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1st Edition

M61 Performance Standards Standards for Antifungal Susceptibility Testing of Filamentous Fungi

This document provides updated quality control tables for the Clinical and Laboratory Standards Institute antifungal susceptibility susceptibi lity testing documents d ocuments M38 and M51. A CLSI supplement for global application.

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M61, 1st ed.  November 2017 Replaces M51-S1

Performance Standards for Antifungal Susceptibility Testing of Filamentous Fungi Barbara D. Alexander, MD, MHS Gary W. Procop, MD, MS Philippe Dufresne, PhD (RMCCM) Jeff Fuller, PhD, FCCM, D(ABMM) Mahmoud A. Ghannoum, PhD, EMBA, FIDSA Kimberly E. Hanson, MD, MHS Denise Holliday, MT(ASCP)  Nicole M. Holliday, BA Luis Ostrosky-Zeichner, MD, FACP, FIDSA, FSHEA Audrey N. Schuetz, MD, MPH, D(ABMM)  Nathan P. Wiederhold, PharmD Adrian M. Zelazny, PhD, D(ABMM)

Abstract Clinical and Laboratory Standards Institute document M61 — Performance Performance Standards for Antifungal Susceptibility Testing of Filamentous Fungi  provides information to use with the testing procedures in CLSI documents M381 and M51.2 The tabular information in this document includes the most current information for antifungal agent selection, results interpretation, interpretation, and quality control and is valid only when the methodology is followed as described in the current editions of CLSI documents M38 M381 and M51. M51.2 Any previously published tables should be replaced with these new tables. Changes since the last edition appear in boldface type. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antifungal Susceptibility Testing of Filamentous Fungi. 1st ed. CLSI supplement M61 (ISBN 1-56238-832-0 [Print]; ISBN 1-56238-833-9 [Electronic]). Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087 USA, 2017. 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 o ngoing 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in technology may affect the procedures, methods, and protocols in a standard or guideline, users should replace outdated editions with the current editions of CLSI documents.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 y ou 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: [email protected];  Website: www.clsi.org.  www.clsi.org.

M61, 1st ed.

Copyright ©2017 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].  [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 procedures manual at a single site. To request permission to use this publication in any other manner, e-mail  [email protected].

Suggested Citation CLSI. Performance Standards for Antifungal Susceptibility Testing of Filamentous Fungi.  1st ed. CLSI supplement M61. Wayne, PA: Clinical and Laboratory Standards Institute; 2017. Previous Edition: M51-S1: May 2010

ISBN 1-56238-832-0 (Print) ISBN 1-56238-833-9 (Electronic) ISSN 1558-6502 (Print) ISSN 2162-2914 (Electronic) ii

Volume 37, Number 16

M61, 1st ed.

Contents Abstract .................................................................................................................................................... i Committee Membership ........................................................................................................................ iii Foreword .............................................................................................................................................. vii Abbreviations and Acronyms ............................................................................................................. viii Table 1. Recommended Minimal Inhibitory Concentration or Minimal Effective Concentrations and Modes for Quality Control and Reference Strains f or Broth Dilution Antifungal Susceptibility Susceptibility Testing Procedures Procedures ................. ................. .................. ................. .................. .................. ................. ........ 1 Table 2. Recommended Zone Diameter Limits and Modes for Quality Control and Reference Strains for Disk Diffusion Antifungal Susceptibility Testing Procedures ..................... ................. ........ 4 Table 3. Solvents and Diluents for Preparation of Stock Solutions of Antifungal Agents ..................... 6 References ............................................................................................................................................... 7 The Quality Management System Approach .................. ................. .................. .................. ................. .. 8 Related CLSI Reference Materials ......................................................................................................... 9

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M61, 1st ed.

Foreword Users of CLSI documents M38 M3 81 and M512 and this document should recognize that the standard methods described in CLSI documents are reference methods. These methods may be used for:   

Routine antifungal testing of patient isolates to guide therapy Evaluating commercial devices that will be used in medical laboratories Testing new agents or systems by drug or device manufacturers

Results generated by reference methods, such as those provided in CLSI documents, may be used by regulatory authorities to evaluate commercial susceptibility testing device performance as part of the approval process. Regulatory clearance indicates that the commercial susceptibility testing device provides results that are substantially equivalent to those generated using reference methods for the organisms and antimicrobial agents described in the device manufacturer’s approved package insert. NOTE: Fungal taxonomy has undergone major changes in recent years with the dual (asexual and sexual stages) nomenclature having been abolished and the constant reclassification and renaming of fungal species that result from improved molecular characterization. 3  Species names listed in CLSI document M38 M381 were revised to reflect the most recent taxonomic changes based on classification according to DNA  bar coding at the time of publication. For more information regarding updated fungal species reclassification, refer to publicly available information. 4

