[1]张诗诗,王 薇,赵海建,等.临床检验测量不确定度的进一步认识[J].现代检验医学杂志,2017,32(02):1-4，9.[doi:10.3969/j.issn.1671-7414.2017.02.001]
　ZHANG Shi-shi,WANG Wei,ZHAO Hai-jian,et al.Further Understanding of Measurement Uncertainty in Clinical Laboratory Medicine[J].Journal of Modern Laboratory Medicine,2017,32(02):1-4，9.[doi:10.3969/j.issn.1671-7414.2017.02.001]
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临床检验测量不确定度的进一步认识()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第32卷
期数:
2017年02期
页码:
1-4，9
栏目:
述评
出版日期:
2017-03-25

文章信息/Info

Title:
Further Understanding of Measurement Uncertainty in Clinical Laboratory Medicine
文章编号:
1671-7414(2017)02-001-05
作者:
张诗诗1; 2; 王 薇1; 赵海建1; 王治国1; 2
1.北京医院 国家老年医学中心 卫生部临床检验中心/北京市临床检验工程技术研究中心,北京 100730;
2.北京协和医学院研究生院,北京 100730
Author(s):
ZHANG Shi-shi1; 2; WANG Wei1; ZHAO Hai-jian1; WANG Zhi-guo1; 2
1.National Center for Clinical Laboratories/Beijing EngineeringResearch Center of Laboratory Medicine,Beijing Hospital,National Center of Gerontology,Beijing 100730,China;
2.Graduate School of Peking Union Medical College,Beijing 100730,China
关键词:
测量不确定度;  总误差;  结果解释
分类号:
R446
DOI:
10.3969/j.issn.1671-7414.2017.02.001
文献标志码:
A
摘要:
在临床检验中,测量不确定度(measurement uncertainty,MU)是测量系统检验结果的固有属性。作为ISO 15189中的一个重要组成部分,MU是临床实验室进行方法确认或性能验证时必须确定的,且需要对其不断进行检查。虽然临床实验室目前提供的检验报告中通常并未包含MU,但是部分实验室已经在常规工作中普遍进行了MU的计算。MU的确定和监测可以辅助临床实验室提供更准确的结果并为临床医生提供客观工具用于结果解释。结果解释一般通过结果比较来进行,主要的结果比较对象有3种,分别是相同患者之前的结果、人群参考区间,以及临床决定点。由于每种类型比较中“真”值的含义以及对MU评定有贡献的组分不同,因此MU的最佳评定方式也有所不同,最终会导致MU的不同并影响临床决策的制定。显然,应该依照检测的实际临床用途选择合适的比较对象来进行结果解释并确定MU的最佳评定方式。对于相同检测的不同临床用途(诊断或监测),需要采用不同的MU估计方式来获取合理的MU。该文通过解释MU的概念和特征、评定和应用,并说明三种主要的结果比较方式如何获取MU,旨在帮助临床实验室进一步认识MU的重要性并为实验室常规工作中的MU评定提供指导。
Abstract:
In clinical laboratory medicine,measurement uncertainty(MU)is a fixed property of testing results in the measuring system.Asan important part of ISO 15189,it is necessary for clinical laboratories to determine MU during the period of validation and verification for each measurementprocedure and to review MU over time.Now,testing reports provided by clinicallaboratories usually do not offer MU,but some clinical laboratories have already estimated MU in their routine work.Estimation and monitoring of MU can helpclinical laboratories offering more accurate results and provide objective toolsfor clinicians used in result interpretation.Generally,result interpretationcan be achieved by the result comparison with three main comparators,includinga previous result from the same patient,a population reference interval and a clinical decision point.The means of “true value” and the components contributing to the estimation of MU are both different when the comparison is conductedbetween testing results and different comparators,so the optimum estimation method of MU is accordingly different,which will subsequently affect the MU valueand the determination of clinical decisions.Obviously,depending on the actualclinical uses,laboratories can choose appropriate comparators to the result interpretation and the determination of optimum estimation method of MU.For different clinical uses(diagnosis or monitoring)of the same mearurands,the adoptionof different estimation methods should be used to acquire reasonable MU.By interpreting the concept,characteristics,estimation,and uses of MU,as well as explaining how three main comparison methods of results exploit their own traceable chain to get MU,this paper intends to help clinical laboratories get furtherunderstanding of the importance of MU and provide guidance for the MU estimation in routine work.

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备注/Memo

备注/Memo:

作者简介:张诗诗(1991-),女,在读硕士研究生,研究方向:实验室质量控制管理,E-mail:Athena0915@163.com。
通讯作者:王治国(1964-),男,硕士,研究员,主要从事临床检验质量控制方法研究和室间质量评价工作,E-mail:zgwang@nccl.org.cn。
更新日期/Last Update: 2017-04-10