For in vitro diagnostic use. The RIDA®GENE Factor II kit uses real-time PCR to qualitatively detect a point mutation of G to A at position 20210 in the human factor II (prothrombin) gene in genomic DNA that was isolated from human EDTA whole blood samples. The RIDA®GENE Factor II kit is intended to support the diagnosis in the assessment of patients with suspected venous thromboembolism.
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 a year. Factor II, a vitamin K-dependent glycoprotein, which plays an essential role in blood coagulation, is considered a risk factor for blood clotting disorders. The second most common genetic defect for inheriting thromboses is a mutation of the factor II gene. This gene is located on chromosome 11 and codes for prothrombin (coagulation factor II). Caused by an increased expression rate, a mutation in 3’UTR of the factor II gene (G20210A) results in an elevated level of prothrombin of 30 % in heterozygous people and of 70 % in homozygous people, compared with the wild type. This elevation in the prothrombin level is defined as a risk factor. Prothrombin is then converted into its enzymatically active form, thrombin (factor Ila), when activated by factor X, factor V, calcium, and phospholipids.
The factor II variant gene can also be associated with other medical conditions like myocardial infarction or pregnancy loss. The susceptibility to disorders increases when multiple genetic risk factors are present (e.g., Factor V Leiden mutation, MTHFR variants, protein C deficiency, or protein S deficiency) or in the event of exposure to other risk factors, such as smoking, pregnancy, overweight, oral contraceptives, or immobility.
|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.