2nd Edition

M60
Performance Standards for Antifungal
Susceptibility Testing of Yeasts

This document provides updated minimal inhibitory

concentration, zone diameter, and quality control tables for
the Clinical and Laboratory Standards Institute antifungal
susceptibility testing documents M27 and M44.

A CLSI supplement for global application.

Clinical and Laboratory Standards Institute
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 M60-Ed2
June 2020
Replaces M60-Ed1
Performance Standards for Antifungal Susceptibility Testing of Yeasts
Gary W. Procop, MD, MS David H. Pincus, MS, RM/SM(NRCM),
Philippe J. Dufresne, PhD, RMCCM SM(ASCP)
Elizabeth Berkow, PhD Audrey N. Schuetz, MD, MPH, D(ABMM)
Jeff Fuller, PhD, FCCM, D(ABMM) Paul E. Verweij, MD, FECMM
Kimberly E. Hanson, MD, MHS Nathan P. Wiederhold, PharmD
Nicole M. Holliday, BA Adrian M. Zelazny, PhD, D(ABMM)

Abstract
Clinical and Laboratory Standards Institute document M60Performance Standards for Antifungal Susceptibility Testing of
Yeasts includes minimal inhibitory concentration, zone diameter, and quality control tables developed following the guidance in
CLSI documents M271 and M44.2 The data in the tables are valid only when the methodologies in CLSI documents M271 and
M442 are followed. 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 Antifungal Susceptibility Testing of Yeasts. 2nd
ed. CLSI supplement M60 (ISBN 978-1-68440-082-9 [Print]; ISBN 978-1-68440-083-6 [Electronic]). Clinical and Laboratory
Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087 USA, 2020.

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guideline, users should replace outdated editions with the current editions of CLSI documents.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:
customerservice@clsi.org; Website: www.clsi.org.
M60-Ed2

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Suggested Citation

CLSI. Performance Standards for Antifungal Susceptibility Testing of Yeasts. 2nd ed. CLSI supplement
M60. Wayne, PA: Clinical and Laboratory Standards Institute; 2020.

Previous Editions:
M27-S4: May 2004, April 2005, April 2008, December 2012
M44-S3: January 2006, August 2007, August 2009
M60-Ed1: November 2017

M60-Ed2
ISBN 978-1-68440-082-9 (Print)
ISBN 978-1-68440-083-6 (Electronic)
ISSN 1558-6502 (Print)
ISSN 2162-2914 (Electronic) Volume 40, Number 8
 M60-Ed2

Committee Membership
Subcommittee on Antifungal Susceptibility Tests

Gary W. Procop, MD, MS Jeff Fuller, PhD, FCCM, D(ABMM) Audrey N. Schuetz, MD, MPH,
Chairholder London Health Sciences Centre D(ABMM)
Cleveland Clinic Canada Mayo Clinic
USA USA
Kimberly E. Hanson, MD, MHS
Philippe J. Dufresne, PhD, RMCCM University of Utah and ARUP Paul E. Verweij, MD, FECMM
Vice-Chairholder Laboratories Radboud University Medical Center
Institut national de santé publique du USA Netherlands
Québec
Canada Nicole M. Holliday, BA Nathan P. Wiederhold, PharmD
Thermo Fisher Scientific University of Texas Health Science
Camille Hamula, PhD, D(ABMM) USA Center at San Antonio
Committee Secretary USA
Saskatoon Health Region/University David H. Pincus, MS, RM/SM(NRCM),
of Saskatchewan SM(ASCP) Adrian M. Zelazny, PhD, D(ABMM)
Canada bioMérieux, Inc. USA
USA
Elizabeth Berkow, PhD
Centers for Disease Control and
Prevention
USA

Working Group on Antifungal Epidemiological Cutoff Values

Shawn R. Lockhart, PhD, D(ABMM), Barbara D. Alexander, MD, MHS Kerian K. Grande Roche, PhD
F(AAM) Duke University Medical Center FDA Center for Drug Evaluation and
Chairholder USA Research
Centers for Disease Control and USA
Prevention Elizabeth Berkow, PhD
USA Centers for Disease Control and Kimberly E. Hanson, MD, MHS
Prevention University of Utah and ARUP
Philippe J. Dufresne, PhD, RMCCM USA Laboratories
Vice-Chairholder USA
Institut national de santé publique du Jeff Fuller, PhD, FCCM, D(ABMM)
Québec London Health Sciences Centre John D. Turnidge, MD, BS, FRACP,
Canada Canada FASM, FRCPA
The University of Adelaide
Nathan P. Wiederhold, PharmD Mahmoud A. Ghannoum, PhD, FIDSA, Australia
Committee Secretary MBA
University of Texas Health Science Case Western Reserve University Thomas J. Walsh, MD, FIDSA, FAAM,
Center at San Antonio USA FECMM
USA Weill Cornell Medicine of Cornell
University and New York Presbyterian
Hospital
USA

iii
M60-Ed2

Working Group on Antifungal Reporting

Audrey N. Schuetz, MD, MPH, Stephanie L. Mitchell, PhD, D(ABMM) Nathan P. Wiederhold, PharmD
D(ABMM) UPMC/University of Pittsburgh University of Texas Health Science
Co-Chairholder USA Center at San Antonio
Mayo Clinic USA
USA Natasha N. Pettit, PharmD, BCPS (AQ-
ID) Matthew A. Wikler, MD, FIDSA, MBA
Vera Tesic, MD, MS, D(ABMM) University of Chicago Medicine IDTD Consulting
Co-Chairholder USA USA
University of Chicago
USA Thomas J. Walsh, MD, FIDSA, FAAM, Yanan (Nancy) Zhao, PhD
FECMM Center for Discovery and Innovation,
Tanis Dingle, PhD, D(ABMM), FCCM Weill Cornell Medicine of Cornell Hackensack Meridian Health
University of Alberta Hospital University and New York Presbyterian USA
Canada Hospital
USA
Kimberly E. Hanson, MD, MHS
University of Utah and ARUP
Laboratories
USA

