This document includes updated tables for the Clinical and Laboratory Standards Institute antimicrobial susceptibility testing standards M02,SAMPLE M07, and M11. A CLSI supplement for global application.
M100, 29th ed. January 2019 Replaces M100, 28th ed. Performance Standards for Antimicrobial Susceptibility Testing
Melvin P. Weinstein, MD James S. Lewis II, PharmD, FIDSA Jean B. Patel, PhD, D(ABMM) Brandi Limbago, PhD April M. Bobenchik, PhD, D(ABMM) Amy J. Mathers, MD, D(ABMM) Shelley Campeau, PhD, D(ABMM) Tony Mazzulli, MD, FACP, FRCP(C)M100S, 26th ed. Sharon K. Cullen, BS, RAC Sandra S. Richter, MD, D(ABMM), FCAP,January FIDSA 2016 Marcelo F. Galas Michael Satlin, MD, MS Replaces M100-S25 Howard Gold, MD, FIDSA Audrey N. Schuetz, MD, MPH, D(ABMM) RomneyPerformance M. Humphries, Standards PhD, D(ABMM) for Anti microbialJana M. Swenson,Susceptibility MMSc Testing Thomas J. Kirn, Jr., MD, PhD Pranita D. Tamma, MD, MHS
Jean B. Patel, PhD, D(ABMM) Franklin R. Cockerill III, MD George M. Eliopoulos, MD Stephen G. Jenkins, PhD, D(ABMM), F(AAM) James S. Lewis II, PharmD Brandi Limbago, PhD David P. Nicolau, PharmD, FCCP, FIDSA AbstractRobin Patel, MD Mair Powell, MD, FRCP, FRCPath TheSandra data S. in theRichter, tables MD, are valid D(ABMM) only if the methodologies in CLSI documents M02,1 M07,2 and M113 are followed. These standards contain information about disk diffusion (M021) and dilution (M072 and M113) test procedures for aerobic and anaerobicJana M. bacteria.Swenson, Clinicians MMSc depend heavily on information from the microbiology laboratory for treating their seriously ill patients.Maria M.The Traczewski, clinical importan BS,ce MT(ASCP)of antimicrobial susceptibility test results demands that these tests be performed under optimal conditionsJohn D. Turnidge,and that laboratories MD have the capability to provide results for the newest antimicrobial agents. The tables presented in M100Melvin represent P. Weinstein, the most MD current information for drug selection, interpretation, and quality control using the procedures 1 2 3 standardizedBarbara L. in Zimmer, M02, M07, PhD and M11. Users 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. 29th ed. CLSI supplement M100 (ISBN 978-1-68440-032-4 [Print]; ISBN 978-1-68440-033-1 [Electronic]). Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087 USA, 2019.
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 given document. Because rapid changes in technology may affect the procedures, methods, and protocols in a standard or guideline, users should replace outdated editions with the current editions of CLSI documents. Current editions are listed in the CLSI catalog and posted on our website at www.clsi.org. If you or your organization is not a member and would like to become one, or to request a copy of the catalog, contact us at: Telephone: +1.610.688.0100; Fax: +1.610.688.0700; E-Mail: [email protected]; Website: www.clsi.org.
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CLSI. Performance Standards for Antimicrobial Susceptibility Testing. 29th ed. CLSI supplement M100. Wayne, PA: Clinical and Laboratory Standards Institute; 2019.
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 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
ISBN 978-1-68440-032-4SAMPLE (Print) ISBN 978-1-68440-033-1 (Electronic) ISSN 1558-6502 (Print) ISSN 2162-2914 (Electronic) Volume 39, Number 1
ii M100, 29th ed.
2 ould ould ould ould ould ould . xxxii xxxii . 1 1 . xxviii xxviii . Table of Contents Table . xxvii xxvii . xxxiii xxxiii . 2 . 3 . atement . atement
Pseudomonas aeruginosa Pseudomonas Enterobacteriaceae tablishing Breakpoints and Quality Control Ranges . Control Ranges tablishing Breakpoints and Quality SAMPLE Table 2B-1. Zone Diameter and MIC Breakpoints for and MIC Breakpoints for Zone Diameter Table 2B-1. Table 1B. Suggested Groupings of Antimicrobial Agents Approved by the US Food and Drug Administration for Clinical Use That Sh for Clinical Administration Drug US Food and by Agents Approved the Groupings of Antimicrobial Table 1B. Suggested 2 . Organisms by Laboratories in the United States Microbiology on Fastidious and Reporting Be Considered for Testing Contents i . Abstract iii . Committee Membership xiv . Overview of Changes Summary of CLSI Processes for Es CLSI Reference Methods vs Commercial Methods and CLSI vs US Food and Drug Administration Breakpoints . Breakpoints CLSI vs US FoodCommercial Methods and vs and Drug Administration Methods Reference CLSI . Use of Tables Instructions for CLSI Breakpoint Additions/Revisions Since 2010 . xxix . Since 2010 CLSI Breakpoint Additions/Revisions xxxii . Value Additions/Revisions Since 2015 CLSI Epidemiological Cutoff . CLSI Archived Resources Susceptibility on Antimicrobial Subcommittee Testing Mission St References . 16 . References Use That Sh for Clinical Administration Drug US Food and by Agents Approved the Groupings of Antimicrobial Table 1A. Suggested 1 . by in the United States Microbiology Laboratories Organisms on Nonfastidious and Reporting Be Considered for Testing Use That Sh for Clinical Administration Drug US Food and by Agents Approved the Groupings of Antimicrobial Table 1C. Suggested 0 . by Organisms Laboratories in the United States on Anaerobic Microbiology and Reporting Be Considered for Testing Table 2A. Zone Diameter and MIC Breakpoints for
viii M100, 29th ed.
