M07-A10 Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically PDF
Preview M07-A10 Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically
January 2015 M07-A10 Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard—Tenth Edition This standard addresses reference methods for the determination of minimal inhibitory concentrations of aerobic bacteria by broth macrodilution, broth microdilution, and agar dilution. A standard for global application developed through the Clinical and Laboratory Standards Institute consensus process. Licensedto:DiagnosticMedicineServices Thisdocumentisprotectedbycopyright.CLSIorder#0,Downloadedon01/06/2014. Clinical and Laboratory Standards Institute Setting the standard for quality in clinical laboratory testing around the world. The Clinical and Laboratory Standards Institute (CLSI) is a not-for-profit membership organization that brings together the varied perspectives and expertise of the worldwide laboratory community for the advancement of a common cause: to foster excellence in laboratory medicine by developing and implementing clinical laboratory standards and guidelines that help laboratories fulfill their responsibilities with efficiency, effectiveness, and global applicability. Consensus Process Consensus—the substantial agreement by materially affected, competent, and interested parties—is core to the development of all CLSI documents. It does not always connote unanimous agreement, but does mean that the participants in the development of a consensus document have considered and resolved all relevant objections and accept the resulting agreement. Commenting on Documents CLSI documents undergo periodic evaluation and modification to keep pace with advancements in technologies, procedures, methods, and protocols affecting the laboratory or health care. CLSI’s consensus process depends on experts who volunteer to serve as contributing authors and/or as participants in the reviewing and commenting process. At the end of each comment period, the committee that developed the document is obligated to review all comments, respond in writing to all substantive comments, and revise the draft document as appropriate. Comments on published CLSI documents are equally essential, and may be submitted by anyone, at any time, on any document. All comments are addressed according to the consensus process by a committee of experts. Appeals Process If it is believed that an objection has not been adequately addressed, the process for appeals is documented in the CLSI Standards Development Policies and Process document. 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ISBN 1-56238-987-4 (Print) M07-A10 ISBN 1-56238-988-2 (Electronic) Vol. 35 No. 2 ISSN 1558-6502 (Print) Replaces M07-A9 ISSN 2162-2914 (Electronic) Vol. 32 No. 2 Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard—Tenth Edition Volume 35 Number 2 Jean B. Patel, PhD, D(ABMM) Linda A. Miller, PhD Franklin R. Cockerill III, MD David P. Nicolau, PharmD, FCCP, FIDSA Patricia A. Bradford, PhD Mair Powell, MD, FRCP, FRCPath George M. Eliopoulos, MD Jana M. Swenson, MMSc Janet A. Hindler, MCLS, MT(ASCP) Maria M. Traczewski, BS, MT(ASCP) Stephen G. Jenkins, PhD, D(ABMM), F(AAM) John D. Turnidge, MD James S. Lewis II, PharmD Melvin P. Weinstein, MD Brandi Limbago, PhD Barbara L. Zimmer, PhD 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. This document describes standard broth dilution (macrodilution and microdilution [the microdilution method described in M07 is the same methodology outlined in ISO 20776-11]) and agar dilution techniques, and it includes a series of procedures to standardize the way the tests are performed. The performance, applications, and limitations of the current CLSI-recommended methods are also described. The supplemental information (M1002 tables) presented with this standard represents the most current information for drug selection, interpretation, and QC using the procedures standardized in M07. 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-S24) appear in boldface type and are also summarized in the front of the document. Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard—Tenth Edition. CLSI document M07-A10 (ISBN 1-56238-987-4 [Print]; ISBN 1-56238-988-2 [Electronic]). Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087 USA, 2015. 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, 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. Licensedto:DiagnosticMedicineServices Thisdocumentisprotectedbycopyright.CLSIorder#0,Downloadedon01/06/2014. Number 2 M07-A10 Copyright ©2015 Clinical and Laboratory Standards Institute. Except as stated below, any reproduction of content from a CLSI copyrighted standard, guideline, companion product, or other material requires express written consent from CLSI. All rights reserved. Interested parties may send permission requests to [email protected]. 