Staff

Clinical and Laboratory Standards Megan L. Tertel, MA, ELS Kristy L. Leirer, MS
Institute Editorial Manager Editor
USA
Catherine E.M. Jenkins Laura Martin
Marcy L. Hackenbrack, MCM, Editor Editor
M(ASCP)
Project Manager

Acknowledgment

CLSI and the Subcommittee on Antifungal Susceptibility Tests gratefully acknowledge the following
volunteers for their important contributions to the revision of this document:

Elizabeth Berkow, PhD Adrian M. Zelazny, PhD, D(ABMM)

Centers for Disease Control and USA
Prevention
USA
 M60-Ed2

Contents

Abstract ....................................................................................................................................................i

Committee Membership........................................................................................................................ iii

Foreword .............................................................................................................................................. vii

Abbreviations and Acronyms ................................................................................................................. x

References ..............................................................................................................................................xi

Table 1. Minimal Inhibitory Concentration Breakpoints for In Vitro Broth Dilution Susceptibility
Testing of Candida spp. and Select Antifungal Agents After 24-Hour Incubation ................................ 1

Table 2. Solvents and Diluents for Preparing Stock Antifungal Agent Solutions for Broth
Dilution Testing ...................................................................................................................................... 5

Table 3. Recommended 24-Hour Minimal Inhibitory Concentration Limits for Quality Control
Strains for Broth Microdilution Procedures ............................................................................................ 6

Table 4. Recommended 48-Hour Minimal Inhibitory Concentration Limits for Two Quality
Control and Four Reference Strains for Broth Macrodilution Procedures.............................................. 8

Table 5. Zone Diameter and Equivalent Minimal Inhibitory Concentration Breakpoints for Select
Antifungal Agents Against Candida spp. After 24-Hour Incubation ..................................................... 9

Table 6. Recommended Quality Control Zone Diameter (mm) Ranges After 24-Hour
Incubation ............................................................................................................................................. 11

The Quality Management System Approach ........................................................................................ 12

Related CLSI Reference Materials ....................................................................................................... 13

v
M60-Ed2
 M60-Ed2

Foreword
The breakpoints and interpretive categories provided in this document are generated using the reference
methods for antifungal susceptibility testing of yeasts described in CLSI documents M271 and M44.2 These
reference methods may be used for:

 Routine antifungal testing of patient isolates to guide therapy

 Evaluation of commercial devices that will be used in medical laboratories
 Testing of new agents or systems by drug or device manufacturers

Results generated by reference methods, such as those described in CLSI documents, may be used by
regulatory authorities to evaluate commercial susceptibility testing device performance as part of the
commercial device 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.

However, CLSI breakpoints may differ from breakpoints approved by various regulatory organizations for
many reasons, including:

 Database differences
 Data interpretation
 Dosage amounts used in different parts of the world
 Public health policies

Differences also exist because CLSI proactively evaluates the need for changing breakpoints. The reasons
that breakpoints may change, as well as the manner in which CLSI evaluates data and determines
breakpoints, are described in CLSI document M23.3

When CLSI decides to change an existing breakpoint, regulatory organizations may also review data to
determine how the changes may affect antimicrobial agent safety and effectiveness for the approved
indications. When a regulatory authority changes breakpoints, commercial device manufacturers may have
to conduct a clinical trial, submit the data to the regulatory organization, and await review and approval.
For these reasons, a delay of one or more years may be needed if a device manufacturer decides to
implement a breakpoint change. Some regulatory and accreditation requirements permit laboratories using
cleared or approved testing devices to use existing regulatory organization breakpoints. Either the
regulatory approved breakpoints or CLSI breakpoints may be acceptable to laboratory accreditation
organizations. Other regulatory and accreditation requirements vary. Each laboratory should consult its
susceptibility test system manufacturer for additional information on the breakpoints used in its system
software. Laboratories should be aware of their specific regulatory and accreditation requirements for using
CLSI breakpoints.

Following discussions with appropriate stakeholders (eg, infectious diseases practitioners and pharmacy
practitioners, the hospital’s pharmacy and therapeutics and infection prevention committees), laboratories
may implement newly approved or revised CLSI breakpoints as soon as they are published. Some devices
might specify antimicrobial test concentrations that are sufficient to interpret susceptibility and resistance
to an agent using the CLSI breakpoints. In such cases, after appropriate validation as outlined in CLSI
document M52,4 a laboratory could choose to interpret and report results from that device using CLSI
breakpoints.

NOTE: Current fungal taxonomy is under revision. Many genera have both a teleomorph (sexual state) and
an anamorph (asexual state) name. In this document, the traditional Candida anamorph names are used to
provide continuity with both past procedures and associated documents such as CLSI document M27.1

vii
M60-Ed2

Overview of Changes

This document replaces the previous edition of the approved document, M60-Ed1, published in 2017.
Several changes were made in this edition, including:

 Table 1. Minimal Inhibitory Concentration Breakpoints for In Vitro Broth Dilution Susceptibility
Testing of Candida spp. and Select Antifungal Agents After 24-Hour Incubation:
 Added footnote and references regarding recommendations for interpreting Candida parapsilosis
breakpoints

 Revised footnote regarding intrinsic resistance of Candida krusei to fluconazole

 Table 2. Solvents and Diluents for Preparing Stock Antifungal Agent Solutions for Broth Dilution
Testing:
 Added solvent and diluent information for:
o Ibrexafungerp
o Manogepix
o Rezafungin

 Table 3. (formerly Table 4) Recommended 24-Hour Minimal Inhibitory Concentration Limits

for Quality Control Strains for Broth Microdilution Procedures:

NOTE 1: In the previous edition of M60, Table 3 contained 48-hour QC ranges, and Table 4 contained
24-hour QC ranges. In this edition, the tables have been transposed.

