BioPlex 2200全自动免疫分析仪检测血清中抗环瓜氨酸肽抗体的临床应用

Clinical application of BioPlex 2200 automatic immunoanalyzer for detecting anti cyclic citrullinated peptide antibody in serum

目的分析比较Bio Plex 2200全自动免疫分析仪和酶联免疫吸附法(ELISA)两种方法检测血清中抗环瓜氨酸肽抗体(抗CCP抗体)的灵敏度与特异度及其优缺点。方法采用Bio Plex 2200全自动免疫分析仪和酶联免疫吸附法测定175例研究对象的血清抗CCP抗体,其中57例临床确诊的RA患者、118例非RA患者(包括40例关节痛、5例结缔组织病、7例风湿性关节炎、66例健康对照者)。结果Bio Plex 2200全自动免疫分析仪检测抗CCP抗体的灵敏度为84.21%,特异度为96.61%;酶联免疫吸附法(ELISA)检测抗CCP抗体的灵敏度为87.71%,特异性为95.76%。两种方法共检测175份血清标本,其中阳性52例,阴性119例,两种方法总体符合率为97.71%,两种方法经配对卡方检验(χ2=156.869,P<0.001)差异有统计学意义,Kappa值评价(K=0.946,P<0.001)有较好的一致性。结论 Bio Plex 2200全自动免疫分析仪和ELISA检测血清抗CCP抗体结果有较好的一致性,值得临床推广应用。

Objective To calculate sensitivity and specificity of a fully automated Bio PlexTM2200 immunoassay analyzer and the method of enzyme linked immunosorbent assay（ ELISA） in detecting serum Anticyclic citrylinated peptide antibody（ anti-CCP） and compare the advantages and the disadvantages between them.Methods We used a fully automated Bio PlexTM2200 immunoassay analyzer and enzyme-linked immunosorbent method to detect anti-CCP antibody of 175 cases of the study,including 57 cases of clinical diagnosed RA patients,118 cases of control group（ including 40 cases of joint pain,5 connective tissue disease,7 rheumatoid arthritis,66 healthy controls）. Results The sensitivity and specificity of fully automated Bio PlexTM2200 immunoassay analyzer was 84.21% and 96.61%,ELISA was 87.71%,and 95.76%. The total coincidence rate of two methods was 97. 71% in the total of 175,including 52 positive and 119 negative examples. There was statistically significant difference（ χ2= 156.869,P〈 0.001） and good consistency（ K = 0. 946,P 〈0. 001） in two methods. Conclusions The results of Bio Plex 2200 automatic immune analyzer and ELISA detection serum anticcp antibody are consistent and worthy of clinical application.