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, e-mail [email protected]. Suggested Citation CLSI. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard—Tenth Edition. CLSI document M07-A10. Wayne, PA: Clinical and Laboratory Standards Institute; 2015. Proposed Standard Approved Standard—Fourth Edition June 1980 January 1997 Tentative Standard Approved Standard—Fifth Edition December 1982 January 2000 Approved Standard Approved Standard—Sixth Edition June 1986 January 2003 Tentative Standard—Second Edition Approved Standard—Seventh Edition November 1988 January 2006 Approved Standard—Second Edition Approved Standard—Eighth Edition April 1990 January 2009 Approved Standard—Third Edition Approved Standard—Ninth Edition December 1993 January 2012 Approved Standard—Tenth Edition January 2015 ISBN 1-56238-987-4 (Print) ISBN 1-56238-988-2 (Electronic) ISSN 1558-6502 (Print) ISSN 2162-2914 (Electronic) Licensedto:Diiai gno sticMedicineServices Thisdocumentisprotectedbycopyright.CLSIorder#0,Downloadedon01/06/2014. Volume 35 M07-A10 Committee Membership Consensus Committee on Microbiology Richard B. Thomson, Jr., PhD, Patrick R. Murray, PhD John D. Turnidge, MD D(ABMM), FAAM BD Diagnostic Systems SA Pathology at Women’s and Chairholder USA Children’s Hospital Evanston Hospital, NorthShore Australia University HealthSystem Jean B. Patel, PhD, D(ABMM) USA Centers for Disease Control and Jeffrey L. Watts, PhD, RM(NRCM) Prevention Zoetis John H. Rex, MD, FACP USA USA Vice-Chairholder AstraZeneca Pharmaceuticals Kerry Snow, MS, MT(ASCP) Nancy L. Wengenack, PhD, USA FDA Center for Drug Evaluation and D(ABMM) Research Mayo Clinic Thomas R. Fritsche, MD, PhD USA USA Marshfield Clinic USA Barbara L. Zimmer, PhD Siemens Healthcare Diagnostics Inc. USA Subcommittee on Antimicrobial Susceptibility Testing Jean B. Patel, PhD, D(ABMM) Janet A. Hindler, MCLS, MT(ASCP) David P. Nicolau, PharmD, FCCP, Chairholder UCLA Medical Center FIDSA Centers for Disease Control and USA Hartford Hospital Prevention USA USA Stephen G. Jenkins, PhD, D(ABMM), F(AAM) Mair Powell, MD, FRCP, FRCPath Franklin R. Cockerill III, MD New York Presbyterian Hospital MHRA Vice-Chairholder USA United Kingdom Mayo Clinic USA James S. Lewis II, PharmD John D. Turnidge, MD Oregon Health and Science University SA Pathology at Women’s and Patricia A. Bradford, PhD USA Children’s Hospital AstraZeneca Pharmaceuticals Australia USA Brandi Limbago, PhD Centers for Disease Control and Melvin P. Weinstein, MD George M. Eliopoulos, MD Prevention Robert Wood Johnson University Beth Israel Deaconess Medical Center USA Hospital USA USA Linda A. Miller, PhD GlaxoSmithKline Barbara L. Zimmer, PhD USA Siemens Healthcare Diagnostics Inc. USA Acknowledgment CLSI, the Consensus Committee on Microbiology, and the Subcommittee on Antimicrobial Susceptibility Testing gratefully acknowledge the following volunteers for their important contributions to the development of this document: Jana M. Swenson, MMSc Maria M. Traczewski, BS, USA MT(ASCP) The Clinical Microbiology Institute USA Licensedto:Di agnosticMedicineServices iii Thisdocumentisprotectedbycopyright.CLSIorder#0,Downloadedon01/06/2014. Number 2 M07-A10 Working Group on AST Breakpoints George M. Eliopoulos, MD David P. Nicolau, PharmD, FCCP, Simone Shurland Co-Chairholder FIDSA FDA Center for Devices and Beth Israel Deaconess Medical Hartford Hospital Radiological Health Center USA USA USA Mair Powell, MD, FRCP, Lauri D. Thrupp, MD James S. Lewis II, PharmD FRCPath UCI Medical Center (University Co-Chairholder MHRA of California, Irvine) Oregon Health and Science United Kingdom USA University USA Michael Satlin, MD, MS Hui Wang, PhD Weill Cornell Medical College Peking University People’s Karen Bush, PhD USA Hospital Indiana University China USA Paul C. Schreckenberger, PhD, D(ABMM), F(AAM) Melvin P. Weinstein, MD Marcelo F. Galas Loyola University Medical Center Robert Wood Johnson University National Institute of Infectious USA Hospital Diseases USA Argentina Audrey N. Schuetz, MD, MPH, D(ABMM) Matthew A. Wikler, MD, MBA, Amy J. Mathers, MD Weill Cornell Medical FIDSA University of Virginia Medical College/NewYork-Presbyterian The Medicines Company Center Hospital USA USA USA Barbara L. Zimmer, PhD Siemens Healthcare Diagnostics Inc. USA Working Group on Methodology Stephen G. Jenkins, PhD, Laura M. Koeth, MT(ASCP) Susan Sharp, PhD, D(ABMM), D(ABMM), F(AAM) Laboratory Specialists, Inc. F(AAM) Co-Chairholder USA American Society for Microbiology New York Presbyterian Hospital USA USA Sandra S. Richter, MD, D(ABMM) Cleveland Clinic Ribhi M. Shawar, PhD, D(ABMM) Brandi Limbago, PhD USA FDA Center for Devices and Co-Chairholder Radiological Health Centers for Disease Control and Darcie E. Roe-Carpenter, PhD, CIC, USA Prevention CEM USA Siemens Healthcare Diagnostics Inc. John D. Turnidge, MD USA SA Pathology at Women’s and Seth T. Housman, PharmD, MPA