CLSI M50

Quality Control for Commercial Microbial Identification Systems, 1st Edition

This document provides guidance for quality control of commercial systems for microbial identification from culture, including information that pertains to manufacturers, distributors, and laboratory users. The intent is to ensure optimal performance of a microbial identification system in an efficient (streamlined) manner.

This archived document is no longer being reviewed through the CLSI Consensus Document Development Process. However, this document is technically valid of as October 2022. Because of its value to the laboratory community, it is being retained in CLSI’s library.

This document is available in electronic format only.

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Chairholder: Nancy L. Anderson, MMSC, MT(ASCP)

Date of Publication: August 29, 2008

Order Code PDF: CLSI M50AE
ISBN Number: 1-56238-675-1

Order Code Print: print not available

Edition: First

Pages: 40

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The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus guideline for use in satisfying a regulatory requirement.

CLSI M50 Abstract

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 yeast-like 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.