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Anti-CCP assay FCCP200 Also FCCP300 with detection at a different wavelength using pNPP substrate Description:
The Axis-Shield anti-CCP assay is an ELISA which detects autoantibodies against second generation cyclic citrullinated peptides in human serum or plasma (CCP2). The test provides an additional tool in the diagnosis and management of patients with rheumatoid arthritis (RA) Background:
Since the first report in 1998 that antibodies reactive 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 early and accurate diagnosis of this disease. The anti-CCP2 assay is as sensitive as the rheumatoid factor test but with much higher specificity. Additionally anti-CCP2 positivity can predict future development of RA in both asymptomatic individuals and in patients with undifferentiated arthritis. It has also been shown that antibody levels at presentation can correlate with progression to erosive disease. Kit Components:
Each kit contains individually-coated microtitre strips (96 wells), reference and positive/negative controls, sample diluent, 5 standards, wash buffer, IgG-alkaline phosphatase conjugate, substrate and stop solution Assay Protocol:
The wells of the Axis-Shield anti-CCP microtitre strips are coated with highly-purified synthetic cyclic citrullinated peptides containing modified arginine residues (CCP2). In the quantitative protocol, the antibody concentration in an unknown sample can be estimated by interpolation from a dose response curve based on reference standards. In the qualitative protocol, the response measured in the unknown sample is compared to that of the known concentration reference control. Performance:
In a sample group of 1036 sera from patients with clinically-confirmed RA, the sensitivity of the test was 78%, and the specificity was 97%. This compared to 74% and 53% for the RF IgM assay Pack Kit Size: 12 x 8 microtitre strips Shelf Life: Minimum 12 months at 2-8 degrees C
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