0 9 10 0 . 10 Table of Contents Table . 110 Proteus mirabilis and Proteus Escherichia coli,
and aeruginosa Pseudomonas . 10 aeruginosa Pseudomonas . 2 . and Klebsiella oxytoca,
. 2 . complex . complex . 7 . . Enterobacteriaceae . spp. β-Hemolytic Group . 8 . spp. β-Hemolytic Group 92 . spp. Viridans Group n spp. 4 . spp. spp (Refer to General Comment 1) . 5 . (Refer to General Comment 1) Enterobacteriaceae Klebsiella pneumoniae,
Streptococcus Streptococcus Streptococcus Stenotrophomonas maltophilia Acinetobacter Burkholderia cepacia Enterococcus Streptococcus pneumoniae spp. 5 . spp. Staphylococcus . parainfluenzae Haemophilus influenzae and Neisseria gonorrhoeae Neisseria meningitidis
Table 2J. MIC Breakpoints for Anaerobes . Table 2J. MIC Breakpoints for Anaerobes Table 2C. Zone Diameter and MIC Breakpoints for Table 2C. Zone Table 2D. Zone Diameter and MIC Breakpoints for Diameter and MIC Breakpoints for Table 2E. Zone Table 2G. Zone Diameter and MIC Breakpoints for and MIC Breakpoints for Table 2H-1. Zone Diameter and MIC Breakpoints for Table 2H-2. Zone Diameter Diameter and MIC Breakpoints for Table 2I. Zone β-Lactamases Extended-Spectrum in for Tests 3A. Table Table 3B-1. Modifications of Table 3B When Using MIC Breakpoints for Carbapenems Described in M100-S20 (January 2010) . 1 1 . 2010) Described in M100-S20 (January for Carbapenems MIC Breakpoints of Table 3B When Using Modifications Table 3B-1. Table 2B-5. MIC Breakpoints for Other Non- Table 2B-5. Table 2B-4. Zone Diameter and MIC Breakpoints for and MIC Breakpoints for Zone Diameter Table 2B-4. in Tables 3B and 3C. Tests for Carbapenemases Introduction to Table 3B. CarbaNP i Test for Suspected Carbapenemase Production Contents (Continued) and MIC Breakpoints for Zone Diameter Table 2B-2. Table 2F. Zone Diameter and MIC Breakpoints for Table 2F. Zone Table 2B-3. Zone Diameter and MIC Breakpoints for and MIC Breakpoints for Zone Diameter Table 2B-3.
ix M100, 29th ed.
2 4 82 62 64 1 1 0 1 1 spp. Table of Contents Table and and and Streptococcus Enterobacteriaceae Streptococcus pneumoniae, Streptococcus spp. (Includes Disk Diffusion) . 1 48 . spp. (Includes Disk Diffusion) spp., spp. 1 . spp. spp. 1 40 . spp. spp. spp. Enterococcus
Staphylococcus Staphylococcus ce in ce n and Enterococcus in
(Agar Dilution Method) . (Agar Dilution Method) SAMPLE . 1 1 . Contents (Continued) Table 3C. Modified Carbapenem Inactivation Methods in Production Carbapenemase Suspected for Table 3C-1. Modifications of Table 3C When Using MIC Breakpoints for Carbapenems Described in M100-S20 (January 2010) . 2010) Described in M100-S20 (January for Carbapenems MIC Breakpoints of Table 3C When Using Modifications Table 3C-1. Table 3D. Test for Detection of β-Lactamase Production in Pseudomonas aeruginosa Pseudomonas Table 3E. Test for Detecting Methicillin (Oxacillin) Resistance Table 3F. Vancomycin Agar Screen for Staphylococcus Table 3F. Vancomycin Table 3G. Test for Detecting Inducible Clindamycin Resistance i Table 5B. MIC QC Ranges for Fastidious Organisms (Broth Dilution Methods) . 17 8 . Methods) Organisms (Broth Dilution Table 5B. MIC QC Ranges for Fastidious Table 5C. MIC QC Ranges for Neisseria gonorrhoeae Table 4A-1. Disk Diffusion QC Ranges for Nonfastidious Organisms and Antimicrobial Agents Excluding β-Lactam Combination Agents . 1 50 . Agents Combination β-Lactam and Antimicrobial Agents Excluding for Nonfastidious Organisms Table 4A-1. Disk Diffusion QC Ranges β-Hemolytic Group . 1 42 . Group β-Hemolytic 46 1 . aureus Resistance Mupirocin for Detecting in Staphylococcus 3H. Test Table High-Level Resistan Table 3I. Test for Detecting High-Level Aminoglycoside Table 4D. Disk Diffusion Troubleshooting Guide . 1 . Guide Troubleshooting Table 4D. Disk Diffusion 1 68 . Agents Combination β-Lactam Agents Excluding and Antimicrobial Table 5A-1. MIC QC Ranges for Nonfastidious Organisms 1 7 . Combination and β-Lactam Agents Ranges QC MIC Nonfastidious Organisms 5A-2. for Table Table 4A-2. Disk Diffusion QC Ranges for Nonfastidious Organisms and β-Lactam Combination Agents . 1 54 . Combination Agents and β-Lactam for Nonfastidious Organisms Table 4A-2. Disk Diffusion QC Ranges 1 58 . Ranges for Fastidious Organisms Table 4B. Disk Diffusion QC . Guide to QC Frequency Table 4C. Disk Diffusion Reference
d Table of Contents Table . 2 2 . 1 od) . od) Anaerobic Organisms . Organisms Anaerobic ovided With Activity Expressed as Units . 200 . ovided With Activity Expressed as Units
ns for Antimicrobial Agents Pr Agents Antimicrobial for ns SAMPLE
Table 5F. MIC Reference Guide to QC Frequency . 1 Reference Guide to QC Frequency Table 5F. MIC 1 90 . Table 5G. MIC Troubleshooting Guide 1 9 . Agents Antimicrobial of Solutions for Preparing Stock and Diluents Table 6A. Solvents Solutio Table 6B. Preparing Stock . Agents of Antimicrobial Combinations Containing and Media Table 6C. Preparing Solutions Contents (Continued) 1 . Table 5D. MIC QC Ranges for Anaerobes (Agar Dilution Method) Meth Table 5E. MIC QC Ranges for Anaerobes (Broth Microdilution Table 7. Preparing Dilutions of Antimicrobial Agents to Be Used in Agar Dilution Susceptibility Tests . 20 . in Agar Dilution Susceptibility Agents to Be Used Tests of Antimicrobial Table 7. Preparing Dilutions 20 . in Broth Dilution Susceptibility Tests Agents to Be Used of Antimicrobial Table 8A. Preparing Dilutions 210 . Susceptibility Tests Agents to Be Used in Broth Dilution Antimicrobial of Water-Insoluble Dilutions 8B. Preparing Table
