Genvinset® PAI-1 4G/5G

PAI-1 is the most important component in fibrinolytic system, which accounts for about 60% of the activity of inhibitors. PAI-1 is a serine protease inhibitor belonging to the serpin superfamily that plays an important role in the regulation of fibrinolysis. The main function of PAI-1 is dissolving blood clots by inhibiting tissue-like and urinokinase-like plasminogen activators (tPA and uPA). These activators enhance fibrinolysis by activation of plasminogen. Overexpression of their inhibitor may compromise normal fibrin clearance mechanism and, thus, promote pathological fibrin deposition and thrombotic events.

INTENDED USE

Genvinset® PAI-1 4G/5G is a semi-automated kit for the in vitro qualitative detection of the 4G/5G deletion (NCBI dbSNP rs1799762; NM_000602.5:c.-820G[(4_5)]) in the promoter region of the Plasminogen activator inhibitor 1 (SERPINE1) gene (OMIM: 173360) associated with thrombophilia risk, in genomic DNA extracted from whole blood using Real Time PCR technology with specific TaqMan® probes.

Patients who can benefit from this determination are those referred by a specialist. The results of this test should not be the only ones on which the therapeutic decision is based and should be used as an aid in the diagnosis together with results of other markers of the disease.

The intended user of the kit is technical personnel trained to carry out the protocol and the interpretation of results described in the instructions for use.

WORKFLOW

RESULTS

Limitations

• Mutations or polymorphisms at annealing primer/probe sites are possible and may result in the lack of allele definition. Other technologies could be necessary to resolve the genotyping.
• Data and result interpretation should be revised by qualified personnel.
• This product is an auxiliary tool for the diagnosis of patients with suspected thrombophilia. Use these results in conjunction with clinical data and results of other tests performed on the patient.