本试剂盒应用双抗体夹心酶标免疫分析法测定标本中CCP水平。用纯化的抗体包被微孔板，制成固相抗体，往包被单抗的微孔中依次加入CCP抗原、生物素化的抗人CCP抗体、HRP标记的亲和素，经过彻底洗涤后用底物TMB显色。TMB在过氧化物酶的催化下转化成蓝色，并在酸的作用下转化成最终的黄色。颜色的深浅和样品中的CCP呈正相关。用酶标仪在450nm波长下测定吸光度（OD值），计算样品浓度。
Intended use
This immunoassay kit allows for the specific measurement of Human anti-cyclic cirtrullinated peptide antibody ,CCP Ab concentrations in cell culture supernates, serum, and plasma.
Introduction
CCP (PRL) is a peptide hormone primarily associated with lactation. In breastfeeding, the infant suckling the teat stimulates the production of CCP, which fills the breast with milk (lactogenesis) in preparation for the next feed. Oxytocin, a similar hormone, is also released, which triggers milk let-down. CCP (PRL) is a polypeptide hormone secreted by anterior pituitary of both male and female. Release of CCP is controlled by a complex neuroendocrine reflex initiated by a tactile stimulus and regulated by hypothalamic releasing and inhibition factors.
Rheumatoid Arthritis (RA), a chronic inflammatory disorder of the synovial membranes, is one of the most common systemic autoimmune diseases. Approximately 1% of the world population is affected. The diagnosis of RA depends primarily on clinical manifestations, but laboratory results are helpful in differential diagnosis and disease management. Early diagnosis of RA is important both in disease treatment and management.
Historically, rheumatoid factor (RF) has long been the serologic indicator for RA. However, it has been known for years that anti-keratin autoantibodies (AKA), also known as anti-perinuclear autoantibodies, are detected in 40-55% of RA patients and in 40-50% of clinically diagnosed RA patients who are RF negative.AKA is considered significantly more specific than RF. Additionally, AKA may precede the clinical appearance of RA by months or years.
Recently it was determined that AKA recognize an epitope that contains citrulline, the deiminated form of arginine.5 IgG antibodies against a synthetic peptide containing citrulline known as CCP (Cyclic Citrullinated Peptide) has proven to be superior to either AKA or RF testing in differentiating RA from other autoimmune diseases. The presence of CCP antibody occurs independently of elevated RF levels in patients with RA.
Test principle
This assay employs the quantitative sandwich enzyme immunoassay technique. A monoclonal antibody specific for CCP Ab has been pre-coated onto a microplate. Standards and samples are pipetted into the wells and any CCP Ab present is bound by the immobilized antibody. An enzyme-linked polyclonal antibody specific for CCP Ab is added to the wells. Following a wash to remove any unbound antibody-enzyme reagent, a substrate solution is added to the wells and color develops in proportion to the amount of CCP Ab bound in the initial step. The color development is stopped and the intensity of the color is measured.
