日立7600全自动生化分析仪的分析性能验证

Performance verification of Hitachi 7600 automatic biochemical analyzer

目的对日立7600全自动生化仪主要分析性能进行验证。方法按实验室认可准则和美国CLIA′88性能验证文件的方法,对在日立7600生化分析仪上开展的19个常规生化项目进行精密度、正确度、参考区间、线性范围和临床可报告范围验证。结果日立7600全自动生化分析仪,在精密度、正确度、参考区间、线性范围和临床可报告范围方面,均符合要求。结论日立7600全自动生化仪器检测性能完全满足预期的临床应用要求。

Objective To verify the performance of Hitachi 7600 automatic biochemical analyzer .Methods According to labora‐tory accreditation criteria and the performance verification documents of American CLIA′88 ,the precision ,accuracy ,reference inter‐val ,linear range and clinical reportable range were verified for the tests of 19 conventional biochemical indicators performed on Hita‐chi 7600 biochemical analyzer most often .Results The precision ,accuracy ,reference interval ,linear range and clinical reportable range were all acceptable .Conclusion Hitachi 7600 automatic biochemical analyzer could fully meet the reqirements in clinical ap‐plication .