Establishment and application of external quality assessment programs for personalized medical diagnostic tests

doi:10.3969/j.issn.1673-8640.2017.010.023

Abstract

Abstract:

Personalized medical diagnostic tests which mainly rely on molecular diagnostic technology have developed rapidly in recent years. Medical tests related to cancer,genetics,pharmacogenomics and microbial determination have been successively carried out in many clinical laboratories and play roles in personalized medical treatments. Accurate and reliable clinical diagnostic results are important for personalized healthcare,and external quality assessment（EQA） program is one of the most effective approaches to ensure the accuracy and reliability of medical tests' results. Establishing EQA programs for molecular diagnostic tests scientifically,developing a new EQA program in time and covering the whole process are focuses for the quality supervision of molecular diagnostic tests.

Key words: Molecular diagnostic technology, Personalized medicine, External quality assessment

CLC Number:

R446.1

XIAO Yanqun, WANG Hualiang. Establishment and application of external quality assessment programs for personalized medical diagnostic tests[J]. Laboratory Medicine, 2017, 32(10): 941-944.

References 11

[1]	China National Accreditation Service for Conformity Assessment. Accreditation criteria for proficiency testing providers[S]. CNAS-CL03,CNAS,2010.
[2]	Clinical and Laboratory Standards Institute. Design of molecular proficiency testing/external quality assessment[S]. MM14-A2,CLSI,2013.
[3]	李艳,李金明. 个体化医疗中的临床分子诊断[M]. 北京:人民卫生出版社,2013:154-173.
[4]	王雪亮,刘芬,蒋玲丽,等. EB病毒核酸检测质控品制备及其应用[J]. 检验医学,2015,30(11):1078-1082.
[5]	WANG X,LIU F,JIANG L,et al.Use of chimeric influenza viruses as a novel internal control for diagnostic rRT-PCR assays[J]. Appl Microbiol Biotechnol,2016,100(4):1667-1676.
[6]	China National Accreditation Service for Conformity Assessment. Guidance on evaluating the homogeneity and stability of samples used for proficiency testing[S]. CNAS-GL03,CNAS,2016.
[7]	VALENTINE-THON E,VAN LOON A M,SCHIRM J,et al. European proficiency testing program for molecular detection and quantitation of hepatitis B virus DNA[J]. J Clin Microbiol,2001,39(12):4407-4412.
[8]	李金明. 标准物质在乙型和丙型肝炎病毒检测标准化中的重要性[J]. 中华检验医学杂志,2007,30(8):850-852.
[9]	王雪亮,刘芬,蒋玲丽,等. 人乳头瘤病毒16和18型核酸检测用质控品制备及应用[J]. 临床检验杂志,2016,34(1):56-59.
[10]	PATTON S,NORMANNO N,BLACKHALL F,et al.Assessing standardization of molecular testing for non-small-cell lung cancer:results of a worldwide external quality assessment(EQA) scheme for EGFR mutation testing[J]. Br J Cancer,2014,111(2):413-420.
[11]	TACK V,LIGTENBERG M J,TEMBUYSER L,et al.External quality assessment unravels interlaboratory differences in quality of RAS testing for anti-EGFR therapy in colorectal cancer[J]. Oncologist,2015,20(3):257-262.

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