[1]章晓燕,王 薇,王治国.临床检验正确度控制品-评估偏倚[J].现代检验医学杂志,2016,31(05):147-149.[doi:10.3969/j.issn.1671-7414.2016.05.044]
 ZHANG Xiao-yan,WANG Wei,WANG Zhi-guo.Trueness Controls of Clinical Laboratory to Assess Bias[J].Journal of Modern Laboratory Medicine,2016,31(05):147-149.[doi:10.3969/j.issn.1671-7414.2016.05.044]
点击复制

临床检验正确度控制品-评估偏倚()
分享到:

《现代检验医学杂志》[ISSN:/CN:]

卷:
第31卷
期数:
2016年05期
页码:
147-149
栏目:
质量控制·实验室管理
出版日期:
2016-10-21

文章信息/Info

Title:
Trueness Controls of Clinical Laboratory to Assess Bias
文章编号:
1671-7414(2016)05-147-03
作者:
章晓燕王 薇王治国
北京医院 国家老年医学中心卫生部临床检验中心,北京 100730
Author(s):
ZHANG Xiao-yanWANG WeiWANG Zhi-guo
National Center for Clinical Laboratories of the Ministry of Health,Beijing Hospital,Beijing 100730,China
关键词:
正确度控制品 偏倚 统计质量控制 系统误差
分类号:
R446
DOI:
10.3969/j.issn.1671-7414.2016.05.044
文献标志码:
A
摘要:
精密度控制监测分析随机误差; 准确度控制评估总误差,包括随机误差和系统误差; 而正确度(偏倚)评估的是系统误差。正确度控制品应具有计量学溯源性,最好通过使用参考物质或参考方法来确定靶值,如果没有溯源至参考测量系统,来自不同实验室的同一患者检测结果的可比性可能是不理想的。正确度控制品还应具有互换性,即控制品与患者标本一样,在不同测量程序上的结果具有一致性,可以显示相同的数值关系。同时正确度控制品定值更适合设置在医学决定水平(MDLs)或其他有临床意义的浓度上,由参考物质的提供者制备并以与校准品相同的方式进行生产。
Abstract:
Precision controls monitor assay random error(reproducibility),accuracy controls assess total error,both random error and systematic error,and trueness(bias)of an assay represents systematic error.A trueness control should be metrological traceable,ideally with a target value determined by use of a reference material or a reference method,without metrological traceable to a reference measurement system,patient test results for the same patient from different laboratories may not be comparable.A trueness controlshould be commutable and its analytical response to a reference method and a routine field method should be equivalent to that of a patient sample.And truenesscontrol values should generally be set at medical decision levels and be prepared by the providers of reference materials and manufactured in the same fashionas a calibrator.

参考文献/References:

[1] 章晓燕,王 薇,张传宝,等.用室间质量评价西格玛图评价脂类项目不同检测系统的质量水平[J].现代检验医学杂志,2015,30(6):80-83. Zhang XY,Wang W,Zhang CB,et al.Assessing quality of different measuring systems on the sigma scale from external quality assessment[J].J ModLab Med,2015,30(6):80-83.
[2] De Leer WB,Lequin RM.The European in-vitro diagnostic medical devicesdirective:it's implications on the clinical marketplace and healthcare measurements standards[J].J Associa Lab Autom,2000,5(2):562-570.
[3] International Organization for Standardization(ISO)17511.In vitro diagnostic medical devices-Measurement of quantities in samples of biological origin-Metrological traceability of values assigned to calibrators and control materials[S].Geneva(IL):International Organization for Standardization,ISO/prEN17511.1999.
[4] 陈文祥,申子瑜,郭 健,等.临床检验量值溯源中的重要术语与概念及有关问题[J].中华检验医学杂志,2005,28(2):142-146. Chen WX,Shen ZY,Guo J,et al.Terms and definitions used in description of measurement traceability in laboratory medicine[J].Chinese Journal of Laboratory Medicine,2005,28(2):142-146.
[5] Clinical and Laboratory Standards Institute(CLSI)C37A.Preparation andvalidation of commutable frozen human serum pools as secondary reference materials for cholesterol measurement procedures[S].Wayne:(PA)Clinical LaboratoryStandards Institute C37A,1999.
[6] Baadenhuijsen H,Kuypers A,Weykamp C,et al.External quality assessmentin the Netherlands:time to introduce commutable survey specimens.Lessons fromthe Dutch “Calibration 2000” project[J].Clin Chem Lab Med,2005,43(3):304-307.
[7] 肖亚玲,赵海建,王 薇,等.临床检验能力验证/室间质量评价标本的互换性及靶值的设定[J].中华检验医学杂志,2014,37(8):634-636. Xiao YL,Zhao HJ,Wang W,et al.The commutability and assignment oftarget values of proficiency testing/external quality assessment sample in clinical laboratory[J].Chin J Lab Med,2014,37(8):634-636.
[8] Clinical and Laboratory Standards Institute(CLSI)EP15-A2.User verification of performance for precision and trueness[S].Wayne.PA,Clinical Laboratory Standards Institute EP15-A2,2005.
[9] Lee W,Chung HJ,Hannestad U,et al.Trueness assessment of Korean nation-wide glucose proficiency testing[J].Clin Chem Lab Med,2011,49(6):1061-1064.
[10] Xia CY,Liu O,Wang LZ,et al.Trueness assessment for serum glucose measurement using commercial systems through the preparation of commutablereference materials[J].Ann Lab Med,2012,32(4):243-249.

相似文献/References:

[1]肖亚玲,王 薇,赵海建,等.西格玛性能验证图在常规化学检测项目性能评价中的应用[J].现代检验医学杂志,2016,31(04):159.[doi:10.3969/j.issn.1671-7414.2016.04.047]
 XIAO Ya-ling,WANG Wei,ZHAO Hai-jian,et al.Application of Sigma Verification of Performance to Evaluate the Performance of Routine Chemistry in One Laboratory[J].Journal of Modern Laboratory Medicine,2016,31(05):159.[doi:10.3969/j.issn.1671-7414.2016.04.047]
[2]胡江红,袁平宗,汤雪彪,等.应用六西格玛性能验证图对18个常规化学项目的性能评价[J].现代检验医学杂志,2018,33(06):161.[doi:10.3969/j.issn.1671-7414.2018.06.042]
 HU Jiang-hong,YUAN Ping-zong,TANG Xue-biao,et al.Performance Evaluation of 18 Conventional Chemical Projects Using Six Sigma Performance Verification Diagram[J].Journal of Modern Laboratory Medicine,2018,33(05):161.[doi:10.3969/j.issn.1671-7414.2018.06.042]

备注/Memo

备注/Memo:

作者简介:章晓燕(1992-),女,硕士研究生,研究方向:实验室质量管理,E-mail:553434613@qq.com。
通讯作者:王治国,研究员,E-mail:zgwang@nccl.org.cn。
更新日期/Last Update: 2016-10-30