4th Edition

M57S
Epidemiological Cutoff Values for Antifungal
Susceptibility Testing

This document includes 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.

A CLSI supplement for global application.

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 Clinical and Laboratory Standards Institute
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 M57S-Ed4
August 2022
Replaces M59-Ed3
Epidemiological Cutoff Values for Antifungal Susceptibility
Testing
Gary W. Procop, MD, MS
Philippe J. Dufresne, PhD, RMCCM
Elizabeth Berkow, PhD
Sharon K. Cullen, BS, RAC
Jeff Fuller, PhD, FCCM, D(ABMM)
Kimberly E. Hanson, MD, MHS
Nicole M. Holliday, BA
Shawn R. Lockhart, PhD, D(ABMM), F(AAM)
Audrey N. Schuetz, MD, MPH, D(ABMM)
Paul E. Verweij, MD, FECMM
Nathan P. Wiederhold, PharmD
Adrian M. Zelazny, PhD, D(ABMM)

Abstract
Clinical and Laboratory Standards Institute document M57S—Epidemiological Cutoff Values for Antifungal
Susceptibility Testing includes epidemiological cutoff values (ECVs) and quality control tables developed
following the guidance in CLSI document M57.1 These ECVs are valid only when they are developed in
accordance with CLSI document M571 and when minimal inhibitory concentrations or minimal effective
concentrations are generated according to the reference broth dilution methods described in CLSI documents
M272 and M38.3 Users should replace previously published tables with these new tables. Changes in the tables
since the previous edition was published appear in boldface type.

Clinical and Laboratory Standards Institute (CLSI). Epidemiological Cutoff Values for Antifungal Susceptibility
Testing. 4th ed. CLSI supplement M57S (ISBN 978-1-68440-158-1 [Print]; ISBN 978-1-68440-159-8 [Electronic]).
Clinical and Laboratory Standards Institute, USA, 2022.

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
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the current editions of CLSI documents. Current editions are listed in the CLSI catalog and posted on our
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If you or your organization is not a member and would like to become one,
The Clinical and Laboratory Standards Institute consensus process, which is the mechanism for moving a document through two
or to request a copy of the catalog, contact us at:
or more levels of review by the health care community, is an ongoing process. Users should expect revised editions of any given
P: +1.610.688.0100;
document. Because rapid changesF: +1.610.688.0700;
in technology E: customerservice@clsi.org;
may affect www.clsi.org
W:protocols
the procedures, methods, and 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:

P: +1.610.688.0100 F: +1.610.688.0700 E: customerservice@clsi.org W: www.clsi.org

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 M57S-Ed4

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Suggested Citation
CLSI. Epidemiological Cutoff Values for Antifungal Susceptibility Testing. 4th ed. CLSI
supplement M57S. Clinical and Laboratory Standards Institute; 2022.

Previous Editions:
M59: April 2016, January 2018, June 2020

M57-Ed1-S-Ed4
ISBN 978-1-68440-158-1 (Print)
ISBN 978-1-68440-159-8 (Electronic)
ISSN 1558-6502 (Print)
ISSN 2162-2914 (Electronic) Volume 42, Number 18

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Committee Membership
Subcommittee on Antifungal Susceptibility Tests
Gary W. Procop, MD, MS
Chairholder
American Board of Pathology
USA
Philippe J. Dufresne, PhD, RMCCM
Vice-Chairholder
Institut national de santé publique
du Québec
Canada
Camille Hamula, PhD, D(ABMM)
Committee Secretary
Saskatoon Health Region/
University of Saskatchewan
Canada
Elizabeth Berkow, PhD
Centers for Disease Control and
Prevention
USA
Working Group on Antifungal Breakpoints
David Andes, MD
Co-Chairholder
University of Wisconsin–
Madison Medical School
USA
Andrew M. Borman, BSc, PhD
Co-Chairholder
Public Health England
United Kingdom
Nathan P. Wiederhold, PharmD
Committee Secretary
University of Texas Health Science
Center at San Antonio
USA
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Sharon K. Cullen, BS, RAC
Beckman Coulter, Inc.
Microbiology Business
USA
Jeff Fuller, PhD, FCCM, D(ABMM)
London Health Sciences Centre
Canada
Kimberly E. Hanson, MD, MHS
University of Utah and
ARUP Laboratories
USA
Nicole M. Holliday, BA
Thermo Fisher Scientific
USA
Mariana Castanheira, PhD
JMI Laboratories
USA
Philippe J. Dufresne, PhD, RMCCM
Institut national de santé publique
du Québec
Canada
Kimberly E. Hanson, MD, MHS
University of Utah and
ARUP Laboratories
USA
M57S-Ed4
Audrey N. Schuetz, MD, MPH,
D(ABMM)
Mayo Clinic
USA
Paul E. Verweij, MD, FECMM
Radboud University Medical Center
the Netherlands
Nathan P. Wiederhold, PharmD
University of Texas Health Science
Center at San Antonio
USA
Adrian M. Zelazny, PhD, D(ABMM)
National Institutes of Health
Department of Laboratory Medicine
USA
Shawn R. Lockhart, PhD, D(ABMM),
F(AAM)
Centers for Disease Control and
Prevention
USA
Gary W. Procop, MD, MS
American Board of Pathology
USA
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 M57S-Ed4

Working Group on Antifungal Epidemiological Cutoff Values

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

Barbara D. Alexander, MD, MHS

Duke University Medical Center
USA

Working Group on Antifungal Reporting

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

Staff

Clinical and Laboratory Standards Laura Martin Kristy L. Leirer, MS

Institute Editorial Manager Editor
USA
Catherine E.M. Jenkins, ELS Lisa M.W. Walker, MS, ELS
Christine M. Lam, MT(ASCP) Editor Editor
Project Manager

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 M57S-Ed4

Contents

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

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

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

Overview of Changes .................................................................................. viii

Abbreviations and Acronyms ......................................................................... xiii

References .............................................................................................. xiv

Table 1. Epidemiological Cutoff Values for In Vitro Susceptibility Testing of

Candida spp. and Other Ascomycete Yeasts With No Breakpoints ............................... 1

Table 2. Epidemiological Cutoff Values for In Vitro Susceptibility Testing of

Cryptococcus spp. and Other Basidiomycete Yeasts With No Breakpoints ..................... 5

