Microbiology
Microbiology
Microbiology
CLSI M100™
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Performance Standards for Antimicrobial
Susceptibility Testing
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CLSI M100 includes updated tables for the Clinical and Laboratory Standards Institute
antimicrobial susceptibility testing standards CLSI M02, M07, and M11.
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Marcelo F. Galas, BSc Pranita D. Tamma, MD, MHS
Romney M. Humphries, PhD, D(ABMM), FIDSA Melvin P. Weinstein, MD
Thomas J. Kirn, Jr., MD, PhD
Abstract
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The data in the tables are valid only if the methodologies in CLSI M02,1 M07,2 and M113 are followed. These standards
contain information about disk diffusion (CLSI M021) and dilution (CLSI M072 and CLSI M113) test procedures for
aerobic and anaerobic bacteria. Clinicians depend heavily on information from the microbiology laboratory for
treating their seriously ill patients. The clinical importance of antimicrobial susceptibility test results demands that
these tests be performed under optimal conditions and that laboratories have the capability to provide results for
the newest antimicrobial agents. The tables presented in CLSI M100 represent the most current information for drug
selection, interpretation, and quality control using the procedures standardized in CLSI M02,1 M07,2 and M11.3 Users
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should replace previously published tables with these new tables. Changes in the tables since the previous edition
appear in boldface type.
Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing.
34th ed. CLSI supplement M100 (ISBN 978-1-68440-220-5 [Print]; ISBN 978-1-68440-221-2 [Electronic]). Clinical and
Laboratory Standards Institute, USA, 2024.
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The Clinical and Laboratory Standards Institute consensus process, which is the mechanism for moving a document through
two or more levels of review by the health care community, is an ongoing process. Users should expect revised editions of any
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Suggested Citation
CLSI. Performance Standards for Antimicrobial Susceptibility Testing. 34th ed. CLSI supplement M100. Clinical and
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Laboratory Standards Institute; 2024.
Previous Editions:
December 1986, December 1987, December 1991, December 1992, December 1994, December 1995, January
1997, January 1998, January 1999, January 2000, January 2001, January 2002, January 2003, January 2004, January
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2005, January 2006, January 2007, January 2008, January 2009, January 2010, June 2010, January 2011, January
2012, January 2013, January 2014, January 2015, January 2016, January 2017, January 2018, January 2019, January
2020, March 2021, February 2022, March 2023
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CLSI M100-Ed34
ISBN 978-1-68440-220-5 (Print)
ISBN 978-1-68440-221-2 (Electronic)
ISSN 1558-6502 (Print)
ISSN 2162-2914 (Electronic) Volume 44, Number 5
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Table of Contents
Contents
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CLSI M100-Ed34
Abstract . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i
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Committee Membership . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii
Overview of Changes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xii
CLSI Breakpoint Additions Since 2010 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xx
CLSI Breakpoint Revisions Since 2010 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xxiii
CLSI Archived Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xxvii
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Summary of CLSI Processes for Establishing Breakpoints and QC Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xxviii
CLSI Reference Methods vs Commercial Methods and CLSI vs US Food and Drug Administration Breakpoints . . . . . . . . . . . . . . . . . . . . . . . . xxix
CLSI Subcommittee on Antimicrobial Susceptibility Testing Mission Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xxx
Instructions for Use of Tables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Introduction to Tables 1A–1J. Antimicrobial Agents That Should Be Considered for Testing and Reporting by Microbiology Laboratories . . . . . 22
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Table 1H-2. Streptococcus spp. Viridans Group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .50
Table 1I. Neisseria meningitidis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Table 1J. Anaerobes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
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Introduction to Tables 2A–2J. Zone Diameter and MIC Breakpoints . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Table 2A-1. Zone Diameter and MIC Breakpoints for Enterobacterales (excluding Salmonella/Shigella) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Table 2A-2. Zone Diameter and MIC Breakpoints for Salmonella and Shigella spp.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Table 2B-1. Zone Diameter and MIC Breakpoints for Pseudomonas aeruginosa . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
