B-127抗ccp IgG化学发光自动免疫分析法在AutoLumo®2000 Plus平台上体外诊断类风湿关节炎(RF

IF 6.3 2区医学 Q1 MEDICAL LABORATORY TECHNOLOGY

Clinical chemistry Pub Date : 2025-10-02 DOI:10.1093/clinchem/hvaf086.524

Don Zheng

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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. 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引用次数: 0

摘要

CCP （cyclic瓜氨酸化肽）是一组含有瓜氨酸的环状短肽，其精氨酸残基经肽基精氨酸脱亚胺酶修饰。抗ccp抗体是诊断类风湿关节炎（RA）的关键血清学标志物，由于其与类风湿因子（RF）相比的高特异性（0.95-0.99），在ACR/EULAR 2010诊断指南中得到认可。抗ccp IgG可在临床RA症状出现前几年出现，为RA诊断提供了有价值的预测潜力。基于AutoLumo®2000自动化学发光免疫分析分析仪平台，我们推出了一款抗ccp体外诊断产品，可根据临床实验室和医院的要求提供卓越的性能。方法采用两步间接法，将稀释后的血清样品与链霉亲和素标记的微颗粒和生物素标记的CCP抗原结合，促进抗CCP IgG抗体与抗原结合。经过一个洗涤步骤后，加入含有小鼠抗人IgG的酶偶联物，促进与结合的抗ccp IgG在固相上形成免疫复合物。最后，添加化学发光底物触发反应，以相对光单位（RLUs）强度测量，这与血清中抗ccp IgG抗体的浓度成正比。根据临床实验室标准协会（CLSI）的指导方针，对罗氏Cobas的Elecsys抗CCP测定法的分析性能、稳定性和方法比较进行了评估。结果抗CCP IgG CLIA微颗粒测定法的分析性能评价表明其在检测人血清中抗CCP IgG抗体方面是可靠的。分析灵敏度高，空白限（LOB）为0.5 AU/mL，检测限（LOD）为2.0 AU/mL，定量限（LOQ）为8.0 AU/mL，确保了测定的准确性。对准确度进行了评定，预期结果与实测结果的偏差在±10%以内。该方法具有良好的特异性，不受常见内源性和外源性物质的干扰。在8.0 ~ 500 AU/mL范围内呈良好的线性关系，R=0.99。方法与罗氏Cobas的Elecsys抗ccp IgG法比较，200份临床样本的符合率为96.5%。此外，AutoLumo®抗ccp IgG检测显示出良好的稳定性，根据实时稳定性数据，在2-8°C保存时可保持性能长达12个月。结论在Autolumo®2000 Plus系统上进行的抗ccp IgG CLIA微颗粒检测与在罗氏Cobas上进行的Elecsys抗ccp IgG检测相比，具有96.5%的总符合率。它还显示了出色的分析性能和高通量能力。AutoLumo®A2000 Plus已被证明是全球IVD市场中强大可靠的自身免疫抗体测试平台。

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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.

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来源期刊

Clinical chemistry 医学-医学实验技术

CiteScore

11.30

自引率

4.30%

发文量

212

审稿时长

1.7 months

期刊介绍： Clinical Chemistry is a peer-reviewed scientific journal that is the premier publication for the science and practice of clinical laboratory medicine. It was established in 1955 and is associated with the Association for Diagnostics & Laboratory Medicine (ADLM). The journal focuses on laboratory diagnosis and management of patients, and has expanded to include other clinical laboratory disciplines such as genomics, hematology, microbiology, and toxicology. It also publishes articles relevant to clinical specialties including cardiology, endocrinology, gastroenterology, genetics, immunology, infectious diseases, maternal-fetal medicine, neurology, nutrition, oncology, and pediatrics. In addition to original research, editorials, and reviews, Clinical Chemistry features recurring sections such as clinical case studies, perspectives, podcasts, and Q&A articles. It has the highest impact factor among journals of clinical chemistry, laboratory medicine, pathology, analytical chemistry, transfusion medicine, and clinical microbiology. The journal is indexed in databases such as MEDLINE and Web of Science.