Table 3. Epidemiological Cutoff Values for In Vitro Susceptibility Testing of

Aspergillus spp. With No Breakpoints ................................................................ 7

Table 4. Epidemiological Cutoff Values for In Vitro Susceptibility Testing of

Candida spp. With Breakpoints ........................................................................ 9

Table 5. Epidemiological Cutoff Values for In Vitro Susceptibility Testing of

Aspergillus fumigatus With Breakpoints ........................................................... 11

Table 6. Summary of Available Epidemiological Cutoff Values and/or Breakpoints

by Fungal Species ...................................................................................... 12

Glossary. Antifungal Agent Abbreviations, Routes of Administration, and Drug Class ...... 16

The Quality Management System Approach ....................................................... 17

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 M57S-Ed4

Foreword
With the development of standard methodologies for testing the susceptibility of fungal
species to several antifungal agents, minimal inhibitory concentration (MIC) and minimal
effective concentration (MEC) distributions are available to determine epidemiological cutoff
values (ECVs) for ascomycete yeasts (Candida spp. and Saccharomyces spp.), basidiomycete
yeasts (Cryptococcus spp., Rhodotorula spp., Trichosporon spp.), and Aspergillus spp. of
clinical importance. The ECVs provided in this document were established using the guidance
in CLSI document M57.1 The ECV, which is the MIC or MEC that separates fungal populations
into those with and without acquired and/or mutational resistance based on their
phenotypes (wild-type [WT] or non-wild-type [NWT]), is useful for distinguishing between
WT isolates without acquired resistance mechanisms and NWT isolates harboring acquired
resistance mechanisms. Unlike breakpoints, ECVs do not classify isolates as treatable
(susceptible) or untreatable (resistant). In lieu of breakpoints, clinicians can use ECVs alone
when deciding whether to treat a patient with a certain agent (see CLSI document M571).
However, ECVs do not predict therapeutic response. For ECVs to be clinically useful, the MIC
or MEC should be determined using the broth microdilution procedure for yeasts (see CLSI
document M272) or the broth microdilution procedure for filamentous fungi (see CLSI
document M383).

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 M272 and others.4-6

NOTE: When serial twofold dilution MICs are being prepared and tested, the actual
dilution scheme is, eg, 128, 64, 32, 16, 8, 4, 2, 1, 0.5, 0.25, 0.125, 0.0625,
0.03125 µg/mL, etc. For convenience only, and not because these are the actual
concentrations tested, it was decided to use the following values in M57S: 128, 64, 32,
16, 8, 4, 2, 1, 0.5, 0.25, 0.12, 0.06, 0.03 µg/mL, etc. The values that appear in the tables
are equivalent to the actual values tested, eg, 0.12 µg/mL = 0.125 µg/mL, and laboratories
should report an ECV of ≤ 0.125 μg/mL as ≤ 0.12 μg/mL.

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 M57S-Ed4

Overview of Changes
This document replaces the previous edition of the approved document, M59-Ed3, published
in 2020. Several changes were made in this edition, including:

Section/Table Action Change to: Reason/Specific Change

General Revised Document code Align with parent document
(M57)
Foreword Added Foreword  Text defining ECV
 Text regarding teleomorph
and anamorph
nomenclature
 Text regarding ECV
reporting concentrations
Table 1. Epidemiological Revised Title Represent yeast species other
Cutoff Values for In Vitro than Candida spp.
Susceptibility Testing of Footnote Regarding potential
Candida spp. and Other limitations of ECVs in rare
Ascomycete Yeasts With instances
No Breakpoints Added ECVs for  Candida pelliculosa
amphotericin B  Saccharomyces cerevisiae
ECVs for  Candida auris
anidulafungin  Candida haemulonii
 S. cerevisiae
ECVs for  C. auris
caspofungin  S. cerevisiae
ECVs for  C. haemulonii
fluconazole  Candida pararugosa
 C. pelliculosa
 Candida rugosa
 S. cerevisiae
ECVs for  C. pelliculosa
itraconazole  S. cerevisiae
ECVs for  C. auris
micafungin  C. pelliculosa
 S. cerevisiae
ECVs for  C. haemulonii
posaconazole  C. pelliculosa
 S. cerevisiae
ECVs for  C. haemulonii
voriconazole  C. pelliculosa
 S. cerevisiae

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 M57S-Ed4

Overview of Changes (Continued)

Section/Table Action Change to: Reason/Specific Change
Table 1. (Continued) Added Footnotes  Regarding newly accepted
teleomorph names for
some Candida spp. to
inform the user of
recently adopted official
alternate taxonomic
names
 Regarding high
fluconazole MICs for
C. haemulonii and
S. cerevisiae
Table 2. Epidemiological Revised Title Represent yeast species other
Cutoff Values for In Vitro than Cryptococcus spp.
Susceptibility Testing of Footnote Regarding potential
Cryptococcus spp. and limitations of ECVs in rare
Other Basidiomycete instances
Yeasts With No Added ECVs for  Rhodotorula mucilaginosa
Breakpoints amphotericin B  Trichosporon asahii
ECV for fluconazole T. asahii
ECVs for  R. mucilaginosa
itraconazole  T. asahii
ECVs for  R. mucilaginosa
posaconazole  T. asahii
ECV for R. mucilaginosa
voriconazole
Table 3. Epidemiological Revised Footnote Regarding potential
Cutoff Values for In Vitro limitations of ECVs in rare
Susceptibility Testing of instances
Aspergillus spp. With No Added Footnote Regarding testing and
Breakpoints treatment of Aspergillus
terreus with amphotericin B
Table 4. Epidemiological Revised Footnote Regarding potential
Cutoff Values for In Vitro limitations of ECVs in rare
Susceptibility Testing of instances
Candida spp. With Added ECVs for rezafungin  Candida albicans
Breakpoints  C. auris
 Candida dubliniensis
 Candida glabrata
 Candida krusei
 Candida parapsilosis
 Candida tropicalis

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 M57S-Ed4

Overview of Changes (Continued)

Section/Table Action
Table 4. (Continued) Added
Table 5. Epidemiological
Cutoff Values for In Vitro
Susceptibility Testing of
Aspergillus fumigatus
With Breakpoints
Change to: Reason/Specific Change
Footnote  Regarding newly accepted
teleomorph names for
some Candida spp. to
inform the user of
recently adopted official
alternate taxonomic
names
 Regarding tentative
rezafungin ECVs
Revised Footnote Regarding potential
limitations of ECVs in rare
instances

