生物学变异的质量规范在全自动干式生化分析仪中的应用  

Quality Specifications of Biological Variation Applied in Biochemical Analyzer

作　　者：史光华[1] 张庆[1] 刘连义[1] 姜慧英[1] SHI Guang- hua;ZHANG Qing;LIU Lian- yi;JIANG Hui- ying(Deparment of Clinical Laboratory, the General Hospital of Beijing Coal Group ,Beijing 102300 ,China)

机构地区：[1]北京京煤集团总医院检验科,北京102300

出　　处：《标记免疫分析与临床》2017年第12期1432-1436,共5页Labeled Immunoassays and Clinical Medicine

摘　　要：目的探讨生物学变异的质量规范在全自动干式生化分析仪中的应用。方法收集2016年VITRO350全自动干式生化分析仪11个检测项目的室内质量控制的不精密度和全年室间质量评价的偏倚,并根据TE=1.96s+│Bias│计算出各项目总误差,然后分别与生物学变异推导出的质量规范的3个层次要求进行比较和分析,并计算出相应的σ值和QGI值,从而评估干式生化分析仪的检测性能,进而进行质量改进。结果按照生物学变异的最佳、适当和最低的3个层次的质量规范要求,仪器11个检测项目的不精密度、偏倚和总误差的符合率分别为60%/36.4%/81.8%;90.9%/81.8%/90.9%;100%/100%/100%;按照3个层次要求σ值的优秀以上和良好以上符合率分别为18.2%/36.4%;63.6%/81.8%;90.9%/90.9%,而刨除ALB外,按照3个层次要求,σ值的良好以上符合率则为36.4%/90%/100%。BUN、TBIL、AST、CK、URIC不需要改进质量,其他检测项目的 QGI均<0.8,都需要改进精密度。结论除了ALB依然按照CLIA'88质量规范要求外,其它10个检测项目均可以按照生物学变异的适当层次的质量规范要求,是更高标准的质量要求,VITRO350全自动干式生化分析仪非常适合临床应用。Objective We would discuss the quality specifications of biological variation applied in biochemical analyzer. Method We used biochemical analyzer VITRO350 and collected 11 assay with data of imprecision and bias of internal quality control of year 2016. Following the calculation of the total errors （TE=1.96s＋│Bias）,variance（σ） and quality goal index（QGI）, we have evaluated the performance of biochemical analyzer and made good improvement of tests. Results The imprecision, bias and total errors of instrumental coincidence rate have been respectively classified into three tiers： the best （60%/36.4%/81.8）;the better （90.9%/81.8%/90.9%）;and the good （100%/100%/100%）, according to the quality specifications of biological variation. We found the variance（σ） of coincidence rate was the best and the better 18.2%/36.4%;72.2%/81.8%;90.9%/90.9% respectively,in three tiers; the variance（σ） of coincidence rate was the better 36.4%/90%/100% without test of item ALB. For items of BUN、TBIL、AST、CK、URIC, there were no need to make improvement of test quality. It was necessary to further improve the precision of those item tests that their QGI were less than 0.8. For the test of item CL, the improvements of both precision and accuracy were necessary. Conclusion In addition to ALB, which was still in accordance with the requirements of CLIA＇88 quality standards, the other 10 test items can be in accordance with the appropriate level of quality requirements of biological variation, which are higher standard of quality requirements. So VITRO350 automatic dry biochemical analyzer is very suitable for clinical application.

关 键 词：生物学变异 质量规范 全自动干式生化分析仪 应用 

分 类 号：R446.1[医药卫生—诊断学]