ViroGene Factor II QPCR Kit
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. The second most common mutation associated with hereditary thrombosis is the G20210A mutation in the prothrombin (Factor II) gene, which is associated with high plasma prothrombin levels.
Heterozygous carriers of the prothrombin 20210 G-A mutation have an estimated 3 to 8-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 | G20210A Polymorphism of Factor II Prothrombin |
| Analytical Sensitivity (LoD) | reaches up to 2 ng/μl |
| Negative Percentage Agreement | 100 % (CI95%: 93.05 % – 100 %) |
| Positive Percentage Agreement | 100 % (CI95%: 82.83 % – 100 %) |
| Overall Percentage Agreement | 100 % (CI95%: 94.84 % – 100 %) |
| Validated Specimen | whole blood |
| Storage | -20 ± 5 °C |
| Validated Extraction Methods | ViroGene DNA Extraction Kit & NA16 MagCore NA Extractor |
| Instruments | Applied Biosystems 7300 / 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 Mic qPCR Cycler QuantStudio™ 3 / 5 Real-Time PCR System Rotor-Gene 3000/6000/Q* SLAN® Real-Time PCR System StepOne™ / StepOnePlus™ Real-Time PCR System |
| Required Detection Channels | FAM, HEX |
