Intended use:

For in vitro diagnostic use. With the RIDA®GENE HLA-B27 kit HLA-B27 alleles in genomic DNA, isolated from human whole blood EDTA samples, are qualitatively detected by using real-time Polyermase Chain Reaction (PCR). The RIDA®GENE HLA-B27 kit is designed to assist in the diagnosis of patients with suspected spondylitis ankylosans (Bechterew’s disease) and other autoimmune diseases. The test is not to be used for tissue typing.

General information:

Many people suffer from low back pain and in some cases a serious illness is the cause: Bechterew’s disease (ankylosing spondylitis, AS). AS is a chronic inflammatory disease that primarily affects the spinal column. In addition to a physical examination and imaging (CT, MRT), an important element of the diagnosis is to check for HLA-B27 in the blood. Patients with Bechterew’s disease frequently have a specific genetic trait, the HLA-B27 gene.

The human leukocyte antigens B27 (HLA-B27) is a major class I histocompatibility complex cell surface antigen and is coded on chromosome 6. Its task is to present microbial antigens to T-cells. Almost all nucleated cells in the body have class I HLA molecules.

An association with specific inflammatory, rheumatic diseases, spondyloarthritis (SpA), particularly ankylosing spondylitis (AS) is a given in carriers of HLA-B27 alleles. The association in the Caucasian population is particularly pronounced with a 90 – 95 % prevalence of HLA-B27 in AS patients. The prevalence of HLA-B27 in the total population varies significantly between the ethnic groups. AS is a chronic, rheumatic inflammation, which mainly affects the spine and the sacroiliac joints. Other rheumatic diseases associated with HLA-B27 include Reiter’s syndrome, acute anterior uveitis and inflammatory intestinal disease.

The pathogenic mechanism, in which HLA-B27 causes an increased susceptibility towards the development of arthritic disease, is still unknown despite intensive research work.

Specifications
Art. No. PY0205
Test format real-time PCR with 100 reactions
Shelf life 24 months after production
Files
Instructions
SDS
sdspy0205_-_ridagene_hla-b27_de.pdf (German)
sdspy0205_-_ridagene_hla-b27_gb.pdf (English)
sdspy0205_-_ridagene_hla-b27_fr.pdf (French)
sdspy0205_-_ridagene_hla-b27_it.pdf (Italian)
sdspy0205_-_ridagene_hla-b27_es.pdf (Spanish)
sdspy0205_-_ridagene_hla-b27_bg.pdf (Bulgarian)
sdspy0205_-_ridagene_hla-b27_cz.pdf (Czech)
sdspy0205_-_ridagene_hla-b27_dk.pdf (Danish)
sdspy0205_-_ridagene_hla-b27_ee.pdf (Estonian)
sdspy0205_-_ridagene_hla-b27_fi.pdf (Finnish)
sdspy0205_-_ridagene_hla-b27_gr.pdf (Greek)
sdspy0205_-_ridagene_hla-b27_hr.pdf (Croatian)
sdspy0205_-_ridagene_hla-b27_hu.pdf (Hungarian)
sdspy0205_-_ridagene_hla-b27_lt.pdf (Lithuanian)
sdspy0205_-_ridagene_hla-b27_lv.pdf (Latvian)
sdspy0205_-_ridagene_hla-b27_nl.pdf (Dutch)
sdspy0205_-_ridagene_hla-b27_no.pdf (Norwegian)
sdspy0205_-_ridagene_hla-b27_pl.pdf (Polish)
sdspy0205_-_ridagene_hla-b27_pt.pdf (Portuguese)
sdspy0205_-_ridagene_hla-b27_ro.pdf (Romanian)
sdspy0205_-_ridagene_hla-b27_se.pdf (Swedish)
sdspy0205_-_ridagene_hla-b27_si.pdf (Slovenian)
sdspy0205_-_ridagene_hla-b27_sk.pdf (Slovakian)
sdspy0205_-_ridagene_hla-b27_tr.pdf (Turkish)

Dear customers,

we have started to provide the documents for our products in an electronic format. These are the Instructions for Use (IFU), the Safety Data Sheets (SDS) and the Certificate of Analysis (CoA). For batches placed on the market after 01 January 2023, you can find our documents on the eIFU portal eifu.r-biopharm.com.

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