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M02-A10 Vol. 29 No. 1 Replaces M02-A9 January 2009 Vol. 26 No. 1 Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard—Tenth Edition This document contains the current Clinical and Laboratory Standards Institute- recommended methods for disk susceptibility testing, criteria for quality control testing, and updated tables for interpretive zone diameters. A standard for global application developed through the Clinical and Laboratory Standards Institute consensus process. Licensed to: Alejandra Corso This document is protected by copyright. CLSI order # 60040, id # 478160, Downloaded on 1/13/2009. Clinical and Laboratory Standards Institute Advancing Quality in Health Care Testing Clinical and Laboratory Standards Institute (CLSI, Most documents are subject to two levels of consensus— formerly NCCLS) is an international, interdisciplinary, “proposed” and “approved.” Depending on the need for nonprofit, standards-developing, and educational field evaluation or data collection, documents may also be organization that promotes the development and use of made available for review at an intermediate consensus voluntary consensus standards and guidelines within the level. health care community. It is recognized worldwide for Proposed A consensus document undergoes the first stage the application of its unique consensus process in the of review by the health care community as a proposed development of standards and guidelines for patient standard or guideline. The document should receive a wide testing and related health care issues. Our process is and thorough technical review, including an overall review based on the principle that consensus is an effective and of its scope, approach, and utility, and a line-by-line review cost-effective way to improve patient testing and health of its technical and editorial content. care services. Approved An approved standard or guideline has achieved In addition to developing and promoting the use of consensus within the health care community. It should be voluntary consensus standards and guidelines, we reviewed to assess the utility of the final document, to provide an open and unbiased forum to address critical ensure attainment of consensus (ie, that comments on earlier issues affecting the quality of patient testing and health versions have been satisfactorily addressed), and to identify care. the need for additional consensus documents. PUBLICATIONS Our standards and guidelines represent a consensus opinion A document is published as a standard, guideline, or on good practices and reflect the substantial agreement by committee report. materially affected, competent, and interested parties obtained by following CLSI’s established consensus Standard A document developed through the consensus procedures. Provisions in CLSI standards and guidelines process that clearly identifies specific, essential may be more or less stringent than applicable regulations. requirements for materials, methods, or practices for use Consequently, conformance to this voluntary consensus in an unmodified form. A standard may, in addition, document does not relieve the user of responsibility for contain discretionary elements, which are clearly compliance with applicable regulations. identified. COMMENTS Guideline A document developed through the consensus process describing criteria for a general operating The comments of users are essential to the consensus practice, procedure, or material for voluntary use. A process. Anyone may submit a comment, and all comments guideline may be used as written or modified by the user are addressed, according to the consensus process, by the to fit specific needs. committee that wrote the document. All comments, including those that result in a change to the document when Report A document that has not been subjected to published at the next consensus level and those that do not consensus review and is released by the Board of result in a change, are responded to by the committee in an Directors. appendix to the document. Readers are strongly encouraged CONSENSUS PROCESS to comment in any form and at any time on any document. Address comments to Clinical and Laboratory Standards The CLSI voluntary consensus process is a protocol Institute, 940 West Valley Road, Suite 1400, Wayne, PA establishing formal criteria for: 19087, USA. • the authorization of a project VOLUNTEER PARTICIPATION • the development and open review of documents Health care professionals in all specialties are urged to volunteer for participation in CLSI projects. Please contact • the revision of documents in response to comments us at [email protected] or +610.688.0100 for by users additional information on committee participation. • the acceptance of a document as a consensus standard or guideline. M02-A10 ISBN 1-56238-688-3 Volume 29 Number 1 ISSN 0273-3099 Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard—Tenth Edition Matthew A. Wikler, MD, MBA, FIDSA Janet F. Hindler, MCLS, MT(ASCP) Franklin R. Cockerill, III, MD Jean B. Patel, PhD, D(ABMM) Karen Bush, PhD Mair Powell, MD, FRCP, FRCPath Michael N. Dudley, PharmD John D. Turnidge, MD George M. Eliopoulos, MD Melvin P. Weinstein, MD Dwight J. Hardy, PhD Barbara L. Zimmer, PhD David W. Hecht, MD Mary Jane