中国医疗设备2018，Vol.33Issue(5)：100-103,4.DOI:10.3969/j.issn.1674-1633.2018.05.027
基层医院中生化分析仪的性能验证方法
Performance Verification on Automatic Chemistry Analyzer in Primary Hospital
何乐春 1陈福军2
作者信息
- 1. 重庆医疗器械质量检验中心&重庆市医疗器械质量与安全控制工程技术研究中心,重庆 401147
- 2. 辽宁省药械审评与监测中心,辽宁 沈阳 110006
- 折叠
摘要
Abstract
Objective To establish an active and reliable performance verification method for automatic chemistry analyzer. Methods By referring to industry standards, this paper verified tow automatic chemistry analyzers for accuracy, repeatability, linearity range and the sample carry-over. Results Analyzer with slow testing speed was failed in testing accuracy, repeatability; analyzer with high testing speed met all standard requirements. Conclusion Because of the long period of absorbance observation, analyzer with slow testing speed was worse than the high speed analyzer, and performance verification for automatic chemistry analyzer should be carried out by using kinetic assay kit.关键词
生化分析仪/准确性/重复性/线性范围/污染携带Key words
automatic chemistry analyzer/accuracy/repeatability/linearity range/carry-over rate分类
医药卫生引用本文复制引用
何乐春,陈福军..基层医院中生化分析仪的性能验证方法[J].中国医疗设备,2018,33(5):100-103,4.
