电化学发光免疫测定与酶联免疫吸附试验检测抗环瓜氨酸多肽抗体比较

Comparison of Electrochemiluminescence Immunoassay with Enzyme-linked Immunosorbent Assay for the Measurement of Anti-cyclic Citrullinated Peptide Antibodies

目的分析酶联免疫吸附试验(ELISA)和电化学发光免疫测定(ECLIA)检测抗环瓜氨酸多肽抗体(抗CCP抗体)的结果,并评价两种方法检测结果的一致性。方法应用ELISA和ECLIA同时检测145例类风湿关节炎(RA)患者(含25例早期RA患者)、155例其他风湿免疫性疾病患者(包括50例骨性关节炎、35例强直性脊柱炎、30例干燥综合征、20例系统性红斑狼疮、10例原发性胆汁性肝硬化和10例系统性硬化症)、50例其他疾病患者和50例健康对照者共400例血清样本的抗CCP抗体含量。用SPSS13.0统计软件对结果进行一致性、敏感性及特异性分析,并分别对3例ECLIA检测高浓度抗CCP抗体血清样本做1∶20、1∶30、1∶40、1∶80和1∶160稀释后进行线性分析。结果 ELISA和ECLIA检测400例血清样本抗CCP抗体的一致性极好;两种方法检测RA患者抗CCP抗体的敏感性和特异性近似,ECLIA分别为77.24%和98.00%,ELISA分别为76.55%和98.00%。3例ECLIA检测高浓度抗CCP抗体血清样本线性回归分析结果显示,样本浓度稀释至1∶160,线性R2值均>0.9。结论 ECLIA和ELISA检测抗CCP抗体具有较好的一致性,且ECLIA线性范围较宽,ECLIA检测抗CCP抗体具有良好的应用前景。

Objective To evaluate the methodological characteristics of electrochemiluminescence immunoassay （ECLIA） and enzyme-linked immunosorbent assay （ELISA） in measuring anti-cyclic citrullinated peptide antibodies （anti-CCP） autoantibodies. Methods A total of 400 specimen were included in this study, in which 145 specimen were from RA patients（25 early RA）, 155 were from patients with other autoimmune diseases （50 with osteo arthritis, 35 with ankylosing spondylitis, 30 with primary sjogren syndrome, 20 with systemic lupus erylhematosus, 10 with primary biliary cirrhosis and 10 with systemic sclerosis）, 50 patients with other diseases and 50 healthy subjects. Consistency analysis of the results and linearity of the dilution test were evaluated by SPSS 13.0 software. Results ELISA and ECLIA had very good consistency in measuring anti-CCP antibodies in 400serum specimens from patients. The two methods also demonstrated similar clinical sensitivity and specificity ECLIA （77.24%, 98.00% ）, ELISA（76.55%, 98.00% ） in RA. Sera from three patients with high concentration of anti-CCP antibodies were diluted in 1 ： 20, 1 ： 30, 1：40, 1：80 and 1：160 ratio, respectively. The results showed that ECLIA had a wide linear range. Conclusions Both ELISA and ECLIA have very good consistency in detecting anti-CCP antibodies. ECLIA has a wider linear range than ELISA. The automated ECLIA processing system for determining anti-CCP antibodies has demonstrated a good analytical performance.