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Quality Control for Commercial Microbial Identification Systems; Approved Guideline, M50AE 商业微生物鉴定系统的质量控制;批准的指南 M50AE
发布日期: 2008-01-01
临床和实验室标准协会文件M50-A——商业微生物鉴定的质量控制 系统;批准的指南包括简化商业微生物鉴定的质量控制(QC)流程 利用多种底物和/或试剂识别需氧或厌氧细菌、酵母、霉菌或类似酵母的系统(MISs) 藻类来自养殖。它规定了制造商、分销商和用户的责任。M50-A包括以下指南: 当使用可靠的MIS采取改进的QC方法,而不是满足要求时,可能会遵循 包括在1988年法规的临床实验室改进修正案中。 开发了简化的质量控制方法 在对美国微生物学会提供的数据进行评估后,进行了一项调查,以确定QC 商业失误的失败率。数据显示,所有接受调查的商业失误的失败率均低于0.1%。这 该文件基于美国(US)法规,也将成为更广泛受众的有用资源。它是 预计M50-A将在美国和国际上广泛使用,以减少过度使用的资源 质量控制测试。
Clinical and Laboratory Standards Institute document M50-A--Quality Control for Commercial Microbial Identification Systems; Approved Guideline includes a process for streamlined quality control (QC) of commercial microbial identification systems (MISs) that utilize multiple substrates and/or reagents to identify aerobic or anaerobic bacteria, yeasts, moulds, or yeastlike algae from culture. It specifies responsibilities of the manufacturer, distributor, and user. M50-A includes guidelines that may be followed when using an MIS of proven reliability to take a modified QC approach, rather than meeting requirements included in the Clinical Laboratory Improvement Amendments of 1988 regulations. The streamlined QC approach was developed following an evaluation of data provided by the American Society for Microbiology for a survey conducted to determine the QC failure rates of commercial MISs. The data showed a failure rate of less than 0.1% for all commercial MISs surveyed. This document is based on United States (US) regulations and will also serve as a useful resource for a wider audience. It is anticipated that M50-A will be used extensively in the United States and internationally to reduce resources spent on excessive QC testing.
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