Automated Determination of Citrullinated Cyclic Peptide Antibodies on AxSYM Analyser

Abstrakt

The aim of the study was to verify reproducibility, limit of detection, reference limits and diagnostic value of a new antiCCP2 method ? AxSYM^® Xtra Anti-CCP as a marker of rheumatoid arthritis. Reference limits were verified on a group of 105 volunteers. Diagnostic performance was assessed in a group of 95 patients with rheumatoid arthritis and 75 patients with systemic connective tissue diseases or polyarthritis. The AxSYM^® Xtra Anti-CCP assay achieved the day-to-day reproducibility 5.0?5.3 %, the detection limit was 0.8 U ml^?1. The assay reached 71 % and 53 % diagnostic sensitivity at 95 % and 100 % diagnostic specificity with cut-off 2.0 U/ml and 5.0 U ml^?1, respectively. We found also 4.2 % of positive values in systemic connective tissue diseases above the cut-off 5.0 U ml^?1. The AxSYM^® Xtra Anti-CCP assay provides automated random access measurement of anti-CCP antibodies with good analytical performance and diagnostic sensitivity and specificity comparable with other methods.