基于CLSI指南EP09-A3比对2套化学发光免疫分析系统血清TT_3测定结果  

Applicability of CLSI EP09-A3 in 2-method comparison determining serum total triiodothyronine

作　　者：陈永伟[1] 王静[1] 杨晓龙 胡芳宇 林芳 CHEN Yongwei;WANG Jing;YANG Xiaolong;HU Fangyu;LIN Fang(Department of Clinical Laboratory,Jiangyuan Hospital Affiliated to Jiangsu Institute of Nuclear Medicine,Wuxi 214063,Jiangsu,China;Development Central Laboratory,Sysmex Wuxi Co.Ltd.,Wuxi 214028,Jiangsu,China)

机构地区：[1]江苏省原子医学研究所附属江原医院医学检验科,江苏无锡214063 [2]希森美康生物科技(无锡)有限公司开发中心实验室,江苏无锡214028

出　　处：《检验医学》2024年第2期176-180,共5页Laboratory Medicine

摘　　要：目的 基于美国临床实验室标准化协会(CLSI)指南EP09-A3探讨2套化学发光免疫分析系统血清总三碘甲状腺原氨酸(TT_3)测定结果的可比性。方法 根据EP09-A3指南要求,使用2个品牌化学发光免疫分析系统(分别命名为系统一和系统二)分别测定111例血清样本TT_3水平。通过广义极端学生化偏差(ESD)法检验离群值,选用EP09-A3指南列举的5种回归模型分析2套系统TT_3检测结果,并计算医学决定水平处的偏移。结果 散点图目测和ESD法检验均未发现离群值。2套系统TT_3检测结果的5种回归分析结果显示,一般线性回归、加权最小二乘法回归、Deming回归、Passing-Bablock回归分析在TT_3医学决定水平处(0.75和1.91 ng·mL~(-1))的偏移均<可接受范围[允许总误差(TEa)±12.5%],偏移的95%可信区间(CI)结果类型解读为可接受的A型和B型,加权Deming回归分析得到的偏移的95%CI部分超出可接受范围,结果类型解读为C型。结论 EP09-A3指南适用于2套系统检测TT_3的方法学比对和偏移评估,且该指南更新的离群值判断方法、回归分类分析法和对应的解读分型方式更为科学、合理。Objective To evaluate the applicability of the Clinical and Laboratory Standards Institute(CLSI)guideline EP09-A3 in 2 chemiluminescence immunoassay systems determining serum total triiodothyronine(TT3).Methods Totally,111 serum samples were determined for TT3 and analyzed by System 1 and System 2.Analytical performance and method comparison were performed according to EP09-A3.Outliers were computed by extreme studentized deviate(ESD),and 5 classified regression techniques were performed to evaluate the 2 methods and interpret biases.Results No outliers were determined in this study by visual judgement or ESD.The biases with 95%confidence interval(CI)of medical decision points(0.75 and 1.91 ng·mL-1)were within the allowable total error(TEa)(±12.5%)by applying general linear regression,weighted least square regression,Deming regression and Passing-Bablock regression,and the outcomes were interpreted as type A or B which were acceptable.While the outcome of weighted Deming regression was interpreted as type C which may be judged as unacceptable.Conclusions The results of 2 systems determining TT3 are comparable,and the analysis methods and interpretation of EP09-A3 are more scientific and reasonable.

关 键 词：EP09-A3 总三碘甲状腺原氨酸 方法学比对 医学决定水平 偏移 

分 类 号：R733.71[医药卫生—肿瘤]