罗氏Cobas e411检测血清NT-ProBNP的性能验证  

Performance Validation of Detection of Serum N-terminal Pro B-type Natriuretic Peptide by Roche Cobas e411

作　　者：陈华[1] 朱剑骞 周懿忆[1] 戴屹东 张华[1] 

机构地区：[1]上海交通大学医学院附属瑞金医院卢湾分院放免检验科,上海200020 [2]Quest医学检验所,上海201321 [3]上海市东南医院检验科,上海200023

出　　处：《标记免疫分析与临床》2015年第10期1047-1050,共4页Labeled Immunoassays and Clinical Medicine

摘　　要：目的在开展新项目血清N末端B型利钠肽原（NT-ProBNP）前,用实验对其进行性能验证,评估其是否能满足临床使用要求。方法根据部分EP文件采用二水平质控品,检测40例新鲜血清标本及20例健康体检者的NT-ProBNP,对检测结果的精密度、准确度,线性范围和参考区间等参数进行性能验证。结果 NT-ProBNP二水平质控品批内精密度分别为1.79、58.33,总精密度分别为1.88、81.40,均小于厂商声明的标准差;Cobas e411与罗氏Modular E170检测结果间具有可比性;NT-ProBNP为一阶线性,线性回归方程和判定系数为Y=1.050X-35.174,R2=0.998,线性范围5.4~33588pg/m L;20例参考个体的检测结果均在厂商声明的参考区间内。结论罗氏Cobas e411检测NT-ProBNP的验证指标均达到规定要求,能满足临床使用要求。Objective To validate the new detection method for serum N-terminal pro B-type Natriuretic Peptide and evaluate its application feasibility in clinical study. Methods 40 cases of serum sample and 20 cases of healthy controls were used to validate the precision, accuracy, linearity and biotic reference interval of NT- proBNP by using two levels of quality materials according to some EP documents. Results The within-run precision of two levels quality materials were 1.79 and 58.33, the total precision were 1.88 and 81.40, respectively, which were all lower than that declared by the manufacturer. The results detected by Cobas e411 and Modular El70 were compared and could provide reliable data. The linear regression and coefficient was Y = 1. 050X-35. 174,R2 = 0. 998. The linearity was 5.4 ~ 33588 pg/mL. All results of twenty individuals were in the range of biotic reference interval which declared by the manufacturer. Conclusion The NT-ProBNP assay by Roche Cobas e411 has a good performance and meets the demand of clinical application.

关 键 词：N-末端B型利钠肽原 性能验证 

分 类 号：R446.1[医药卫生—诊断学]