2种肌钙蛋白I检测系统结果的一致性评价  

An Evaluation of the Harmonization of Two cTnI Measurement Systems

作　　者：由婷婷 赵芳[1] 王丹晨 张殿喜[1] 尚雪松[1] 程歆琦[1] 邱玲[1] YOU Ting-ting;ZHAO Fang;WAND Dan-chen;ZHANG Dian-xi;SHANG Xue-song;CHENG Xin-qi;QIU Ling(Department of Laboratory Medicine,Chinese Academic Medical Science and Peking Union Medical College Hospital,Beijing 100730,China)

机构地区：[1]中国医学科学院北京协和医院检验科

出　　处：《标记免疫分析与临床》2019年第11期1945-1948,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);首都卫生发展科研专题项目(编号:首发2016-2-4017);宁夏重点研发计划-重大重点项目(东西部合作项目)(编号:2018BFG02010)

摘　　要：目的比较2种肌钙蛋白I (cardiac troponin I,cTn I)化学发光检测系统结果的一致性。方法收集2018年5月北京协和医院临床检测剩余血浆样本共130例,分别采用Siemens cTnI测定试剂盒(化学发光法)和超敏cTnI测定试剂盒(直接化学发光免疫分析法)检测上述样本的cTnI水平。采用Passing-Bablok和Bland-Altman分析2种方法的一致性和偏差。结果待评价试剂和对比试剂的测定值的Pearson相关系数(r)为0.991(95%CI:0.9866~0.9936,P<0.0001)。以待评价试剂测定值为Y变量,对比试剂测定值为X变量拟合线性回归方程,Y=0.95X,其斜率的95%可信区间为0.943~0.974,线性回归方程具有统计学意义,结果表明待评价试剂和对比试剂检测结果相关性良好。在0.5ng/mL医学决定水平处,绝对偏倚为0.025ng/mL,相对偏倚为5%。结论两种cTnI检测试剂盒的一致性较好,在临床应用中两者之间具有等效性。Objective To evaluate the harmonization of two cTnI measurement systems.Methods To conduct the performance validation,130 residual plasma samples were obtained from Peking Union Medical College Hospital in May 2018.All the samples were measured by Siemens cTnI(chemiluminescence method) and hypersensitive cTnI assays.Using Passing Babloke and Bland Altman, we compared the results between two assays.Results The Pearson correlation coefficient(r) between reagent to be evaluated and reference reagent was 0.991(95% CI:0.9866 to 0.9936,P<0.0001). We used value of the reagent to be evaluated as Y variable, and the value of the reference reagent as X variable to fit into the linear regression equation:Y=0.95X and the 95% confidence interval of the slope was 0.943~0.974. The linear regression equation was statistically significant, indicating that the detection results of the reagent to be evaluated and the reference reagent were correlated well. At the 0.5 ng/mL medical decision level, the absolute bias was 0.025 ng/mL and the relative bias was 5%.Conclusion The consistency of the two cTnI assays is optimal, and there is equivalence between two assays in clinical applications.

关 键 词：肌钙蛋白I 方法学比对 化学发光 

分 类 号：R54[医药卫生—心血管疾病]