NOTE 2: The minimal inhibitory concentration (MIC) QC ranges for ibrexafungerp were adopted by
the Subcommittee on Antifungal Susceptibility Tests during the annual meetings in January 2019 and
January 2020. These QC ranges are tentative and are open for comment for one year from the
publication of M60.

 Added MIC QC ranges for:

o Ibrexafungerp
 C. krusei ATCC® 6258
 C. parapsilosis ATCC® 22019

o Manogepix
 Candida albicans ATCC® 90028
 C. parapsilosis ATCC® 22019

o Rezafungin
 C. krusei ATCC® 6258
 C. parapsilosis ATCC® 22019

 Revised NOTE regarding MICs

 Deleted NOTE regarding tentative 24-hour MIC QC ranges

 Table 5. Zone Diameter and Equivalent Minimal Inhibitory Concentration Breakpoints for
Select Antifungal Agents Against Candida spp. After 24-Hour Incubation:
 Revised footnote regarding intrinsic resistance of C. krusei to fluconazole

 Deleted footnotes regarding tentative zone diameter interpretive categories

 M60-Ed2

 Table 6. Recommended Quality Control Zone Diameter (mm) Ranges After 24-Hour Incubation:

NOTE: The QC zone diameter ranges were adopted by the Subcommittee on Antifungal Susceptibility
Tests during the annual meetings in January 2019 and January 2020. These zone diameter QC ranges
are tentative and are open for comment for one year from the publication of M60.

 Added disk diffusion QC ranges for:

o Manogepix
 C. albicans ATCC® 90028
 C. parapsilosis ATCC® 22019
 Candida tropicalis ATCC® 750

o Rezafungin
 C. albicans ATCC® 90028
 C. krusei ATCC® 6258
 C. parapsilosis ATCC® 22019
 C. tropicalis ATCC® 750

 Deleted footnote regarding tentative zone diameter QC ranges

NOTE: The content of this document is supported by the CLSI consensus process and does not necessarily
reflect the views of any single individual or organization.

Key Words

Antifungal agent, azole, breakpoint, broth dilution, disk diffusion, echinocandin, interpretive category,
minimal inhibitory concentration, quality control, susceptibility testing, yeasts, zone diameter

ix
M60-Ed2

Abbreviations and Acronyms

ATCC®a American Type Culture Collection
DMSO dimethyl sulfoxide
DNA deoxyribonucleic acid
ECV epidemiological cutoff value
I intermediate
MIC minimal inhibitory concentration
QC quality control
R resistant
S susceptible
SDD susceptible-dose dependent

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

 M60-Ed2

References
1
CLSI. Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts. 4th ed. CLSI standard M27. Wayne, PA:
Clinical and Laboratory Standards Institute; 2017.
2
CLSI. Method for Antifungal Disk Diffusion Susceptibility Testing of Yeasts. 3rd ed. CLSI guideline M44. Wayne, PA: Clinical and
Laboratory Standards Institute; 2018.
3
CLSI. Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters. 5th ed. CLSI guideline M23.
Wayne, PA: Clinical and Laboratory Standards Institute; 2018.
4
CLSI. Verification of Commercial Microbial Identification and Antimicrobial Susceptibility Testing Systems. 1st ed. CLSI guideline
M52. Wayne, PA: Clinical and Laboratory Standards Institute; 2015.

xi
M60-Ed2
 M60-Ed2

Table 1. Minimal Inhibitory Concentration Breakpoints for In Vitro Broth Dilution

Susceptibility Testing of Candida spp. and Select Antifungal Agents After 24-Hour
Incubation
MIC Breakpoints and Interpretive
Categories, µg/mL
Antifungal Agenta Species S Ib SDDc R
Anidulafungin1,d C. albicans ≤ 0.25 0.5 – ≥1
C. glabrata ≤ 0.12 0.25 – ≥ 0.5
C. guilliermondii ≤2 4 – ≥8
C. krusei ≤ 0.25 0.5 – ≥1
C. parapsilosise ≤2 4 – ≥8
C. tropicalis ≤ 0.25 0.5 – ≥1
Caspofungin1,d,f C. albicans ≤ 0.25 0.5 – ≥1
C. glabrata ≤ 0.12 0.25 – ≥ 0.5
C. guilliermondii ≤2 4 – ≥8
C. krusei ≤ 0.25 0.5 – ≥1
C. parapsilosise ≤2 4 – ≥8
C. tropicalis ≤ 0.25 0.5 – ≥1
Fluconazole2,c C. albicans ≤2 – 4 ≥8
C. glabratag – – ≤ 32 ≥ 64
C. kruseih – – – –
C. parapsilosise ≤2 – 4 ≥8
C. tropicalis ≤2 – 4 ≥8
Micafungin1,d C. albicans ≤ 0.25 0.5 – ≥1
C. glabrata ≤ 0.06 0.12 – ≥ 0.25
C. guilliermondii ≤2 4 – ≥8
C. krusei ≤ 0.25 0.5 – ≥1
C. parapsilosise ≤2 4 – ≥8
C. tropicalis ≤ 0.25 0.5 – ≥1
Voriconazole3,d C. albicans ≤ 0.12 0.25–0.5 – ≥1
C. glabratai – – – –
C. krusei ≤ 0.5 1 – ≥2
C. parapsilosise ≤ 0.12 0.25–0.5 – ≥1
C. tropicalis ≤ 0.12 0.25–0.5 – ≥1
Abbreviations: I, intermediate; MIC, minimal inhibitory concentration; R, resistant; S, susceptible; SDD, susceptible-dose
dependent.