Overview of Changes This document replaces the previous edition of the approved supplement M51-S1, published in 2010, and incorporates information from CLSI document M38-A2. Several changes were made in this edition, including: 

General: – Combined supplemental information from M38-A2 (broth dilution susceptibility testing of filamentous fungi) and M51-S1 (disk diffusion testing of filamentous fungi) into one informational supplement, which has been recoded as M61

–



Deleted the glossary with abbreviations, routes of administration, and drug classes for antifungal agents

Tables: – Moved Table 1 from M38-A2 (Solvents and Diluents for Preparation of Stock Solutions of Antifungal Agents) to M61, where it is now Table 3, and added information for isavuconazole

–

Updated QC ranges for itraconazole and posaconazole for Candida parapsilosis  and added QC ranges for isavuconazole in Table 1

–

Moved Table 4 from M38-A2 (Recommended MIC or MEC Limits for QC and Reference Strains for Broth Dilution Procedures) to M61, where it is now Table 1, and revised the title (Recommended Minimal Inhibitory Concentration or Minimal Effective Concentrations and Modes for Quality Control and Reference Strains for Broth Dilution Antifungal Susceptibility Testing Procedures)

–

Moved Table 1 from M51-S1 (Tentative Zone Diameter Epidemiological Cutoff Values [ECV] and Corresponding Minimal Inhibitory Concentration [MIC] or Minimal Effective Concentration [MEC] for Filamentous Fungi) to CLSI document M59, 5 the supplement to CLSI document M57 6 vii

M61, 1st ed.

Table 1. Recommended Minimal Inhibitory Concentration or Minimal Effective Concentrations and Modes for Quality Control and Reference Strains for Broth Dilution Antifungal Susceptibility Testing Procedures

Organism Paecilomyces variotii ATCC®† MYA-36301,2

Candida parapsilosis ATCC® 220193,4

Purpose

QC

Reference (MEC)‡  QC

Candida krusei ATCC® 62583,4

QC

 Aspergillus flavus ATCC® 2043045,6,§

Reference

 A. flavus ATCC® MYA-36311  Aspergillus fumigatus ATCC® MYA-36261,2

QC Reference

Reference

Reference (MEC)‡ 

©

Antifungal Agent Amphotericin B Isavuconazole Itraconazole Posaconazole Voriconazole

Anidulafungin Amphotericin B Anidulafungin Caspofungin Caspofungin Fluconazole Flucytosine Isavuconazole Itraconazole Ketoconazole Micafungin Posaconazole Ravuconazole Voriconazole Amphotericin B Anidulafungin Caspofungin Caspofungin Fluconazole Flucytosine Isavuconazole Itraconazole Ketoconazole Micafungin Posaconazole Ravuconazole Voriconazole Amphotericin B Itraconazole Posaconazole Ravuconazole Voriconazole Isavuconazole Amphotericin B Posaconazole Voriconazole Amphotericin B Itraconazole Voriconazole Anidulafungin

Clinical and Laboratory Standards Institute. All rights reserved.

MIC/MEC Range, µg/mL 1 – 4 0.06 – 0.5 0.5 0.06 – 0.5 0.5 0.03 – 0.25 0.25 0.015 –  0.12 ≤ 0.015 0.5 – 4 0.5 – 2 0.25 – 1 0.5 – 4 1 – 4 0.12 – 0.5 0.5 0.03 – 0.12 0.12 0.5 0.06 – 0.5 0.06 – 0.5 0.5 0.5 – 4 0.25 0.03 – 0.25 0.03 – 0.25 0.25 0.03 – 0.25 0.25 1 – 4 0.03 – 0.12 0.12 0.12 – 1 0.25 – 1 16 – 128 128 8 – 32 32 0.12 – 0.5 0.5 0.25 – 1 0.25 – 1 0.12 – 0.5 0.5 0.12 – 1 0.25 – 1 0.12 – 1 0.5 – 4 0.25 – 0.5 0.5 0.06 – 0.5 0.5 0.5 – 4 0.5 – 4 0.5 – 4 1 – 8 0.12 – 1 0.5 – 2 0.5 – 4 0.25 – 2 0.25 – 1 ≤ 0.015

MIC/  MEC Mode, µg/mL 2 0.12 0.12 0.06 0.06

MICs/  MECs Within Range, % 100 96.7 100 99.5 100

Incubation Time, hours* 48 48 48 48 48

N/A 2 1 0.5 1 2 0.25 0.03 0.25 0.12 1 0.12 0.06 0.06 2 0.06 0.5 0.5 32 16 0.12 0.5 0.5 0.25 0.5 0.5 0.5 ND ND ND ND ND 1 2 0.5 1 2 1 0.5 N/A