Table 6. Summary of Added ECV designation for  C. pelliculosa

Available Epidemiological amphotericin B  R. mucilaginosa
Cutoff Values and/or  S. cerevisiae
Breakpoints by Fungal  T. asahii
Species TR-H designation Candida duobushaemulonii
for amphotericin B
ECV designation for  C. auris
anidulafungin  C. haemulonii
 S. cerevisiae
IR designation for  R. mucilaginosa
anidulafungin  T. asahii
ECV designation for  C. auris
caspofungin  S. cerevisiae
IR designation for  R. mucilaginosa
caspofungin  T. asahii
ECV designation for  C. haemulonii
fluconazole  C. pararugosa
 C. pelliculosa
 C. rugosa
 S. cerevisiae
 T. asahii
IR designation for Rhodotorula spp.
fluconazole
TR-L designation  C. auris
for flucytosine  C. pelliculosa
 R. mucilaginosa
 S. cerevisiae
ECV designation for  C. pelliculosa
itraconazole  R. mucilaginosa
 S. cerevisiae
 T. asahii

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 M57S-Ed4

Overview of Changes (Continued)

Section/Table Action Change to: Reason/Specific Change
Table 6. (Continued) Added ECV designation for  C. auris
micafungin  C. pelliculosa
 S. cerevisiae
IR designation for  R. mucilaginosa
micafungin  T. asahii
ECV designation for  C. haemulonii
posaconazole  C. pelliculosa
 R. mucilaginosa
 S. cerevisiae
 T. asahii
BP/ECV designation  C. albicans
for rezafungin  C. auris
 C. dubliniensis
 C. glabrata
 C. krusei
 C. parapsilosis
 C. tropicalis
ECV designation for  C. haemulonii
voriconazole  C. pelliculosa
 R. mucilaginosa
 S. cerevisiae
TR-L designation C. rugosa
for voriconazole
Footnotes  Regarding tentative
rezafungin ECVs and
breakpoints
 Regarding newly accepted
teleomorph names for
some Candida spp. to
inform the user of
recently adopted official
alternate taxonomic
names
 Noting adoption of IR for
echinocandins with
Rhodotorula spp. and
Trichosporon spp.
 Noting adoption of IR for
fluconazole with
Rhodotorula spp.
 Warning against reporting
IR of Aspergillus spp. to
flucytosine
 Regarding testing and
treatment of A. terreus
with amphotericin B

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 M57S-Ed4

Overview of Changes (Continued)

Section/Table Action Change to: Reason/Specific Change
Table 6. (Continued) Deleted IR designation for  Aspergillus flavus
flucytosine  Aspergillus fumigatus
 Aspergillus niger
 A. terreus
 Aspergillus versicolor
Glossary. Antifungal Added Associated Rezafungin
Agent Abbreviations, information
Routes of Administration,
and Drug Class
Abbreviations: BP, breakpoint; ECV, epidemiological cutoff value; IR, intrinsic resistance; MIC, minimal inhibitory
concentration; TR-H, truncated high; TR-L, truncated low.

Request for antifungal susceptibility testing data from fungal pathogens needed for the
development of ECVs to be included in future editions of M57S:

The Working Group on Antifungal Epidemiological Cutoff Values requests submission of raw
antifungal susceptibility testing data for yeasts and filamentous fungi generated using the
protocols provided in CLSI documents M272 and M38.3 This request is only for reference
broth microdilution and should not include data generated using commercially available
panels. Because the data will be combined with data from other laboratories, even a small
amount of data is useful, especially for less frequently identified species. All species should
be identified using a molecular assay or matrix-assisted laser desorption/ionization
time-of-flight mass spectrometry.

A standardized worksheet for data submission is available on the CLSI website at

https://clsi.org/meetings/sub-antifungal/ecv-data-submission/. This worksheet can also be
requested by contacting CLSI at standard@clsi.org. Completed worksheets can be submitted
directly to CLSI at standard@clsi.org.

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

epidemiological cutoff value, minimal effective concentration, minimal inhibitory

concentration, non-wild-type, wild-type

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 M57S-Ed4

Abbreviations and Acronyms

BP breakpoint
DNA deoxyribonucleic acid
ECV epidemiological cutoff value
IR intrinsic resistance
IV intravenous
MEC minimal effective concentration
MIC minimal inhibitory concentration
NWT non-wild-type
pH negative logarithm of hydrogen ion concentration
PO oral
QMS quality management system
QSE quality system essential
TR-H truncated high
TR-L truncated low
WT wild-type

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 M57S-Ed4

References
1 CLSI. Principles and Procedures for the Development of Epidemiological Cutoff Values for Antifungal
Susceptibility Testing. 1st ed. CLSI guideline M57. Clinical and Laboratory Standards Institute; 2016.
2 CLSI. Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts. 4th ed. CLSI
standard M27. Clinical and Laboratory Standards Institute; 2017.
3 CLSI. Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi. 3rd ed.
CLSI standard M38. Clinical and Laboratory Standards Institute; 2017.
4 Borman AM, Johnson EM. Name changes for fungi of medical importance, 2018 to 2019. J Clin Microbiol.
2021;59(2). doi:10.1128/jcm.01811-20
5 Warnock DW. Name changes for fungi of medical importance, 2012 to 2015. J Clin Microbiol.
2017;55(1):53-59. doi:10.1128/jcm.00829-16
6 Warnock DW. Name changes for fungi of medical importance, 2016-2017. J Clin Microbiol. 2019;57(2).
doi:10.1128/jcm.01183-18