Ferraro, PhD, MPH Jana M. Swenson, MMSc Abstract Susceptibility testing is indicated for any organism that contributes to an infectious process warranting antimicrobial chemotherapy, if its susceptibility cannot be reliably predicted from knowledge of the organism’s identity. Susceptibility tests are most often indicated when the causative organism is thought to belong to a species capable of exhibiting resistance to commonly used antimicrobial agents. A variety of laboratory methods can be used to measure the in vitro susceptibility of bacteria to antimicrobial agents. In many clinical microbiology laboratories, an agar disk diffusion method is used routinely for testing common, rapidly growing, and certain fastidious bacterial pathogens. Clinical and Laboratory Standards Institute document M02-A10—Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard—Tenth Edition includes a series of procedures to standardize the way disk diffusion tests are performed. The performance, applications, and limitations of the current CLSI-recommended methods are also described. The supplemental information (M100 tables) presented with this standard represents the most current information for drug selection, interpretation, and quality control using the procedures standardized in M02. These tables, as in previous years, have been updated and should replace tables published in earlier years. Changes in the tables since the previous edition (M100-S18) appear in boldface type and are also summarized in the front of the document. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard—Tenth Edition. CLSI document M02-A10 (ISBN 1-56238-688-3). Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2009. Number 1 M02-A10 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/NCCLS documents. Current editions are listed in the CLSI catalog and posted on our website at www.clsi.org. If your organization is not a member and would like to become one, and to request a copy of the catalog, contact us at: Telephone: 610.688.0100; Fax: 610.688.0700; E-Mail: [email protected]; Website: www.clsi.org Copyright ©2009 Clinical and Laboratory Standards Institute. Except as stated below, neither this publication nor any portion thereof may be adapted, copied, or otherwise reproduced, by any means (electronic, mechanical, photocopying, recording, or otherwise) without prior written permission from Clinical and Laboratory Standards Institute (“CLSI”). CLSI hereby grants permission to each individual member or purchaser to make a single reproduction of this publication for use in its laboratory procedure manual at a single site. To request permission to use this publication in any other manner, contact the Executive Vice President, Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898, USA. Suggested Citation (CLSI. Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard—Tenth Edition. CLSI document M02-A10. Wayne, PA: Clinical and Laboratory Standards Institute; 2009.) Proposed Standard Approved Standard—Sixth Edition July 1975 January 1997 Tentative Standard Approved Standard—Seventh Edition October 1979 January 2000 Approved Standard Approved Standard—Eighth Edition December 1984 January 2003 Tentative Standard—Fourth Edition Approved Standard—Ninth Edition November 1988 January 2006 Approved Standard—Fourth Edition Approved Standard—Tenth Edition April 1990 January 2009 Approved Standard—Fifth Edition December 1993 ISBN 1-56238-688-3 ISSN 0273-3099 ii Volume 29 M02-A10 Committee Membership Area Committee on Microbiology Mary Jane Ferraro, PhD, MPH John D. Turnidge, MD Michael A. Pfaller, MD Chairholder Women’s and Children’s Hospital University of Iowa College of Massachusetts General Hospital North Adelaide, Australia Medicine Boston, Massachusetts Iowa City, Iowa Michael L. Wilson, MD John H. Rex, MD, FACP Denver Health Medical Center Robert P. Rennie, PhD Vice-Chairholder Denver, Colorado University of Alberta Hospital AstraZeneca Edmonton, Alberta, Canada Cheshire, United Kingdom Advisors Thomas R. Shryock, PhD Barbara Ann Body, PhD, Nancy L. Anderson, MMSc, Elanco Animal Health D(ABMM) MT(ASCP) Greenfield, Indiana Laboratory Corporation of America Centers for Disease Control and Burlington, North Carolina Prevention Jana M. Swenson, MMSc Atlanta, Georgia Centers for Disease Control and Betty (Betz) A. Forbes, PhD, Prevention D(ABMM) Ellen Jo Baron, PhD Atlanta, Georgia Medical College of Virginia Stanford Hospital and Clinics Campus Palo Alto, California Melvin P. Weinstein, MD Richmond, Virginia Robert Wood Johnson University Donald R. Callihan, PhD Hospital Freddie Mae Poole BD Diagnostic Systems New Brunswick, New Jersey FDA Center for Devices and Sparks, Maryland Radiological Health Matthew A. Wikler, MD, MBA, Rockville, Maryland Lynne S. Garcia, MS FIDSA LSG & Associates Pacific Beach BioSciences, Inc. Daniel F. Sahm, PhD Santa Monica, California San Diego, California Eurofins Medinet Herndon, Virginia Richard L. Hodinka, PhD Gail L. Woods, MD Children’s Hospital of Philadelphia Central Arkansas Veterans Fred C. Tenover, PhD, ABMM Philadelphia, Pennsylvania Healthcare System Cepheid Little Rock, Arkansas Sunnyvale, California James H. Jorgensen, PhD University of Texas Health Science Center San Antonio, Texas Subcommittee on Antimicrobial Susceptibility Testing Matthew