Genvinset® Factor V G1691A

The Factor V Leiden is a variant of the Factor V of human coagulation. It has an important role in the coagulation cascade. The mutation G1691A is the most common hereditary hypercoagulability disorder amongst Eurasians. Its prevalence varies between 1% and 13%, depending on the geographical location and ethnicity.

INTENDED USE

Genvinset® Factor V G1691A is a semi-automated kit for the in vitro qualitative detection of the G1691A mutation (NCBI dbSNP rs6025; NM_000130.5:c.1601G>A) in the factor V (FV) gene (OMIM: 612309) 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 typing.
• 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.