Footnotes

a. Breakpoints may also be used for 48-hour readings if the 24-hour growth control shows insufficient growth.

b. The intermediate category provides a buffer zone for antimicrobial susceptibility testing that is necessary to avoid major and
very major errors that may occur, given the inherent variability of the in vitro testing method. Available data do not permit
isolates with minimal inhibitory concentration (MIC) results in the intermediate range to be clearly categorized as either
“susceptible” or “resistant.” Strains with intermediate MICs may respond clinically to a higher-than-standard dose of drug or
in situations in which drug penetration is maximized.

c. Susceptibility depends on achieving the maximum possible blood level. For fluconazole, doses higher than the standard dosing
amount (6 mg/kg/day) may be needed in adults with normal renal function and body habitus.

d. For these antifungal agents, the data are based largely on experience with non-neutropenic patients with candidemia. The
clinical relevance of the antifungal agents in other settings is uncertain.

©
Clinical and Laboratory Standards Institute. All rights reserved. 1
M60-Ed2

Table 1. (Continued)

e. For C. parapsilosis complex, when no further species determination has been performed, because the prevalence of the
cryptic species (C. orthopsilosis or C. metapsilosis) is low, C. parapsilosis breakpoints may be applied.4-8 However, if
further species determination identifies one of the cryptic species within the complex, C. parapsilosis breakpoints
should not be applied. Instead, it should be indicated on the laboratory report that no breakpoints exist for
interpretation, and use of epidemiological cutoff values (ECVs) should be considered (see CLSI document M599).

f. Caspofungin susceptibility testing in vitro has been associated with significant interlaboratory variability, contributing to
reports of false resistance when the reference method described in CLSI document M2710 is used.11 The cause of the variability
is unclear. When caspofungin is tested, susceptible results may be reported as “susceptible.” However, laboratories should
confirm “intermediate” or “resistant” results with one of the following options:

 Additional susceptibility testing with micafungin12 or anidulafungin13

 DNA sequence analysis of FKS genes to identify resistance hot-spot mutations in FKS1 (all Candida spp.) and FKS2 (C.
glabrata only)14,15
 Sending the isolate to a referral laboratory for confirmation

Candida spp. that are resistant to anidulafungin or micafungin or that possess characteristic FKS hot-spot mutations are
considered resistant to all echinocandins, including caspofungin, and should be reported as such. 12,13

g. For fluconazole, these breakpoints are based on extensive experience with mucosal and invasive infections due to Candida
spp. When an isolate is identified as C. glabrata and the MIC is ≤ 32 µg/mL, the clinician should determine whether
fluconazole is appropriate in the specific clinical context. If so, patients should receive the maximum dosage regimen of
fluconazole. Expert consultation on selecting a maximum dosage regimen may be useful.

h. Isolates of C. krusei are intrinsically resistant to fluconazole, so their MICs should not be interpreted using this scale.

i. For C. glabrata and voriconazole, current data are insufficient to demonstrate a correlation between in vitro susceptibility
testing and clinical outcome.

NOTE 1: Information in boldface type is new or modified since the previous edition.

NOTE 2: The selected breakpoints have been established to distinguish resistant variants from susceptible
isolates. Differences in breakpoints reflect methodological issues. Owing to in vitro methodological issues,
the breakpoint for micafungin against C. glabrata is lower than that of other echinocandins, which does not
reflect any inherent clinical differences in efficacy. True differences in antifungal activity among the
echinocandins are rare.16

NOTE 3: The MIC breakpoints (µg/mL) for Candida spp. are shown against the indicated agents. If MICs
are measured using a scale yielding results that fall between the categories, the next highest category is
implied. Thus, an isolate for which the fluconazole MIC equals 3 µg/mL would be placed in the
“susceptible-dose dependent” category.

NOTE 4: Per CLSI document M61,17 previous breakpoints for itraconazole and flucytosine were
established with minimal clinical data. Emerging data now suggest that the previous breakpoints were not
correct and should not be used. For Candida spp. and itraconazole, ECVs that define the limit of the wild-
type distribution are established and may be useful for distinguishing between wild-type and non-wild-type
isolates (those with acquired known resistance mechanisms) (see CLSI documents M5718 and M599).

References for Table 1

1
Pfaller MA, Diekema DJ, Andes D, et al.; CLSI Subcommittee for Antifungal Testing. Clinical
breakpoints for the echinocandins and Candida revisited: integration of molecular, clinical, and
microbiological data to arrive at species-specific interpretive criteria. Drug Resist Updat.
2011;14(3):164-176.

