现代检验医学杂志2011，Vol.26Issue(2)：153-156,4.DOI:10.3969/j.issn.1671-7414.2011.02.056
应用操作过程规范图设计、评价临床基因扩增实验室的质量控制水平
Use of Operational Process Specifications to Design and Evaluate the Quality Control of Clinical Gene Amplification Laboratory
张军 1张薇薇 1方超平 1李闻捷 1沈茜1
作者信息
摘要
Abstract
Objective To design and evaluate the quality control level of clinical gene amplification laboratory by Operational Process Specifications (OPSpecs). Methods Bias was calculated using the data of external quality control results,which was organized by the National Center for Clinical Laboratory. Imprecision was indicated as coefficient of variation (CV) ,which was calculated using the internal quality control data of recent one year. OPSpecs charts were made using the Unity Real Time software from BIO-RAD. The total allowable error (TEa) and rules of quality control of HBV and HCV assay were calculated using the software. Results Using two level controls and the multiple Westguard control rules (1-3s,2-2s,R-4s,4-1s and 10-x),to achieve the 50％～90％ quality assurance goal,the TEa of individual control ranged from 8. 3％～20. 5％. Conclusion The current quality control level of laboratory could achieve the requirement of clinical assay. But in the low level control the imprecision level was relatively high,which needs further improvement.关键词
操作过程规范图/基因扩增/质量控制/总误差分类
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张军,张薇薇,方超平,李闻捷,沈茜..应用操作过程规范图设计、评价临床基因扩增实验室的质量控制水平[J].现代检验医学杂志,2011,26(2):153-156,4.
