Enzyme Linked Immunosorbent Assay (ELISA) for the Quantitative Determination of IgG class autoantibodies against cyclic citrullinated peptides in Human Serum.

Rheumatoid arthritis (RA) is an inflammatory rheumatic disorder with a worldwide prevalence of about 0.5-1%. The serum of RA patients contains a variety of antibodies directed against self-antigens. The most widely known of these autoantibodies is the Rheumatoid Factor (RF) antibody directed against the constant domain of IgG molecules. Although the RF test has good sensitivity for RA, it is not very specific for the disease as it can also be detected in the serum of patients with other rheumatic or inflammatory diseases and even in a substantial percentage of the healthy (elderly) population. The RF antibodies are sensitive but not very specific markers In contrast, Anti-CCPs are characterized by a specificity of over 90% in patients affected by RA and are detectable in a very early asymptomatic stage in the approximately 70% of RA patients whereas only 2% of the control subjects resulted positive.

Therefore, the presence of Anti-CCP antibodies can be used in the diagnosis of RA, particularly in the case of erosive arthritis, in childhood in the case of juvenile RA. The Anti-CCP antibody test, together with the determination of RF, increases the ratio of sensitivity/specificity. The simultaneous positive result of a sample to RF and CCP has a positive predictive value of about 100%. The advantage of CCP antibodies is a higher sensitivity and specificity for the diagnosis of rheumatoid arthritis in comparison to the rheumatoid factors alone. Anti-CCP is often found at a very early stage of the disease and it has a high predictive value for development of the disease.

This test kit must be stored at 2 – 8°C upon receipt. For the expiration date of the kit refer to the label on the kit box. All components are stable until this expiration date.