©
Clinical and Laboratory Standards Institute. All rights reserved.
 M60-Ed2

Table 1. (Continued)
2
Pfaller MA, Andes D, Diekema DJ, Espinel-Ingroff A, Sheehan D; CLSI Subcommittee for Antifungal
Susceptibility Testing. Wild-type MIC distributions, epidemiological cutoff values and species-specific
clinical breakpoints for fluconazole and Candida: time for harmonization of CLSI and EUCAST broth
microdilution methods. Drug Resist Updat. 2010;13(6):180-195.
3
Pfaller MA, Andes D, Arendrup MC, et al. Clinical breakpoints for voriconazole and Candida spp.
revisited: review of microbiologic, molecular, pharmacodynamic, and clinical data as they pertain to
the development of species-specific interpretive criteria. Diagn Microbiol Infect Dis. 2011;70(3):330-
343.
4
Borman AM, Muller J, Walsh-Quantick J, et al. Fluconazole resistance in isolates of uncommon
pathogenic yeast species from the United Kingdom. Antimicrob Agents Chemother. 2019;63(8):pii.
e00211-19.
5
Pfaller MA, Diekema DJ, Turnidge JD, Castanheira M, Jones RN. Twenty years of the SENTRY
Antifungal Surveillance Program: results for Candida species from 1997-2016. Open Forum
Infect Dis. 2019;6(suppl 1):S79-S94.
6
Maria S, Barnwal G, Kumar A, et al. Species distribution and antifungal susceptibility among
clinical isolates of Candida parapsilosis complex from India. Rev Iberoam Micol. 2018;35(3):147-
150.
7
Vigezzi C, Icely PA, Dudiuk C, et al. Frequency, virulence factors and antifungal susceptibility
of Candida parapsilosis species complex isolated from patients with candidemia in the central
region of Argentina. J Mycol Med. 2019;29(4):285-291.
8
Castanheira M, Deshpande LM, Messer SA, Rhomberg PR, Pfaller MA. Analysis of global
antifungal surveillance results reveals predominance of Erg11 Y132F alteration among azole-
resistant Candida parapsilosis and Candida tropicalis and country-specific isolate dissemination.
Int J Antimicrob Agents. 2020;55(1):105799.
9
CLSI. Epidemiological Cutoff Values for Antifungal Susceptibility Testing. 3rd ed. CLSI supplement
M59. Wayne, PA: Clinical and Laboratory Standards Institute; 2020.
10
CLSI. Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts. 4th ed. CLSI
standard M27. Wayne, PA: Clinical and Laboratory Standards Institute; 2017.
11
Espinel-Ingroff A, Arendrup MC, Pfaller MA, et al. Interlaboratory variability of caspofungin MICs
for Candida spp. using CLSI and EUCAST methods: should the clinical laboratory be testing this
agent? Antimicrob Agents Chemother. 2013;57(12):5836-5842.
12
Pfaller MA, Messer SA, Diekema DJ, Jones RN, Castanheira M. Use of micafungin as a surrogate
marker to predict susceptibility and resistance to caspofungin among 3,764 clinical isolates of Candida
by use of CLSI methods and interpretive criteria. J Clin Microbiol. 2014;52(1):108-114.
13
Pfaller MA, Diekema DJ, Jones RN, Castanheira M. Use of anidulafungin as a surrogate marker to
predict susceptibility and resistance to caspofungin among 4,290 clinical isolates of Candida by using
CLSI methods and interpretive criteria. J Clin Microbiol. 2014;52(9):3223-3229.

©
Clinical and Laboratory Standards Institute. All rights reserved. 3
M60-Ed2

Table 1. (Continued)
14
Arendrup MC, Perlin DS. Echinocandin resistance: an emerging clinical problem? Curr Opin Infect
Dis. 2014;27(6):484-492.
15
Garcia-Effron G, Lee S, Park S, Cleary JD, Perlin DS. Effect of Candida glabrata FKS1 and FKS2
mutations on echinocandin sensitivity and kinetics of 1,3-beta-D-glucan synthase: implication for the
existing susceptibility breakpoint. Antimicrob Agents Chemother. 2009;53(9):3690-3699.
16
Arendrup MC, Perlin DS, Jensen RH, Howard SJ, Goodwin J, Hope W. Differential in vivo activities
of anidulafungin, caspofungin, and micafungin against Candida glabrata isolates with and without FKS
resistance mutations. Antimicrob Agents Chemother. 2012;56(5):2435-2442.
17
CLSI. Performance Standards for Antifungal Susceptibility Testing of Filamentous Fungi. 2nd ed.
CLSI supplement M61. Wayne, PA: Clinical and Laboratory Standards Institute; 2020.
18
CLSI. Principles and Procedures for the Development of Epidemiological Cutoff Values for Antifungal
Susceptibility Testing. 1st ed. CLSI guideline M57. Wayne, PA: Clinical and Laboratory Standards
Institute; 2016.

©
Clinical and Laboratory Standards Institute. All rights reserved.
 M60-Ed2

Table 2. Solvents and Diluents for Preparing Stock Antifungal Agent Solutions for
Broth Dilution Testing
Solventa,b
(Full-Strength and Diluent
Antifungal Agent Intermediate Solutions) (Final Concentration)
Amphotericin B DMSO Medium
Anidulafungin DMSO Medium
Caspofungin DMSO Medium
Fluconazole DMSO Medium
Flucytosine DMSO Medium
Ibrexafungerp DMSO Medium
Isavuconazole DMSO Medium
Itraconazole DMSO Medium
Ketoconazole DMSO Medium
Manogepix DMSO Medium
Micafungin DMSO Medium
Posaconazole DMSO Medium
Rezafungin DMSO Medium
Voriconazole DMSO Medium
Abbreviation: DMSO, dimethyl sulfoxide.

Footnotes

a. Dimethyl sulfoxide (DMSO) can be toxic and also enables other drugs to be absorbed through the skin. Before DMSO is used,
the DMSO safety data sheet should be consulted.

b. The laboratory should follow the manufacturer’s recommendations when selecting a solvent.

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

©
Clinical and Laboratory Standards Institute. All rights reserved. 5
M60-Ed2

Table 3. Recommended 24-Hour Minimal Inhibitory Concentration Limits for

Quality Control Strains for Broth Microdilution Procedures1,2
MIC Range, % of MICs
Organism Antifungal Agent µg/mL Mode Within Range
Candida albicans Manogepix 0.004–0.015 0.008 100
ATCC®a 90028
Candida krusei Amphotericin B 0.5–2 1 100
ATCC® 6258 Anidulafungin 0.03–0.12 0.06 97.9
Caspofunginb 0.12–1 0.5 98.8
Fluconazole 8–64 16 100
Flucytosine 4–16 8 97.5
Ibrexafungerpc 0.25–1 0.5 100
Isavuconazole 0.06–0.5 0.25 95.2
Itraconazole 0.12–1 0.5 95.8
Ketoconazole 0.12–1 0.5 95.4
Micafungin 0.12–0.5 0.25 99.6
Posaconazole 0.06–0.5 0.25 100
Rezafungin 0.015–0.12 0.03 99.5
Voriconazole 0.06–0.5 0.25 98.3
Candida parapsilosis Amphotericin B 0.25–2 0.5 97.1
ATCC® 22019 Anidulafungin 0.25–2 1 95
Caspofungin 0.25–1 0.5 96.7
Fluconazole 0.5–4 2 98.2
Flucytosine 0.06–0.25 0.12 99.2
Ibrexafungerpc 0.06–0.25 0.12 99.0
Isavuconazole 0.015–0.06 0.06 90.5
Itraconazole 0.06–0.5 0.25 95.8
Ketoconazole 0.03–0.25 0.06/0.12 97.5
Manogepix 0.008–0.03 0.015 100
Micafungin 0.5–2 1 100
Posaconazole 0.03–0.25 0.12 96.7
Rezafungin 0.25–2 0.5 99.2
Voriconazole 0.016–0.12 0.06 100
Abbreviations: ATCC®, American Type Culture Collection; MIC, minimal inhibitory concentration.