A. Wikler, MD, MBA, George M. Eliopoulos, MD Jean B. Patel, PhD, D(ABMM) FIDSA Beth Israel Deaconess Medical Centers for Disease Control and Chairholder Center Prevention Pacific Beach BioSciences, Inc. Boston, Massachusetts Atlanta, Georgia San Diego, California Dwight J. Hardy, PhD Mair Powell, MD, FRCP, FRCPath Franklin R. Cockerill, III, MD University of Rochester Medical MHRA Vice-Chairholder Center London, United Kingdom Mayo Clinic/Mayo Foundation Rochester, New York Rochester, Minnesota John D. Turnidge, MD David W. Hecht, MD Women’s and Children’s Hospital Karen Bush, PhD Loyola University Medical Center North Adelaide, Australia Johnson & Johnson Pharmaceutical Maywood, Illinois Research Institute Melvin P. Weinstein, MD Raritan, New Jersey Janet F. Hindler, MCLS, Robert Wood Johnson Medical MT(ASCP) School Michael N. Dudley, PharmD UCLA Medical Center New Brunswick, New Jersey Mpex Pharmaceuticals Los Angeles, California San Diego, California iii Number 1 M02-A10 Members (continued) Yoichi Hirakata, MD, PhD Dale A. Schwab, PhD, D(ABMM) Tohoku University Graduate School Quest Diagnostics, Nichols Institute Barbara L. Zimmer, PhD of Medicine San Juan Capistrano, California Siemens Healthcare Diagnostics Sendai, Japan West Sacramento, California Daniel J. Sheehan, PhD Ronald N. Jones, MD Greenwich, Conneticut Advisors JMI Laboratories North Liberty, Iowa Jana M. Swenson, MMSc Paul G. Ambrose, PharmD, FIDSA Centers for Disease Control and ICPD/Orway Research Institute Gunnar Kahlmeter, MD, PhD Prevention Albany, New York ESCMID Atlanta, Georgia Växjö, Sweden Patricia A. Bradford, PhD George H. Talbot, MD Wyeth Research Frederic J. Marsik, PhD, ABMM Talbot Advisors LLC Pearl River, New York FDA Center for Drug Evaluation Wayne, Pennsylvania and Research Steven D. Brown, PhD Rockville, Maryland Fred C. Tenover, PhD, ABMM The Clinical Microbiology Institute Cepheid Wilsonville, Oregon John E. McGowan, Jr., MD Sunnyvale, California Emory University, Rollins School Karen Carroll, MD of Public Health Richard B. Thomson, Jr., PhD Johns Hopkins Medical Institutions Atlanta, Georgia Northwestern University, Feinberg Baltimore, Maryland School of Medicine Linda A. Miller, PhD Evanston, Illinois Edward M. Cox, Jr., MD, MPH GlaxoSmithKline FDA Center for Drug Evaluation Collegeville, Pennsylvania Fredricka Valentine, MS, and Research MT(ASCP)SM Rockville, Maryland Janice Pohlman, MD, MPH FDA Center for Devices and FDA Center for Drug Evaluation & Radiological Health William A. Craig, MD Research Rockville, Maryland University of Wisconsin Silver Spring, Maryland Madison, Wisconsin Sandra S. Richter, MD, D(ABMM) Cynthia L. Fowler, MD University of Iowa Carver College BioMérieux, Inc. of Medicine Durham, North Carolina Iowa City, Iowa Lawrence V. Friedrich, PharmD Flavia Rossi, MD Cubist Pharmaceuticals University of Sao Paulo Mt. Pleasant, South Carolina Sao Paulo, Brazil Text and Table Working Group Janet F. Hindler, MCLS, Susan D. Munro, MT(ASCP) Jana M. Swenson, MMSc MT(ASCP) Stanford Hospital and Clinics Chairholder UCLA Medical Center Palo Alto, California Centers for Disease Control and APHL Prevention Los Angeles, California Dale A. Schwab, PhD, D(ABMM) Atlanta, Georgia Quest Diagnostics, Nichols Institute Judy Johnston, MS San Juan Capistrano, California Donald R. Callihan, PhD Siemens Healthcare Diagnostics BD Diagnostic Systems West Sacramento, California Albert T. Sheldon, Jr., PhD Sparks, Maryland Antibiotic & Antiseptic Consultants Ronald N. Jones, MD Cypress, Texas Franklin R. Cockerill, III, MD JMI Laboratories Mayo Clinic and Mayo College of North Liberty, Iowa Richard B. Thomson, Jr., PhD Medicine Northwestern University Feinberg Rochester, Minnesota Dyan Luper, BS, MT(ASCP)SM School of Medicine BD Diagnostic Systems Evanston, Illinois Sharon K. Cullen, BS, RAC Sparks, Maryland Siemens Healthcare Diagnostics Mary K. York, PhD, ABMM W. Sacramento, California Linda M. Mann, PhD, D(ABMM) MKY Microbiology Consulting Siemens Healthcare Diagnostics Walnut Creek, California West Sacramento, California iv Volume 29 M02-A10 Quality Control Working Group Steve Brown, PhD Michael D. Huband Paul E. Oefinger, PhD, D(ABMM) Co-Chairholder Pfizer Global R&D Covance Central Laboratory Institutes for Microbiology Groton, Connecticut Services Inc. Research Indianapolis, Indiana Franklin, Tennessee Ronald N. Jones, MD JMI Laboratories Jean Patel, PhD, D(ABMM) Sharon K. Cullen, BS, RAC North Liberty, Iowa Centers for Disease Control and Co-Chairholder Prevention Siemens Healthcare Diagnostics Ann Macone Atlanta, Georgia West Sacramento, California Paratek Pharmaceuticals, Inc. Boston, Massachusetts Robert P. Rennie, PhD William Brasso University of Alberta Hospital BD Diagnostic Systems Ross Mulder, MT(ASCP) Edmonton, Canada Sparks, Maryland BioMérieux, Inc. Hazelwood, Missouri Janet F. Hindler, MCLS, MT(ASCP) Susan D. Munro, MT(ASCP) UCLA Medical Center Stanford Hospital and Clinics APHL Palo Alto, California Los Angeles, California Staphylococcal Working Group Fred C. Tenover, PhD, ABMM Michael N. Dudley, PharmD, Maria M. Traczewski, BS, Chairholder FIDSA MT(ASCP) Cepheid Mpex Pharmaceuticals The Clinical Microbiology Institute Sunnyvale, California San Diego, California Wilsonville, Oregon Patricia A. Bradford, PhD George M. Eliopoulos, MD Melvin P. Weinstein, MD