Verification Process of American CLSI M52-Commercial Microbial Identification System and Antimicrobial Susceptibility Testing System
10.3969/j.issn.1671-7414.2017.04.043
- VernacularTitle:美国CLSI M52商品化微生物鉴定及药敏试验系统的验证过程
- Author:
Yuzhu HUANG
;
Wei WANG
;
Haijian ZHAO
;
Zhiguo WANG
- Keywords:
microbial identification system;
antimicrobial susceptibility testing system;
commercial;
verification
- From:
Journal of Modern Laboratory Medicine
2017;32(4):148-151
- CountryChina
- Language:Chinese
-
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 Institute has set up a committeeto develop a verification process and a quality assurance program 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 widely used 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.