Table 2B-2. Zone Diameter and MIC Breakpoints for Acinetobacter spp. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
Table 2B-3. MIC Breakpoints for Burkholderia cepacia complex . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
m Table 2B-4. Zone Diameter and MIC Breakpoints for Stenotrophomonas maltophilia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
Table 2B-5. MIC Breakpoints for Other Non-Enterobacterales . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
Table 2C. Zone Diameter and MIC Breakpoints for Staphylococcus spp. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
Table 2D. Zone Diameter and MIC Breakpoints for Enterococcus spp. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
Table 2E. Zone Diameter and MIC Breakpoints for Haemophilus influenzae and Haemophilus parainfluenzae . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112
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Table 2F. Zone Diameter and MIC Breakpoints for Neisseria gonorrhoeae . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118
Table 2G. Zone Diameter and MIC Breakpoints for Streptococcus pneumoniae . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122
CLSI M100-Ed34
Table 2H-1. Zone Diameter and MIC Breakpoints for Streptococcus spp. β-Hemolytic Group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128
Table 2H-2. Zone Diameter and MIC Breakpoints for Streptococcus spp. Viridans Group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134
Table 2I. Zone Diameter and MIC Breakpoints for Neisseria meningitidis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138
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Table 2J. MIC Breakpoints for Anaerobes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142
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Introduction to Table 2 Dosages. Antimicrobial Agent Dosage Regimens Used to Establish Susceptible or Susceptible-Dose
Dependent Breakpoints . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146
Table 2 Dosages. Antimicrobial Agent Dosage Regimens Used to Establish Susceptible or Susceptible-Dose Dependent Breakpoints . . . . . . . . 148
Table 3A. Tests for Extended-Spectrum β-Lactamases in Klebsiella pneumoniae, Klebsiella oxytoca, Escherichia coli,
and Proteus mirabilis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154
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Introduction to Tables 3B and 3C. Tests for Carbapenemases in Enterobacterales and Pseudomonas aeruginosa . . . . . . . . . . . . . . . . . . . . . . . . . . . 158
Table 3B. CarbaNP Test for Suspected Carbapenemase Production in Enterobacterales and Pseudomonas aeruginosa . . . . . . . . . . . . . . . . . . . . . . 160
Table 3C. Modified Carbapenem Inactivation Methods for Suspected Carbapenemase Production in Enterobacterales and
Pseudomonas aeruginosa . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 168
Table 3D. Aztreonam Plus Ceftazidime-Avibactam Broth Disk Elution Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 182
m Table 3E. Tests for Colistin Resistance for Enterobacterales and Pseudomonas aeruginosa . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 192
Table 3F-1. Test for Performing Disk Diffusion Directly From Positive Blood Culture Broth . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 198
Table 3F-2. Zone Diameter Disk Diffusion Breakpoints for Enterobacterales Direct From Blood Culture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 202
Table 3F-3. Zone Diameter Disk Diffusion Breakpoints for Pseudomonas aeruginosa Direct From Blood Culture. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 204
Table 3F-4. Zone Diameter Disk Diffusion Breakpoints for Acinetobacter spp. Direct From Blood Culture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 206
Table 3G. Tests for Detecting β-Lactamase Production in Staphylococcus spp. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 208
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Table 3H. Oxacillin Salt Agar Test for Detecting Methicillin (Oxacillin) Resistance in Staphylococcus aureus. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 212
Table 3I. Vancomycin Agar Screen for Staphylococcus aureus and Enterococcus spp.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 214
Table 3J. Tests for Detecting Inducible Clindamycin Resistance in Staphylococcus spp., Streptococcus pneumoniae,
and Streptococcus spp. β-Hemolytic Group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 216
Table 3K. Test for Detecting High-Level Mupirocin Resistance in Staphylococcus aureus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 220
Table 3L. Test for Detecting High-Level Aminoglycoside Resistance in Enterococcus spp. (including disk diffusion) . . . . . . . . . . . . . . . . . . . . . . . . . . . 222
Contents (Continued)
Table 4A-1. Disk Diffusion QC Ranges for Nonfastidious Organisms and Antimicrobial Agents Excluding β-Lactam
Combination Agents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 226
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Table 4A-2. Disk Diffusion QC Ranges for Nonfastidious Organisms and β-Lactam Combination Agents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 232
Table 4B. Disk Diffusion QC Ranges for Fastidious Organisms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 236
Table 4C. Disk Diffusion Reference Guide to QC Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 240