Footnotes

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

b. The QC ranges were established using data generated in 2010 from 15 reference laboratories. Since then, caspofungin
susceptibility testing has been associated with significant variation. Therefore, misclassification of susceptible isolates may
occur despite acceptable performance of the QC strains according to the range in this table (see CLSI document M273).4-6

c. The 48-hour microdilution minimal inhibitory concentration (MIC) QC range for ibrexafungerp is available for C.
krusei ATCC® 6258: 0.25 to 1 µg/mL. No 48-hour MIC QC range for ibrexafungerp is currently available for C.
parapsilosis ATCC® 22019.

NOTE 1: Information in boldface type is new or modified since the previous edition.

NOTE 2: The MIC for anidulafungin, caspofungin, ibrexafungerp, manogepix, micafungin, and
rezafungin is the lowest concentration at which a score of 2 (prominent decrease in turbidity, or > 50%
inhibition of growth compared with the growth control; see CLSI document M273) is observed after 24
hours of incubation.

©
Clinical and Laboratory. Standards Institute. All rights reserved.
 M60-Ed2

Table 3. (Continued)

NOTE 3: When a commercial test system is used for susceptibility testing, the users should refer to the
manufacturer’s instructions for QC test recommendations and QC ranges.

References for Table 3

1
Barry AL, Pfaller MA, Brown SD, et al. Quality control limits for broth microdilution susceptibility
tests of ten antifungal agents. J Clin Microbiol. 2000;38(9):3457-3459.
2
Krisher K, Brown SD, Traczewski MM. Quality control parameters for broth microdilution tests of
anidulafungin. J Clin Microbiol. 2004;42(1):490.
3
CLSI. Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts. 4th ed. CLSI
standard M27. Wayne, PA: Clinical and Laboratory Standards Institute; 2017.
4
Shields RK, Nguyen MH, Press EG, et al. The presence of an FKS mutation rather than MIC is an
independent risk factor for failure of echinocandin therapy among patients with invasive candidiasis
due to Candida glabrata. Antimicrob Agents Chemother. 2012;56(9):4862-4869.
5
Arendrup MC, Pfaller MA; Danish Fungaemia Study Group. Caspofungin Etest susceptibility testing
of Candida species: risk of misclassification of susceptible isolates of C. glabrata and C. krusei when
adopting the revised CLSI caspofungin breakpoints. Antimicrob Agents Chemother. 2012;56(7):3965-
3968.
6
Espinel-Ingroff A, Arendrup MC, Pfaller MA, et al. Interlaboratory variability of caspofungin MICs
for Candida spp. using CLSI and EUCAST methods: should the clinical laboratory be testing this
agent? Antimicrob Agents Chemother. 2013:57(12):5836-5842.

©
Clinical and Laboratory Standards Institute. All rights reserved. 7
M60-Ed2

Table 4. Recommended 48-Hour Minimal Inhibitory Concentration Limits for Two

Quality Control and Four Reference Strains for Broth Macrodilution Procedures1,2
MIC Range, % of MICs
Organism Purpose Antifungal Agent µg/mL Within Range
Candida krusei QC Amphotericin B 0.25–2 99.5
ATCC®a 6258 Fluconazole 16–64 99.1
Flucytosine 4–16 96.8
Itraconazole 0.12–0.5 94
Ketoconazole 0.12–0.5 100
Candida QC Amphotericin B 0.25–1 99.1
parapsilosis Fluconazole 2–8 99.1
ATCC® 22019 Flucytosine 0.12–0.5 98.6
Itraconazole 0.06–0.25 99
Ketoconazole 0.06–0.25 99
Candida albicans Reference Amphotericin B 0.5–2 91.9
ATCC® 90028 Fluconazole 0.25–1 97.3
Flucytosine 0.5–2 95
C. albicans Reference Amphotericin B 0.25–1 99.5
ATCC® 24433 Fluconazole 0.25–1 95.9
Flucytosine 1–4 91.9
C. parapsilosis Reference Amphotericin B 0.5–2 96.4
ATCC® 90018 Fluconazole 0.25–1 98.2
Flucytosine  0.12–0.25 99.5
Candida tropicalis Reference Amphotericin B 0.5–2 93.7
ATCC® 750 Fluconazole 1–4 95.5
Flucytosine  0.12–0.25 99.5
Abbreviations: ATCC®, American Type Culture Collection; MIC, minimal inhibitory concentration; QC, quality control.

Footnote

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

References for Table 4

1
Pfaller MA, Bale M, Buschelman B, et al. Quality control guidelines for National Committee for
Clinical Laboratory Standards recommended broth macrodilution testing of amphotericin B,
fluconazole, and flucytosine. J Clin Microbiol. 1995;33(5):1104-1107.
2
Rex JH, Pfaller MA, Lancaster M, Odds FC, Bolmström A, Rinaldi MG. Quality control guidelines for
National Committee for Clinical Laboratory Standards--recommended broth macrodilution testing of
ketoconazole and itraconazole. J Clin Microbiol. 1996;34(4):816-817.

