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文档简介
January2014
M100-S24
PerformanceStandardsforAntimicrobial
SusceptibilityTesting;Twenty-Fourth
InformationalSupplement
ThisdocumentprovidesupdatedtablesfortheClinicaland
LaboratoryStandardsInstituteantimicrobialsusceptibilitytesting
standardsM02-A11,M07-A9,andM11-A8.
AninformationalsupplementforglobalapplicationdevelopedthroughtheClinicalandLaboratoryStandardsInstitute
consensusprocess.
ClinicalandLaboratoryStandardsInstituteSettingthestandardforqualityinclinicallaboratorytestingaroundtheworld.
TheClinicalandLaboratoryStandardsInstitute(CLSI)isanot-for-profitmembershiporganizationthatbrings
togetherthevariedperspectivesandexpertiseoftheworldwidelaboratorycommunityfortheadvancementof
acommoncause:tofosterexcellenceinlaboratorymedicinebydevelopingandimplementingclinicallaboratory
standardsandguidelinesthathelplaboratoriesfulfilltheirresponsibilitieswithefficiency,effectiveness,and
globalapplicability.
ConsensusProcess
Consensus—thesubstantialagreementbymateriallyaffected,competent,andinterestedparties—iscoretothe
developmentofallCLSIdocuments.Itdoesnotalwaysconnoteunanimousagreement,butdoesmeanthatthe
participantsinthedevelopmentofaconsensusdocumenthaveconsideredandresolvedallrelevantobjections
andaccepttheresultingagreement.
CommentingonDocuments
CLSIdocumentsundergoperiodicevaluationandmodificationtokeeppacewithadvancementsintechnologies,
procedures,methods,andprotocolsaffectingthelaboratoryorhealthcare.
CLSI’sconsensusprocessdependsonexpertswhovolunteertoserveascontributingauthorsand/oras
participantsinthereviewingandcommentingprocess.Attheendofeachcommentperiod,thecommitteethat
developedthedocumentisobligatedtoreviewallcomments,respondinwritingtoallsubstantivecomments,
andrevisethedraftdocumentasappropriate.
CommentsonpublishedCLSIdocumentsareequallyessential,andmaybesubmittedbyanyone,atanytime,on
anydocument.Allcommentsareaddressedaccordingtotheconsensusprocessbyacommitteeofexperts.
AppealsProcess
Ifitisbelievedthatanobjectionhasnotbeenadequatelyaddressed,theprocessforappealsisdocumentedin
theCLSIStandardsDevelopmentPoliciesandProcessdocument.
AllcommentsandresponsessubmittedondraftandpublisheddocumentsareretainedonfileatCLSIandare
availableuponrequest.
GetInvolved—Volunteer!
DoyouuseCLSIdocumentsinyourworkplace?Doyouseeroomforimprovement?Wouldyouliketoget
involvedintherevisionprocess?Ormaybeyouseeaneedtodevelopanewdocumentforanemerging
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talentstoimprovethestandardsthataffectyourownwork,youwillplayanactiveroleinimprovingpublic
healthacrosstheglobe.
Forfurtherinformationoncommitteeparticipationortosubmitcomments,contactCLSI.
ClinicalandLaboratoryStandardsInstitute
950WestValleyRoad,Suite2500
Wayne,PA19087USA
P:610.688.0100F:610.688.0700standard@
Vol.34No.1M100-S24
PerformanceStandardsforAntimicrobialSusceptibilityTesting;
Twenty-FourthInformationalSupplement
Abstract
Thesupplementalinformationpresentedinthisdocumentisintendedforusewiththeantimicrobial
susceptibilitytestingprocedurespublishedinthefollowingClinicalandLaboratoryStandardsInstitute
(CLSI)–approvedstandards:M02-A11—PerformanceStandardsforAntimicrobialDiskSusceptibility
Tests;ApprovedStandard—EleventhEdition;M07-A9—MethodsforDilutionAntimicrobial
SusceptibilityTestsforBacteriaThatGrowAerobically;ApprovedStandard—NinthEdition;and
M11-A8—MethodsforAntimicrobialSusceptibilityTestingofAnaerobicBacteria;ApprovedStandard—
EighthEdition.Thestandardscontaininformationaboutbothdisk(M02)anddilution(M07andM11)
testproceduresforaerobicandanaerobicbacteria.