Table 4D. Disk Diffusion Troubleshooting Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 242
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Table 5A-1. MIC QC Ranges for Nonfastidious Organisms and Antimicrobial Agents Excluding β-Lactam Combination Agents . . . . . . . . . . . . . . 248
Table 5A-2. MIC QC Ranges for Nonfastidious Organisms and β-Lactam Combination Agents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 258
Table 5B. MIC QC Ranges for Fastidious Organisms (Broth Dilution Methods) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 264
Table 5C. MIC QC Ranges for Neisseria gonorrhoeae (Agar Dilution Method) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 270
Table 5D. MIC QC Ranges for Anaerobes (Agar Dilution Method) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 272
m Table 5E. MIC QC Ranges for Anaerobes (Broth Microdilution Method) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 276
Table 5F. MIC Reference Guide to QC Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 278
Table 5G. MIC Troubleshooting Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 280
Table 6A. Solvents and Diluents for Preparing Stock Solutions of Antimicrobial Agents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 288
Table 6B. Preparing Stock Solutions for Antimicrobial Agents Provided With Activity Expressed as Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 296
Table 6C. Preparing Solutions and Media Containing Combinations of Antimicrobial Agents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 298
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Table 7. Preparing Dilutions of Antimicrobial Agents to Be Used in Agar Dilution Susceptibility Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 304
Table 8A. Preparing Dilutions of Antimicrobial Agents to Be Used in Broth Dilution Susceptibility Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 306
CLSI M100-Ed34
Table 8B. Preparing Dilutions of Water-Insoluble Antimicrobial Agents to Be Used in Broth Dilution Susceptibility Tests . . . . . . . . . . . . . . . . . . . . 308
Appendix A. Suggestions for Confirming Antimicrobial Susceptibility Test Results and Organism Identification for Agents
Approved by the US Food and Drug Administration for Clinical Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 310
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Appendix B. Intrinsic Resistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 318
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Appendix C. QC Strains for Antimicrobial Susceptibility Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 324
Appendix D. Anaerobe Cumulative Antibiogram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 330
Appendix E. Susceptible-Dose Dependent Interpretive Category . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 334
Appendix F. Epidemiological Cutoff Values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 338
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Appendix G. Using Molecular Assays for Resistance Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 342
Appendix H. Cefiderocol Broth Preparation and Reading Broth Microdilution Minimal Inhibitory Concentration End Points . . . . . . . . . . . . . . . . . 358
Glossary I (Part 1). β-Lactams: Class and Subclass Designations and Generic Names . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 364
Glossary I (Part 2). Non–β-Lactams: Class and Subclass Designations and Generic Names . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 368
Glossary II. Antimicrobial Agent Abbreviations, Routes of Administration, and Drug Class . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 372
mGlossary III. List of Identical Abbreviations Used for More Than One Antimicrobial Agent in US Diagnostic Products . . . . . . . . . . . . . . . . . . . . . . . . 380
The Quality Management System Approach . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 382
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Overview of Changes
Overview of Changes
xii
CLSI M100-Ed34
CLSI M100-Ed34 replaces the previous edition of the supplement, CLSI M100-Ed33, published in 2023. Major additions, reformatting, and/or table relocation
changes are summarized below, followed by additional noteworthy changes detailed by section/table. Changes to content since the previous edition appear in
e
boldface type; however, minor editorial or formatting changes are not listed here, nor highlighted in boldface type. To learn more about the organization of
CLSI M100-Ed34, check the “Instructions for Use.”
CLSI M100 is updated and reviewed annually as new data and new agents become available. Use of outdated documents is strongly discouraged.
Major Additions/Revisions
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• Tables 1 and Tables 2 (general): These tables were renumbered so that each Table 1 has a corresponding Table 2.
• Table 1I: A new table for suggested drugs to test and report on Neisseria meningitidis was added.
• Table 1J: A combined table for suggested drugs to test and report on anaerobes was added. Previously, these suggestions were listed in separate
gram-negative and gram-positive tables.
• Table 2A-2: A new table with breakpoints specific to Salmonella and Shigella spp. was added. Table 2A-1 no longer addresses these organism groups.
