EliGene® Spondylitis HLA-B27 C6

EliGene® Spondylitis HLA-B27 C6 is intended for the genotypization of HLA-B27 allele (subtypes B*2701-2759) from isolated DNA. The kit is designed for cobas® 6800/8800 Systems (Roche).

Principle of the method

This diagnostic kit is based on RealTime PCR method. In this kit primers and labeled probes (FAM and HEX) for the detection of HLA-B27 alleles and for the detection of internal control are used.

Introduction

Human Leukocyte Antigen (HLA) B27 (subtypes B*2701-2759) is an HLA class I surface antigen that is encoded in the B locus in the major histocompatibility complex (MHC) on the short arm of chromosome 6. In HLA-B27 antigen a strong association with ankylosing spondylitis (AS) and spondyloarthropathies (SpA) was found. Moreover the increased incidence of this antigen in other diseases as Reiter´s syndrome or uveitis was found. Association studies found an association between HLA-B27 antigen and AS in all ethnic and racial groups worldwide however the prevalence of HLA-B27 antigen and the strength of its association with AS does vary. For example, the prevalence of HLA-B27 antigen is about 8% in Caucasians, 4% in North Africans, 2-9% in Chinese, and 0.1-0.5% in Japanese. Further, among northern Europeans only 8% of the general population possesses HLA-B27, but more than 90% of the patients with AS possess this gene. In contrast, among African Americans 2% to 4% of the general population and only 50% to 60% of patients with AS possess this gene.
From this reasons HLA-B27 test cannot be used to screen an asymptomatic population to detect AS but the test provides a statement of increased probability of the existence of AS in the symptomatic patient. Also, the presence of HLA-B27 antigen influences the clinical manifestations of AS disesase, because HLA-B27–positive patients have a significantly younger age at onset of their disease and a higher prevalence of episodes of eye inflammation (acute anterior uveitis) and hip joint involvement.
EliGene® Spondylitis HLA-B27 RT kit detects HLA-B27 allele (subtypes B*2701-2759). As an internal control the gene SYPL2 (synaptophysin-like 2) is used.

Clinical material and recommended DNA isolation procedure

Blood

Recommended DNA isolation procedure: Automatic: cobas® 6800/8800 Systems (Roche)

CE IVD