Cliniciansdependheavilyoninformationfromtheclinicalmicrobiologylaboratoryfortreatmentoftheir
seriouslyillpatients.Theclinicalimportanceofantimicrobialsusceptibilitytestresultsrequiresthatthese
testsbeperformedunderoptimalconditionsandthatlaboratorieshavethecapabilitytoprovideresultsfor
thenewestantimicrobialagents.
Thetabularinformationpresentedhererepresentsthemostcurrentinformationfordrugselection,
interpretation,andQCusingtheproceduresstandardizedinthemostcurrenteditionsofM02,M07,and
M11.Usersshouldreplacethetablespublishedearlierwiththesenewtables.(Changesinthetablessince
themostcurrenteditionappearinboldfacetype.)
ClinicalandLaboratoryStandardsInstitute.PerformanceStandardsforAntimicrobialSusceptibility
Testing;Twenty-FourthInformationalSupplement.CLSIdocumentM100-S24(ISBN1-56238-897-5
[Print];ISBN1-56238-898-3[Electronic]).ClinicalandLaboratoryStandardsInstitute,950WestValley
Road,Suite2500,Wayne,Pennsylvania19087USA,2014.
Thedataintheinterpretivetablesinthissupplementarevalidonlyifthe
methodologiesinM02-A11—PerformanceStandardsforAntimicrobialDisk
SusceptibilityTests;ApprovedStandard—EleventhEdition;M07-A9—Methods
forDilutionAntimicrobialSusceptibilityTestsforBacteriaThatGrow
Aerobically;ApprovedStandard—NinthEdition;andM11-A8—Methodsfor
AntimicrobialSusceptibilityTestingofAnaerobicBacteria;ApprovedStandard—
EighthEditionarefollowed.
1
January2014M100-S24
2
ISBN1-56238-897-5(Print)M100-S24
ISBN1-56238-898-3(Electronic)Vol.34No.1
ISSN1558-6502(Print)ReplacesM100-S23
ISSN2162-2914(Electronic)Vol.33No.1
PerformanceStandardsforAntimicrobialSusceptibilityTesting;
Twenty-FourthInformationalSupplement
Volume34Number1
JeanB.Patel,PhD,D(ABMM)
FranklinR.CockerillIII,MD
JeffAlder,PhD
PatriciaA.Bradford,PhDGeorgeM.Eliopoulos,MD
DwightJ.Hardy,PhD
JanetA.Hindler,MCLS,MT(ASCP)
StephenG.Jenkins,PhD,D(ABMM),F(AAM)
JamesS.LewisII,PharmDLindaA.Miller,PhD
MairPowell,MD,FRCP,FRCPath
JanaM.Swenson,MMSc
MariaM.Traczewski,BS,MT(ASCP)
JohnD.Turnidge,MDMelvinP.Weinstein,MDBarbaraL.Zimmer,PhD
January2014M100-S24
Copyright©2014ClinicalandLaboratoryStandardsInstitute.Exceptasstatedbelow,anyreproductionof
contentfromaCLSIcopyrightedstandard,guideline,companionproduct,orothermaterialrequires
expresswrittenconsentfromCLSI.Allrightsreserved.Interestedpartiesmaysendpermissionrequeststo
permissions@.
CLSIherebygrantspermissiontoeachindividualmemberorpurchasertomakeasinglereproductionof
thispublicationforuseinitslaboratoryproceduremanualatasinglesite.Torequestpermissiontouse
thispublicationinanyothermanner,e-mailpermissions@.
SuggestedCitation
CLSI.PerformanceStandardsforAntimicrobialSusceptibilityTesting;Twenty-FourthInformational
Supplement.CLSIdocumentM100-S24.Wayne,PA:ClinicalandLaboratoryStandardsInstitute;2014.
