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,