• Tables 2, Tables 3, and former Appendix E: In previous editions of CLSI M100, dosage regimens were listed in Tables 2, 3E-2 (now 3F-2), 3E-3 (now 3F-3), and
former Appendix E.
– Dosage regimens were removed from all Tables 2 and Tables 3F-2 and 3F-3.
m – Former Appendix E was reformatted, relocated to follow the Tables 2 containing breakpoints, and renamed “Table 2 Dosages. Antimicrobial Agent
Dosage Regimens Used to Establish Susceptible or Susceptible-Dose Dependent Breakpoints” (referred to as “Table 2 Dosages” throughout).
• Tables 3 (general): These tables were renumbered to accommodate the addition of new Table 3D.
• Table 3D: A new table describing a broth disk elution method for aztreonam plus ceftazidime-avibactam was added.
• Table 3F-4: A new table with breakpoints specific to testing Acinetobacter spp. directly from positive blood cultures was added.
• Table 3H: Former Tables 3G-1 and 3G-2, which described ancillary methods for testing oxacillin and cefoxitin against staphylococci, were condensed into
Table 3H, which describes the oxacillin salt agar test only.
• Appendixes (general): These sections were relabeled to accommodate the relocation of former Appendix E (now Table 2 Dosages).
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Section/Table Changes
General
Throughout Added:
• “Lower” qualifier to comment that daptomycin should not be routinely reported on organisms isolated
from the lower respiratory tract
Revised:
• Suggestion for repeat testing of isolates initially susceptible that may develop resistance after initiation of
therapy, from “within 3 to 4 days” to “within a few days”
Overview of Changes (Continued)
Section/Table Changes
General (Continued)
CLSI Breakpoint Additions Since 2010 Added:
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• Sulbactam-durlobactam disk diffusion and MIC breakpoints for Acinetobacter spp.
• Tedizolid disk diffusion breakpoints for Staphylococcus spp. (Staphylococcus aureus only)
• Tedizolid disk diffusion breakpoint for Streptococcus spp. β-hemolytic group (Streptococcus pyogenes and
Streptococcus agalactiae only)
• Tedizolid disk diffusion breakpoint for Streptococcus spp. viridans group (Streptococcus anginosus group only)
CLSI Breakpoint Revisions Since 2010 Revised:
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• Minocycline disk diffusion and MIC breakpoints for Stenotrophomonas maltophilia
• Linezolid disk diffusion breakpoints for Staphylococcus spp.
Deleted:
• Ceftazidime disk diffusion breakpoints for Burkholderia cepacia complex
• Meropenem disk diffusion breakpoints for B. cepacia complex
• Minocycline disk diffusion breakpoints for B. cepacia complex
• Trimethoprim-sulfamethoxazole disk diffusion breakpoints for B. cepacia complex
CLSI M100-Ed34
Table 1B-2. Acinetobacter spp. Added:
• Sulbactam-durlobactam to Tier 3
Table 1B-4. Stenotrophomonas maltophilia Deleted:
• Ceftazidime
xiii
Overview of Changes
Overview of Changes
xiv
CLSI M100-Ed34
Section/Table Changes
Tables 1. (Continued)
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Table 1D. Enterococcus spp. Revised:
• Footnote d regarding susceptibility to penicillin
Table 1H-1. Streptococcus spp. β-Hemolytic Added:
Group • Reference corresponding to intrapartum prophylaxis recommendations
Revised:
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• Footnote b regarding intrapartum prophylaxis recommendations
Table 1I. Neisseria meningitidis New table
Table 1J. Anaerobes New combined table
Added:
• Footnote a regarding tier placement of ampicillin and penicillin for anaerobes
Tables 2. Zone Diameter and/or MIC Breakpoints
Introduction to Tables 2A–2J. Zone Diameter Added:
and MIC Breakpoints
Added:
• General comment regarding using positive blood culture broth as an inoculum for direct disk diffusion
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testing
• Sulbactam-durlobactam disk diffusion and MIC breakpoints
Table 2B-3. MIC Breakpoints for Burkholderia Deleted:
cepacia complex • General disk diffusion testing recommendations (disk diffusion no longer recommended for B. cepacia)
• Ceftazidime disk diffusion breakpoints
• Meropenem disk diffusion breakpoints
• Minocycline disk diffusion breakpoints
• Trimethoprim-sulfamethoxazole disk diffusion breakpoints
Overview of Changes (Continued)
Section/Table Changes
Tables 2. (Continued)
Table 2B-4. Zone Diameter and MIC Added:
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Breakpoints for Stenotrophomonas • Comment regarding trimethoprim-sulfamethoxazole antimicrobial therapy
maltophilia
Revised:
• Minocycline disk diffusion and MIC breakpoints
Deleted:
• Ceftazidime MIC breakpoints
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Table 2C. Zone Diameter and MIC Added:
Breakpoints for Staphylococcus spp. • Tedizolid disk diffusion breakpoints (S. aureus)
Revised:
• Linezolid disk diffusion breakpoints
• Table describing methods or targets for detection of methicillin (oxacillin)-resistant Staphylococcus spp.
