酶学指标检测验证罗氏Modular P800全自动生化分析仪性能的分析  

A Performance Analysis by the Detection of Enzyme Parameters for Roche Modular P800 Full Automatic Biochemical Analyzer

作　　者：雷忠英[1] 张梅香[1] 李春梅 张露[1] 焦梅[1] LEI Zhongying;ZHANG Meixiang;LI Chunmei;ZHANG Lu;JIAO Mei(Laboratory Medicine Center, The Second Affiliated Hospital of Nanjing Medical University, Nanjing 210011,China)

机构地区：[1]南京医科大学第二附属医院检验医学中心,江苏南京210011

出　　处：《标记免疫分析与临床》2020年第4期691-696,共6页Labeled Immunoassays and Clinical Medicine

摘　　要：目的通过检测酶学指标丙氨酸氨基转移酶(ALT)和天门冬氨酸氨基转移酶(AST)验证罗氏Modular P800全自动生化分析仪的分析性能。方法根据美国临床实验室标准协会(CLSI)系列文件(EP15-A2,EP6-A2)和其他相关文献的实验方案,对罗氏Modular P800全自动生化分析仪检测ALT、AST的精密度、正确度、线性、临床可报告范围、生物参考区间5大性能进行验证,参照昆涞Q-expertTM质控软件进行结果判断,并与厂商声明的性能或公认的质量标准进行比较。结果精密度均符合制造商性能标准;ALT与AST相对偏倚(SE%)均在临床可接受水平范围内;ALT、AST检测均呈一阶线性,线性范围分别为10.63~600U/L、4~800U/L;ALT和AST临床可报告范围分别为10.63~9600U/L、4~12800U/L;ALT、AST生物参考区间验证结果均符合要求。结论罗氏Modular P800全自动生化分析仪ALT、AST检测的主要分析性能符合质量目标要求。Objective To evaluate the analytical performance of the Roche Modular P800 full automatic biochemical analyzer by detecting alanine aminotransferase(ALT)and aspartate aminotransferase(AST).Methods According to experimental schemes mentioned in a series of documents(EP15-A2,EP6-A2)of the Clinical and Laboratory Standards Institute(CLSI)and other related literatures,the performances of precision,accuracy,linear and clinical reportable range,and biological reference interval of Roche Modular P800 full automatic biochemical analyzer in detection of ALT and AST were investigated.Referring to Q-expertTM quality control software,the results were judged and compared with the performance stated by the manufacturer or the recognized quality standards.Results The precision was in accordance with the performance standards of the manufacturer.The relative bias of ALT and AST(SE%)was within the clinically acceptable range.The detection of ALT and AST showed a first-order linearity,and the linear ranges were 10.63-600 U/L and 4-800 U/L,respectively.The clinical reportable ranges of ALT and AST were 10.63-9600 U/L and 4-12800 U/L.The verification results of ALT and AST biological reference intervals met the demand.Conclusion The main analytical performance of Roche Modular P800 full automatic biochemical analyzer for detecting ALT and AST is in line with the targeted quality.

关 键 词：丙氨酸氨基转移酶 天门冬氨酸氨基转移酶 罗氏MODULAR P800全自动生化分析仪 

分 类 号：R392-33[医药卫生—免疫学]