Intended use

The Immunoscan CCPlus® test kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative and semi-quantitative determination of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human sera. The assay is used to detect antibodies in a single serum specimen. The results of the assay are to be used as an aid to the diagnosis of Rheumatoid Arthritis (RA), in conjunction with other laboratory and clinical findings. The analysis should be performed by trained laboratory professionals. 

FOR IN VITRO DIAGNOSTIC USE

Background

Since the first report in 1998 that antibodies react with synthetic peptides containing the amino acid citrulline are highly specific for RA, the measurement of anti-CCP antibodies has become the method of choice in the accurate diagnosis of this disease. The anti-CCP2 assay is as sensitive as the rheumatoid factor test but with much higher specificity. Anti-CCP antibodies have a high positive predictive value and can be detected years before the development of clinical symptoms. A diagnostic value for the measurement of the anti-CCP antibodies has been found in relation to joint involvement and radiological damage on early RA. The presence of anti-citrullinated protein antibodies is now one of the ACR-criteria for classification of RA as well as part of EULARs recommendations.

Vossenaar, E. Van Venrooij, W. Anti-CCP antibodies, a highly specific marker for (early) rheumatoid arthritis. Clinical and Applied Immunology Reviews 4 (2004) 239–262.

Relevant links
ACR-criteria for classification of RA
European League Against Rheumatism (EULAR) Recommendations

Kit Components

Each kit contains CCP-coated microtitre plate (96 wells), reference and positive/negative controls, sample diluent, 5 standards, wash buffer, conjugate (peroxidase conjugated to IgG-antibodies), substrate and stop solution.