M38-A Replaces M38-P Vol. 22 No. 16 Vol. 18 No. 3 Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi; Approved Standard This document addresses the selection of antifungal agents, preparation of antifungal stock solutions and dilutions for testing implementation and interpretation of test procedures, and quality control requirements for susceptibility testing of filamentous fungi (moulds) that cause invasive fungal infections. A standard for global application developed through the NCCLS consensus process. NCCLS... 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Please consensus—“proposed” and “approved.” Depending on contact the NCCLS Executive Offices for additional information on committee participation. Volume 22 M38-A Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi; Approved Standard Abstract NCCLS document M38-A—Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi; Approved Standard describes a method for testing the susceptibility of filamentous fungi (moulds) that cause invasive fungal infections, including Aspergillus species, Fusarium species, Rhizopus arrhizus, Pseudallescheria boydii (Scedosporium apiospermum), and Sporothrix schenckii and other opportunistic pathogenic moulds to antifungal agents. Selection of antifungal agents, preparation of antifungal stock solutions and dilutions for testing, implementation, and interpretation of test procedures, and the purpose and implementation of quality control procedures are discussed. A careful examination of the responsibilities of the manufacturer and the user in quality control is also presented. NCCLS. Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi; Approved Standard. NCCLS document M38-A (ISBN 1-56238-470-8). NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2002. THE NCCLS consensus process, which is the mechanism for moving a document through two or more levels of review by the healthcare 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in technology may affect the procedures, methods, and protocols in a standard or guideline, users should replace outdated editions with the current editions of NCCLS documents. Current editions are listed in the NCCLS Catalog, which is distributed to member organizations, and to nonmembers on request. If your organization is not a member and would like to become one, and to request a copy of the NCCLS Catalog, contact the NCCLS Executive Offices. Telephone: 610.688.0100; Fax: 610.688.0700; E-Mail: [email protected]; Website: www.nccls.org i Number 16 NCCLS ii M38-A ISBN 1-56238-470-8 ISSN 0273-3099 Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi; Approved Standard Volume 22 Number 16 Michael A. Pfaller, M.D., Chairholder Vishnu Chaturvedi, Ph.D. Ana Espinel-Ingroff, Ph.D. Mahmoud A. Ghannoum, M.Sc., Ph.D. Linda L. Gosey, M.T. (ASCP) Frank C. Odds, Ph.D., FRC Path. John H. Rex, M.D. Michael G. Rinaldi, Ph.D. Daniel J. Sheehan, Ph.D. Thomas J. Walsh, M.D. David W. Warnock, Ph.D., FRC Path. Number 16 NCCLS This publication is protected by copyright. No part of it may be reproduced, stored in a retrieval system, transmitted, or made available in any form or by any means (electronic, mechanical, photocopying, recording, or otherwise) without prior written permission from NCCLS, except as stated below. NCCLS hereby grants permission to reproduce limited portions of this publication for use in laboratory procedure manuals at a single site, for interlibrary loan, or for use in educational programs provided that multiple copies of such reproduction shall include the following notice, be distributed without charge, and, in no event, contain more than 20% of the document’s text. Reproduced with permission, from NCCLS publication M38-A—Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi; Approved Standard (ISBN 1-56238-470-8). Copies of the current edition may be obtained from NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898, USA. Permission to reproduce or otherwise use the text of this document to an extent that exceeds the exemptions granted here or under the Copyright Law must be obtained from NCCLS by written request. To request such permission, address inquiries to the Executive Director, NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898, USA. Copyright ©2002. The National Committee for Clinical Laboratory Standards. Suggested Citation (NCCLS. Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi; Approved Standard. NCCLS document M38-A [ISBN 1-56238-470-8]. NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2002.) Proposed Standard November 1998 Approved Standard August 2002 ISBN 1-56238-470-8 ISSN 0273-3099 iv Volume 22 M38-A Committee Membership Area Committee on Microbiology James H. Jorgensen, Ph.D. University of Texas Health Center Chairholder San Antonio, Texas Mary Jane Ferraro, Ph.D., M.P.H. Massachusetts General Hospital Vice-Chairholder Boston, Massachusetts Subcommittee on Antifungal Susceptibility Tests Michael A. Pfaller, M.D. University of Iowa College of Medicine Chairholder Iowa City, Iowa Vishnu Chaturvedi, Ph.D. New York State Department of Health Albany, New York Ana Espinel-Ingroff, M.S., Ph.D. Medical College of Virginia/VCU Richmond, Virginia Mahmoud A. Ghannoum, M.Sc., Ph.D. Center for Medical Mycology, Case Western Reserve University and University Hospitals of Cleveland Cleveland, Ohio Linda L. Gosey, M.T. (ASCP) Food and Drug Administration Rockville, Maryland Frank C. Odds, Ph.D., FRC Path University of Aberdeen Scotland, United Kingdom John H. Rex, M.D. University of Texas Health Science Ctr. at Houston Houston, Texas Michael G. Rinaldi, Ph.D. University of Texas Health Science Center San Antonio, Texas Daniel J. Sheehan, Ph.D. Pfizer Inc. New York, New York Thomas J. Walsh, M.D. National Cancer Institute Bethesda, Maryland David W. 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