ViroGene Factor V Leiden QPCR Kit

Factor V Leiden is a genetic disorder inherited in an autosomal dominant manner. The disorder results in 50% of familial thrombophilia cases. Thrombophilia is a term used to describe a group of conditions in which there is an increased tendency for excessive clotting. The development of a blood clot is called thrombosis. The vascular system includes both the venous system (the veins that deliver blood from the tissues to the heart) and the arterial system (the system that delivers blood from the heart to the tissues). Thrombotic episodes may occur in either system. The severity of the symptoms depends on the part of the vascular system in which they occur, the extent of the clot, and whether the clot breaks off and travels to another part of the body (e.g. the lungs—pulmonary embolus, the brain—embolic stroke, etc). Several types of conditions have been identified which may lead to dangerous clots. These conditions may be present at birth (congenital or inherited) or may occur as a result of another condition (acquired). Thrombophilia affects a large number of individuals in the world. The most common mutation associated with inherited thrombosis in the Caucasian population is the Factor V Leiden mutation, which leads to resistance to activated protein C. A point mutation at position 1691 of the Factor V gene renders the gene product resistant to degradation by APC (activated protein C), which results in excessive clotting.

Heterozygotes for the Factor V Leiden mutation have an approximately 5 to 10-fold increased risk for venous thrombosis.

Indication	in vitro diagnostic medical device
Regulatory Status	CE IVD
Intended User	For professional use in laboratories with trained staff
Technology	Real-time PCR
Type of Analysis	Qualitative
Target Sequence	G1691A polymorphism of factor V Leiden
Diagnostic Specificity	100 %
Diagnostic Sensitivity	100 %
Validated Specimen	Whole blood
Storage	-20 ± 5 °C
Validated Extraction Methods	ViroGene DNA Extraction Kit & NA16 MagCore NA Extractor
Instruments	Applied Biosystems 7500 Real-Time PCR System AriaMx Real-Time PCR System LightCycler® 2.0 / 480 CFX Connect™ / CFX96™ / Dx Real-Time PCR Detection System LineGene 9600 Plus Rotor-Gene 3000/6000/Q SLAN® Real-Time PCR System QuantStudio™ 3 / 5 Real-Time PCR System StepOne™ / StepOnePlus™ Real-Time PCR System Mic qPCR Cycler
Required Detection Channels	FAM, HEX