Intended Use:
QUANTA Lite™ CCP3 IgG ELISA is a semiquantitative enzyme-linked immunosorbent assay for the detection of IgG anti-CCP3 (Cyclic Citrullinated Peptide third generation antigen) antibodies in either sera or citrated plasma or EDTA plasma. The presence of these antibodies, when considered in conjunction with other laboratory and clinical findings, is an aid in the diagnosis of rheumatoid arthritis.

Overview Testing for Rheumatoid Arthritis using CCP Antigen
Rheumatoid Arthritis (RA) is one of the most common systemic autoimmune diseases, affecting approximately 0.5% of the world population.¹ A diagnosis of RA still primarily depends on clinical manifestations of the disease. Until recently, the only serological test routinely used in the diagnosis of RA was the determination of the presence of rheumatoid factor (RF), found in approximately 50%-90% of these patients.^1,2 However, RF is also found in people with infections, other autoimmune diseases and also in some healthy individuals.^1,2

It is important for disease management to diagnose and treat individuals with RA as early as possible.3 It has been known for many years that anti-perinuclear autoantibodies, which are also called anti-keratin autoantibodies, are found in people with RA.4 Several years ago it was discovered that these antibodies recognize an epitope (an antibody binding site) that contains the deimidated form of arginine called citrulline.5,6 A circular peptide containing citrulline, called CCP (Cyclic Citrullinated Peptide), was found to be better at discriminating RA patients from other rheumatic patients than either the perinuclear antibody test or the tests for rheumatoid factor.4,7,8 In a review of the published literature6, 77% of patients with RA are positive for anti-CCP, while an average of 3% of non-RA subjects are positive.

Over the years, further clinical use, research and refinement has dramatically improved the utility of the CCP peptide as new generations of peptide have been developed.6,9 The latest peptide, CCP3 shows a 5% increase in sensitivity at detecting RA patients than the previous widely-marketed peptide 4,7,8 suggesting that additional epitopes were not available in the previous generation CCP antigen.