美国CLSIM52商品化微生物鉴定及药敏试验系统的验证过程

Verification Process of American CLSI M52-Commercial Microbial Identification System and Antimicrobial Susceptibility Testing System

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。

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 （reproducibili- ty） ,and reportable range of test results,and verifying that the manufacturer＇s reference ranges are appropriate for the labo- ratory＇s patient population. American Clinical and Laboratory Standards Institute has set up a committeeto develop a verifi cation 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 applica- ble to instrument systems widely used in clinical laboratories and can also be used for manual testing of microbiological iden- tification and antimicrobial susceptibility testing. The aim of this article is to provide advice for the microbial identification system and antimicrobial susceptibility testing system verification tion and antimierobial susceptibility and CLSI M52 guideline. process, based on principles of microbiological identifica