For in vitro diagnostic use. The RIDA®GENE Factor V kit uses real-time PCR to qualitatively detect a point mutation of G to A at position 1691 in the human factor V gene (Factor V Leiden mutation) in genomic DNA that was isolated from human EDTA whole blood samples.
The RIDA®GENE Factor V kit is intended to support the diagnosis in the assessment of patients with suspected thrombophilia.
Thromboses are a major medical problem that increases with age. Roughly 1 in 100,000 people under 40 years develop venous thrombosis. This probability increases in people over 75 years to 1 in 100 people per year. Factor V Leiden is considered the most common genetic factor that is described in combination with the development of venous thromboembolism. In this case, it is a point mutation in the factor V gene at position 1691 that leads to a base exchange from G to A. As a result, the binding site for activated protein C with anticoagulant effect is no longer available (APC resistance), and factor V is broken down less compared with the wild type, which results in a hypercoagulable state. Factor V Leiden is widely distributed with high prevalence in Europa and with practically no cases in Asia or Africa. The probability of developing venous thrombosis is 3 to 8 times higher with a genetic mutation in the factor V gene if this mutation is heterozygous. For a homozygous mutation at position 1691, the probability increases 10 to 80 times. In addition, the chance of developing venous thrombosis at a young age also increases in this case. If other factors, such as a mutation in the factor II gene (G20210A), are present with this mutation, the risk of recurrent thromboses increases as well.
|Test format||real-time PCR with 100 reactions|
we have started to provide the documents for our products in an electronic format. These are the Instructions for Use (IFU), the Safety Data Sheets (SDS) and the Certificate of Analysis (CoA). For batches placed on the market after 01 January 2023, you can find our documents on the eIFU portal eifu.r-biopharm.com.