Appendix A. Suggestions for Confirming Resistant, Intermediate, or Nonsusceptible Antimicrobial Susceptibility Test Results an Results Test Susceptibility or Nonsusceptible Antimicrobial Resistant, Intermediate, Confirming Suggestions for Appendix A. Organism Identification . 212 Identification Organism . 21 Resistance Intrinsic Appendix B. Susceptibility Tests Appendix C. QC Strains for Antimicrobial Appendix G. Epidemiological Cutoff Values . 2 Cutoff Values Epidemiological Appendix G. Appendix D. Cumulative Antimicrobial Susceptibility Report for Antimicrobial Appendix D. Cumulative Appendix E. Dosage Regimens Used to Establish Susceptible or Susceptible-Dose Dependent Breakpoints . 2 Dependent Breakpoints Appendix E. Dosage Regimens Used to Establish Susceptible or Susceptible-Dose 2 2 . Appendix F. Susceptible-Dose Dependent Interpretive Category
xi M100, 29th ed. 2 Table of Contents Table
. 2 2 . SAMPLE . -Lactams: Class and Subclass Designations Generic Name -Lactams: Class and Subclass Designations and Generic Name . 2 . Class-Lactams: and Subclass Designations Generic Name Glossary I (Part 1). The Quality Management System Approach . 280 . Approach The QualitySystem Management 281 . Related CLSI Reference Materials Contents (Continued) Appendix H. Using Molecular Assays for Resistance Detection . Glossary I (Part 2). Non– Glossary2). (Part I Glossary II. Antimicrobial Agent Abbreviation(s), Route(s) of Administration, and Drug Class . 272 and Drug Class Glossary of Administration, Route(s) Abbreviation(s), Agent II. Antimicrobial Agent in US Diagnostic Products. 278 One Antimicrobial Than More for Used Abbreviations Identical of GlossaryList III.
xii M100, 29th ed. bles bles
.” 29th ed., are deletion “ s a Overview of Changes Overview (p. xxix), Pseudomonas (p. xxx) xxx) (p. (p. xxx) xxx) (p.
Enterobacteriaceae P. aeruginosa P. aeruginosa (p. xxix) (p. xxx) (p. (p. xxxi) (p. xxxi) (now assigned a breakpoint in Table 2F) (now assigned a breakpoint in (p. xxix) and (p. xxix) (p. xxix) and (p. xxix)
placed placed with language to reflect species-dependent testing Enterobacteriaceae
5: on of M100 of on N. gonorrhoeae N. Enterobacteriaceae Enterobacteriaceae M100, 28th ed., published in 2018. The major changes in M100, general formatting and to some of the table footnotes and comments. Changes to Neisseria gonorrhoeae (p. xxx) xxx) (p. aureus Staphylococcus Stenotrophomonas maltophilia and Stenotrophomonas
spp. (p. xxx) spp. (p. xxx)
(p. xxx), . spp Enterococcus ffusion and MIC breakpoints for ffusion SAMPLE
Acinetobacter xxx), Acinetobacter (p. iological Cutoff Value Additions/Revisions Since 201 azithromycin epidemiological cutoff value (ECV) for epidemiological azithromycin Coagulase-negative staphylococci (CoNS) designation removed in Surrogate Agent Tests table (for cefoxitin testing only), in Ta 1A, 2C, and 3E, recommendation and in direct references to these tables and re CoNS designation retained in all other locations for this editi for this CoNS designation retained in all other locations Meropenem-vaborbactam disk di Meropenem-vaborbactam aeruginosa Azithromycin for susceptible-only MIC breakpoint Cefiderocol investigational minimal inhibitory concentration (MIC) breakpoints for Ciprofloxacin disk diffusion and MIC breakpoints for and MIC breakpoints disk diffusion Ciprofloxacin Levofloxacin disk diffusion and MIC breakpoints for disk diffusion Levofloxacin
Ceftaroline disk diffusion and MIC breakpoints for MIC breakpoints for Ceftaroline disk diffusion and MIC breakpoints for Daptomycin
Terminology: Terminology: o Updated the Web address for the archived table of breakpoints eliminated from M100 since 2010 (p. xxxii) (p. xxxii) from2010 M100 since eliminated Updated the Web address for the archived table of breakpoints o Deleted o o Added: o Revised: o o o o
General: General: CLSI Archived Resources: CLSI Breakpoint Additions/Revisions Since 2010: CLSI Breakpoint Additions/Revisions Since 2010: CLSI Epidem
Overview of Changes M100, 29th ed. replaces the previous edition of the supplement, listed below. Other minor or editorial changes were made to the unless otherwise noted a type.The following are additions or changes the tables since previous edition appear in boldface
xiv M100, 29th ed. MICs n (p. 4) n (p. 4) Overview of Changes Overview Acinetobacter baumannii baumannii Acinetobacter and P. aeruginosa, P. aeruginosa,
which provides revised and restated guidance for reporting MIC s Enterobacteriaceae, regarding overcalling of resistance when testing for oxacillin nt Agent Testing to Determine Susceptibility and Resistance to spp. (p. 18) NOTE section, revised the susceptible-dose dependent (SDD) definitio dependent the susceptible-dose revised section, in the list of organisms for testing cefazolin testing for (p. 12) organisms list of in the
MIC Reporting Concentrations, SAMPLE Klebsiella pneumoniae table:
spp. to spp. to section, added
Ceftazidime-avibactam (p. 18) 18) (p. Ceftazidime-avibactam 18) (p. Ceftolozane-tazobactam Piperacillin-tazobactam (p. 18) Ceftazidime-avibactam (p. 18) 18) (p. Ceftazidime-avibactam 18) (p. Ceftolozane-tazobactam
Changed Revised the list of organisms for testing cefoxitin and the complex (p. 12) (p. 12) (p. 12) Added colistin as a surrogate for polymyxin B when testing 18) (p. B group to meropenem-vaborbactam Added Relocated to its own box: . . . Relocated to its own box: Relocated to its own box: . . Reporting Reporting Results Breakpoint and Interpretive Category Interpretive and Breakpoint Definitions Surrogate Agent Tests Agent Surrogate
In In In In 7) (p. only) 7 Table in ed. 28th M100, in listed (previously o o In In o Enterobacteriaceae: o o aeruginosa: Pseudomonas o for MIC testing Revised the footnote regarding
Instructions for Use of Tables: Routine, Supplemental, Screening, Surrogate Agent, and Equivale Antimicrobial Agents: Table 1A. Suggested Groupings of Antimicrobial Agents Approved by the US Food and Drug States: United the in Microbiology by Laboratories Organisms Should Be Considered for Testing and Reporting on Nonfastidious Administration for Clinical Use That
Overview of Changes (Continued)