• Text explaining mecA, cefoxitin, and oxacillin and associated testing relationships
Deleted:
• Comment regarding MIC confirmation requirement for staphylococci resistant to linezolid by disk diffusion
CLSI M100-Ed34
Susceptible-Dose Dependent Breakpoints
• Dosage for sulbactam-durlobactam for Acinetobacter spp.
• Dosage for minocycline for S. maltophilia
• Dosage for ceftriaxone for MSSA
xv
Overview of Changes
Overview of Changes
CLSI M100-Ed34
Section/Table Changes
Tables 3. Specialized Resistance Testing
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Table 3B. CarbaNP Test for Suspected Added:
Carbapenemase Production in • Reference pertaining to performance of the test
Enterobacterales and Pseudomonas
aeruginosa
Table 3C. Modified Carbapenem Inactivation Revised:
Methods for Suspected Carbapenemase • Test interpretation criterion from positive, negative, “indeterminate” to positive, negative, “inconclusive”
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Production in Enterobacterales and
Pseudomonas aeruginosa
Table 3D. Aztreonam Plus Ceftazidime- New table
Avibactam Broth Disk Elution Method
Table 3F-1. Test for Performing Disk Diffusion Added:
Directly From Positive Blood Culture Broth • Breakpoint Additions/Revisions Since 2021 table for disk diffusion directly from positive blood culture broth
Revised:
• Table to include testing Acinetobacter spp. directly from positive blood cultures
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Detecting Inducible • Reference corresponding to intrapartum prophylaxis recommendations
Clindamycin Resistance
Revised:
in Staphylococcus spp.,
Streptococcus pneumoniae, • Footnote b regarding intrapartum prophylaxis recommendations
and Streptococcus spp. • Reference pertaining to prevention of perinatal group B streptococcal disease updated to the American College of
β-Hemolytic Group Obstetricians and Gynecologists guidelines
Tables 4. Disk Diffusion QC Ranges and Associated Tables
pl
Table 4A-1. Disk Diffusion Added:
QC Ranges for Nonfastidious • Footnote c regarding S. aureus ATCC®a 43300 as a supplemental QC strain
Organisms and Antimicrobial
Revised:
Agents Excluding β-Lactam
Combination Agents • Linezolid QC range for S. aureus ATCC® 25923
• Tedizolid QC range for S. aureus ATCC® 25923
Deleted:
• Footnote regarding reading zones of inhibition for linezolid and tedizolid for S. aureus ATCC® 25923 using transmitted light
CLSI M100-Ed34
• Aztreonam QC range for E. coli ATCC® 25922
• Colistin QC range for P. aeruginosa ATCC® 27853
• Footnote o and associated figures regarding exebacase QC range for S. aureus ATCC® 29213 and additional testing guidance
Deleted:
xvii
Overview of Changes
Overview of Changes
xviii
CLSI M100-Ed34
Section/Table Changes
Tables 5. (Continued)
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Table 5A-2. MIC QC Ranges for Nonfastidious Added:
Organisms and β-Lactam Combination • Column headers to highlight QC organisms recommended for routine QC testing
Agents
• Imipenem-funobactam QC ranges for:
– E. coli ATCC® 25922
– P. aeruginosa ATCC® 27853
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– Klebsiella pneumoniae ATCC® 700603
– K. pneumoniae ATCC® BAA-1705™
Revised:
• Aztreonam QC ranges for:
– E. coli ATCC® 25922
– K. pneumoniae ATCC® 700603
Tables 6. Preparing Antimicrobial Agent Stock Solutions
Table 6A. Solvents and Diluents for Preparing Added:
Deleted:
• Footnote g regarding Serratia marcescens and elevated MICs to tobramycin
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Appendix C. QC Strains for Antimicrobial Added:
Susceptibility Tests • E. coli AR Bank #0348
• Oxacillin MIC testing for MIC tests for S. aureus ATCC® 43300
Appendix G. Using Molecular Assays for Revised:
Resistance Detection • Table column headers
Table G3. Reporting Results From ESBL Added:
Resistance and Carbapenemase Molecular • Text to clarify suggested action when a carbapenemase marker is detected in an Enterobacterales isolate
