摘要
目的 应用操作过程规范图（Operational Process Specifications,简称OPSpecs）设计、评价保证临床基因扩增实验室的质量控制水平.方法 以卫生部临检中心室间质评结果计算偏倚（Bias）,以近一年的室内质控CV为方法的不精密度,利用BIO-RAD公司的Unity Real Time软件制作OPSpecs图,计算、选择HBV,HCV检测项目的 TEa和室内质控规则.结果 采用两个水平的质控品,以1-3s,2-2s,R-4s,4-1s,10 Westguard多规则为质控规则,实验室50%～90%的分析质量保证水平的TEa是8.3%-20.5%.结论 目前实验室的质量控制水平基本能够满足临床病毒检测的需求,在低水平的检测上,由于存在较大的变异系数,仍需要进一步提高其不精密度.
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 102）, 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.
出处
《现代检验医学杂志》
CAS
2011年第2期153-156,共4页
Journal of Modern Laboratory Medicine
关键词
操作过程规范图
基因扩增
质量控制
总误差
operational process specifications
gene amplification
quality control
TE