Wyeth Research Beth Israel Deaconess Medical Robert Wood Johnson University Pearl River, New Jersey Center Hospital Boston, Massachusetts New Brunswick, New Jersey Karen Bush, PhD Johnson & Johnson Pharmaceutical Daniel F. Sahm, PhD Research & Development, L.L.C. Eurofins Medinet Raritan, New Jersey Herndon, Virginia William A. Craig, MD Jana Swenson, MMSc University of Wisconsin Centers for Disease Control and Madison, Wisconsin Prevention Atlanta, Georgia Enterobacteriaceae Working Group Michael N. Dudley, PharmD, Ronald N. Jones, MD Melvin P. Weinstein, MD FIDSA JMI Laboratories Robert Wood Johnson University Chairholder North Liberty, Iowa Hospital Mpex Pharmaceuticals New Brunswick, New Jersey San Diego, California David Paterson, MD University of Pittsburgh Barbara L. Zimmer, PhD Paul G. Ambrose, PharmD, FIDSA Pittsburgh, Pennsylvania Siemens Healthcare Diagnostics ICPD/Ordway Research West Sacramento, California Albany, New York Jana Swenson, MMSc Centers for Disease Control and Karen Bush, PhD Prevention Johnson & Johnson Pharmaceutical Atlanta, Georgia Research & Development, L.L.C. Raritan, New Jersey Lauri D. Thrupp, MD Univ. of California Irvine Medical Ctr. William A. Craig, MD Orange, California University of Wisconsin Madison, Wisconsin v Number 1 M02-A10 Staff Clinical and Laboratory Standards Tracy A. Dooley, BS, MLT(ASCP) Institute Staff Liaison Wayne, Pennsylvania Melissa A. Lewis Lois M. Schmidt, DA Editor Vice President, Standards Development and Marketing vi Volume 29 M02-A10 Contents Abstract .................................................................................................................................................... i  Committee Membership ........................................................................................................................ iii  Foreword ................................................................................................................................................. x  Summary of Major Changes in This Document ..................................................................................... x  Summary of CLSI Processes for Establishing Interpretive Criteria and QC Ranges ......................... xiii  CLSI Reference Methods vs Commercial Methods and CLSI vs FDA Breakpoints (interpretive criteria) ............................................................................................................................ xiv  Subcommittee on Antimicrobial Susceptibility Testing Mission Statement ........................................ xv  1  Scope .......................................................................................................................................... 1  2  Introduction ................................................................................................................................ 1  3  Standard Precautions .................................................................................................................. 1  4  Terminology ............................................................................................................................... 2  4.1  Definitions .................................................................................................................... 2  4.2  Abbreviations/Acronyms .............................................................................................. 3  5  Indications for Performing Susceptibility Tests ......................................................................... 3  6  Selection of Antimicrobial Agents for Routine Testing and Reporting ..................................... 4  6.1  Routine Reports ............................................................................................................ 4  6.2  Nonproprietary Names .................................................................................................. 4  6.3  Selection Guidelines ..................................................................................................... 7  6.4  Suggested Guidelines for Routine and Selective Testing and Reporting ..................... 7  7  Reagents for the Disk Diffusion Test ......................................................................................... 8  7.1  Mueller-Hinton Agar .................................................................................................... 8  7.2  Testing Strains That Fail to Grow Satisfactorily .......................................................... 9  7.3  Antimicrobial Disks ...................................................................................................... 9  8  Inoculum Preparation for Disk Diffusion Tests ....................................................................... 10  8.1  Turbidity Standard for Inoculum Preparation ............................................................. 10  8.2  Inoculum Preparation .................................................................................................. 10  9  Procedure for Performing the Disk Diffusion Test .................................................................. 11  9.1  Inoculation of Test Plates............................................................................................ 