AffiPCR® HLA B*5701 Real Time PCR

Target Disease Type: HIV Associated Kits

Specific Application: HIV Associated Kits

Storage and Shipping : 4 weeks

HLA B*5701 RT-PCR (CE) H53-100FRT DataSheet

INTRODUCTION

Abacavir is a nucleoside reverse-transcriptase inhibitor with activity against the human immunodeficiency virus (HIV), available for once-daily use in combination with other antiretroviral agents, that has shown efficacy, few drug interactions, and a favorable long-term toxicity profile. The most important adverse effect of abacavir that limits its use in therapy and mandates a high degree of clinical vigilance is an immunologically mediated hypersensitivity reaction affecting 5 to 8% of patients during the first 6 weeks of treatment. Symptoms of a hypersensitivity reaction to abacavir are nonspecific and include combinations of fever, rash, constitutional symptoms, gastrointestinal tract symptoms, and respiratory symptoms that become more severe with continued dosing. Immediate and permanent discontinuation of abacavir is mandated, resulting in a rapid reversal of symptoms. Subsequent rechallenge with abacavir is contraindicated, since it can result in a more severe, rapid, and potentially life-threatening reaction. In 2002, an association between a diagnosis of hypersensitivity reaction to abacavir and carriage of the major histocompatibility complex class I allelee HLA-B*5701 was reported independently by several independent studies.

Studies of cohorts with HIV infection have also shown that avoiding abacavir in HLA-B*5701–positive patients significantly reduced the incidence of suspected hypersensitivity reaction up to 0,5%. Many clinical studies recommend for this reason, the pharmacogenetic molecular testing of the carriage of the major histocompatibility complex class I allelee HLA-B*5701 in all HIV positive patients treated with abacovir.

HLA-B*5701 Real-TM test can predict who will develop a severe allergic reaction to the anti-HIV drug abacavir as the presence of HLA-B*5701 is significantly associated with an abacavir hypersensitivity.

INTENDED USE

HLA B*5701 Real-TM is a Real-Time amplification test for the detection of HLA-B (major histocompatibility complex, class I, B) Allele 5701 in the biological materials. The kit HLA B*5701 Real-TM can be used as screening test for the prevention of abacavir hypersensitivity reactions.

PRINCIPLE OF ASSAY

HLA B*5701 Real-TM Test is based on two major processes: isolation of genomic DNA from specimens and Real Time amplification with allele specific primers. The real-time PCR monitoring of fluorescence intensities allows the accumulating product detection without reopening of reaction tubes after the PCR run. HLA B*5701 Real-TM PCR kit is a qualitative test which contains the Internal Control IC (human beta-globine gene), which allows to control the presence of cellular material in the sample.