Tests for Enterobacterales that is cefepime S or SDD
Overview of Changes (Continued)
Section/Table Changes
Appendixes (Continued)
Appendix H. Cefiderocol Broth Preparation Added:
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and Reading Broth Microdilution Minimal • Figures showing determination of broth microdilution end points for cefiderocol
Inhibitory Concentration End Points,
Revised:
H3. Determining Broth Microdilution End
Points • Steps for reading and interpreting broth microdilution end points for cefiderocol, including figures showing
determination of end points
Glossaries
Glossary I (Part 1). β-Lactams: Class and
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Added:
Subclass Designations and Generic Names • Imipenem-funobactam
Glossary I (Part 2). Non β-Lactams: Class and Added:
Subclass Designations and Generic Names • Upleganan
Glossary II. Antimicrobial Agent Added:
Abbreviations, Routes of Administration, • Imipenem-funobactam
and Drug Class
• Upleganan
Abbreviations: AR, antimicrobial resistance; ATCC®, American Type Culture Collection; MIC, minimal inhibitory concentration; MSSA, methicillin (oxacillin) susceptible Staphylococcus aureus;
m NCTC, National Collection of Type Cultures; QC, quality control; S, susceptible; SDD, susceptible-dose dependent.
Footnote
a. ATCC® is a registered trademark of the American Type Culture Collection.
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CLSI M100-Ed34
xix
Overview of Changes
Summary of CLSI Processes for Establishing Breakpoints and QC Ranges
xxviii
CLSI M100-Ed34
The Clinical and Laboratory Standards Institute (CLSI) is an international, voluntary, not-for-profit, interdisciplinary, standards-developing, and educational
organization accredited by the American National Standards Institute that develops and promotes the use of consensus-developed standards and guidelines
e
within the health care community. These consensus standards and guidelines are developed in an open and consensus-seeking forum to cover critical areas of
diagnostic testing and patient health care. CLSI is open to anyone or any organization that has an interest in diagnostic testing and patient care. Information
about CLSI can be found at www.clsi.org.
The CLSI Subcommittee on Antimicrobial Susceptibility Testing reviews data from a variety of sources and studies (eg, in vitro, pharmacokinetics/
pharmacodynamics, and clinical studies) to establish antimicrobial susceptibility test methods, breakpoints, and QC parameters. The details of the data
pl
necessary to establish breakpoints, QC parameters, and how the data are presented for evaluation are described in CLSI M23.4
Over time, a microorganism’s susceptibility to an antimicrobial agent may decrease, resulting in a lack of clinical efficacy and/or safety. In addition,
microbiological methods and QC parameters may be refined to ensure more accurate and better performance of susceptibility test methods. Because of
these types of changes, CLSI continually monitors and updates information in its documents. Although CLSI standards and guidelines are developed using the
most current information available at the time, the field of science and medicine is always changing; therefore, standards and guidelines should be used in
conjunction with clinical judgment, current knowledge, and clinically relevant laboratory test results to guide patient treatment.
Additional information, updates, and changes in this document are found in the meeting summary minutes of the CLSI Subcommittee on Antimicrobial
e
suggestions include clinical efficacy, current consensus recommendations for first-choice and alternative drugs, and US Food and Drug Administration
(FDA) clinical indications for use. In other countries, placement of antimicrobial agents in Tables 1A through 1J should be based on available drugs
approved for clinical use by relevant regulatory organizations.
