Genvinset® Diabetes Mellitus T1

Insulin-dependent or type 1 diabetes mellitus (IDDM) is an autoimmune disorder characterized by destruction of insulin producing beta cells in the pancreas. Progression to disease involves both genetic and environmental factors.It is the most common form of diabetes among children and young adults in populations of Caucasoid origin, where the prevalence is approximately 0.4%. In the 1970s, association and affected-sib pair linkage studies established the role of HLA genes in IDDM predisposition.

Initial association studies of serologically determined HLA alleles with IDDM showed increased frequencies of B8-DR3 and B15 (w62)-DR4 in Caucasians. Both DR3 and DR4 are very strongly associated with IDDM.

It is clear that some combinations of HLA-DQ genes are associated with susceptibility to IDDM. From both human genetics and animal model studies there is good evidence that particular alleles of the HLA-DQB1 (*03:02 and *02:01) and DRB1 (*03 and *04) loci all are primarily involved in the genetic predisposition to IDDM.

INTENDED USE

Genvinset® HLA Diabetes Mellitus Type I is a semi-automated in vitro diagnostic kit for HLA-DRB1*03/ DRB1*04/ DQB1*02:01/ DQB1*03:02 alleles qualitative detection in genomic DNA extracted from whole blood, associated with diabetes mellitus type 1 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 diabetes mellitus type 1. Use these results in conjunction with clinical data and results of other tests performed on the patient.