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EliA CCP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to CCP in human serum and plasma. The presence of anti-CCP antibodies can be used in conjunction with clinical findings and other laboratory tests as an aid in the clinical diagnosis of rheumatoid arthritis (RA). EliA CCP uses the EliA IgG method on the instruments ImmunoCAP 100 and ImmunoCAP 250. EliA CCP Control is intended for laboratory use in monitoring the performance of in vitro measurement of anti-cyclic citrullinated peptide (CCP) antibodies with ImmunoCAP using the EliA IgG method.

The new device belongs to a fully integrated and automated system for immunodiagnostic testing. It comprises a Fluorescence-Immunoassay test system using EliA single wells as the solid phase and is intended to be performed on the instruments ImmunoCAP 100 and ImmunoCAP 250. The conjugate for the EliA IgG method is mouse anti-human IgG beta-galactosidase, which uses 4-Methylumbelliferyl-BD-Galactoside as substrate. The total IgG calibration is based on a set of six WHO-standardized IgG Calibrators derived from human serum. They are used to establish an initial calibration curve, which may be used for up to one month on additional assays and can be stored by the instrument. Each additional assay includes calibrator (curve) controls that have to be measured in defined ranges to check whether the stored calibration curve is still valid. The Fluorescence-Immunoassay test system includes test-, method specific and general reagents that are packaged as separate units.