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Inteded use
The EDIA™ anti-CCP test kit is an enzyme-linked immunosorbent assay (ELISA) for detection and semi-quantitation of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human serum or plasma. The assay is used to detect antibodies in a single 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.
Principle of the assay
The EDIA™ anti-CCP antibody kit is based on an ELISA method. The test utilizes microtitre wells coated with citrullinated synthetic peptides (antigen). Diluted patient serum or plasma is applied to the wells and incubated. If specific antibodies are present, they will bind to the antigen in the wells. Unbound material is washed away and any bound antibody is detected by adding alkaline phosphatase labelled antibodies to human IgG, followed by a second washing step and incubation with a chromogenic substrate.
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