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Genvinset®

Genvinset® HLA B57v5

Kit for detecting the HLA-B*57:01 alleles by Real time PCR using TaqMan® probes technology

Information about the product

Abacavir sulfate is a synthetic carboxylic nucleoside drug, reverse transcriptase inhibitor, which is used to treat HIV and AIDS.

This drug has been associated with the occurrence of fatal hypersensitivity reaction. Symptoms include fever, skin rash, fatigue, gastrointestinal symptoms such as nausea, vomiting, diarrhea or abdominal pain. Others are respiratory symptoms such as pharyngitis, dyspnea or cough. Hypersensitivity is associated with the

HLA-B*5701, for which before starting treatment with this drug it is necessary to conduct a study of the presence of this allele in the patient to avoid such a hypersensitivity reaction.

 

INTENDED USED

Genvinset® HLA B57v5 is a semi-automated in vitro diagnostic kit for the qualitative detection of the HLA-B*57:01 allele in genomic DNA extracted from whole blood, associated with abacavir hypersensitivity reaction, 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 can assess the administration of the convenient treatment and, in fact, HLA-B*57:01 analysis should be performed previous to the delivery of abacavir.

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.
  • The results of this test can help to assess the administration of the correct treatment, and in fact, the analysis of HLA-B*57:01 should be carried out before abacavir is given.”

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