期刊文献+

2台生化分析仪多项目测定结果比对分析和偏倚评估 被引量:10

The comparative analysis and bias assessment of test results using two biochemical analyzers
暂未订购
导出
摘要 目的对OLYMPUS AU5421和Beckman CX9两种不同检测系统的多个项目进行方法比对和偏倚评估,探讨同一医院不同检测系统间测定结果是否具有可比性。方法依据美国国家临床实验室标准委员会EP9-A2文件要求,每天收集8份不同浓度的新鲜患者血清,分别用两种检测系统测定钾、钠、氯(Cl-)、葡萄糖、尿素氮及肌酐等6项生化指标,连续测定5 d,记录测定结果,计算相关系数和直线回归方程,根据回归方程计算各指标在医学决定水平上的预期偏倚和预期偏倚的95%可信区间并判断偏倚是否可以接受。结果 Cl-的预期偏倚的95%可信区间大于CLIA′88允许误差范围的1/4,不可接受,其余5个项目测定结果的预期偏倚均可以接受。结论不同检测系统应定期对相同测定指标进行方法比对和偏倚评估,以确保检测结果的可比性。 Objective To explore the comparability of multiple projects detected by OLYMPUS AU5421 Beckman CX9 detection systems in the same hospital by methodology comparing and bias assessing. Methods Ba on the U. S. National Committee for Clinical Laboratory Standards (NCCLS) EPg-A2,8 copies of different eoncent tions of fresh serum were collected,and then we tested 6 biochemical projects of K+ ,Na+ ,C1-,Glu,Bun,and Cr with two detection systems for 5 days, then we recorded the results and calculated correlation coefficient and linear regr sion equation. We calculated each indicator in the medical decision level of the expected bias and the expected bias the 95% confidence interval and determined the bias according to the regression equation. Results The expected bias of the 95 % confidence interval of C1- was larger than 1/4 of CLIA′88 permissible error range,and it was unacceptable. The expected bias of the remaining 5 projects could be accepted. Conclusion Methodology comparison and bias estimation of the same test items in different detection systems should be carried out regularly in order to cns comparability of test results.
出处 《检验医学与临床》 CAS 2011年第10期1203-1205,共3页 Laboratory Medicine and Clinic
关键词 EP9-A2 方法比对 偏倚评估 EP9-A2 method comparison bias estimation
  • 相关文献

参考文献5

二级参考文献19

  • 1李传达,袁平宗.两种丙氨酸氨基转移酶试剂的对比研究及偏倚评估[J].中华检验医学杂志,2005,28(10):1082-1083. 被引量:15
  • 2张秀明,庄俊华,徐宁,黄宪章,陈茶,尹一兵,梁伟雄.不同检测系统血清酶测定结果的偏倚评估与可比性研究[J].中华检验医学杂志,2006,29(4):346-349. 被引量:137
  • 3邱玲,程歆琦,鄢盛恺,沈瑛,刘茜,刘荔,刘福成,葛增梅.临床化学方法验证与表格化管理[J].现代检验医学杂志,2006,21(4):5-9. 被引量:10
  • 4徐国宾,吴南,王清涛.要重视血清酶学测定的标准化工作[J].临床检验杂志,2007,25(3):161-164. 被引量:25
  • 5[1]National Committee for Clinical Laboratory Standards.Method comparison and bias eatimation using patient samples[S].Approved Guideline,2nd ed,EP9-A2,2002.
  • 6[2]Anonymous,Medicare,Medicaid and CLIA programs,regulations imple-menting the Clinical Laboratory Improvement Amendments of 1988(CLIA 88)HCFA.Final rule with comment period[S].Fed Regist,1992,57(40):700227186.
  • 7魏吴 丛玉隆.医学实验室质量管理与认可指南[M].北京:中国计量出版社,2004.27-80.
  • 8International Organization for Standardization.General Requirements for the Competence of Testing and Calibration Laboratories.ISO/IEC 17025,International Organization for Standardization,Geneva,1999.
  • 9The National Committee for Clinical Laboratory Standards.Method Comparison and Bias Estimation Using Patient Samples.Approved Guideline,Second Edition,EP9-A2,2002.
  • 10Siekmann L,Bonora R,Burtis CA,et al.IFCC primary reference procedures for the measurement of catalytic activity concentrations of enzymes at 37 degrees C.International Federation of Clinical Chemistry and Laboratory Medicine.Part 7.Certification of four reference materials for the determination of enzymatic activity of gamma-glutamyltransferase,lactate dehydrogenase,alanine aminotransferase and creatine kinase accord.Clin Chem Lab Med,2002,40:739-745.

共引文献196

同被引文献59

引证文献10

二级引证文献42

相关作者

内容加载中请稍等...

相关机构

内容加载中请稍等...

相关主题

内容加载中请稍等...

浏览历史

内容加载中请稍等...
;
使用帮助 返回顶部