B-127 Anti-CCP IgG Chemiluminescence Automatic Immunoassay for Rheumatoid Arthritis (RF) In-vitro Diagnostic on AutoLumo® 2000 Plus Platform

Background CCP (cyclic citrullinated peptide) is a group of cyclic short peptides containing citrulline with peptidyl-arginine deiminase modification on the arginine residues. Anti-CCP antibodies are critical serological markers for diagnosing rheumatoid arthritis (RA), recognized in the ACR/EULAR 2010 diagnostic guidelines due to their high specificity (0.95-0.99) compared to rheumatoid factor (RF). Anti-CCP IgG can emerge years before clinical RA symptoms, offering valuable predictive potential for RA diagnosis. Built on AutoLumo® 2000 Automatic Chemiluminescence Immunoassay Analyzer platform, here we introduce an anti-CCP In-vitro Diagnostics that delivers superior performance in accordance with requirements of clinical laboratories and hospitals. Methods This assay utilizes a two-step indirect method in which a diluted serum sample is combined with streptavidin-labeled microparticles and biotin-labeled CCP antigen, facilitating the binding of anti-CCP IgG antibodies to the antigen. After a washing step, an enzyme conjugate containing mouse anti-human IgG is added, promoting the formation of an immunological complex with the bound anti-CCP IgG on the solid phase. Finally, the addition of a chemiluminescent substrate triggers a reaction that is measured in relative light units (RLUs) intensities, that is proportional to the concentration of anti-CCP IgG antibodies in the serum. Analytical performance, stability, and method comparison with the Elecsys anti-CCP assay on Roche Cobas were assessed according to Clinical & Laboratory Standards Institute (CLSI) guideline Results The analytical performance evaluation of the Anti-CCP IgG CLIA Microparticles assay demonstrates its reliability in detecting IgG antibodies to CCP in human serum. The assay exhibits high analytical sensitivity, with a limit of blank (LOB) at 0.5 AU/mL, a limit of detection (LOD) at 2.0 AU/mL, and a limit of quantitation (LOQ) at 8.0 AU/mL, ensuring precise measurement. The trueness was evaluated, and the deviation of expected and measured results is within the ±10%. The assay showed excellent specificity, exhibiting no interference from common endogenous and exogenous substances. A high linearity with R=0.99 was observed within the measuring range of 8.0-500 AU/mL. Method comparison with the Elecsys anti-CCP IgG assay on Roche Cobas showed a 96.5% total coincidence rate across 200 clinical samples. Additionally, the AutoLumo® anti-CCP IgG assay demonstrated good stability, maintaining performance for up to 12 months when stored at 2–8°C based on real-time stability data. Conclusion Anti-CCP IgG CLIA microparticles assay performed on Autolumo® 2000 Plus system has demonstrated superior clinical performance with 96.5% total coincidence as compared to the Elecsys anti-CCP IgG assay on Roche Cobas. It also showed excellent analytical performance and high throughput capabilities. The AutoLumo® A2000 Plus has proven to be a robust and reliable platform for the autoimmunity antibody test in the global IVD market.