CE MarkEER052032

32 Tests

DUPLICA RealTime HLA-B*5701 EZ Type Kit

DuplicαRealTime HLA-B*5701 EZ Type Kit is an in vitro diagnostic test for the detection of the presence of the HLA-B*57:01 allele in genomic DNA​, by Real-Time PCR.



The HLAB* 57 family consists of at least 57 closely related genes. Around 5% to 8% of the Western European and Hispanic populations express 57-like antigens, so this represents a common HLA genotype. This genotype is less frequent in other ethnic groups, and is found in <2% of people of African origin.

Abacavir (ABC) is a nucleoside reverse-transcriptase inhibitor antiretroviral indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection, in adult and paediatric patients. Abacavir is associated with potentially serious hypersensitivity reactions in 3–9% of Caucasian patients that require immediate and permanent discontinuation of the drug.

It has been shown that carriers of the allele 57:01 of the HLA locus B (HLA-B*57:01) are at high risk for developing Abacavir Hypersensitivity Reaction (ABC-HSR) and that prospective genetic screening for HLA-B*57:01 greatly diminishes or abolishes the occurrence of ABC-HSR. In July 2008, the US FDA approved a label change for Abacavir to include a boxed warning indicating that patients who carry the HLA-B*57:01 allele are at high risk for experiencing a hypersensitivity reaction to Abacavir and a recommendation to screen for HLA-B*57:01 prior to the initiation of Abacavir therapy.


  •  HLA-B*57:01 allele
  • Internal Control (IC)

Diagnostic samples:

  •  Peripheral whole blood samples collected in EDTA

DNA Extraction:

  • Compatible with the most common DNA Extraction and Purification Systems

Real-Time PCR instruments:

  • Compatible with the most common Real-Time PCR Systems