©
Clinical and Laboratory Standards Institute. All rights reserved.
 Table 5. Zone Diameter and Equivalent Minimal Inhibitory Concentration Breakpoints for Select Antifungal Agents
©
Clinical and Laboratory Standards Institute. All rights reserved.

Against Candida spp. After 24-Hour Incubation1-9

Zone Diameter Breakpoints and Equivalent MIC Breakpoints and Interpretive
Interpretive Categories, mm Categories, µg/mL
Antifungal Agenta Species S I SDD R S I SDD R
Caspofungin C. albicans ≥ 17 15–16 – ≤ 14 ≤ 0.25 0.5 – ≥1
C. glabrata – – – – ≤ 0.12 0.25 – ≥ 0.5
C. guilliermondii ≥ 13 11–12 – ≤ 10 ≤2 4 – ≥8
C. krusei ≥ 17 15–16 – ≤ 14 ≤ 0.25 0.5 – >1
C. parapsilosis ≥ 13 11–12 – ≤ 10 ≤2 4 – ≥8
C. tropicalis ≥ 17 15–16 – ≤ 14 ≤ 0.25 0.5 – >1
Fluconazole C. albicans ≥ 17 – 14–16 ≤ 13 ≤2 – 4 ≥8
C. glabrata – – ≥ 15 ≤ 14 – – ≤ 32 ≥ 64
C. kruseib – – – – – – – –
C. parapsilosis ≥ 17 – 14–16 ≤ 13 ≤2 – 4 ≥8
C. tropicalis ≥ 17 – 14–16 ≤ 13 ≤2 – 4 ≥8
Micafungin C. albicans ≥ 22 20–21 – ≤ 19 ≤ 0.25 0.5 – ≥1
C. glabrata ≥ 30 28–29 – ≤ 27 ≤ 0.06 0.12 – ≥ 0.25
C. guilliermondii ≥ 16 14–15 – ≤ 13 ≤2 4 – ≥8
C. krusei ≥ 22 20–21 – ≤ 19 ≤ 0.25 0.5 – ≥1
C. parapsilosis ≥ 16 14–15 – ≤ 13 ≤2 4 – ≥8
C. tropicalis ≥ 22 20–21 – ≤ 19 ≤ 0.25 0.5 – ≥1
Voriconazole C. albicans ≥ 17 15–16 – ≤ 14 ≤ 0.12 0.25–0.5 – ≥1
C. glabratac – – – – – – – –
C. krusei ≥ 15 13–14 – ≤ 12 ≤ 0.5 1 – ≥2
C. parapsilosis ≥ 17 15–16 – ≤ 14 ≤ 0.12 0.25–0.5 – ≥1
C. tropicalis ≥ 17 15–16 – ≤ 14 ≤ 0.12 0.25–0.5 – ≥1
Abbreviations: I, intermediate; MIC, minimal inhibitory concentration; R, resistant; S, susceptible; SDD, susceptible-dose dependent.

Footnotes

a. Breakpoints may also be used for 48-hour readings if the 24-hour growth control shows insufficient growth.

b. Isolates of C. krusei are intrinsically resistant to fluconazole. Therefore, their minimal inhibitory concentrations should not be interpreted using this scale.

c. For C. glabrata and voriconazole, current data are insufficient to demonstrate a correlation between in vitro susceptibility testing and clinical outcome.

M60-Ed2
9
M60-Ed2

Table 5. (Continued)

References for Table 5

1
Arendrup MC, Park S, Brown S, Pfaller M, Perlin DS. Evaluation of CLSI M44-A2 disk diffusion and
associated breakpoint testing of caspofungin and micafungin using a well-characterized panel of wild-
type and fks hot spot mutant Candida isolates. Antimicrob Agents Chemother. 2011;55(5):1891-1895.
2
Brown SD, Traczewski MM. Caspofungin disk diffusion breakpoints and quality control. J Clin
Microbiol. 2008;46(6):1927-1929.
3
Pfaller MA, Diekema DJ, Ostrosky-Zeichner L, et al. Correlation of MIC with outcome for Candida
species tested against caspofungin, anidulafungin, and micafungin: analysis and proposal for
interpretive MIC breakpoints. J Clin Microbiol. 2008;46(8):2620-2629.
4
Pfaller MA, Andes D, Arendrup MC, et al. Clinical breakpoints for voriconazole and Candida spp.
revisited: review of microbiologic, molecular, pharmacodynamic, and clinical data as they pertain to
the development of species-specific interpretive criteria. Diagn Microbiol Infect Dis. 2011;70(3):330-
343.
5
Pfaller MA, Diekema DJ, Rex JH, et al. Correlation of MIC with outcome for Candida species tested
against voriconazole: analysis and proposal for interpretive breakpoints. J Clin Microbiol.
2006;44(3):819-826.
6
Barry AL, Pfaller MA, Rennie RP, Fuchs PC, Brown SD. Precision and accuracy of fluconazole
susceptibility testing by broth microdilution, Etest, and disk diffusion methods. Antimicrob Agents
Chemother. 2002;46(6):1781-1784.
7
Pfaller MA, Diekema DJ, Sheehan DJ. Interpretive breakpoints for fluconazole and Candida revisited:
a blueprint for the future of antifungal susceptibility testing. Clin Microbiol Rev. 2006;19(2):435-447.
8
Pfaller MA, Hazen KC, Messer SA, et al. Comparison of results of fluconazole disk diffusion testing
for Candida species with results from a central reference laboratory in the ARTEMIS Global Antifungal
Surveillance Program. J Clin Microbiol. 2004;42(8):3607-3612.
9
Rex JH, Pfaller MA, Galgiani JN, et al.; Subcommittee on Antifungal Susceptibility Testing of the
National Committee for Clinical Laboratory Standards. Development of interpretive breakpoints for
antifungal susceptibility testing: conceptual framework and analysis of in vitro-in vivo correlation data
for fluconazole, itraconazole, and Candida infections. Clin Infect Dis. 1997;24(2):235-247.

