不同化学发光分析系统检测丙型肝炎病毒抗体的性能评价  

Performance Verification of Different Chemiluminescence Analysis System in the Detection of Anti-HCV

作　　者：赵乔妹[1] 张静[1] 刘英丽[1] 时宇[1] 王海滨[1] 徐成 

机构地区：[1]解放军总医院第一附属医院检验科 [2]新疆巴音郭愣自治州轮台县69222部队

出　　处：《标记免疫分析与临床》2015年第4期345-347,351,共4页Labeled Immunoassays and Clinical Medicine

摘　　要：目的 评价罗氏Cobas e601及雅培Architect i2000两种化学发光免疫分析系统检测抗-HCV的分析性能和一致性.方法 按照CLSI推荐的方法对两台分析仪检测抗-HCV的精密度、检出限、阴阳性符合率等性能进行验证试验;两台仪器分别检测120例有反应性血清样本及30例无反应性样本,用Kappa检验评价检测结果的一致性.结果 两台仪器的精密度良好;检出限均为0.3NCU;阴阳性符合率为100％;两个分析系统检测抗-HCV总体符合率为70.67％,无反应性、e601 S/CO≥15.0、i2000 S/CO≥6.0样本结果的符合率为100％,e601 S/CO为1.01 ～5.0和i2000 S/CO为1.01 ～2.0样本结果的符合率为0和44.4％：经统计分析κ=0.35在Kappa系数区段中一致性程度属于弱（κ=0.35,P＜0.05）.结论 两个分析系统检测抗-HCV的分析性能均良好,适用于临床标本的常规检测,对于两台仪器检测结果不一致的样本,尤其是e601 S/CO 1 ～ 15及i2000 S/CO 1～6的样本,建议进行补充实验（RIBA,NAT）来明确诊断.Objective To evaluate the analysis performance and consistency of Roche Cobas e601 and Abbott Architect 12000 chemiluminescence immunoassay systems in the detection of Anti-HCV. Methods Verification experiments were taken to measure the precision, the detection limit and the masculine coincidence rate for two analyzers in the detection of anti-HCV based on the method recommended by CLSI. 120 reactive samples and 30 non-reactive samples were detected by two analyzers respectively. Kappa statistic was used to measure the agreement between the results. Results The precision of two analyzers was good. The detection limit of the two analyzers was 0.3 NCU and the masculine coincidence rate was 100%. The total coincidence rate of the two analysis system for the detection of anti-HCV was 70.67%. The coincidence rate for non-reactive, e601 S/CO ≥15.0 and i2000 S/CO≥6.0 sample was 100%. The coincidence rate of e601 S/CO 1.01 - 5.0 and i2000 S/CO 1.01 - 2.0 samples were 0 and 44.4% respectively. The degree of consistency in the Kappa coefficient section was weak （ K = 0.35, P 〈 0.05 ）. Conclusion The analysis performance of the two analysis systems for detection of anti-HCV is good, which is suitable for the routine inspection of clinical specimens.

关 键 词：丙型肝炎抗体 化学发光测定法 Kappa检验 

分 类 号：R446.6[医药卫生—诊断学] R512.63[医药卫生—临床医学]