临床实验室分析质量目标的共识（上）

doi:10.3969/j.issn.1673-8640.2016.01.001

摘要/Abstract

摘要：

临床实验室的检验质量关系到患者的生命安全,因此建立评价检测结果质量（即分析质量）的方法及指标成为检测结果使用者研究、评论和实践的重点。为了在全球范围内统一分析质量指标的认识、定义以及实际检验质量评估的方法,全世界已召开多次国际协同会议。1999年4月,斯德哥尔摩会议发表的协同声明是临床实验室建立和评估分析质量指标分级的指导原则。2014年5月,在意大利米兰召开的国际会议发表的协同声明对1999年斯德哥尔摩会议确定的分析质量指标的分类做了修改,为今后进一步实施与探讨分析质量指标奠定了基础。

关键词: 分析性能, 性能指标, 质量目标, 允许误差, 协同声明, 不精密度, 偏移, 允许变异系数, 允许偏移

Abstract:

The determination quality of clinical laboratory tests is related to the life safety of patients,and the establishment of evaluation methods and indicators for determination result quality（analysis quality） becomes the focus of study,comment and practice. In order to unify the understanding and definition of analysis quality indicators and the practical evaluation methods of determination quality around the world,there were several international consensus meetings. The consensus statement on the Stockholm consensus conference,April 1999,was the guideline for the establishment and evaluation of quality indicator grading for clinical laboratories. At the Milan conference,Italy,May 2014,the consensus statement modified the classification of analysis quality indicators published at the Stockholm consensus conference,1999,and became the base of further implement and investigation.

Key words: Analytical performance, Performance indicator, Quality goal, Allowable error, Consensus statement, Imprecision, Bias, Allowable coefficient of variation, Allowable bias

中图分类号:

R446.1

冯仁丰. 临床实验室分析质量目标的共识（上）[J]. 检验医学, 2016, 31(1): 1-8.

FENG Renfeng. Consensus on the analysis quality goal of clinical laboratories（Ⅰ）[J]. Laboratory Medicine, 2016, 31(1): 1-8.

图/表 1

参考文献 23

1	PANTEGHINI M,SANDBERG S. Defining analytical performance specifications 15 years after the Stockholm conference[J]. Clin Chem Lab Med,2015,53(6):829-832.
2	WESTGARD JO,CAREY RN,WOLD S. Criteria for judging precision and accuracy in method development and evaluation[J]. Clin Chem,1974,20(7):825-833.
3	WESTGARD JO,HUNT MR. Use and interpretation of common statistical tests in method-comparison studies[J]. Clin Chem,1973,19(1):49-57.
4	WESTGARD JO,DE VOS DJ,HUNT MR,et al. Concepts and practices in the evaluation of clinical chemistry methods. Ⅰ. Background and approach[J]. Am J Med Technol,1978,44(4):290-300.
5	WESTGARD JO,DE VOS DJ,HUNT MR,et al. Concepts and practices in the evaluation of clinical chemistry methods. Ⅱ. Experimental procedures[J]. Am J Med Technol,1978,44(5):420-430.
6	WESTGARD JO,DE VOS DJ,HUNT MR,et al. Concepts and practices in the evaluation of clinical chemistry methods. Ⅲ:Statistics[J]. Am J Med Technol,1978,44(6):552-571.
7	WESTGARD JO,DE VOS DJ,HUNT MR,et al. Concepts and practices in the evaluation of clinical chemistry methods: Ⅳ. Decisions of acceptability[J]. Am J Med Technol,1978,44(7):727-742.
8	BARNETT RN. Medical significance of laboratory results[J]. Am J Clin Pathol,1968,50(6): 671-676.
9	CAMPBELL DG,OWEN JA. Clinical laboratory error in perspective[J]. Clin Biochem,1967,1(1):3.
10	TONKS DB.A study of the accuracy and precision of clinical chemistry determinations in 170 Canadian laboratories[J]. Clin Chem,1963,9:217-233.
11	COTLOVE E,HARRIS EK,WILLIAMS GZ. Biological and analytic components of variation in long-term studies of serum constituents in normal subjects. 3. Physiological and medical implications[J]. Clin Chem,1970,16(12):1028-1032.
12	WILLIAMS GZ,YOUNG DS,STEIN MR,et al. Biological and analytic components of variation in long-term studies of serum constituents in normal subjects.Ⅰ. Objectives,subject selection,laboratory procedures,and estimation of analytic deviation[J]. Clin Chem,1970,16(12):1016-1021.
13	DUNCAN BM,GEARY TD. A method for analysing results of medical laboratory proficiency surveys[J]. Pathology,1973,5(2):91-98.
14	FRASER CG,PETERSEN PH. Analytical performance characteristics should be judged against objective quality specifications[J]. Clin Chem,1999,45(3):321-323.
15	FRASER CG.The 1999 Stockholm Consensus Conference on quality specifications in laboratory medicine[J]. Clin Chem Lab Med,2015,53(6):837-840.
16	FRASER CG,HYLTOFT PETERSEN P,LIBEER JC,et al. Proposals for setting generally applicable quality goals solely based on biology[J]. Ann Clin Biochem,1997,34(Pt 1):8-12.
17	National Cholesterol Education Program Laboratory Standardization Panel. Current status of blood cholesterol measurement in clinical laboratories in the United States: a report from the Laboratory Standardization Panel of the National Cholesterol Education Program[J]. Clin Chem,1988,34(1):193-201.
18	SEBASTIÁN-GÁMBARO MA,LIRÓN-HERNÁNDEZ FJ,FUENTES-ARDERIU X,et al. Intra- and inter-individual biological variability data bank[J]. Eur J Clin Chem Clin Biochem,1997,35(11): 845-852.
19	KALLNER A,MCQUEEN M,HEUCK C. The Stockholm Consensus Conference on quality specifications in laboratory medicine,25-26 April 1999[J]. Scand J Clin Lab Invest,1999,59(7):475-476.
20	FRASER CG,KALLNER A,KENNY D,et al. Introduction: strategies to set global quality specifications in laboratory medicine[J]. Scand J Clin Lab Invest,1999,59(7):477-478.
21	KAPLAN LA.Determination and application of desirable analytical performance goals: the ISO/TC 212 approach[J]. Scand J Clin Lab Invest,1999,59(7):479-482.
22	KENNY D,FRASER CG,HYLTOFT PETERSEN P,et al. Consensus agreement[J]. Scand J Clin Lab Invest,1999,59:585.
23	WESTGARD JO.The need for a system of quality standards for modern quality management[J]. Scand J Clin Lab Invest,1999,59(7):483-486.

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