) [deep vein thrombosis (DVT) or pulmonary embolism], especially in women with a history of VTE during pregnancy or in association with oral contraceptive use, and families with a high incidence of VTE. 


Mylab FVL Mutation Detection test is an in vitro diagnostic test for the detection and genotyping of the Factor V Leiden mutation – R506Q as an aid to diagnosis in the evaluation of patients with suspected thrombophilia by allele specific real time PCR.

Kit Features

  • Highly Sensitive allelic discrimination testing for FVL R506Q mutation
  • Multiplex analysis with no need for optimization- Detects Wild and Mutant type in one go
  • Easy workflow with ready-to-use solutions and optimal quality control
  • Simple reaction setup and data interpretation
  • Includes all reagent required to perform Sample to Result analysis no additional reagents needed.
  • Results aligned with Wild and Mutant controls Included with the kit.
  • Low contamination risk – no post-PCR product handling
  • High-throughput – can screen up to 90 samples in a single run
  • Fast – results within 80 minutes after PCR start

Kit Contents

  • Reagents for nucleic acid extraction
  • Reagents for real time PCR
  • Quality controls