Quantification of cartilage oligomeric matrix protein (COMP) and a COMP neoepitope in synovial fluid of patients with different joint disorders by novel automated assays

Objective: To develop automated immunoassays for the quantification of Cartilage Oligomeric Matrix Protein (COMP) and a COMP neoepitope in synovial fluid and to investigate their diagnostic potential in different joint conditions. Methods: Two sandwich immunoassays were developed for the quantification of COMP and a COMP neoepitope, using an automated analyser (IDS-iSYS, Immunodiagnostic Systems, Boldon, UK). Assay performance was evaluated in terms of sensitivity, recovery, linearity, and intra- and inter-assay precision. Clinical performance was evaluated by analysing synovial fluid from patients diagnosed with rheumatoid arthritis (RA), reactive arthritis (ReA), osteoarthritis (OA) or acute trauma (AT). Results: Both automated assays showed good performance for all parameters tested. Quantification of these biomarkers showed the highest median values for Total COMP in the OA group, followed by the AT group, the ReA group, and the RA group. For the COMP neoepitope the AT group showed the highest median value, followed by the ReA group, the OA group, and the RA group. The ratio COMP neoepitope/Total COMP showed distinct differences between the patients groups, as well as between RA patients with slow or rapid progression of joint damage. Conclusions: The newly developed automated assays have a good technical performance, can reliably quantify different epitopes on the COMP molecule and show different levels of the two biomarkers in synovial fluid in patients with different joint diseases. The combination of these two assays, measuring their ratio, shows promise for early detection of patients with RA with different prognosis regarding progression of joint damage.