CLSI M45
Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria
This CLSI guideline provides essential guidance for susceptibility testing of bacterial pathogens when antimicrobial resistance is a concern and susceptibility cannot be predicted by organism identity alone. It is particularly useful for testing infrequently isolated or fastidious bacteria that are not covered in CLSI M02, M07, or M100.
The document includes recommendations for antimicrobial agent selection, test interpretation, and quality control, supporting clinical, public health, and research laboratories in improving treatment decisions.
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{{FormatPrice(nonMemberPrice)}} List PriceIf a bacterial pathogen’s susceptibility to antimicrobial agents cannot be predicted based on the identity of the organism alone, in vitro antimicrobial susceptibility testing of the isolated organism may be indicated. Susceptibility testing is particularly necessary in those situations in which the etiological agent belongs to a bacterial species for which resistance to commonly used antimicrobial agents has been documented, or could arise.
A variety of laboratory techniques can be used to measure the in vitro susceptibility of bacteria to antimicrobial agents. Clinical and Laboratory Standards Institute document M45—Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria describes the standard microdilution and agar disk diffusion methods. It also includes a series of procedures designed to standardize test performance. The performance, applications, and limitations of the current CLSI-recommended methods are described.
CLSI documents M02,1 M07,2 and M100,3 describe standardized methods and interpretive criteria for antimicrobial susceptibility testing of common aerobic bacteria, including some fastidious organisms. However, a number of less frequently encountered or fastidious bacteria are not addressed in those CLSI documents despite their potential to cause serious infections. M45 addresses these latter organisms with the goal of providing recommendations for clinical microbiology laboratories on how and when to determine the susceptibility of these diverse organisms. This document also provides guidance for public health laboratory testing of bacteria potentially associated with bioterrorism.
This edition of M45 includes taxonomic updates and several new tables to address organisms more likely to be identified in laboratories using sequencing or matrix-assisted laser desorption/ionization time-of-flight mass spectrometry for the identification of bacteria. The intent of this revision is to assist laboratories in determining an approach for testing that is relevant to their individual practice settings.
The methods provided may be used in clinical, public health, and research laboratories.
This guideline does not address commercial susceptibility testing devices.
This edition of the document has been corrected, read the full correction notice here.
The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.
If a bacterial pathogen’s susceptibility to antimicrobial agents cannot be predicted based on the identity of the organism alone, in vitro antimicrobial susceptibility testing of the isolated organism may be indicated. Susceptibility testing is particularly necessary in those situations in which the etiological agent belongs to a bacterial species for which resistance to commonly used antimicrobial agents has been documented, or could arise.
A variety of laboratory techniques can be used to measure the in vitro susceptibility of bacteria to antimicrobial agents. Clinical and Laboratory Standards Institute document M45—Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria describes the standard microdilution and agar disk diffusion methods. It also includes a series of procedures designed to standardize test performance. The performance, applications, and limitations of the current CLSI-recommended methods are described.
CLSI documents M02,1 M07,2 and M100,3 describe standardized methods and interpretive criteria for antimicrobial susceptibility testing of common aerobic bacteria, including some fastidious organisms. However, a number of less frequently encountered or fastidious bacteria are not addressed in those CLSI documents despite their potential to cause serious infections. M45 addresses these latter organisms with the goal of providing recommendations for clinical microbiology laboratories on how and when to determine the susceptibility of these diverse organisms. This document also provides guidance for public health laboratory testing of bacteria potentially associated with bioterrorism.
This edition of M45 includes taxonomic updates and several new tables to address organisms more likely to be identified in laboratories using sequencing or matrix-assisted laser desorption/ionization time-of-flight mass spectrometry for the identification of bacteria. The intent of this revision is to assist laboratories in determining an approach for testing that is relevant to their individual practice settings.
The methods provided may be used in clinical, public health, and research laboratories.
This guideline does not address commercial susceptibility testing devices.
This edition of the document has been corrected, read the full correction notice here.
The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.