xv M100, 29th ed. ) Overview of Changes Overview urinary tract isolates only
E. coli E. spp. (p. 31) Parabacteroides spp. (p.
openem-vaborbactam (p. 33) openem-vaborbactam box in group C (p. 25) 25) C (p. group in box spp. and and Bacteroides spp.
group column heading to “Gram-Negative Anaerobes” (p. 30) group column fosfomycin fosfomycin testing recommendations and breakpoints are for
that SAMPLE group to B. fragilis group to from Bacteroides fragilis Bacteroides
spp. β-hemolytic group: spp. β-hemolytic group: disk diffusion and MIC breakpoints for norfloxacin MIC breakpoints for norfloxacin disk diffusion and Added azithromycin to group A (p. 24) 24) A (p. to group Added azithromycin Relocated dalbavancin, oritavancin, and telavancin to a single and telavancin Relocated dalbavancin, oritavancin, Nomenclature in the Nomenclature in NOTE 2 Nomenclature Instructions for performing MIC testing for ceftazidime-avibactam with specific disk diffusion zone diameters (p. 33) zone diameters (p. 33) specificwith disk diffusion ceftazidime-avibactam for MIC testing performing Instructions for Disk diffusion and MIC breakpoints and a dosage regimen for mer and and MIC breakpoints Disk diffusion Investigational MIC breakpoints, a dosage regimen, and a comment regarding special media needed for testing cefiderocol (p. 36 special cefiderocol regarding for testing needed media regimen, and a comment MIC breakpoints, a dosage Investigational Ciprofloxacin disk diffusion and MIC breakpoints and added a dosage regimen for the revised breakpoints (p. 38) 38) added a dosage and regimen for the revised breakpoints (p. and MIC breakpoints disk diffusion Ciprofloxacin 38) added a dosage regimen for the revised breakpoints (p. and MIC breakpoints disk diffusion Levofloxacin
(p. 40) (p. 40) N. gonorrhoeae: N. o Deleted Added dirithromycin to general footnote (a) (p. 24) (a) (p. 24) footnote to general Added dirithromycin Streptococcus o Updated: o o
Added: o o o Clarified carbapenems 37) (p. carbapenems section comment Clarified Revised: o o Reinforced the reporting comments
Table 1B. Suggested Groupings of Antimicrobial Agents Approved by the US Food and in the United States: Drug Laboratories by Microbiology Organisms Fastidious on and Reporting Testing for Be Considered Should Administration for Clinical Use That –
Table 1C. Suggested Groupings of Antimicrobial Agents Approved by the US Food and Drug in the United States: Laboratories Should Be Considered for Testing and Reporting on Anaerobic Org anisms by Microbiology Administration for Clinical Use That Table 2A. Diameter and MIC Breakpoints for Enterobacteriaceae: Zone – – –
Overview of Changes (Continued)
xvi M100, 29th ed. ) ) Overview of Changes Overview baumannii complex (ie, colistin A. spp. (p. 59) 59) Staphylococcus spp. (p.
g and reporting polymyxin B for spp.: spp.: illin resistance for specific ac
spp. with each agent with each Staphylococcus spp. Pseudomonas aeruginosa: Acinetobacter Stenotrophomonas maltophilia:
mments section: section: mments disk diffusion and MIC breakpoints for norfloxacin MIC breakpoints for norfloxacin disk diffusion and
MIC breakpoints for norfloxacin norfloxacin MIC breakpoints for Investigational MIC breakpoints, a dosage regimen, and a comment regarding special media needed for testing cefiderocol (p. 43 (p. special cefiderocol regarding for testing needed media regimen, and a comment MIC breakpoints, a dosage Investigational Comment regarding the use of colistin as a surrogate for testing and reporting polymyxin B MICs) (p. 44) (ie, colistin MICs predict polymyxin B Ciprofloxacin disk diffusion and MIC breakpoints and added a dosage regimen for the revised breakpoints (p. 44) 44) added a dosage and regimen for the revised breakpoints (p. and MIC breakpoints disk diffusion Ciprofloxacin 44) added a dosage regimen for the revised breakpoints (p. and MIC breakpoints disk diffusion Levofloxacin 47 (p. special cefiderocol regarding for testing needed media regimen, and a comment MIC breakpoints, a dosage Investigational MICs predict polymyxin B MICs) (p. 48) B MICs predict polymyxin Comment regarding the use of colistin as a surrogate for testin Added a column listing the indications for specific listing the indications for Added a column Revised the comments regarding reporting oxacillin resistance results (p. 59) (p. 59) oxacillin resistance results Revised the comments regarding reporting Revised the table with the methods available for detecting o detecting for available Revised the table with methods
Added: o o Revised: o o Added: o Deleted o Deleted Added investigational MIC breakpoints, a dosage regimen, and a comment regarding special media needed for testing cefiderocol (p.needed 53) regarding special media comment dosage regimen, and a a MIC breakpoints, Added investigational General: o Co General o o
Table 2B-1. Zone DiameterZone and MIC Table 2B-1. Breakpoints for – DiameterZone and MIC Table 2B-2. Breakpoints for Table 2B-4. Zone DiameterZone and MIC Table 2B-4. Breakpoints for Non- Other for Breakpoints MIC 2B-5. Table Table 2C. Diameter and MIC Breakpoints for Staphylococcus Zone
Overview of Changes (Continued)
xvii M100, 29th ed.