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 M57S-Ed4

Table 1. Epidemiological Cutoff Values for In Vitro Susceptibility Testing of

Candida spp. and Other Ascomycete Yeasts With No Breakpoints1-6,a
Antifungal Agent Species ECV, µg/mLb,c,d
Amphotericin B C. albicans 2
C. dubliniensis 0.5
C. glabratae 2
C. guilliermondiie 2
C. kefyre 2
C. kruseie 2
C. lusitaniaee,f 2
C. metapsilosis 1
C. orthopsilosis 2
C. parapsilosis 1
C. pelliculosae 1
C. tropicalis 2
Saccharomyces cerevisiae 2
Anidulafungin C. auris 1
C. dubliniensis 0.12
C. duobushaemulonii 1
C. haemulonii 0.5
C. kefyre 0.25
C. lusitaniaee 1
C. metapsilosis 0.5
C. orthopsilosis 2
S. cerevisiae 1
Caspofungin C. auris 0.5
C. duobushaemulonii 0.25
C. lusitaniaee 1
C. metapsilosis 0.25
C. orthopsilosis 1
S. cerevisiae 2
Fluconazole C. dubliniensis 0.5
C. duobushaemulonii 32
C. guilliermondiie 8
C. haemulonii 128g
C. kefyre 1
C. lusitaniaee 1
C. metapsilosis 4
C. orthopsilosis 2
C. pararugosae 16
C. pelliculosae 8
C. rugosae 8
S. cerevisiae 32h
Isavuconazole C. duobushaemulonii 0.25

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 M57S-Ed4

Table 1. (Continued)
Antifungal Agent Species ECV, µg/mLb,c,d
Itraconazole C. dubliniensis 0.25
C. duobushaemulonii 1
C. glabratae 4
C. guilliermondiie 2
C. kefyre 0.5
C. kruseie 1
C. lusitaniaee 1
C. metapsilosis 1
C. orthopsilosis 0.5
C. parapsilosis 0.5
C. pelliculosae 1
C. tropicalis 0.5
S. cerevisiae 2
Micafungin C. auris 0.5
C. dubliniensis 0.12
C. duobushaemulonii 0.5
C. kefyre 0.12
C. lusitaniaee 0.5
C. metapsilosis 1
C. orthopsilosis 1
C. pelliculosae 0.12
S. cerevisiae 0.5
Posaconazole C. albicans 0.06
C. dubliniensis 0.12
C. duobushaemulonii 1
C. glabratae 1
C. guilliermondiie 0.5
C. haemulonii 1
C. kefyre 0.5
C. kruseie 0.5
C. lusitaniaee 0.06
C. metapsilosis 0.25
C. orthopsilosis 0.25
C. parapsilosis 0.25
C. pelliculosae 2
C. tropicalis 0.12
S. cerevisiae 2
Voriconazole C. duobushaemulonii 0.5
C. glabratae 0.25
C. haemulonii 2
C. metapsilosis 0.06
C. orthopsilosis 0.12
C. pelliculosae 0.25
S. cerevisiae 0.5
Abbreviation: ECV, epidemiological cutoff value.

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 M57S-Ed4

Table 1. (Continued)

Footnotes

a. All Candida spp. listed are sensu stricto except when stated otherwise.

b. The ECVs in this document were established using broth microdilution as outlined in CLSI document M27.1 If
another methodology is used for susceptibility testing, that method must be validated against broth
microdilution before the ECVs are used, just as other methods must be validated before breakpoints
established using broth microdilution are used.

c. ECVs capture ≥ 97.5% of the statistically modeled population. Because ECVs are defined by phenotypic
rather than genotypic data, in rare instances, ECVs may not identify some potentially resistant isolates
(non-wild-type).

d. If the 24-hour growth control is insufficient, it should be incubated for an additional 24 hours.

e. These Candida spp. are also recognized under the following alternate taxonomic names:
 C. glabrata: Nakaseomyces glabrata
 C. guilliermondii: Meyerozyma guilliermondii
 C. kefyr: Kluyveromyces marxianus
 C. krusei: Pichia kudriavzevii
 C. lusitaniae: Clavispora lusitaniae
 C. pararugosa: Wickerhamiella pararugosa
 C. pelliculosa: Wickerhamomyces anomalus
 C. rugosa: Diutina rugosa

f. C. lusitaniae is not intrinsically resistant to amphotericin B. However, C. lusitaniae may develop resistance to
amphotericin B in vivo during therapy. When phenotypic resistance was noted in studies, the phenotype was
observed using only agar gradient strips and was not detected by broth microdilution methods.7

g. The fluconazole ECV for C. haemulonii is very high and may be an indication of intrinsic resistance or of
limited susceptibility to this agent. A minimal inhibitory concentration (MIC) value lower than the ECV
does not imply that the isolate is susceptible to fluconazole.

h. The fluconazole ECV for S. cerevisiae is high and may be an indication of intrinsic resistance or of limited
susceptibility to this agent. An MIC value lower than the ECV does not imply that the isolate is susceptible
to fluconazole.

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

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 M57S-Ed4

Table 1. (Continued)

References for Table 1

1 CLSI. Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts. 4th ed. CLSI
standard M27. Clinical and Laboratory Standards Institute; 2017.
2 CLSI. Principles and Procedures for the Development of Epidemiological Cutoff Values for Antifungal
Susceptibility Testing. 1st ed. CLSI guideline M57. Clinical and Laboratory Standards Institute; 2016.
3 Dalhoff A, Ambrose PG, Mouton JW. A long journey from minimum inhibitory concentration testing to
clinically predictive breakpoints: deterministic and probabilistic approaches in deriving breakpoints.
Infection. 2009;37(4):296-305. doi:10.1007/s15010-009-7108-9
4 Pfaller MA, Espinel-Ingroff A, Bustamante B, et al. Multicenter study of anidulafungin and micafungin MIC
distributions and epidemiological cutoff values for eight Candida species and the CLSI M27-A3 broth
microdilution method. Antimicrob Agents Chemother. 2014;58(2):916-922. doi:10.1128/aac.02020-13
5 Pfaller MA, Espinel-Ingroff A, Canton E, et al. Wild-type MIC distributions and epidemiological cutoff
values for amphotericin B, flucytosine, and itraconazole and Candida spp. as determined by CLSI broth
microdilution. J Clin Microbiol. 2012;50(6):2040-2046. doi:10.1128/jcm.00248-12
6 Turnidge J, Kahlmeter G, Kronvall G. Statistical characterisation of bacterial wild-type MIC value
distributions and the determination of epidemiological cut-off values. Clin Microbiol Infect.
2006;12(5):418-425. doi:10.1111/j.1469-0691.2006.01377.x
7 Peyron F, Favel A, Michel-Nguyen A, Gilly M, Regli P, Bolmström A. Improved detection of amphotericin B-
resistant isolates of Candida lusitaniae by Etest. J Clin Microbiol. 2001;39(1):339-342.
doi:10.1128/jcm.39.1.339-342.2001

4 © Clinical and Laboratory Standards Institute. All rights reserved.

