Performance evaluation of Elecsys analysis system for anti-cyclic citrullinated peptide detection in comparison with commercially available ELISA assays in rheumatoid arthritis diagnosis

ObjectivesTo evaluate performance consistency of electrochemical luminescence with ELISA for anti-cyclic citrullinated peptide (CCP) antibodies detection and define their diagnostic efficacy on rheumatoid arthritis (RA).Design and methodsSerum anti-CCP antibodies of 144 subjects (93 RA, 17 non-RA autoimmune diseases,11 involution diseases and 23 healthy volunteers) were simultaneously determined by Elecsys assay, Immunoscan CCPlus® Euro-diagnostica ELISA kit and Euroimmun anti-CCP ELISA kit.ResultsThe consistent rate and Kappa coefficients among three assays were all more than 0.97. AUCs of ROC for anti-CCP antibodies detection by Elecsys, Euro-diagnostica ELISA and Euroimmun ELISA assays were respectively 0.790, 0.773 and 0.794 (all P values = 0.000), and under the optimal cutoff values their diagnostic accurate rates for RA diagnosis were 78.47%, 77.08% and 76.39% respectively.ConclusionsThe diagnostic performance of Elecsys assay for anti-CCP antibodies detection was satisfactory and comparable to that of classical ELISA assay. Under the same specificity Elecsys assay has a slightly but not significantly higher diagnostic accuracy and sensitivity than ELISA assay.