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Genvinset®

Genvinset® HLA B27v5

Kit for detecting HLA-B*27 alleles by Real time PCR using TaqMan® probes technology

Information about the product

The major histocompatibility complex (MHC) is the genetic region that contains the most polymorphic loci of the genome involved in the mechanism of antigen presentation and, as such, defines the general immunological response.
Within the MHC, the allelic family HLA B27 is part of the HLA-B locus and presents a frequency between 3 and 8% of the Caucasian population. Despite this frequency the interest in this allelic family relies in its relation with different rheumatic diseases called spondyloarthropathies, from which we can highlight ankylosing spondylitis (AS).

Around 90% of the patients with AS are HLA B27 positive. Other related autoimmune diseases are Juvenile rheumatoid arthritis (80% of patients), and the Reiter syndrome or reactive arthritis (50-80%). The HLA B27 is also present in 50% of the patients with inflammatory bowel disease with spondylitis and plaque psoriasis with spondylitis. HLA B27 is not the root cause of these pathologies, but there is a higher prevalence of this antigen in affected patients.

 

INTENDED USED

Genvinset® HLA B27v5is a semi-automated in vitro diagnostic kit for HLA-B*27 group of alleles qualitative detection in genomic DNA extracted from whole blood, associated with ankylosing spondylitis predisposition, by real-time PCR using TaqMan® probes technology.

Patients who can benefit from this determination are those referred by a specialist with clinical symptoms compatible with rheumatoid diseases such as ankylosing spondylitis, reactive arthritis, psoriatic arthritis or juvenile enthesitis related arthritis, and acute anterior uveitis.. 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 ankylosing spondylitis. Use these results in conjunction with clinical data and results of other tests performed on the patient.

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