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 M57S-Ed4

Table 2. Epidemiological Cutoff Values for In Vitro Susceptibility Testing of

Cryptococcus spp. and Other Basidiomycete Yeasts With No Breakpoints1-5,a
Antifungal Agent Species (genotype) ECV, µg/mLb,c
Amphotericin B C. gattii (VGI) 0.5
C. deuterogattii (VGII) 1
C. neoformans (VNI) 0.5
Rhodotorula mucilaginosa 2
Trichosporon asahii 1
Fluconazole C. gattii (VGI) 16
C. deuterogattii (VGII) 32
C. neoformans (VNI) 8
T. asahii 8
Flucytosine C. gattii (VGI) 4
C. deuterogattii (VGII) 32
C. neoformans (VNI) 8
Itraconazole C. gattii (VGI) 0.5
C. deuterogattii (VGII) 1
C. neoformans (VNI) 0.25
R. mucilaginosa 4
T. asahii 1
Posaconazole C. neoformans (VNI) 0.25
R. mucilaginosa 4
T. asahii 1
Voriconazole C. gattii (VGI) 0.5
C. deuterogattii (VGII) 0.5
C. neoformans (VNI) 0.25
R. mucilaginosa 16
Abbreviation: ECV, epidemiological cutoff value.

Footnotes

a. The ECVs for Cryptococcus were established for the distinct molecular types. The phylogeny for Cryptococcus
is currently in transition. VGI and VGII are molecular genotypes of C. gattii and C. deuterogattii (formerly
C. gattii), respectively, that can be recognized only by molecular typing of isolates by polymerase chain
reaction or DNA sequencing–based methods, including multilocus sequence typing and amplified-fragment
length polymorphism typing. The molecular types may or may not be unique species, and future editions of
this document may name them differently according to accepted taxonomic changes.4 Globally, VNI is the
most common molecular genotype of C. neoformans.

b. The ECVs in this document were established using broth microdilution as outlined in CLSI document M27.6 If
another method is used for susceptibility testing, it must be validated against broth microdilution before the
ECVs are used, just as other methods must be validated before breakpoints established using broth
microdilution are used.

c. ECVs capture ≥ 97.5% of the statistically modeled population. Because ECVs are defined by phenotypic
rather than genotypic data, in rare instances, ECVs may not identify some potentially resistant isolates
(non-wild-type).

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

© Clinical and Laboratory Standards Institute. All rights reserved. 5

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 M57S-Ed4

Table 2. (Continued)

References for Table 2

1 CLSI. Principles and Procedures for the Development of Epidemiological Cutoff Values for Antifungal
Susceptibility Testing. 1st ed. CLSI guideline M57. Clinical and Laboratory Standards Institute; 2016.
2 Espinel-Ingroff A, Aller AI, Canton E, et al. Cryptococcus neoformans-Cryptococcus gattii species complex:
an international study of wild-type susceptibility endpoint distributions and epidemiological cutoff values
for fluconazole, itraconazole, posaconazole, and voriconazole. Antimicrob Agents Chemother.
2012;56(11):5898-5906. doi:10.1128/aac.01115-12
3 Espinel-Ingroff A, Chowdhary A, Cuenca-Estrella M, et al. Cryptococcus neoformans-Cryptococcus gattii
species complex: an international study of wild-type susceptibility endpoint distributions and
epidemiological cutoff values for amphotericin B and flucytosine. Antimicrob Agents Chemother.
2012;56(6):3107-3113. doi:10.1128/aac.06252-11
4 Hagen F, Khayhan K, Theelen B, et al. Recognition of seven species in the Cryptococcus
gattii/Cryptococcus neoformans species complex. Fungal Genet Biol. 2015;78:16-48.
doi:10.1016/j.fgb.2015.02.009
5 Turnidge J, Kahlmeter G, Kronvall G. Statistical characterisation of bacterial wild-type MIC value
distributions and the determination of epidemiological cut-off values. Clin Microbiol Infect.
2006;12(5):418-425. doi:10.1111/j.1469-0691.2006.01377.x
6 CLSI. Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts. 4th ed. CLSI
standard M27. Clinical and Laboratory Standards Institute; 2017.

6 © Clinical and Laboratory Standards Institute. All rights reserved.

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 M57S-Ed4

Table 3. Epidemiological Cutoff Values for In Vitro Susceptibility Testing of

Aspergillus spp. With No Breakpoints1-7,a
Antifungal Agent Species ECV, µg/mLb,c
Amphotericin B A. flavus 4
A. fumigatus 2
A. niger 2
A. terreusd 4
A. versicolor 2
Caspofungine A. flavus 0.5
A. fumigatus 0.5
A. niger 0.25
A. terreus 0.12
Isavuconazole A. flavus 1
A. fumigatus 1
A. niger 4
A. terreus 1
Itraconazole A. flavus 1
A. fumigatus 1
A. niger 4
A. terreus 2
Posaconazole A. flavus 0.5
A. niger 2
A. terreus 1
Voriconazole A. flavus 2
A. niger 2
A. terreus 2
Abbreviation: ECV, epidemiological cutoff value.

Footnotes

a. ECVs for Aspergillus spp. are determined after 48 hours of incubation for testing triazoles and amphotericin B
and after 24 hours of incubation for testing caspofungin (see CLSI document M381).

b. The ECVs in this document were established using broth microdilution as outlined in CLSI document M38.1 If
another method is used for susceptibility testing, it must be validated against broth microdilution before the
ECVs are used, just as other methods must be validated before breakpoints established using broth
microdilution are used.

c. ECVs capture ≥ 97.5% of the statistically modeled population. Because ECVs are defined by phenotypic
rather than genotypic data, in rare instances, ECVs may not identify some potentially resistant isolates
(non-wild-type).

d. Low minimal inhibitory concentrations for A. terreus do not correlate with positive clinical outcomes, and
testing is not recommended. Use of this antifungal agent is not recommended according to published
treatment guidelines.8,9

e. The caspofungin minimal effective concentration is the lowest concentration of caspofungin that leads to the
growth of small, rounded, compact hyphal forms compared with the hyphal growth seen in the growth control
well (see CLSI document M381).

