[1]王 威,王 刚.全自动血凝分析仪性能验证方案[J].现代检验医学杂志,2017,32(05):157-160.[doi:10.3969/j.issn.1671-7414.2017.05.017]
 WANG Wei,WANG Gang.Protocol for Evaluation of the Automated Coagulation Analyzer[J].Journal of Modern Laboratory Medicine,2017,32(05):157-160.[doi:10.3969/j.issn.1671-7414.2017.05.017]
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全自动血凝分析仪性能验证方案()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第32卷
期数:
2017年05期
页码:
157-160
栏目:
质量控制·实验室管理
出版日期:
2017-11-02

文章信息/Info

Title:
Protocol for Evaluation of the Automated Coagulation Analyzer
文章编号:
1671-7414(2017)05-157-04
作者:
王 威王 刚
西安交通大学第一附属医院检验科,西安 710061
Author(s):
WANG WeiWANG Gang
Department of Clinical Laboratory,the First Affiliated Hospital of Medical College of Xi'an Jiaotong University,Xi'an 710061,China
关键词:
全自动血凝分析仪 性能验证 CLSI文件
分类号:
R446
DOI:
10.3969/j.issn.1671-7414.2017.05.017
文献标志码:
A
摘要:
摘 要:设备在安装时及常规使用中需要通过性能验证来评估其性能指标,来判断设备是否符合相关检验所要求的规格。全自动血凝分析仪由于其检测项目的特殊性,必须建立和实施与之相匹配的性能验证方案。该文参照CLSI相关文件总结出可行的适用于全自动血凝分析仪的性能验证方案,并进行综述。
Abstract:
Abstract:When the device is installed,it needs to be verified by some special tests to evaluate its performance and to determine whetherthe device is in accordance with the requirements of the relevant inspection specifications.The projects of the automated coagulation analyzer are particularity different from other tests,especially the biochemistry tests.So the clinical laboratory should establish and implement the matching performance validationprotocol.This article refers to the CLSI related documents to summarize a feasible and applicable evaluation protocol,helping for evaluating automated coagulation analyzer.

参考文献/References:

[1] 中国合格评定国家认可委员会.CNAS-CL02医学实验室质量和能力认可准则[S].北京:中国计量出版社,2006:6. China National Accreditation Service for Conformity Assessment.CNAS-CL02 Accreditation Criteria of the Quality and Competence of Medical Laboratories[s].Beijing:China Metrology Publishing House,2006:6.
[2] Clinical and Laboratory Standards Institute.Protocol for the evaluation,validation and implementation of coagulometers; approved guideline[S].Wayne:PA,CLSI H57-A,2008.
[3] International Organization for Standardization.Clinical laboratory testing and in vitro diagnostic test system-Requirements for in vitro monitoring system for self-testing of oral-anticoagulant therapy[S].Switzerland:Geneva,ISO/FDIS 17593,2005.
[4] International Organization for Standardization.Clinical laboratory testing and in vitro diagnostic test system-guidance on risk analysis for in vitro diagnostic medical devices-complementary element[S].Switzerland:Geneva,ISO/DIS 14971,2004.
[5] Clinical and Laboratory Standards Institute.Managing and validating laboratory information systems; approved guideline[S].Wayne:PA,CLSI ATUO 08-A,2006.
[6] Clinical and Laboratory Standards Institute.Protection of laboratory workers from occupationally acquired infections; approved guideline-third edition[S].Wayne:PA,CLSI M29-A3,2005.
[7] Clinical and Laboratory Standards Institute.Collection,transport,and processing of blood specimens for testing plasma-based coagulation assays and molecular hemostasis assays; approved guideline-fifth edition[S].Wayne:PA,CLSI H21-A5,2008.
[8] Woodhans B,Girardot O,Blanco MJ,et al.Stability of coagulation proteins in frozen plasma[J].Blood Coagul Fibrinol,2001,12(4):229-236.
[9] Clinical and Laboratory Standards Institute.Evaluation of precision performance of quantitative measurement methods; approved guideline-second edition[S].Wayne:PA,CLSI EP5-A2,2004.
[10] Clinical and Laboratory Standards Institute.User verificationof performance for precision and trueness; approved guideline-second edition[S].Wayne:PA,CLSI EP15-A2,2005.
[11] Clinical and Laboratory Standards Institute.Protocol for determination of limits of detection and limits of quantitation; approved guideline[S].Wayne:PA,CLSI EP17-A,2004.
[12] Clinical and Laboratory Standards Institute.Method comparison and biasestimation using patient samples; approved guideline-second edition[S].Wayne:PA,CLSI EP9-A2,2002.
[13] Clinical and Laboratory Standards Institute.Procedure for validation ofINR and local calibration of PT/INR systems; approved guideline[S].Wayne:PA,CLSI H54-A,2005.
[14] Clinical and Laboratory Standards Institute.One-stage prothrombin time(PT)test and activated partial thromboplastin time(APTT)test; approved guideline-second edition[S].Wayne:PA,CLSI H47-A2,2010.
[15] Clinical and Laboratory Standards Institute.How to define and determinereference intervals in the clinical laboratory; approved guideline-second edition[S].Wayne:PA,CLSI C28-A2,2000.
[16] England JM,Rowan RM,Van Assendelft OW,et al.Guidelines for the evaluation of blood cell analysers including those used for differential leucocyte counting and cell marker applications[J].International Council for Standardization in Haematology:Prepared by the ICSH Expert Panel on Cytometry.Clin Lab Haematol,1994,16(2):157-174.
[17] Clinical and Laboratory Standards Institute.Preliminary evaluation of quantitative clinical laboratory measurement procedures; approved guideline-third edition[S].Wayne:PA,CLSI EP10-A3,2006.
[18] Clinical and Laboratory Standards Institute.Evaluation of the linearityof quantitative measurement procedures:A Statistical Approach; approved guideline[S].Wayne:PA,CLSI EP6-A,2000.
[19] 中华人民共和国国家卫生和计划生育委员会.WS/T 406-2012 临床血液学检验常规项目分析质量要求[S].北京:中国标准出版社,2013. National Health and Family Panning Cmmission of the People's Republic ofChina.Analytical quality specifications for routine tests in clinical hematology[S].Beijing:Standards Press of China,2013.
[20] 陆 红,李臣宾,周文宾,等.《临床血液学检验常规项目分析质量要求》的适用性评价[J].现代检验医学杂志,2014,29(3):169-172. Lu H,Li CB,Zhou WB,et al.Applicability evaluation of “Analytical Quality Specifications for Routine Tests in Clinical Hematology”[J].Journal of Modern Laboratory Medicine,2014,29(3):169-172.

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备注/Memo

备注/Memo:
作者简介:王 威(1984-),女,硕士,主管检验师,主要从事临床血液学检验相关工作,Tel:029-85324014,E-mail: wangwei-1516@163.com。 通讯作者:王 刚,副教授,主要从事临床检验工作。
更新日期/Last Update: 1900-01-01