11  9.2  Application of Disks to Inoculated Agar Plates .......................................................... 11  9.3  Reading Plates and Interpreting Results ..................................................................... 12  10  Fastidious Organisms ............................................................................................................... 13  10.1  Haemophilus influenzae and H. parainfluenzae ......................................................... 13  10.2  Neisseria gonorrhoeae ................................................................................................ 14  10.3  Neisseria meningitidis ................................................................................................. 14  vii Number 1 M02-A10 Contents (Continued) 10.4  Streptococcus pneumoniae and Other Streptococcus spp. .......................................... 15  11  Organisms Requiring Special Consideration ........................................................................... 16  11.1  Staphylococci .............................................................................................................. 17  11.2  Enterococci ................................................................................................................. 22  11.3  β-Lactamase-Mediated Resistance in Gram-Negative Bacilli .................................... 23  11.4  Streptococcus pneumoniae.......................................................................................... 25  12  Inducible Clindamycin Resistance ........................................................................................... 25  13  β-Lactamase Tests ................................................................................................................... 26  13.1  Purpose ....................................................................................................................... 26  13.2  Selecting a β-Lactamase Test ..................................................................................... 26  14  Interpretation of Disk Diffusion Test Results .......................................................................... 27  14.1  Zone Diameter Interpretive Standards ........................................................................ 27  14.2  Interpretive Categories ................................................................................................ 27  15  Quality Control and Quality Assurance Procedures ................................................................ 27  15.1  Purpose ....................................................................................................................... 27  15.2  Quality Control Responsibilities ................................................................................. 27  15.3  Selection of Quality Strains for Quality Control and Quality Assurance ................... 28  15.4  Storing and Testing Quality Control Strains ............................................................... 29  15.5  Batch or Lot Quality Control ...................................................................................... 29  15.6  Zone Diameter Quality Control Limits ....................................................................... 29  15.7  Frequency of Quality Control Testing ....................................................................... 30  15.8  Corrective Action ........................................................................................................ 30  15.9  Reporting Patient Results When Out-of-Control Tests Occur .................................... 32  15.10  Verification of Patient Test Results ............................................................................ 32  15.11  Other Control Procedures ........................................................................................... 33  16  Limitations of Disk Diffusion Methods ................................................................................... 33  16.1  Application to Various Organism Groups .................................................................. 33  16.2  Misleading Results ...................................................................................................... 34  16.3  Emergence of Resistance ............................................................................................ 34  17  Screening Tests ........................................................................................................................ 34  References ............................................................................................................................................. 35  Appendix A. Quality Control Protocol Flow Charts ............................................................................. 37  Appendix B. Preparation of Media and Reagents ................................................................................. 39  Appendix C. Conditions for Disk Diffusion Antimicrobial Susceptibility Tests ................................. 42  Appendix D. Quality Control Strains for Antimicrobial Susceptibility Tests ...................................... 44  Appendix E. Quality Control Strain Maintenance ................................................................................ 47  viii

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