The measurement of anti-CCP antibodies has become the method of choice in the accurate diagnosis of Rheumatoid Arthritis.
Assays using the second-generation CCP2 peptide are as sensitive as the rheumatoid factor (RF) 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.
Proven, reliable CCP2 technology
CE-marked and FDA 510k-cleared
Excellent Clinical Specificity of 99%
Low Total Imprecision
Linear up to 300 U/mL
Intended Use
The Axis-Shield Anti-CCP test is a semi-quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum (including Serum Separator Tubes) or plasma (EDTA, lithium heparin, or sodium citrate). Detection of anti-CCP antibodies is used as an aid in the diagnosis of Rheumatoid Arthritis (RA), and should be used in conjunction with other clinical information. Autoantibody levels represent one parameter in a multi-criterion diagnostic process, encompassing both clinical and laboratory-based assessments.
Assay Principle
The wells of the microtitre strips are coated with a highly purified synthetic cyclic citrullinated peptide containing modified arginine residues. During the first incubation, specific autoantibodies in diluted serum or plasma bind to the antigen-coated surface.