INFINITI System Assay for Factor V Leiden (IVD)
- The INFINITI System Assay for Factor V is FDA 510(k) cleared as an in vitro diagnostic assay (IVD).
- The INFINITI System Assay for Factor V is indicated for use as an aid to diagnosis in the evaluation of patients with suspected thrombophilia.
- The INFINITI System Assay for Factor V utilizes the Factor V Intellipac, Factor V Amp Mix and Factor V BioFlimChip Microarray.
- The INFINITI System Assay for Factor V is automated by the INFINITI Analyzer.
- Factor V Leiden G1691A
- Determination of genetic variant for Factor V Leiden.
- Rapid turnaround time enhances workflow efficiency.
- Load & Go automated on the INFINITI/INFINITI PLUS Analyzer.
- Replicate determinations on a single BioFilmChip Microarray ensures quality results.
Sample Type and Volume:
- Uses 0.2 – 2.0 mL of peripheral whole blood in EDTA (purple top) tube.
- Requires 50 ng DNA / reaction
- The Factor V Leiden mutation is the most common variant associated with inherited thrombosis.1
- This mutation has a high prevalence in the general population (4 – 6% of US Population), and accounts for 85-95% of activated protein C resistant cases.1
- Enhanced risk of venous thrombosis, with the presence the Factor V Leiden variant, with odds ratios (ORs) of 3 to 8 in heterzygotes and 30 to 140 OR in homozygotes.2
- The risk of thrombosis is substantially increased for patients with multiple genetic risk factors (i.e. The “double hit hypothesis”) including factor V Leiden mutation, hyperhomocysteinemia, protein C deficiency, protein S deficiency and antiphospholipid antibody syndrome(s).3
- Grody W, Griffin J, Taylor A, Korf B, Heit, J. (2001) American College of Medical Genetics Consensus Statement on Factor V Leiden Leiden Mutation Testing, Genetics in Medicine, 3:2, 139-147.2.
- Salomon O. et al; Single and Combined Prothrombotic Factors in Patients With Idiopathic Venous Thromboembolism;
- Arteriosclerosis Thrombosis and Vascular Biology, 1999, 19: 511-518 © 1999 American Heart Association http://pathology.mc.duke.edu/coag/PTGlflyer2.html
To obtain the IFU for this application, please Click Here.
For more product information please Contact Us.