[1]黄钰竹,王 薇,赵海建,等.美国CLSI M52商品化微生物鉴定及药敏试验系统的验证过程[J].现代检验医学杂志,2017,32(04):148-151.[doi:10.3969/j.issn.1671-7414.2017.04.043]
　HUANG Yu-zhu,WANG Wei,ZHAO Hai-jian,et al.Verification Process of American CLSI M52-Commercial Microbial Identification System and Antimicrobial Susceptibility Testing System[J].Journal of Modern Laboratory Medicine,2017,32(04):148-151.[doi:10.3969/j.issn.1671-7414.2017.04.043]
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美国CLSI M52商品化微生物鉴定及药敏试验系统的验证过程()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第32卷
期数:
2017年04期
页码:
148-151
栏目:
质量控制·实验室管理
出版日期:
2017-07-25

文章信息/Info

Title:
Verification Process of American CLSI M52-Commercial Microbial Identification System and Antimicrobial Susceptibility Testing System
文章编号:
1671-7414(2017)04-148-04
作者:
黄钰竹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):
HUANG Yu-zhu1; 2; WANG Wei1; ZHAO Hai-jian1; WANG Zhi-guo1; 2
1.National Center for Clinical Laboratories,Beijing Engineering Research 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:
微生物鉴定系统;  药敏试验系统;  商品化;  验证
分类号:
R446.5
DOI:
10.3969/j.issn.1671-7414.2017.04.043
文献标志码:
A
摘要:
应用商品化微生物检测系统检测患者样本前,每个实验室须确定其是否能达到厂商规定的性能规范,包括正确度、精密度(重复性)、检测结果的报告范围,以及厂商参考范围是否适用于实验室患者。对此,美国临床和实验室标准化研究院成立了委员会以制定商品化微生物鉴定和药敏试验系统的验证过程及质量保证计划,为美国食品药品管理局的商品化检测提供建议。该指导方针聚焦于临床实验室广泛应用的仪器系统,也可用于微生物鉴定和药敏试验的手工检测方法。现根据微生物鉴定及药敏试验系统的原理及CLSI M52为商品化微生物鉴定和药敏试验系统的验证过程提供一些参考。
Abstract:
Before performing patient testing with commercial microbial test systems, each laboratory must verify that it can obtain performance specifications comparable to those of the manufacturer.This includes trueness,precision(reproducibility),and reportable range of test results,and verifying that the manufacturer's reference ranges are appropriate for the laboratory's patient population.American Clinical and Laboratory Standards Institutehas set up a committeeto develop a verification process and a quality assuranceprogram for commercial microbial identification system and antimicrobial susceptibility testing system,in order to provide recommendations for US Food and Drug Administration(FDA).This guidance is applicable to instrument systems widelyused in clinical laboratories and can also be used for manual testing of microbiological identification and antimicrobial susceptibility testing.The aim of this article is to provide advice for the microbial identification system and antimicrobial susceptibility testing system verification process,based on principles of microbiological identification and antimicrobial susceptibility and CLSI M52 guideline.

参考文献/References:

[1] Clinical and Laboratory Standards Institute.Verification of Commercial Microbial Identification and Antimicrobial Susceptibility Testing Systems[S].Wayne:PA,CLSI M52,2015.
[2] Clinical and Laboratory Standards Institute.Laboratory QualityControl Based on Risk Management; Approved Guideline[S].Wayne:PA,CLSI EP23-ATM,2011.
[3] Clinical and Laboratory Standards Institute.Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Fifth Informational Supplement[S].Wayne:PA,CLSI M100-S25,2015.
[4] Clinical and Laboratory Standards Institute M50-A.Quality Control for Commercial Microbial Identification Systems; Approved Guideline[S].Wayne:PA,CLSI M50-A,2008.
[5] Clinical and Laboratory Standards Institute.Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standards-Twelfth Edition[S].Wayne:PA,CLSI M02-A12,2015.
[6] Clinical and Laboratory Standards Institute.Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standards-Tenth Edition[S].Wayne:PA,CLSI M07-A10,2015.
[7] U S Food and Drug Administration.Procedures for Class II Device Exemptions from Premarket Notification,Guidance for Industry and CDRH Staff[EB/OL].(2015-07-23).https://www.fda.gov/Medical Devices/Device Regulation and Guidance/Guidance Documents/ucmo 80198.htm.
[8] US Food and Drug Administration.ClassⅡSpecial Controls Guidance Document:Antimicrobial Susceptibility Test(AST)Systems:Guidance for Industry and FDA[EB/OL].(2015-07-17).https://www.fda.gov/Regulatory Information/Guidances/ucm 080564.htm.
[9] Jorgensen JH,Ferraro MJ.Antimicrobial susceptibility testing:a reviewof general principles and contemporary practices[J].Clin Infect Dis,2009,49(11):1749-1755.

备注/Memo

备注/Memo:
基金项目:北京市自然科学基金(7143182); 北京医院课题资助(BJ-2015-025)。 作者简介:黄钰竹(1995-),女,硕士研究生,研究方向:实验室质量管理,E-mail: yuzhu_huang9533@163.com。 通讯作者:王治国,E-mail: zgwang@nccl.org.cn。
更新日期/Last Update: 1900-01-01