日立7600全自动生化分析仪检测系统性能验证

Performance verification of Hitachi 7600 automatic biochemical analyzer detection system

目的对日立7600全自动生化分析仪的检测系统进行性能验证。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,对日立7600全自动生化分析仪的精密度、正确度、线性范围、临床可报告范围进行性能评价。结果批内精密度小于1/4TEa(实验室允许总误差)、日间精密度小于1/3TEa;正确度不超过1/2TEa;线性范围、临床可报告范围与厂家说明书提供的性能指标相符。结论日立7600全自动生化分析仪的分析性能符合质量目标要求。

Objective To verify the analytical performance of Hitachi 7600 automatic biochemical analyzer. Methods The preci- sion, accuracy, linearity and clinical reportable range were validated according to Clinical and Laboratory Standards Institute （CLSI） docu-ments（ EP5 - A and EP6 - A）. Results The within precision was less than 1/4TEa（ Laboratory permissible total error）, the day precision was less than 1/3TEa, the accuracy was not more than 1/2 TEa, the linearity and clinical reportable range was within the manufacturer＇s standards. Conclusion The analytical performance of Hitachi 7600 automatic biochemical analyzer is consistent with acceptable quality standards.