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Anti-CCP hs (high sensitive)®

PRODUCT NAME: Anti-CCP hs (high sensitive)®
INTENDED USE: Anti-CCP hs (high sensitive) is an ELISA test system for the quantitative determination of IgG antibodies against cyclic citrullinated peptides (CCP) in human serum or plasma.
PRODUCT OVERVIEW: Anti-CCP hs (high sensitive) is based on selected and optimized peptide epitopes from the body’s own MCV protein (modified citrullinated vimentin). Due to its tailored antigen profile, this ELISA attains the highest sensitivity while maintaining high specificity. It is thus positioned as a powerful serological test for the rapid and precise routine diagnosis of rheumatoid arthritis (RA), as well as for the diagnosis of early RA. In conjunction with rheumatoid factor, autoantibodies against citrullinated antigens (ACPA) have been included as determinate factors in the current ACR criteria for the classification of rheumatoid arthritis. Anti-CCP hs (high sensitive) is an ACPA test that allows for the diagnosis of RA with comparable sensitivity and significantly higher specificity and prognostic power than conventional rheumatoid factor tests.
TECHNICAL SPECIFICATIONS:

Method: Indirect Enzyme Linked Immune Reaction
Capture: Cyclic citrullinated vimentin peptides (CCP)
Calibrators: 0, 20, 40, 100, 300, 1000 U/ml
Sample type: Serum or plasma
Sample volume: 10 µl
Measuring range: 0 - 1000 U/ml
Reading: Absorbance at 450 nm
Cut-off: 20 U/ml
Total time: 65 minutes
Storage: 2 - 8 ºC
Kit Contents: Microplate
Calibrators: A, B, C, D, E, F
Controls: Positive & Negative
Enzyme Conjugate
TMB Substrate
Diluent
Stop Solution
Wash Concentrate
*Please refer to the product Instruction-For-Use (IFU) for complete details.