70) 70) Overview of Changes Overview
S. aureus, S. lugdunensis, aureus, S. lugdunensis, S. Staphylococcus epidermidis [MRSA]) (p. 63) (p. 63) [MRSA]) spp. (except S. aureus mediated mediated resistance in that grow poorly on Mueller-Hinton agar or cation- Staphylococcus mecA- spp. spp. spp.: only (including methicillin-resistant only (including and Staphylococcus schleiferi ) (p. 62)
Staphylococcus lugdunensis Staphylococcus Staphylococcus
Haemophilus influenzae and Haemophilus parainfluenzae: and
(p. 62) S. aureus SAMPLE and MIC Breakpoints for
disk diffusion and MIC breakpoints for all disk diffusion and all disk diffusion and MIC breakpoints MIC breakpoints all disk diffusion and
Comment regarding the reliability of cefoxitin MIC testing for detecting (p. 62) epidermidis S. for specific Breakpoints S. epidermidis, Staphylococcus pseudintermedius, S. epidermidis, Staphylococcus The testing comment regarding adjusted Mueller-Hinton broth (p. 61) 61) (p. adjusted Mueller-Hinton broth The testing comment regarding overcalling oxacillin resistance for other disk diffusion and MIC breakpoints for telithromycin MIC breakpoints for telithromycin disk diffusion and disk diffusion and MIC breakpoints for norfloxacin MIC breakpoints for norfloxacin disk diffusion and Zone DiameterZone
Deleted . . . . Deleted Added: Revised zone diameter and MIC breakpoints for S. aureus
(p. 63) (p. 63) regimen dosage and appropriate Added SDD interpretive category Revised:
Telithromycin: Telithromycin: Revised the comment providing additional guidance on results interpretation for tetracyclines (p. 76) guidance on results interpretation Revised the comment providing additional Ceftaroline: Norfloxacin o Deleted Deleted
Revised susceptible MIC breakpoint and added SDD and resistant interpretive categories and dosage regimens for daptomycin (p. regimens for daptomycin added SDD and resistant interpretive categories dosage and Revised susceptible MIC breakpoint Oxacillin: o o o o o
– – Table 2E. – Table 2D. Diameter and MIC Breakpoints for Enterococcus Zone – –
Overview of Changes (Continued)
xviii M100, 29th ed.
Overview of Changes Overview
and Pseudomonas aeruginosa: spp. throughout the table and comments the table Parabacteroides spp. throughout spp. and and spp. spp. β-Hemolytic Group: Enterobacteriaceae
Streptococcus Streptococcus spp. Viridans Group: Streptococcus pneumoniae: Neisseriagonorrhoeae:
group to Bacteroides group
SAMPLE Bacteroides fragilis
and MIC Breakpoints for disk diffusion and MIC breakpoints for telithromycin disk diffusion and
disk diffusion and MIC breakpoints for: MIC breakpoints for: disk diffusion and Cefuroxime Cefmetazole Ceftazidime Cefetamet Enoxacin Fleroxacin Lomefloxacin Ofloxacin Comment providing additional guidance on results interpretation for tetracyclines (p. 90) 90) tetracyclines (p. for on results interpretation guidance additional Comment providing Comment clarifying viridans streptococcal groups for which dalbavancin testing is appropriate (p. 93) (p. 93) is appropriate which dalbavancin testing Comment streptococcal groups for clarifying viridans Comment providing additional guidance on results interpretation for tetracyclines (p. 94) 94) tetracyclines (p. for on results interpretation guidance additional Comment providing
Deleted o o o o o o o o Revised: o Added a susceptible-only MIC breakpoint and dosage regimen comment (p. 80) for azithromycin regimen MIC breakpoint and dosage Added a susceptible-only Revised the comment providing additional guidance on results interpretation for tetracyclines (p. 85) guidance on results interpretation Revised the comment providing additional Updated nomenclature from 101) and penicillin (p. resistance to ampicillin Revised the comment regarding intrinsic (p. 108) described in M100-S20 carbapenems use of MIC breakpoints for Revised the paragraph regarding Deleted Revised: o o
– Table 2G. Diameter and MIC Breakpoints for Zone Table 2H-1. Zone Diameter and MIC Breakpoints for Table 2F. Zone DiameterTable 2F. Zone – Table 2H-2. Zone Diameter and MIC Breakpoints for – Introduction to Tables 3B and 3C. Tests for Carbapenemases for Tests in 3C. and 3B Tables to Introduction Table 2J. MIC Breakpoints for Anaerobes: Table 2J. MIC
Overview of Changes (Continued)
xix M100, 29th ed. (p. 151) (p. 151)
Overview of Changes Overview )
25923 with linezolid (p. 151) (p. linezolid with 25923 S. schleiferi ® and spp.: ATCC S. aureus or or S. pseudintermedius
n with imipenem and tebipenem QC strai n with imipenem as a supplemental 700603 ® 27853 QC ranges for tebipenem (p. 152) for tebipenem QC ranges 27853
® spp. (excluding ATCC SAMPLE ATCC pneumoniae K. s and β-Lactam Combination Agents: Agents: Combination Organism β-Lactam and s Nonfastidious for nges Staphylococcus P. aeruginosa 27853 27853
® 25922 and and 25922 25922 ATCC ® ® NCTC 13304 as a QC strain NCTC 13304
Cefepime-zidebactam Imipenem-relebactam Cefepime-zidebactam Imipenem-relebactam all QC ranges for:
A. baumannii (p. 154) to establish QC ranges for imipenem-relebactam single a from manufacturer data disk of use regarding Footnote E. coli ATCC
. . Footnote with recommendations for reading zones of inhibition f recommendations inhibition Footnote with for reading zones of Methicillin Mezlocillin Norfloxacin . . E. coli ATCC P. aeruginosa Table title and first column heading other CoNS designation to Footnote regarding the use of the Footnote regarding
Added: o o Added QC ranges for: o
o o o o Deleted o
o Revised: o o Added: o
– – Table 4A-2. Disk Diffusion QC Ra Table 3E. Test for Detecting Methicillin (Oxacillin) Resistance in Staphylococcus Table 3E. Test for Detecting Methicillin (Oxacillin) Resistance –
Table Table 4A-1. Disk Diffusion QC Ranges for Nonfastidious Agents: Organisms and Antimicrobial Agents Excluding β-Lactam Combination –
Overview of Changes (Continued)
xx M100, 29th ed. Overview of Changes Overview (p. 164) (p. 164) 164, 166) 166) 164,
SAMPLE 49226 QC ranges for azithromycin and gepotidacin QC ranges for and gepotidacin azithromycin 49226 ® 700603 700603 BAA-1705™ BAA-2814™ ® ® ®
ATCC ATCC ATCC ATCC NCTC 13304 NCTC 13304
Cefepime Cefepime-zidebactam Imipenem Imipenem-relebactam Cefepime Cefepime-zidebactam Imipenem Imipenem-relebactam Imipenem Imipenem-relebactam Cefepime Cefepime-zidebactam all QC ranges for norfloxacin single-agent rows for β-lactam antimicrobial agents and replaced with troubleshooting recommendations for β-lactam N. gonorrhoeae N.
