ViroGene PAI-1(4G/5G) QPCR Kit

Plasminogen activator inhibitor-1(PAI-1), or serpin E1, is a serine protease inhibitor (serpin) encoded by the human SERPINE1 gene. PAI-1 is a major inhibitor of fibrinolysis, a process that prevents blood clots from growing and becoming problematic. Increased PAI-1 activity results in depressed fibrinolytic activity resulting in elevated risk for thrombosis (formation of blood clots)

The normal (wild-type) promoter for the PAI-1 gene contains a tract of five consecutive G residues. However, there is a mutant form of the PAI-1 promoter that has been identified that only contains four consecutive G residues. This mutant promoter causes higher amounts of PAI-1 to be made compared to the wild-type. Increased amounts of PAI-1 inhibit more tPA and uPA and, therefore, inhibits fibrinolysis more than the wild-type gene, resulting in an elevated risk of thrombosis.

Homozygous wild-type (5G/5G) – Normal PAI-1 activity and normal risk of thrombosis. Heterozygous (4G/5G) – Increased PAI-1 activity resulting in depressed fibrinolysis and increased risk of thrombosis. Homozygous mutant (4G/4G) – Significantly increased PAI-1 activity resulting in depressed fibrinolysis and increased risk of thrombosis

This genotype result is one-factor affecting thrombosis risk, and other genetic and clinical factors should also be considered. Multiple thrombosis risk factors are usually additive. Additional risk factors for the development of thrombosis include: Older age, surgery, obesity, prolonged travel, immobility, hospitalization, oral contraceptive use, hormonal replacement therapy, pregnancy, and malignancy

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	Polymorphism in promoter of the PAI-1 gene in site 675
Analytical Sensitivity (LoD)	Reaches up to 2 ng/μl
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 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