©
Clinical and Laboratory Standards Institute. All rights reserved.
 M60-Ed2

Table 6. Recommended Quality Control Zone Diameter (mm) Ranges After 24-Hour
Incubation1-5
Disk Candida Candida Candida
Antifungal Content, albicans Candida krusei parapsilosis tropicalis
Agent µg ATCC®a 90028 ATCC® 6258 ATCC® 22019 ATCC® 750
Caspofungin 5 18–27 19–26 14–23 20–27
Fluconazole 25 28–39 –b 22–33 26–37
Manogepix 5 32–44 – 26–34 33–43
Micafungin 10 24–31 23–29 14–23 24–30
Posaconazole 5 24–34 23–31 25–36 23–33
Rezafunginc 5 13–20 14–20 9–16 14–20
Voriconazole 1 31–42 16–25 28–37 –b
Abbreviation: ATCC®, American Type Culture Collection.

Footnotes

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

b. QC ranges have not been established for these fungal strain–antifungal agent combinations, owing to their extensive
interlaboratory variation during initial QC studies.

c. QC ranges for rezafungin were established using data from only one disk manufacturer. Disks from other
manufacturers were not available at the time of testing.

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

References for Table 6

1
Arendrup MC, Park S, Brown S, Pfaller M, Perlin DS. Evaluation of CLSI M44-A2 disk diffusion and
associated breakpoint testing of caspofungin and micafungin using a well-characterized panel of wild-
type and fks hot spot mutant Candida isolates. Antimicrob Agents Chemother. 2011;55(5):1891-1895.
2
Barry A, Bille J, Brown S, et al. Quality control limits for fluconazole disk susceptibility tests on
Mueller-Hinton agar with glucose and methylene blue. J Clin Microbiol. 2003;41(7):3410-3412.
3
Brown SD, Traczewski M. Caspofungin disk diffusion breakpoints and quality control. J Clin
Microbiol. 2008;46(6):1927-1929.
4
Brown S, Traczewski M. Quality control limits for posaconazole disk susceptibility tests on Mueller-
Hinton agar with glucose and methylene blue. J Clin Microbiol. 2007;45(1):222-223.
5
Pfaller MA, Barry A, Bille J, et al. Quality control limits for voriconazole disk susceptibility tests on
Mueller-Hinton agar with glucose and methylene blue. J Clin Microbiol. 2004;42(4):1716-1718.

©
Clinical and Laboratory Standards Institute. All rights reserved. 1. 11
M60-Ed2

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 and Leadership  Supplier and Inventory  Information Management

 Customer Focus Management  Nonconforming Event
 Facilities and Safety Management  Equipment Management Management
 Personnel Management  Process Management  Assessments
 Documents and Records  Continual Improvement
Management

M60 covers the QSE indicated by an “X.” For a description of the other documents listed in the grid, please refer to
the Related CLSI Reference Materials section.

Event Management
Organization and

Customer Focus

Nonconforming
Documents and

Improvement
Facilities and

Management

Management

Management

Management

Management

Management

Management

Assessments
Supplier and

Information
Leadership

Equipment
Personnel

Continual
Inventory

Records
Process
Safety

X
M23
M27
M44
M52
M57
M59
M61

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 their services, namely quality laboratory information.

M60 covers the medical laboratory path of workflow processes indicated by an “X.” For a description of the other
documents listed in the grid, please refer to the Related CLSI Reference Materials section.

Preexamination Examination Postexamination

Communication of
Laboratory results
Specimen receipt,
accessioning, and

method selection

alert values and

Release of final
Results review
and follow-up

interpretation
Examination

Examination

Examination

management
performance

preliminary
issuance of
processing
collection
Specimen

Specimen

Specimen
transport
ordering

reports

reports

X X X
M27 M27 M27 M27
M44 M44 M44 M44
M59 M59 M59
M61 M61 M61

©
Clinical and Laboratory Standards Institute. All rights reserved.
 M60-Ed2

Related CLSI Reference Materials

M23 Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters. 5th ed., 2018.
This guideline discusses the necessary and recommended data for selecting appropriate breakpoints and quality
control ranges for antimicrobial agents.

M27 Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts. 4th ed., 2017. This
standard covers antifungal agent selection and preparation, test procedure implementation and interpretation, and
quality control requirements for susceptibility testing of yeasts that cause invasive fungal infections.

M44 Method for Antifungal Disk Diffusion Susceptibility Testing of Yeasts. 3rd ed., 2018. This guideline provides
an established methodology for disk diffusion testing of Candida spp., along with recommendations for results
interpretation and quality control testing.

M52 Verification of Commercial Microbial Identification and Antimicrobial Susceptibility Testing Systems.
1st ed., 2015. This guideline includes recommendations for verification of commercial US Food and Drug
Administration–cleared microbial identification and antimicrobial susceptibility testing systems by clinical
laboratory professionals to fulfill regulatory or quality assurance requirements for the use of these systems for
diagnostic testing.

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. 3rd ed., 2020. This document provides
epidemiological cutoff values developed according to the criteria in the Clinical and Laboratory Standards
Institute (CLSI) guideline M57 and generated according to the reference broth dilution methods described in the
CLSI standards M27 and M38.

M61 Performance Standards for Antifungal Susceptibility Testing of Filamentous Fungi. 2nd ed., 2020. This
document provides minimal inhibitory concentration breakpoints and quality control tables for the Clinical and
Laboratory Standards Institute antifungal susceptibility testing documents M38 and M51.

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

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M60-Ed2

NOTES

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