. . . . 13353 NCTC E. coli . A. baumannii . . K. pneumoniae K. pneumoniae K. pneumoniae
o o o o o Added Added Deleted for cefepime and imipenem recommendations Added troubleshooting Deleted agents combination Revised general comment agent observations (pp. (1) and various
Table 4B. Disk Diffusion QC Ranges for QC Ranges Diffusion 4B. Disk Table Organisms:Fastidious Table 4D. Disk Diffusion Troubleshooting Guide:
Overview of Changes (Continued)
xxi M100, 29th ed. Overview of Changes Overview
700603: 700603: 27853 QC ranges for meropenem QC ranges 27853 for ciprofloxacin QC range 27853 27853: ®
® ® ® ATCC 25922: 25922: 35218: ATCC ATCC ATCC ® ®
all QC ranges for: Meropenem-nacubactam Meropenem-nacubactam Nacubactam Cefpodoxime Cefpodoxime Cefpodoxime Meropenem-nacubactam Meropenem-nacubactam Nacubactam Cefpodoxime
Methicillin Mezlocillin Norfloxacin . . E. coli ATCC . E. coli NCTC 13353: . . K. pneumoniae . . P. aeruginosa QC ranges forQC ranges tebipenem E. coli ATCC P. aeruginosa Footnote regarding special media required for testing cefideroc Footnote P. aeruginosa
o o o o o o o Deleted o Added QC ranges for: o Added: o Revised: o o
Table 5A-2. MIC QC Ranges for Nonfastidious Organisms and β-Lac tam MIC QC Ranges for Nonfastidious Organisms CombinationTable 5A-2. Agents: Table 5A-1. MIC QC Ranges for Nonfastidious Organisms and Antimicrobial Agents Excluding β-Lactam Combination Agents: and Antimicrobial Agents Excluding β-Lactam Combination Agents: MIC QC Ranges for Nonfastidious Organisms Table 5A-1.
Overview of Changes (Continued)
xxii M100, 29th ed. Overview of Changes Overview 190) 190) f Antimicrobial Agents:
ATCC 35218 35218 ® all QC ranges for norfloxacin solvent and diluent information for: information solvent and diluent
Meropenem-nacubactam Meropenem-nacubactam Nacubactam Cefepime Cefepime single-agent rows for β-lactam antimicrobial agents and replaced with troubleshooting recommendations for combination all QC ranges for mezlocillin : (Broth Dilution Methods) Organisms for Fastidious Ranges MIC QC
. . . K. pneumoniae E. coli ATCC . NCTC 13353 E. coli NCTC Nacubactam Tebipenem Zidebactam Methicillin Mezlocillin Norfloxacin
o Revised general comment agent observations (p. (1) and various Deleted Revised QC rangesRevised for: o Deleted Deleted
o Added solvent and diluent information for: information and diluent Added solvent o o o Deleted o o o β-lactam agents β-lactam
– – Table 5D. MIC QC Ranges for Anaerobes (Agar Dilution Method): Table 5D. MIC QC Ranges for Anaerobes – Table 5G. MIC Troubleshooting Guide: Guide: Troubleshooting MIC 5G. Table – Table 6A. Solvents and Diluents for Preparing Stock Solutions o and Diluents for Preparing Stock Solutions Table 6A. Solvents Table 5B.