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

© Clinical and Laboratory Standards Institute. All rights reserved. 7

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 M57S-Ed4

Table 3. (Continued)

References for Table 3

1 CLSI. Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi. 3rd ed.
CLSI standard M38. Clinical and Laboratory Standards Institute; 2017.
2 CLSI. Principles and Procedures for the Development of Epidemiological Cutoff Values for Antifungal
Susceptibility Testing. 1st ed. CLSI guideline M57. Clinical and Laboratory Standards Institute; 2016.
3 Espinel-Ingroff A, Chowdhary A, Gonzalez GM, et al. Multicenter study of isavuconazole MIC distributions
and epidemiological cutoff values for Aspergillus spp. for the CLSI M38-A2 broth microdilution method.
Antimicrob Agents Chemother. 2013;57(8):3823-3828. doi:10.1128/aac.00636-13
4 Espinel-Ingroff A, Cuenca-Estrella M, Fothergill A, et al. Wild-type MIC distributions and epidemiological
cutoff values for amphotericin B and Aspergillus spp. for the CLSI broth microdilution method (M38-A2
document). Antimicrob Agents Chemother. 2011;55(11):5150-5154. doi:10.1128/aac.00686-11
5 Espinel-Ingroff A, Diekema DJ, Fothergill A, et al. Wild-type MIC distributions and epidemiological cutoff
values for the triazoles and six Aspergillus spp. for the CLSI broth microdilution method (M38-A2
document). J Clin Microbiol. 2010;48(9):3251-3257. doi:10.1128/jcm.00536-10
6 Espinel-Ingroff A, Fothergill A, Fuller J, Johnson E, Pelaez T, Turnidge J. Wild-type MIC distributions and
epidemiological cutoff values for caspofungin and Aspergillus spp. for the CLSI broth microdilution
method (M38-A2 document). Antimicrob Agents Chemother. 2011;55(6):2855-2859.
doi:10.1128/aac.01730-10
7 Turnidge J, Kahlmeter G, Kronvall G. Statistical characterisation of bacterial wild-type MIC value
distributions and the determination of epidemiological cut-off values. Clin Microbiol Infect.
2006;12(5):418-425. doi:10.1111/j.1469-0691.2006.01377.x
8 Patterson TF, Thompson GR, 3rd, Denning DW, et al. Practice guidelines for the diagnosis and
management of aspergillosis: 2016 update by the Infectious Diseases Society of America. Clin Infect Dis.
2016;63(4):e1-e60. doi:10.1093/cid/ciw326
9 Ullmann AJ, Aguado JM, Arikan-Akdagli S, et al. Diagnosis and management of Aspergillus diseases:
executive summary of the 2017 ESCMID-ECMM-ERS guideline. Clin Microbiol Infect. 2018;24(suppl 1):e1-
e38. doi:10.1016/j.cmi.2018.01.002

8 © Clinical and Laboratory Standards Institute. All rights reserved.

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 M57S-Ed4

Table 4. Epidemiological Cutoff Values for In Vitro Susceptibility Testing of

Candida spp. With Breakpoints1-5,a,b
Antifungal Agent Species ECV, µg/mLc,d,e
Anidulafungin C. albicans 0.12
C. glabrataf 0.25
C. guilliermondiif 8
C. kruseif 0.25
C. parapsilosis 4
C. tropicalis 0.12
Caspofungin C. guilliermondiif 2
C. parapsilosis 1
Fluconazole C. albicans 0.5
C. glabrataf 8
C. parapsilosis 2
C. tropicalis 1
Micafungin C. albicans 0.03
C. glabrataf 0.03
C. guilliermondiif 2
C. kruseif 0.25
C. parapsilosis 2
C. tropicalis 0.06
Rezafunging C. albicans 0.06
C. auris 0.5
C. dubliniensis 0.12
C. glabrataf 0.12
C. kruseif 0.12
C. parapsilosis 4
C. tropicalis 0.12
Voriconazole C. albicans 0.03
C. kruseif 0.5
C. tropicalis 0.12
Abbreviation: ECV, epidemiological cutoff value.

Footnotes

a. All Candida spp. listed are sensu stricto except when stated otherwise.

b. Unlike breakpoints, ECVs do not predict clinical response to therapy. When breakpoints are available for the
fungal species and antifungal agents being evaluated, the ECV should not be used in clinical practice (see CLSI
documents M271 and M27M44S2).

c. The ECVs in this document were established using broth microdilution as outlined in CLSI document M27.1 If
another method is used for susceptibility testing, it must be validated against broth microdilution before the
ECVs are used, just as other methods must be validated before breakpoints established using broth
microdilution are used.

d. ECVs capture ≥ 97.5% of the statistically modeled population. Because ECVs are defined by phenotypic
rather than genotypic data, in rare instances, ECVs may not identify some potentially resistant isolates
(non-wild-type).

e. If the 24-hour growth control is insufficient, it should be incubated for an additional 24 hours.

© Clinical and Laboratory Standards Institute. All rights reserved. 9

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 M57S-Ed4

Table 4. (Continued)

f. These Candida spp. are also recognized under the following alternate taxonomic names:
 C. glabrata: Nakaseomyces glabrata
 C. guilliermondii: Meyerozyma guilliermondii
 C. kefyr: Kluyveromyces marxianus
 C. krusei: Pichia kudriavzevii
 C. lusitaniae: Clavispora lusitaniae
 C. pararugosa: Wickerhamiella pararugosa
 C. pelliculosa: Wickerhamomyces anomalus
 C. rugosa: Diutina rugosa

g. ECVs for rezafungin were adopted during a meeting with the Subcommittee on Antifungal Susceptibility
Tests held in June 2021. The ECVs are considered tentative for one year from the publication of this
document and are open for comment.

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

References for Table 4

1 CLSI. Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts. 4th ed. CLSI
standard M27. Clinical and Laboratory Standards Institute; 2017.
2 CLSI. Performance Standards for Antifungal Susceptibility Testing of Yeasts. 3rd ed. CLSI supplement
M27M44S. Clinical and Laboratory Standards Institute; 2022.
3 CLSI. Principles and Procedures for the Development of Epidemiological Cutoff Values for Antifungal
Susceptibility Testing. 1st ed. CLSI guideline M57. Clinical and Laboratory Standards Institute; 2016.
4 Pfaller MA, Espinel-Ingroff A, Bustamante B, et al. Multicenter study of anidulafungin and micafungin MIC
distributions and epidemiological cutoff values for eight Candida species and the CLSI M27-A3 broth
microdilution method. Antimicrob Agents Chemother. 2014;58(2):916-922. doi:10.1128/aac.02020-13
5 Turnidge J, Kahlmeter G, Kronvall G. Statistical characterisation of bacterial wild-type MIC value
distributions and the determination of epidemiological cut-off values. Clin Microbiol Infect.
2006;12(5):418-425. doi:10.1111/j.1469-0691.2006.01377.x

10 © Clinical and Laboratory Standards Institute. All rights reserved.

