摘要
目的:对日立7100全自动生化分析仪的血尿素氮(BUN)、肌酸激酶(CK)项目从精密度、正确度、参考区间进行性能验证,保证其检测结果的可信度。方法:参照美国临床实验室标准化协会(CLSI)的指南文件EP5-A、EP6-A进行性能验证。结果:7100全自动生化分析仪的BUN、CK项目批内精密度均小于1/4TEa(实验室允许总误差)、批间精密度均小于1/3TEa;正确度均小于1/2TEa;参考区间验证通过,本实验室可以直接使用厂商提供的参考区间。结论:日立7100全自动生化分析仪及配套试剂系统,其分析性能符合质量目标要求。
Objective Objective： To verify the analytical performance of the precision, accuracy, ref-erence range linearity of Hitachi 7100 biochemical analyzer so as to ensure the credibility of test re-sults. Method： According to the documents （EP5-A and EP6-A） of the Clinical and LaboratoryStandards Institute （CLSI） to verify the analytical performance. Result： The within-run precision ofBUN and CK was less than1 /4TEa （Laboratory permissible total error）. The between-run precisionwas less than 1/3TEa. The accuracy was not more than 1/2 TEa and the linearity range was withinthe manufacturer＇s standards.The laboratory may directly use the reference range provided by themanufacturer. Conclusion： The analytical performance of Hitachi 7100 automatic biochemical ana-lyzer and the supporting reagent system meet the quality standards.
作者
王永梅
WANG Yong mei(Shanghai Research Institute Of Sport Science Shanghai 200030,China)
出处
《体育科研》
2018年第4期102-104,共3页
Sport Science Research
基金
上海市体育科技重点备战计划项目(15J001)