Children’s Hospital Hartford Hospital Katherine Sei Australia USA Siemens Healthcare Diagnostics Inc. USA Romney M. Humphries, PhD, D(ABMM) UCLA Medical Center USA Licensedto:Diiavg nos ticMedicineServices Thisdocumentisprotectedbycopyright.CLSIorder#0,Downloadedon01/06/2014. Volume 35 M07-A10 Working Group on Quality Control Steven D. Brown, PhD, ABMM Stephen Hawser, PhD Ross Mulder, MT(ASCP) Co-Chairholder IHMA Europe Sàrl bioMérieux, Inc. USA Switzerland USA Sharon K. Cullen, BS, RAC Janet A. Hindler, MCLS, MT(ASCP) Susan D. Munro, MT(ASCP), CLS Co-Chairholder UCLA Medical Center USA Siemens Healthcare Diagnostics Inc. USA USA Robert P. Rennie, PhD Denise Holliday, MT(ASCP) Provincial Laboratory for Public William B. Brasso BD Diagnostic Systems Health BD Diagnostic Systems USA Canada USA Michael D. Huband Frank O. Wegerhoff, PhD, Patricia S. Conville, MS, MT(ASCP) AstraZeneca Pharmaceuticals MSc(Epid), MBA FDA Center for Devices and Radiological USA USA Health USA Erika Matuschek, PhD Mary K. York, PhD, ABMM ESCMID MKY Microbiology Consulting Robert K. Flamm, PhD Sweden USA JMI Laboratories USA Working Group on Text and Tables Jana M. Swenson, MMSc Linda M. Mann, PhD, D(ABMM) Dale A. Schwab, PhD, D(ABMM) Co-Chairholder USA Quest Diagnostics Nichols Institute USA USA Melissa B. Miller, PhD, D(ABMM) Maria M. Traczewski, BS, MT(ASCP) UNC Hospitals Richard B. Thomson, Jr., PhD, Co-Chairholder USA D(ABMM), FAAM The Clinical Microbiology Institute Evanston Hospital, NorthShore USA Susan D. Munro, MT(ASCP), CLS University HealthSystem USA USA Janet A. Hindler, MCLS, MT(ASCP) UCLA Medical Center Nancy E. Watz, MS, MT(ASCP), Flavia Rossi, MD USA CLS University of São Paulo Stanford Hospital and Clinics Brazil Peggy Kohner, BS, MT(ASCP) USA Mayo Clinic Jeff Schapiro, MD USA Mary K. York, PhD, ABMM Kaiser Permanente MKY Microbiology Consulting Dyan Luper, BS, MT(ASCP)SM, MB USA USA BD Diagnostic Systems USA Staff Clinical and Laboratory Standards Megan L. Tertel, MA Institute Editorial Manager USA Joanne P. Christopher, MA Luann Ochs, MS Editor Senior Vice President – Operations Patrice E. Polgar Tracy A. Dooley, MLT(ASCP) Editor Project Manager Licensedto:Di agnosticMedicineServices v Thisdocumentisprotectedbycopyright.CLSIorder#0,Downloadedon01/06/2014. Number 2 M07-A10 Licensedto:Divaig nosticMedicineServices Thisdocumentisprotectedbycopyright.CLSIorder#0,Downloadedon01/06/2014. Volume 35 M07-A10 Contents Abstract .................................................................................................................................................... i Committee Membership ........................................................................................................................ iii Foreword ................................................................................................................................................ ix Summary of Changes ............................................................................................................................. ix Summary of CLSI Processes for Establishing Interpretive Criteria and Quality Control Ranges ....... xii CLSI Reference Methods vs Commercial Methods and CLSI vs US Food and Drug Administration Interpretive Criteria (Breakpoints) ............................................................................. xiii Subcommittee on Antimicrobial Susceptibility Testing Mission Statement ....................................... xiv Chapter 1: Introduction ........................................................................................................................... 1 1.1 Scope ............................................................................................................................. 1 1.2 Background ................................................................................................................... 1 1.3 Standard Precautions ..................................................................................................... 2 1.4 Terminology.................................................................................................................. 2 Chapter 2: Indications for Performing Susceptibility Tests .................................................................... 7 2.1 Selection of Antimicrobial Agents for Routine Testing and Reporting ........................ 8 2.2 Selection Guidelines ................................................................................................... 12 2.3 Suggested Guidelines for Routine and Selective Testing and Reporting ................... 12 Chapter 3: Susceptibility Testing Process ............................................................................................. 15 3.1 Antimicrobial Agents .................................................................................................. 