100 91.7 95 96.7 92.9 98.1 97.9 98.3 97.5 98.3 100 98.8 98.3 100 100 97.5 98.8 97.5 100 99.6 94.2 100 99.6 99 99.6 100 100 100 100 100 100 100 95.8 98.8 97.1 98.3 98.7 95.7 100 100

24 48 24 24 48 48 48 48 48 48 24 48 48 48 48 48 24 48 48 48 48 48 48 48 48 48 48 48 48 48 48 48 48 48 48 48 48 48 48 24

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M61, 1st ed. Table 1. (Continued)

Reference (MIC) ‡

MIC/MEC Range, µg/mL 0.5 – 4 ≥ 16 0.25 – 1 2 – 8 0.25 – 1 ≤ 0.015 2 – 8 > 16 0.5 – 2 1 – 4 >8

Reference (MIC)‡

Anidulafungin

>8

N/A

96.7

48

Reference

Amphotericin B Posaconazole Voriconazole Anidulafungin

4 – 16 16 1 – 4 0.5 – 2 1 – 4

8 2 1 2

98.8 98.3 100 96.7

72 72 72 48 – 72 72

0.5 – 2 0.12 – 0.5 0.5 0.03 – 0.25 0.25 0.03 – 0.25 0.25 0.002 –  0.008 0.03 – 0.25 0.25 0.5 – 2 0.5 – 4 0.008 –  0.06

1 0.25 0.06 0.06 0.004

97.5 96.3 96.2 95.2 97.9

96 96 96 96 96

0.06 1 1 0.015

95.2 97.5 95.2 96.1

96 96 96 96

Purpose Reference

 Aspergillus terreus ATCC® MYA-36331,2

Reference

F. verticillioides verticillioides (moniliforme) ATCC®† MYA-36291,2 Fusarium solani ATCC® MYA-36362 Scedosporium apiospermum ATCC® MYA-36355,6 S. apiospermum ATCC® MYA-36342 Trichophyton mentagrophytes ¶ MRL 1957 ATCC® MYA-44397

 ¶

Trichophyton rubrum MRL 666 ATCC® MYA-44387

Incubation Time, hours* 48 48 48 48 48 24 48 48 48 48 48

Antifungal Agent Amphotericin B Itraconazole Voriconazole Amphotericin B Voriconazole Anidulafungin Amphotericin B Itraconazole Posaconazole Voriconazole Anidulafungin

Organism  A. fumigatus ATCC® MYA-36271

Fusarium verticillioides (moniliforme) ATCC® MYA-36291,2

MICs/  MECs Within Range, % 99.2 95 99.2 98.3 99.2 99.6 99.6 97.9 98.1 100 97.5

MIC/  MEC Mode, µg/mL 2 ≥ 16 0.5 4 0.5 N/A 4 > 16 1 2 N/A

Reference (MEC)‡  Reference

Reference (MEC)‡ Reference

Reference

Ciclopirox Griseofulvin Itraconazole Posaconazole Terbinafine Voriconazole Ciclopirox Fluconazole Voriconazole

*

 MIC ranges correspond to the indicated incubation time. In some cases, MIC ranges are also available by the macrodilution method (48 hours only) and after 24 hours by the microdilution method.8-10 One of the QC isolates should be used per standard QC testing procedures (see CLSI document M3811).

†

 ATCC® is a registered trademark of the American Type Culture Collection.

‡

 Although the anidulafungin concentration range in the study was 0.015 to 32 µ g/mL, off-scale MICs >32 >32 µg/mL from that study are reported in Table 1 as > 8 µ g/mL to be consistent with the recommended routine testing range for this compound. 2

§

 The MIC ranges for A. flavus ATCC® 204304 are based on data from a collaborative study5,6 that were not obtained according to the CLSI document M23 12 process. However, A. flavus is the only mould for which reproducible reference limits for ravuconazole have been established, so it is included in Table 1.

 ¶

 Ninety-six hours or until good growth (confluent hyphal growth covering the bottom of the well) is obtained in the growth control well.13

Abbreviations: ATCC®, American Type Culture Collection; MEC, minimal effective concentration; MIC, minimal inhibitory concentration; N/A, not applicable; ND, not determined; QC, quality control.

NOTE: Information in boldface type is new or modified since the previous edition.

2

©

Clinical and Laboratory Standards Institute. All rights reserved.

M61, 1st ed.

