电化学发光免疫分析法检测T_3及T_4的性能验证  

Performance Verification of Electrochemiluminescence Immunoassay System in the Detection of T_3 and T_4

作　　者：庄岳鹏[1] 赵婉婷[1] 赵桂梅[1] 吴双[1] 肖辉建 

机构地区：[1]解放军第180医院检验科,福建泉州362000

出　　处：《标记免疫分析与临床》2014年第6期736-739,共4页Labeled Immunoassays and Clinical Medicine

摘　　要：目的 验证罗氏Cobas E601全自动电化学发光免疫分析系统检测T3及T4的分析性能,并探讨配套系统性能验证的简易方案.方法 通过室内质控数据分析,并参考美国临床和实验室标准研究院（CLSI）相关文件,对罗氏Cobas E601全自动电化学发光免疫分析仪检测T3及T4的精密度、正确度、可报告范围和生物参考区间进行试验分析,并与厂商声明的性能或公认的质量目标比较.结果T3及T4的批内精密度变异系数（CV）为1.29％ ～ 6.15％％,＜1/4TEa（CLIA＇ 88）,实验室内精密度CV为4.02％～ 5.65％,＜1/3TEa（CLIA＇ 88）;室间质控品的检测结果与靶值的相对偏倚在-（1.38％～4.18％）之间,＜ 1/2TEa（CLIA＇ 88）;可报告范围与厂家提供的范围相近;T3及T4的测量数值均在提供的参考区间内.结论 罗氏Cobas E601全自动电化学发光免疫分析仪T3、T4检测的主要分析性能符合质量目标要求,能满足临床需要,所采用的验证方案简便可行,且具有实用性.Objective To verify the analytical performance of Roche Cohas E601 automatic electrochemiluminescence immunoassay（ECLIA） system in the detection of triiodothyronine （T3 ） and thyronine （T4 ） and to explore a simple verification strategy of the matching detection system. Methods By analysis of internal quality control data and test according to Clinical and Laboratory Standards Institute （CLSI） related guideline, the precision, trueness, reportable range and reference interval of Roche Cobas E601 ECLIA system in the detection of T3 and T4 were verified. The results were compared with manufacturer＇s claims or acceptable quality standards. Results The within-run precision coefficients of variation（CV） of T3 and T4 was 1.29% - 6.15%, 〈 1/4Tea （ CLIA＇ 88 ）. The within- laboratory precision CV was 4.02% - 5.65%, 〈 1/3Tea （ CLIA＇ 88）. The system error（ SE% ） of external quality assessment control samples was -1.38% --4.18%, 〈 1/2Tea （CLIA＇88）. The reportable range was comparable with the declaration of the manufacturer. The verification results of reference interval of T3 and T4were in line with manufacturer reference interval. Conclusion The main analytical performance of T3 and T4measurement by Roche Cobas E601 automatic ECLIA system is consistent with acceptable quality standards, and the used verification projects are simple, feasible and practical.

关 键 词：电化学发光免疫分析法 三碘甲状腺原氨酸 甲状腺素 性能验证 

分 类 号：R446.6[医药卫生—诊断学]