17 3.2 Preparing Stock Solutions ........................................................................................... 18 3.3 Inoculum Preparation for Dilution Tests .................................................................... 19 3.4 Agar Dilution Procedure ............................................................................................. 20 3.5 Preparing Agar Dilution Plates ................................................................................... 21 3.6 Broth Dilution Procedures (Macrodilution and Microdilution) .................................. 24 3.7 Macrodilution (Tube) Broth Method .......................................................................... 26 3.8 Broth Microdilution Method ....................................................................................... 27 3.9 Incubation ................................................................................................................... 29 3.10 Colony Counts of Inoculum Suspensions ................................................................... 30 3.11 Determining Broth Macro- or Microdilution End Points............................................ 30 3.12 Special Considerations for Fastidious Organisms ...................................................... 32 3.13 Special Consideration for Detecting Resistance ......................................................... 36 3.14 Screening Tests ........................................................................................................... 45 3.15 Limitations of Dilution Test Methods ......................................................................... 47 Chapter 4: Quality Control and Quality Assurance .............................................................................. 49 4.1 Purpose........................................................................................................................ 49 4.2 Quality Control Responsibilities ................................................................................. 49 4.3 Selection of Strains for Quality Control ..................................................................... 50 4.4 Maintenance and Testing of Quality Control Strains .................................................. 51 4.5 Batch or Lot Quality Control ...................................................................................... 52 4.6 Minimal Inhibitory Concentration Quality Control Ranges ....................................... 52 4.7 Frequency of Quality Control Testing (also refer to Appendix A and M1002 Table 5F) ......................................................................................................... 52 4.8 Out-of-Range Results With Quality Control Strains and Corrective Action .............. 54 Licensedto:Di agnosticMedicineServices vii Thisdocumentisprotectedbycopyright.CLSIorder#0,Downloadedon01/06/2014. Number 2 M07-A10 Contents (Continued) 4.9 Reporting Patient Results When Out-of-Range Quality Control Results Are Observed ..................................................................................................................... 57 4.10 Confirmation of Results When Testing Patient Isolates ............................................. 57 4.11 Reporting of Minimal Inhibitory Concentration Results ............................................ 58 4.12 End-Point Interpretation Control ................................................................................ 58 Chapter 5: Conclusion ........................................................................................................................... 60 Chapter 6: Supplemental Information ................................................................................................... 60 References ................................................................................................................................ 61 Appendix A. Quality Control Protocol Flow Charts ................................................................ 64 Appendix B. Preparation of Supplements, Media, and Reagents ............................................ 68 Appendix C. Conditions for Dilution Antimicrobial Susceptibility Tests ............................... 74 Appendix D. Quality Control Strains for Antimicrobial Susceptibility Tests (refer to current edition of M1001 for the most current version of this table) ....................................... 79 Appendix E. Quality Control Strain Maintenance (also refer to Subchapter 4.4) ................... 83 The Quality Management System Approach ........................................................................... 86 Related CLSI Reference Materials .......................................................................................... 87 Licensedto:Divaigiin osticMedicineServices Thisdocumentisprotectedbycopyright.CLSIorder#0,Downloadedon01/06/2014.
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