نقد و بررسی

1 Intended Use
AESKULISA CCP is a solid phase enzyme immunoassay for the quantitative and qualitative
detection of IgG antibodies to specific cyclic citrullinated peptides.
The assay is an aid in the diagnosis of rheumatoid arthritis (RA).
2 Clinical Application and Principle of the Assay
Rheumatoid arthritis (RA) is one of the most common autoimmune diseases, affecting
approximately 1% of the population worldwide. It is a chronic, systemic, inflammatory
disease that predominantly affects the synovial membranes of multiple joints in the body.
Up to now, rheumatoid factors (RF) have been the main serological markers for this disease.
Rheumatoid factors , first described in 1940 as antibodies reacting with gamma globulins, are
autoantibodies directed against the C-terminal part of the constant region of the IgG heavy
chain, the IgG Fc.
Although named after the disease they were initially associated with, RFs are found both in
the healthy population and several diseases. The diseases commonly associated with high
RF concentrations are rheumatoid arthritis (50-90%) and Sjögren`s syndrome (75-95%).
They are also found in systemic lupus erythematosus (SLE; 15-35%), systemic sclerosis (20-
30%) polymyositis / dermatomyositis (5-10%), cryoglobulinemia (40-100%) and mixed
connective tissue diseases (MCTD; 50-60%). Therefore, despite being a sensitive marker for
RA, rheumatoid factor lack specificity for the disease.
It has long been known that anti-perinuclear autoantibodies, also called anti-keratin
antibodies, are found in patients with RA. Recently it has been discovered that these
autoantibodies target an epitope containing the deimidated form of arginine called citrulline.
Antibodies against synthetic cyclic citrullinated peptides (CCP) have been described as being
highly specific markers for RA with sensitivities comparable to RF.
AESKU.DIAGNOSTICS has developed a novel ELISA test, the AESKULISA CCP, which
detects sera from patients with rheumatoid arthritis with comparable sensitivities and
specificities as CCP ELISA tests. By employing specific cyclic citrullinated peptides, the
AESKULISA CCP represents a highly specific serological test for the diagnosis of RA and is
an adequate and cost-effective alternative to the CCP ELISA tests. Studies have shown a
sensitivity of 75% and a specificity of 99,2% in a control group of overlapping rheumatic
diseases.