日立7100生化分析仪BUN、CK指标的性能验证
Performance Verification of BUN、CK of Hitachi 7100 Biochemical Analyzer Detection System
投稿时间:2018-04-17  
DOI:
中文关键词:7100全自动生化分析仪  精密度  正确度
英文关键词:7100 automatic biochemical analyzer  precision  accuracy
基金项目:上海市体育科技重点备战计划项目(15J001)
作者单位E-mail
王永梅 上海体育科学研究所 wangyongmei369@163.com 
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中文摘要:
      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。
英文摘要:
      Objective: To verify the analytical performance of the precision, accuracy, reference range linearity of Hitachi 7100 biochemical analyzer so as to ensure the credibility of test results. Method: According to the documents (EP5-A and EP6-A) of the Clinical and Laboratory Standards Institute(CLSI) to verify the analytical performance. Result: The within-run precision of BUN and CK was less than 1 /4TEa (Laboratory permissible total error). The between-run precision was less than 1/3TEa. The accuracy was not more than 1/2 TEa and the linearity range was within the manufacturer's standards.The laboratory may directly use the reference range provided by the manufacturer. Conclusion: The analytical performance of Hitachi 7100 automatic biochemical analyzer and the supporting reagent system meet the quality standards.
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