• Tables 2A through 2J: tables for each organism group that contain:
– Recommended testing conditions
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– Routine QC recommendations (also see CLSI M021 and CLSI M072)
– General comments for testing the organism group and specific comments for testing particular agent/organism combinations
– Agents that should be considered for routine testing and reporting by medical microbiology laboratories, as specified in Tables 1A through 1J (test/
report Tiers 1, 2, 3, and 4), including agents reported only on organisms isolated from the urinary tract (designated by “U”)
– Agents that are appropriate for the respective organism group but are not listed in Tables 1 and would generally not warrant routine testing by a
medical microbiology laboratory in the United States (designated with an asterisk as “other”; designated with “Inv.” for “investigational” [not yet FDA
m approved]), including agents reported only on organisms isolated from the urinary tract (designated by “U”)
– Zone diameter and minimal inhibitory concentration (MIC) breakpoints
• Tables 1J and 2J: tables containing specific recommendations for testing and reporting results on anaerobes and some of the information listed in the
bullets above
• Tables 3A through 3L: tables describing tests to detect particular resistance types in specific organisms or organism groups
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CLSI M100-Ed34
1
Table 1B-1
Pseudomonas aeruginosa
CLSI M02 and CLSI M07
CLSI M100-Ed34
Tier 3: Antimicrobial agents that are
Tier 2: Antimicrobial agents that are appropriate for routine, primary testing Tier 4: Antimicrobial agents that
appropriate for routine, primary testing in institutions that serve patients at may warrant testing and reporting
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but may be reported following cascade high risk for MDROs but should only be by clinician request if antimicrobial
Tier 1: Antimicrobial agents that are appropriate reporting rules established at each reported following cascade reporting agents in other tiers are not
for routine, primary testing and reporting institution rules established at each institution. optimal because of various factors
Ceftazidime Imipenem Cefiderocol
Cefepime Meropenem Ceftazidime-avibactam
Piperacillin-tazobactam Ceftolozane-tazobactam
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Imipenem-relebactam
Tobramycin
Ciprofloxacin
Levofloxacin
Aztreonam
Urine Only
Amikacin
CLSI M100-Ed34
Tier 3: Antimicrobial agents that are
Tier 2: Antimicrobial agents that are appropriate for routine, primary testing Tier 4: Antimicrobial agents that
appropriate for routine, primary testing in institutions that serve patients at may warrant testing and reporting
e
but may be reported following cascade high risk for MDROs but should only be by clinician request if antimicrobial
Tier 1: Antimicrobial agents that are appropriate reporting rules established at each reported following cascade reporting agents in other tiers are not
for routine, primary testing and reporting institution rules established at each institution optimal because of various factors
Ceftazidime Cefepime
Imipenem
Meropenem
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Gentamicin Amikacin
Tobramycin
Piperacillin-tazobactam
Trimethoprim-sulfamethoxazole
Aztreonam
Ciprofloxacin
Levofloxacin
m Minocycline
Cefotaxime
© Clinical and Laboratory Standards Institute. All rights reserved.
Ceftriaxone
Urine Only
Tetracyclinec
Abbreviations: MDRO, multidrug-resistant organism; MIC, minimal inhibitory concentration.
CLSI M100-Ed34
Tier 3: Antimicrobial agents that are
Tier 2: Antimicrobial agents that are appropriate for routine, primary testing Tier 4: Antimicrobial agents that
appropriate for routine, primary testing in institutions that serve patients at may warrant testing and reporting
e
but may be reported following cascade high risk for MDROs but should only be by clinician request if antimicrobial
Tier 1: Antimicrobial agents that are appropriate reporting rules established at each reported following cascade reporting agents in other tiers are not
for routine, primary testing and reporting institution rules established at each institution optimal because of various factors
Ampicillina,b
Penicillina,b
Cefotaxime Cefepime
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Ceftriaxone
Vancomycin
Linezolid
Tedizolidc
Dalbavancina,c
Oritavancina
Telavancina
m Ceftolozane-tazobactam
Clindamycind
© Clinical and Laboratory Standards Institute. All rights reserved.
Erythromycind,e
Levofloxacin
Abbreviations: MDRO, multidrug-resistant organism; MIC, minimal inhibitory concentration.
Footnotes
CLSI M100-Ed34