Overview of Changes (Continued)
xxiii M100, 29th ed. / d A. baumannii Overview of Changes Overview (p. 213) (p. 213) may have activity against isolates in
spp. (p. 215) Parabacteroides spp. (p. 215) N. gonorrhoeae complex (p. 221) (p. 221) complex row with same “R” results spp. and and spp. or Nonsusceptible Antimicrobial Susceptibility Test Results an row with same “R” results and a footnote listing the species included in
complex: B. cepacia complex: to the K. pneumoniae to group to Bacteroides group Citrobacter koseri group to the SAMPLE
Klebsiella variicola Klebsiella BAA-2146™ (p. 227) BAA-2146™ (p. 227) ®
Bacteroides fragilis (p. 219): ATCC complex complex spp., with a footnote listing the species included in this gro up species included in this listing the spp., with a footnote me me “R” results for the following agents for “R” results for the following agents the footnote for ampicillin-sulbactam that suggested sulbactam Enterobactericeae: Ceftriaxone Ceftriaxone Imipenem Piperacillin-tazobactam Trimethoprim Citrobacter amalonaticus this group and oxytoca Klebsiella Raoultella Aminoglycosides Aminoglycosides Aztreonam Cefepime Cefotaxi K. pneumoniae
. . . . Added: . . . Deleted Added a footnote regarding intrinsic resistance in Burkholderia cepacia resistance intrinsic regarding a footnote Added . . . . A. calcoaceticus
Added preparation instructions for meropenem-nacubactam Added preparation instructions for meropenem-nacubactam Added B1. Enterobacteriaceae Added azithromycin nonsusceptible (NS) for resistance phenotype detected to (NS) for resistance phenotype nonsusceptible Added azithromycin Updated nomenclature from Updated nomenclature from o B2. Non- o o o
Table 6C. Preparing Solutions and Media Containing Combinations of Antimicrobial Agents: CombinationsAntimicrobial of and Media Containing Table 6C. Preparing Solutions
Appendix C. QC Strains for Antimicrobial Susceptibility Tests: Appendix A. Suggestions for Confirming Resistant, Intermediate, Appendix B. Intrinsic Resistance: Organism Identification:
Overview of Changes (Continued)
xxiv M100, 29th ed.
S. aureus Overview of Changes Overview Enterobacteriaceae (p. 234) 234) (p. acnes )
spp. throughout Appendix D D Appendix Parabacteroides spp. throughout and . (formerly Propionibacterium (formerly and Carbapenemase Molecular Tests for and with all six species and all and agents species six all with and ebsite only: sceptible-Dose Dependent Breakpoints: and with all six species agents Bacteroides spp Parabacteroides spp.: Parabacteroides Cutibacterium and . group to group B. fragilis fragilis B. spp
); Table G3 (ECVs for Specific Anaerobic Species) is now Table G2 Species)now is Anaerobic Specific for (ECVs G3 Table );
Bacteroides group without B. fragilis
Bacteroides fragilis Bacteroides Values: SAMPLE gonorrhoeae
spp. spp. Parabacteroides spp.:
group without fragilis group Bacteroides Enterococcus spp. and rows fragilis for Bacteroides rows for
Table G2 (ECVs for N. Table H1. Strategies for Reporting Methicillin (Oxacillin) Results When Using Molecular and Phenotypic AST Methods for Methods for Phenotypic AST and When Using Molecular Results (Oxacillin) Methicillin Table H1. Strategies for Reporting Updated the nomenclature from from Updated the nomenclature Table H2. Strategies for Reporting Vancomycin Results When Using Molecular and Phenotypic Antim icrobial Susceptibility Testing Methods for β-Lactamase Extended-Spectrum From Results Reporting H3. Table Deleted Deleted Added footnote regarding antibiogram data collection for regarding antibiogram Added footnote 238–239) (pp. Cefiderocol 238–239) (pp. Ciprofloxacin (pp. 238–239) Levofloxacin (pp. 238–239) Meropenem-vaborbactam Ceftaroline (p. 239) 240) Daptomycin (p.
Added a comment in Table G1 regarding the use of colistin as a surrogate for testing and reporting polymyxin B (p. 249) B (p. 249) polymyxin surrogate for testing and reporting as a the use of colistin Added a comment in Table G1 regarding Deleted Added new appendix with tables previously located on the CLSI w tables previously located on with Added new appendix o General: o o o D1. Bacteroides o D2. Anaerobic Organisms Other Than o o for: breakpoints used to establish susceptible and/or SDD Added dosage regimens o o o o o o Revised to provide recommendations for all antimicrobial agents with SDD interpretive categories agents Revised to provide recommendations for all antimicrobial
– Resistance for Assays Detection: Molecular H. Using Appendix Appendix D. Cumulative Antimicrobial Susceptibility Report for Anaerobic Organisms: – – Appendix E. Dosage Regimens Regimens E. Dosage Appendix toUsed or Susceptible Establish Su Appendix F. Susceptible-Dose Dependent Interpretive Category: – Appendix G. Epidemiological Cutoff
Overview of Changes (Continued)
xxv M100, 29th ed. le Overview of Changes Overview
process and does not necessarily reflect the views of any sing ions and Generic Name: SAMPLE norfloxacin SC row because methicillin is no longer available, negating the use of an abbreviation for two agents abbreviation for two agents an use of SC row because methicillin is no longer available, negating the Meropenem-nacubactam Meropenem-nacubactam Tebipenem Methicillin Mezlocillin
Abbreviation for imipenem-relebactam Abbreviation for imipenem-relebactam Meropenem-nacubactam Tebipenem Methicillin Mezlocillin Norfloxacin
The content of this document is supported by the CLSI consensus Added: o o Deleted: o o Deleted Added: o o o Deleted: o o o Deleted
Glossary I (Part 1). β-Lactams: Class and Subclass Designations and Generic Name: Designations Class and Subclass β-Lactams: 1). I (Part Glossary Glossary I (Part 2). Non–β-Lactams: Class and Subclass Designat Glossary I (Part 2). Non–β-Lactams: – Class: and Drug II. Glossary Administration, of Route(s) Abbreviation(s), Antimicrobial Agent Glossary III. Than for More Used List of Identical A bbreviations One Antimicrobial Agent in US Diagnostic Products: –
Overview of Changes (Continued)
NOTE: individual or organization. organization. or individual
xxvi For Use With M02 and M07 M100, 29th ed. d in
tation with the of proven efficacy that show gent/organism combinationsgent/organism for infection control purposes. control infection for sidered for testing and reporting by microbiology in specific organisms or organism groups organisms or organism in specific ) 2 oints ctive organism group but would generally not warrant routine testing by generallyctive organism group but would warrant routine testing not and M07 and report is a decision best made by each laboratory in consul
cation for the respe
SAMPLE tables for each organism group that contain: that contain: group organism for each tables test performance. Considerations in the assignment of agents t o specific test/report groups include clinical efficacy, tables containing specific recommendations for testing and reporting results on anaerobes and some of the information in vitro in
