[1]张诗诗,章晓燕,王薇,等.感染性疾病诊断和监测微阵列技术的质量控制[J].现代检验医学杂志,2015,30(06):160-162.[doi:10.3969/j.issn.1671-7414.2015.06.049]
　ZHANG Shi-shi,ZHANG Xiao-yan,WANG Wei,et al.Quality Control of Microarrays for Diagnosis and Monitoring of Infectious Diseases[J].Journal of Modern Laboratory Medicine,2015,30(06):160-162.[doi:10.3969/j.issn.1671-7414.2015.06.049]
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感染性疾病诊断和监测微阵列技术的质量控制()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第30卷
期数:
2015年06期
页码:
160-162
栏目:
质量控制·实验室管理
出版日期:
2015-12-30

文章信息/Info

Title:
Quality Control of Microarrays for Diagnosis and Monitoring of Infectious Diseases
作者:
张诗诗; 章晓燕; 王薇; 王治国
北京医院卫生部临床检验中心，北京100730
Author(s):
ZHANG Shi-shi; ZHANG Xiao-yan; WANG Wei; WANG Zhi-guo
National Center for Clinical Laboratories，Beijing Hospital，Beijing 100730，China
关键词:
感染性疾病; 微阵列分析; 核酸检测; 病原体检测
分类号:
R446
DOI:
10.3969/j.issn.1671-7414.2015.06.049
文献标志码:
A
摘要:
随着越来越多的临床实验室采用微阵列技术(Microarrays)进行诊断性测试，不同类型的微阵列以及它们在临床实验室中的运用突飞猛进。微阵列技术是目前较为新颖的一项技术，主要用于感染性疾病中病原体的检测、鉴定、基因分型以及耐药性的确定。该文以建立微阵列检测的一般要求为起始，按照检验前、检验中和检验后的顺序进行具体说明；同时描述微阵列技术分析性能的验证和确认；提出关于微阵列技术质量控制和质量保证的考虑；并讨论数据分析和解释部分所需的方法和参数。
Abstract:
With a growing number of clinical laboratories adopted Microarrays for diagnostic testing，the different types of Microarrays and their application in clinical laboratories had improved enormously．Microarrays was a relatively new technology．It mainly deals with infectious pathogen detection，identification，and genotyping，as well as drug resistance determination．This article begins with the general requirements for the establishment of Microarrays，with detailed explanations in the sequence of before，during and after the assay．Meanwhile，it also describes the verification and validation of analytical performance of Microarrays，raises several considerations for the quality control and quality arrurance，and discusses methods and parameters needed for data analysis and interpretation．

参考文献/References:

［1］Clinical and Laboratory Standards Institute MM13-A．Collection，Transport，Preparation，and Storage ofSpecimens for Molecular Methods；Approved Guideline［S］．Wayne:PA,CLSI MM13-A，2005．
[2]Clinical and Laboratory Standards Institute MM06-A2．Quantitative Molecular Methods for Infectious Disease；Approved Guideline-Second Edition［S］．Wayne:PA,CLSI MM06-A2，2010．
[3]Clinical and Laboratory Standards Institute MM12-A．Diagnostic Nucleic Acid Microarrays；Approved Guideline［S］．Wayne：PA，CLSI MMN-A，2006．
[4]Clinical and Laboratory Standards Institute MM17-A．Verification and Validation of Multiplex Nucleic Acid Assays；Approved Guideline［S］．Wayne:PA,CLSI MMN-A，2008．
[5]Clinical and Laboratory Standards Institute MM19-A．Establishing Molecular Testing in Clinical Laboratory Environments；Approved Guideline［S］．Wayne：PA，CLSI MM19-A，2011．
[6]王治国．临床检验方法确认与性能验证［M］．北京：人民卫生出版社，2009．
[7]王治国．临床检验质量控制技术［M］．3版．北京：人民卫生出版社，2014．
[8]Clinical and Laboratory Standards Institute MM03-A2．Molecular Diagnostic Methods for Infectious Disease；Approved Guideline［S］．Second Edition．Wayne：PA，CLSI MM03-A2，2006．
[9]Clinical and Laboratory Standards Institute EP17-A2．Evaluation of detection capability for clinical laboratory measurement procedures；approved guideline［S］．Second Edition．Wayne：PA，CLSI EP17-A2，2012．

备注/Memo

备注/Memo:
基金项目：北京市自然科学基金(基金编号：7143182)，北京医院资助课题(BJ-2015-025)。 作者简介：张诗诗(1991-)，女，在读硕士研究生，研究方向：实验室质量管理，E-mail：792743875@qq.com。 通讯作者：王治国，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: 1900-01-01