The Quality Management System Approach Clinical and Laboratory Standards Institute (CLSI) subscribes to a quality management system (QMS) approach in the development of standards and guidelines that facilitates project management, defines a document structure using a template, and provides a process to identify needed documents. The QMS approach applies a core set of “quality system essentials” (QSEs), basic to any organization, to all operations in any health care service’s path of workflow (ie, operational aspects that define how a particular product or service is provided). The QSEs provide the framework for delivery of any type of product or service, serving as a manager’s guide. The QSEs are: Organization Customer Focus Facilities and Safety

Personnel Purchasing and Inventory Equipment

Process Management Documents and Records Information Management

Nonconforming Event Management Assessments Continual Improvement

M61 covers the QSE indicated by an “X.” For “X.”  For a description of the documents listed in the grid, please refer to the Related CLSI Reference Materials section.

  n   o    i    t   a   z    i   n   a   g   r    O

  s   u   c   o    F   r   e   m   o    t   s   u    C

   d   n   a   y   s    t   e   f   e    i    t    i   a    l    i    S   c   a    F

   l   e   n   n   o   s   r   e    P

   d   n   a   y   r   g   o   n   t    i   s   n   a   e    h   v   n   c   I   r   u    P

   t   n   e   s   s   m   e   e   c   g   o   r   a    P   n   a    M

   t   n   e   m   p    i   u   q    E

   d   n   a   s   s    t    d   r   n   e   o   m  c   e   u   R   c   o    D

  n   t   n   o   e    i    t   m   a   e   m  g   r   a   o   n    f   n   a    I    M

   t   g   n   e   n    i   m   e   m  g   r   a   o   n    f   a   n   o   M   c   n   t   o   n   e    N  v    E

  s    t   n   e   m   s   s   e   s   s    A

   t    l   n   a   e   u   m   n   e    i    t   v   n   o   o   r    C  p   m    I

X M23 M38 M51 M57 M59

Path of Workflow A path of workflow is the description of the necessary processes to deliver the particular product or service that the organization or entity provides. A laboratory path of workflow consists of the sequential processes: preexamination, examination, and postexamination and their respective sequential subprocesses. All laboratories follow these  processes to deliver deliver their services, services, namely quality quality laboratory information. information. M61 does not cover any medical laboratory path of workflow processes. For a description of the other documents listed in the grid, please refer to the Related CLSI Reference Materials section. section. Preexamination   n   o   g    i    t   a   n   r   n   i    i   e   m   d   r   a   o   x    E

  n   o    i    t   c   e    l    l   o   c   e    l   p   m   a    S

   t   r   o   p   s   n   a   r    t   e    l   p   m   a    S

Examination    d   n   a    t   g   p   n    i    i   e   c   s   e   s   e   r   c   e   o    l   r   p   p   m   a    S

  n   o    i    t   a   n    i   m   a   x    E

M38 M51 M59

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   d   n   a   w  p   e   u    i     v   w   e   o   r    l   s    l    t   o    l   u   f   s   e    R

M38 M51 M59

©

Postexamination   n   o    i    t   a    t   e   r   p   r   e    t   n    I

M38 M51 M59

  g   n   g    i    t   r   n   o   i   v   p   i   e   h   r   c   s   r   a    t    l    d   u   n   s   e   a    R

M38 M51

   t   n   e   m   e   g   a   n   a   m   e    l   p   m   a    S

M38 M51

Clinical and Laboratory Standards Institute. All rights reserved.

M61, 1st ed.

Related CLSI Reference Materials



M23

Development of  In Vitro Susceptibility Testing Criteria and Quality Control Parameters. 4th ed., 2016. This document discusses the necessary and recommended data for the selection of appropriate interpretive criteria and quality control ranges fo r antimicrobial agents.

M38

Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi. 3rd ed., 2017. This standard includes the antifungal agent selection, preparation of antifungal stock solutions and dilutions for testing, test procedure implementation and interpretation, and quality control requirements for susceptibility testing of filamentous fungi (moulds) that cause invasive and cutaneous fungal infections.

M51

Method for Antifungal Disk Diffusion Susceptibility Testing of Nondermatophyte Filamentous Fungi. 1st ed., 2010. This document describes the guidelines for antifungal susceptibility susceptibility testing by the disk diffusion method of nondermatophyte filamentous fungi (moulds) that cause invasive disease.

M57

Principles and Procedures for the Development of Epidemiological Cutoff Values for Antifungal Susceptibility Testing. 1st ed., 2016.   This guideline includes the criteria for developing and using epidemiological cutoff values for guiding clinical decisions when testing fungal species and antifungal agent combinations for which there are no breakpoints.

M59

Epidemiological Cutoff Values for Antifungal Susceptibility Testing. 1st ed., 2016 . This document includes the epidemiological cutoff value and quality control tables developed according to criteria provided in the Clinical and Laboratory Standards Institute guideline M57.

 CLSI documents are continually reviewed and revised throug h the CLSI consensus process; therefore, readers should refer to the most current editions. 

©

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