Genvinset® HLA Behçet v5

Behçet’s disease (BD) is a form of vasculitis that manifests with urogenital ulcers, uveitis, skin inflammation, arthritis, enterocolitis and inflammation in other organs. Despite being a worldwide-distributed illness, BD is more frequent in the area that extends from East Asia to the Mediterranean basin. It is also relatively common in countries such as Turkey and Japan.

According to various scientific studies, there are several genetic factors that partially determine the susceptibility to develop the illness. More specifically, it is known that BD is associated with the HLA-B*5 antigen, belonging to the Major Histocompatibility Complex (MCH), encoded by the HLA-B*51/52 group of alleles. Therefore, the HLA-B*5 antigen is a risk factor strongly associated with BD.

INTENDED USE

Genvinset® HLA Behçet v5 is a semi-automated in vitro diagnostic kit for the qualitative detection of the HLA-B*51/52 group of alleles in genomic DNA extracted from whole blood, associated with Behçet’s disease predisposition, by Real-Time PCR using TaqMan® probes technology.

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

• See detected alleles acceding to Download section.
• 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 Behçet’s disease. Use these results in conjunction with clinical data and results of other tests performed on the patient.