自动生化分析仪的能力验证  

Method for verification of performance of automatic biochemical analyzer

作　　者：吴宗勇[1] 贾德强[1] 李佳[1] 齐军[1] 

机构地区：[1]中国医学科学院肿瘤医院检验科,北京100021

出　　处：《临床和实验医学杂志》2011年第7期524-525,共2页Journal of Clinical and Experimental Medicine

摘　　要：目的建立自动生化分析仪的性能验证方案和实验方法,验证仪器能否正常工作。方法用中值质控品和高值质控品验证Moudlar P-800自动生化分析仪的精密度、准确度、线性和相关性,判断仪器的分析性能可否接受。结果各检测指标全部符合要求。结论 Moudlar PI自动生化分析仪有较好的精密度、准确度、线性和相关性,分析性能可以接受。该验证方案和实验方法简便易行,对规范医学实验室建设和实验认可,提高临床化学检验质量有重要意义。Objective To establish a protocol for verification and experimental method for the performance of automatic biochemical analyzer and to verify whether it is normal in working and determination.Methods Medium and high level control materials were applied to verify the precision,accuracy,linearity and correlation of the analyzer in order to decide whether the performance is acceptable or not.Results All indexes of examinations are qualified.Conclusion The performance of automatic biochemical analyzer Moudlar PI possesses good precision and accuracy,linearity and correlation,and its determinations were acceptable.This method is simple and practical,and it has important significance for building medical laboratory accreditation and improving quality of clinical chemical assay.

关 键 词：自动生化分析仪 性能验证 质量管理 

分 类 号：R446.1[医药卫生—诊断学]