贝克曼免疫法检测促甲状腺素二代与三代试剂间一致性的比较  

The Comparison of the Second and Third Generation of Reagents for Thyroid Stimulating Hormones Detection by Beckman Immunoassay

作　　者：邹雨桐 王丹晨 禹松林[1] 尹逸丛 马超超 方佳丹 刘茜[1] 刘荔[1] 国秀芝[1] 夏良裕[1] 程歆琦[1] 邱玲[1] ZOU Yutong;WANG Danchen;YU Songlin;YIN Yicong;MA Chaochao;FANG Jiadan;LIU Qian;LIU Li;GUO Xiuzhi;XIA Liangyu;CHENG Xinqi;QIU Ling(Department of Clinical Laboratory, Peking Union Medical College Hospital, Peking Union Medical College &Chinese Academy of Medical Science, Beijing 100730, China)

机构地区：[1]中国医学科学院北京协和医院检验科,北京100730

出　　处：《标记免疫分析与临床》2020年第5期879-881,897,共4页Labeled Immunoassays and Clinical Medicine

基　　金：国家自然科学基金青年项目(编号:81702060);首发卫生发展科研专题项目(编号:首发2016-2—4017);国家临床重点专科建设项目(编号:2011AA02A1110)。

摘　　要：目的比较贝克曼DXI800免疫法检测促甲状腺素的二代与三代试剂间检测结果的一致性。方法收集北京协和医院2019年4月至5月临床检测剩余标本共110例,参考CLSI EP15-A3及EP9-A2文件,采用passing-bablok及Bland Altman等方法,进行贝克曼二代与三代试剂检测TSH的精密度评价、方法学比对及性能验证。结果二代与三代试剂检测结果的重复性分别为2.73%~4.73%和1.86%~3.39%,实验室内不精密度分别为2.55%~4.98%和2.40%~3.41%,由passing-bablok得到的回归方程为Y=1.03X-0.009(R^2=0.991),Bland Altman偏倚图显示二代和三代试剂检测结果间的平均偏倚为-1.8%,其95%的置信区间为-33.4%~29.8%。结论贝克曼免疫法检测促甲状腺素的二代试剂与三代试剂间检测结果的一致性较好,且三代试剂的精密度更高。Objective To compare the harmonization of the 2nd and 3rd generation of reagents of Beckman DXI800 immunoassay for thyroid stimulating hormones(TSH)measurements.Methods A performance validation was conducted as described in the following.During April and May in 2019,110 remained serum samples used for the comparison study were collected from the clinical laboratory in Peking Union Medical College Hospital.According to documents of CLSI EP15-A3 and EP9-A2,the precision evaluation and method comparison of Beckman 2nd and 3rd generation of reagents for the measurements of TSH were conducted,and analyzed with Passing-Bablok and Bland Altman methods.Results The repeatability of the 2nd and 3rd generation of reagents were 2.73%-4.73%and 1.86%-3.39%,and the within laboratory imprecision were 2.55%-4.98%and 2.40%-3.41%,respectively.By Passing-Bablok method,the regression equation was calculated as Y=1.030 X-0.009,with R^2 equal to 0.991.And Bland Altman method showed the average bias(%)between two generations of reagents was-1.8%,and the 95%confidence interval was-33.4%-29.8%.Conclusion The harmonization of the 2nd and 3rd generation of reagents of Beckman DXI800 immunoassay for the measurements of TSH is good,and the precision of the 3rd generation of reagents is better.

关 键 词：促甲状腺素 贝克曼DXI800 精密度评价 方法学比对 一致性 

分 类 号：R392-33[医药卫生—免疫学]