General comments for testing the organism group and specific comments for testing particular a specific comments for testing particular group and General comments for testing the organism Suggested agents that should be considered for routine testing and reporting by medical microbiology laboratories, as specifie Recommended testing conditions Recommended testing conditions Routine QC recommendations M02 QC in see 4 Routine (also Chapter Tables 1A and 1B (test/report groups A, B, C, U) groups A, 1B (test/report 1A and Tables that have an approved indi Additional drugs a medical microbiology laboratory in the United States (test/report group yet FDA approved]) [not O for “other”; test/report group Inv. for “investigational” breakp (MIC) concentration inhibitory minimal and diameter Zone acceptable prevalence prevalence of resistance, recommendations for first-choice and alternative drugs. Tests on selected agents may be useful minimizing emergence of resistance, cost, FDA clinical indications for use, and current consensus infectious diseases and pharmacy practitioners, the pharmacy and therapeutics and infection control committees of the medical staff, and the antimicrobial stewardship team. The recommendations for eac h organism group include agents
– – laboratories. These guidelines are based on antimicrobial approvedagents by the US Food and Drug Administration (FDA) for clinical use in the United States. In other countries, regulatory organizations. clinical use by relevant approved for placement of antimicrobial agents in Tables 1A and 1B should be based on available drugs Tables Tables 1A and 1B: suggested groupings of antimicrobial agents that should be con Tables 2A through 2I: – – – – Tables 1C and 2J: above listed in the bullets to det ect particular resistance tests describing Tables 3A to 3I: tables types
These instructions apply to: Instructions for Use of Tables I. A. Selecting AntimicrobialTesting for Agents Reporting and Selecting the most appropriate antimicrobial agents to test
©Clinical and Laboratory Standards Institute. All rights reserved. 1 M100, 29th ed. For Use With M02 and M07 mic or iaxone iaxone sted (see combined combined or urinary ion to this also used for lure to respond to and ciprofloxacin). and ciprofloxacin). Salmonella spp.); or for reporting to Enterococcus trimethoprim-sulfamethoxazole f trimethoprim-sulfamethoxazole for oral cephalosporins. Other antimicrobial -lactams); for treatment of patients allergic to may testingnecessitate those in institutions that harbor ende ndicates ndicates agents for which -resistance cross and cross-susceptibi lity are , as in group A. Other indications for reporting the result might include a nterpretive categories (susceptible, intermediate, or resistant ) and clinical poses. g multiple sites; cases of patient allergy, intolerance, or fai ific organism groups. groups. ific organism In addition, to qualify for an “or,” at least 100 strains with resistance to the agents in e considered susceptible to ceftriaxone. The results obtained from testing cefotaxime
inst inst organisms for which “susceptible-only” breakpoints are provided (eg, cefotaxime or ceftr as listed in Tables 1A, 1B, and 1C, are considered appropriate for inclusion in a routine, primary testing SAMPLE in Table 1A, in which cefazolin is listed as a surrogate agent several several of the primary drugs (especially in the same class, eg, for description of error types). 4 includes antimicrobial agents that have a clinical indication for the organism group but are generally not candidates susceptible to cefotaxime can b ). When no “or” connects agents within a box, testing of one agent cannot be used to predict results for another, owing Enterobacteriaceae includes antimicrobial agents that may warrant primary testing, but they may be reported only selectively, such as when the includes alternative or supplemental antimicrobial agents that agents antimicrobial includes alternative or supplemental H. influenzae major and very major errors are fewer than 3%, and minor errors are fewer than 10%, based on a large population of bacteria te CLSI document M23 efficacy are similar. Within each box, an “or” between agents i could be reported along with a comment that the isolate is also susceptible to ceftriaxone. For drugs connected with an “or,” Group C nearly complete. Results from one Enterobacteriaceae agent connected by an “or” can be used to predict results for the other agent. For example, Group U (“urine”) includes certain antimicrobial agents (eg, nitrofurantoin and certain quinolones) that treating are UTIs. These used agents should only not be or routinely reported primarily against pathogens for recovered from other infection sites. An except epidemic epidemic strains resistant to primary drugs; for treatment of unusual organisms (eg, chloramphenicol for extraintestinal isolates of aid. as an epidemiological infection control with either to discrepancies or insufficient data. comparable agents when tested aga Group A antimicrobial agents, question question must be tested, and a result of “resistant” must be obtained with all agents for at least 95% of the strains. “Or” is an antimicrobial agent in group A; or for infection control pur infection control A; or for agent in group an antimicrobial tract isolates); a polymicrobial infection; infections involvin rule is for Group O (“other”) States. United the in testing and reporting for routine panel, as well as for routine reporting of results for the spec of results reporting panel, as well as for routine Group Group B organism is resistant to agents of the same antimicrobial class selected specimen source (eg, a third-generation cephalosporin for enteric bacilli from CSF or agents with broader indications may be included in group U for specific urinary pathogens (eg, urinarypathogens (eg, U for specific group be included in agents with broader indications may 3. 4. B. Drugs listed together in a single box are agents for which i C. Test/Report Groups 1.
2 ©Clinical and Laboratory Standards Institute. All rights reserved. M100, 29th ed. For Use With M02 and M07
m,* m,* Table 1B Table Viridans Group Streptococcus M02 and M07 Cefepime Cefotaxime Ceftriaxone Vancomycin Vancomycin Penicillin Ampicillin Suggested Fastidious Groupings Fastidious Suggested
c,o † or n, n,† Streptococcus β-Hemolytic Group ampicillin Vancomycin Vancomycin Cefepime or or cefotaxime ceftriaxone Clindamycin Penicillin
j j c k b k,* k,* k,*
* k pneumoniae Streptococcus (oxacillin disk) disk) (oxacillin sulfamethoxazole Ceftriaxone Tetracycline Cefepime Clindamycin Doxycycline Meropenem Vancomycin Cefotaxime Moxifloxacin Levofloxacin Erythromycin Trimethoprim- Penicillin