Licensed to: Ignasi Baliarda
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 M57S-Ed4

Table 5. Epidemiological Cutoff Values for In Vitro Susceptibility Testing of

Aspergillus fumigatus With Breakpoints1-8,a
Antifungal Agent ECV, µg/mLb,c,d
Voriconazole 1
Abbreviation: ECV, epidemiological cutoff value.

Footnotes

a. Unlike breakpoints, ECVs do not predict clinical response to therapy. When breakpoints are available for the
fungal species and antifungal agents being evaluated, the ECV should not be used in clinical practice (see CLSI
documents M572 and M38M51S3).

b. The ECVs in this document were established using broth microdilution as outlined in CLSI document M38.1 If
another method is used for susceptibility testing, it must be validated against broth microdilution before the
ECVs are used, just as other methods must be validated before breakpoints established using broth
microdilution are used.

c. ECVs capture ≥ 97.5% of the statistically modeled population. Because ECVs are defined by phenotypic
rather than genotypic data, in rare instances, ECVs may not identify some potentially resistant isolates
(non-wild-type).

d. ECVs for Aspergillus spp. are determined after 48 hours of incubation for testing voriconazole (see CLSI
document M381).

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

References for Table 5

1 CLSI. Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi. 3rd ed.
CLSI standard M38. Clinical and Laboratory Standards Institute; 2017.
2 CLSI. Principles and Procedures for the Development of Epidemiological Cutoff Values for Antifungal
Susceptibility Testing. 1st ed. CLSI guideline M57. Clinical and Laboratory Standards Institute; 2016.
3 CLSI. Performance Standards for Antifungal Susceptibility Testing of Filamentous Fungi. 3rd ed. CLSI
supplement M38M51S. Clinical and Laboratory Standards Institute; 2022.
4 Espinel-Ingroff A, Chowdhary A, Gonzalez GM, et al. Multicenter study of isavuconazole MIC distributions
and epidemiological cutoff values for Aspergillus spp. for the CLSI M38-A2 broth microdilution method.
Antimicrob Agents Chemother. 2013;57(8):3823-3828. doi:10.1128/aac.00636-13
5 Espinel-Ingroff A, Cuenca-Estrella M, Fothergill A, et al. Wild-type MIC distributions and epidemiological
cutoff values for amphotericin B and Aspergillus spp. for the CLSI broth microdilution method (M38-A2
document). Antimicrob Agents Chemother. 2011;55(11):5150-5154. doi:10.1128/aac.00686-11
6 Espinel-Ingroff A, Diekema DJ, Fothergill A, et al. Wild-type MIC distributions and epidemiological cutoff
values for the triazoles and six Aspergillus spp. for the CLSI broth microdilution method (M38-A2
document). J Clin Microbiol. 2010;48(9):3251-3257. doi:10.1128/jcm.00536-10
7 Espinel-Ingroff A, Fothergill A, Fuller J, Johnson E, Pelaez T, Turnidge J. Wild-type MIC distributions and
epidemiological cutoff values for caspofungin and Aspergillus spp. for the CLSI broth microdilution
method (M38-A2 document). Antimicrob Agents Chemother. 2011;55(6):2855-2859.
doi:10.1128/aac.01730-10
8 Turnidge J, Kahlmeter G, Kronvall G. Statistical characterisation of bacterial wild-type MIC value
distributions and the determination of epidemiological cut-off values. Clin Microbiol Infect.
2006;12(5):418-425. doi:10.1111/j.1469-0691.2006.01377.x

© Clinical and Laboratory Standards Institute. All rights reserved. 11

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Licensed to: Ignasi Baliarda
Table 6. Summary of Available Epidemiological Cutoff Values and/or Breakpoints by Fungal Species
12

M57S-Ed4
Antifungal Agent

Amphotericin B

Isavuconazole
Anidulafungin

Posaconazole

Voriconazole
Itraconazole
Caspofungin

Fluconazole

Rezafungina
Flucytosine

Micafungin
Species
YEASTS
Candida albicans ECV BP/ECV BP BP/ECV – – – BP/ECV ECV BP/ECV BP/ECV
Candida auris – ECV ECV – TR-L – – ECV – BP/ECV –
Candida dubliniensis ECV ECV – ECV TR-L – ECV ECV ECV BP/ECV –
Candida TR-H ECV ECV ECV TR-L ECV ECV ECV ECV – ECV
duobushaemulonii
Candida glabratab ECV BP/ECV BP BP/ECV – – ECV BP/ECV ECV BP/ECV ECV
Candida ECV BP/ECV BP/ECV ECV TR-L – ECV BP/ECV ECV – –
guilliermondiib
Candida haemulonii – ECV – ECV – – – – ECV – ECV
Candida kefyrb ECV ECV – ECV TR-L – ECV ECV ECV – –
Candida kruseib ECV BP/ECV BP IR – – ECV BP/ECV ECV BP/ECV BP/ECV
Candida lusitaniaeb ECV ECV ECV ECV TR-L – ECV ECV ECV – –
© Clinical and Laboratory Standards Institute. All rights reserved.

Candida metapsilosis ECV ECV ECV ECV TR-L – ECV ECV ECV – ECV
Candida orthopsilosis ECV ECV ECV ECV TR-L – ECV ECV ECV – –
Candida parapsilosis ECV BP/ECV BP/ECV BP/ECV TR-L TR-L ECV BP/ECV ECV BP/ECV BP
Candida pararugosab – – – ECV – – – – – – –
Candida pelliculosab ECV – – ECV TR-L – ECV ECV ECV – ECV
Candida rugosab – – – ECV – – – – – – TR-L
Candida tropicalis ECV BP/ECV BP BP/ECV – – ECV BP/ECV ECV BP/ECV BP/ECV
Cryptococcus gattii ECV IR IR ECV ECV – ECV IR – – ECV
(VGI)
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Table 6. (Continued)
© Clinical and Laboratory Standards Institute. All rights reserved.

Antifungal Agent

Amphotericin B

Isavuconazole
Anidulafungin

Posaconazole

Voriconazole
Itraconazole
Caspofungin

Fluconazole

Rezafungina
Flucytosine

Micafungin
Species
Yeasts (Continued)
Cryptococcus ECV IR IR ECV ECV – ECV IR – – ECV
deuterogattii (VGII)
Cryptococcus ECV IR IR ECV ECV – ECV IR ECV – ECV
neoformans (VNI)
Rhodotorula ECV IRc IRc IRd TR-L – ECV IRc ECV – ECV
mucilaginosa
Saccharomyces ECV ECV ECV ECV TR-L – ECV ECV ECV – ECV
cerevisiae
Trichosporon asahii ECV IRc IRc ECV – – ECV IRc ECV – –
Molds
Aspergillus flavus ECV – ECV IR –e ECV ECV – ECV – ECV
Aspergillus fumigatus ECV – ECV IR –e ECV ECV – – – BP/ECV
Aspergillus niger ECV – ECV IR –e ECV ECV – ECV – ECV
Aspergillus terreus ECVf – ECV IR –e ECV ECV – ECV – ECV
Aspergillus versicolor ECV – – IR –e – – – – – –
Abbreviation: ECV, epidemiological cutoff value.

Key: –, ECV not defined; ECV, ECV defined; BP, clinical breakpoint defined; IR, this species is intrinsically resistant to this antifungal agent; TR-H, ECV cannot
be defined for this species–antifungal agent combination because minimal inhibitory concentration (MIC) distribution is truncated on the high end of the
recommended testing range; TR-L, ECV cannot be defined for this species–antifungal agent combination because the MIC distribution is truncated on the low
end of the recommended testing range.

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Table 6. (Continued)
14

M57S-Ed4
Footnotes

a. ECVs and MIC breakpoints for rezafungin were adopted during a meeting with the Subcommittee on Antifungal Susceptibility Tests held in
June 2021. The ECVs and MIC breakpoints are considered tentative for one year from the publication of this document and CLSI document
M27M44S1 and are open for comment.

b. These Candida spp. are also recognized under the following alternate taxonomic names:
 C. glabrata: Nakaseomyces glabrata
 C. guilliermondii: Meyerozyma guilliermondii
 C. kefyr: Kluyveromyces marxianus
 C. krusei: Pichia kudriavzevii
 C. lusitaniae: Clavispora lusitaniae
 C. pararugosa: Wickerhamiella pararugosa
 C. pelliculosa: Wickerhamomyces anomalus
 C. rugosa: Diutina rugosa

c. The intrinsic resistance (IR) of Rhodotorula spp. and Trichosporon spp. for echinocandins was adopted during a meeting with the Subcommittee on
Antifungal Susceptibility Tests held in January 2020. See CLSI document M27M44S1 for a complete IR listing.

d. The IR of Rhodotorula spp. for fluconazole was adopted during a meeting with the Subcommittee on Antifungal Susceptibility Tests held in
June 2021.

e. Do not report.2 IR of Aspergillus spp. to flucytosine cannot be determined because pH differences cause significant variation in MICs in vitro. There
are no robust studies on correlation of MICs to clinical outcome.
© Clinical and Laboratory Standards Institute. All rights reserved.

f. Low MICs for A. terreus do not correlate with positive clinical outcomes, and testing is not recommended. Use of this antifungal agent is not
recommended according to published treatment guidelines.3,4

NOTE: Information in boldface type is new or modified since the previous edition.
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© Clinical and Laboratory Standards Institute. All rights reserved.

Table 6. (Continued)

References for Table 6

1 CLSI. Performance Standards for Antifungal Susceptibility Testing of Yeasts. 3rd ed. CLSI supplement M27M44S. Clinical and Laboratory Standards
Institute; 2022.
2 Te Dorsthorst DTA, Mouton JW, van den Beukel CJP, van der Lee HAL, Meis JFGM, Verweij PE. Effect of pH on the in vitro activities of amphotericin B,
itraconazole, and flucytosine against Aspergillus isolates. Antimicrob Agents Chemother. 2004;48(8):3147-3150. doi:doi:10.1128/AAC.48.8.3147-
3150.2004
3 Patterson TF, Thompson GR, 3rd, Denning DW, et al. Practice guidelines for the diagnosis and management of aspergillosis: 2016 update by the
Infectious Diseases Society of America. Clin Infect Dis. 2016;63(4):e1-e60. doi:10.1093/cid/ciw326
4 Ullmann AJ, Aguado JM, Arikan-Akdagli S, et al. Diagnosis and management of Aspergillus diseases: executive summary of the 2017 ESCMID-ECMM-ERS
guideline. Clin Microbiol Infect. 2018;24(suppl 1):e1-e38. doi:10.1016/j.cmi.2018.01.002

M57S-Ed4
15
 M57S-Ed4

Glossary. Antifungal Agent Abbreviations, Routes of Administration, and

Drug Class
Routes of
Administrationb
Antifungal Agent Abbreviationsa PO IV Drug Class
Amphotericin B AMB X Polyene
Anidulafungin AND X Echinocandin
Caspofungin CAS, CFG X Echinocandin
Fluconazole FLC, FLU, FLS, FCA, FLZ, FZ X X Azole
Flucytosine 5-FC X Fluorinated
pyrimidine
Isavuconazole ISA X X Azole
Itraconazole ITR X Xc Azole
Micafungin MCF X Echinocandin
Posaconazole POS, PCO, POC X X Azole
Rezafungin RZF X Echinocandin
Voriconazole VRC, VCO, VOC, VO X X Azole
Abbreviations: IV, intravenous; PO, oral.

Footnotes

a. These abbreviations are assigned to one or more diagnostic products in the United States. If no diagnostic
product is available, the abbreviation is that of the manufacturer.

b. As available in the United States.

c. Itraconazole is not available for IV administration in the United States.

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

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The Quality Management System Approach

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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
 Facilities and Safety  Equipment Management
Management  Process Management
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Management
 Nonconforming Event
Management
 Assessments
 Continual Improvement

The QSEs covered by M57S and its related CLSI documents are available on the CLSI website:
https://clsi.org/qse

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NOTES

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