Twenty-FourthInformationalSupplement
January2014
SixteenthInformationalSupplement
January2006
Twenty-ThirdInformationalSupplement
January2013
FifteenthInformationalSupplement
January2005
Twenty-SecondInformationalSupplement
January2012
FourteenthInformationalSupplement
January2004
Twenty-FirstInformationalSupplement
January2011
ThirteenthInformationalSupplement
January2003
TwentiethInformationalSupplement(Update)
June2010
TwelfthInformationalSupplement
January2002
TwentiethInformationalSupplement
January2010
EleventhInformationalSupplement
January2001
NineteenthInformationalSupplement
January2009
TenthInformationalSupplement
January2000
EighteenthInformationalSupplement
January2008
NinthInformationalSupplement
January1999
SeventeenthInformationalSupplementJanuary2007
ISBN1-56238-897-5(Print)
ISBN1-56238-898-3(Electronic)
ISSN1558-6502(Print)ISSN2162-2914(Electronic)
4
Vol.34No.1M100-S24
CommitteeMembership
ConsensusCommitteeonMicrobiology
RichardB.Thomson,Jr.,PhD
Chairholder
EvanstonHospital,NorthShore
UniversityHealthSystem
Evanston,Illinois,USA
JohnH.Rex,MD,FACP
Vice-Chairholder
AstraZenecaPharmaceuticals
Waltham,Massachusetts,USA
NancyL.Anderson,MMSc,
MT(ASCP)
CentersforDiseaseControland
Prevention
Atlanta,Georgia,USA
ThomasR.Fritsche,MD,PhD
MarshfieldClinic
Marshfield,Wisconsin,USA
PatrickR.Murray,PhD
BDDiagnostics
Sparks,Maryland,USA
KerrySnow,MS,MT(ASCP)
FDACenterforDrugEvaluationand
Research
SilverSpring,Maryland,USA
FredC.Tenover,PhD,D(ABMM)
Cepheid
Sunnyvale,California,USA
JohnD.Turnidge,MD
SAPathologyatWomen’sand
Children’sHospital
NorthAdelaide,Australia
JeffreyL.Watts,PhD,RM(NRCM)
Zoetis,Inc.
Kalamazoo,Michigan,USA
NancyL.Wengenack,PhD,
D(ABMM),FIDSA
MayoClinic
Rochester,Minnesota,USA
SubcommitteeonAntimicrobialSusceptibilityTesting
JeanB.Patel,PhD,D(ABMM)
Chairholder
CentersforDiseaseControland
Prevention
Atlanta,Georgia,USA
FranklinR.CockerillIII,MD
Vice-Chairholder
MayoCollegeofMedicine
Rochester,Minnesota,USA
JeffAlder,PhD
BayerHealthCare
Whippany,NewJersey,USA
PatriciaA.Bradford,PhD
AstraZenecaPharmaceuticals
Waltham,Massachusetts,USA
DwightJ.Hardy,PhD
UniversityofRochesterMedicalCenter
Rochester,NewYork,USA
JanetA.Hindler,MCLS,MT(ASCP)
UCLAMedicalCenter
LosAngeles,California,USA
StephenG.Jenkins,PhD,D(ABMM),
F(AAM)
NewYorkPresbyterianHospital
NewYork,NewYork,USA
JamesS.LewisII,PharmD
UniversityofTexasHealthScience
Center
SanAntonio,Texas,USA
MairPowell,MD,FRCP,FRCPath
MHRA
London,UnitedKingdom
JohnD.Turnidge,MD
SAPathologyatWomen’sand
Children’sHospital
NorthAdelaide,Australia
MelvinP.Weinstein,MD
RobertWoodJohnsonMedicalSchool
NewBrunswick,NewJersey,USA
BarbaraL.Zimmer,PhD
SiemensHealthcareDiagnosticsInc.
WestSacramento,California,USA
GeorgeM.Eliopoulos,MD
BethIsraelDeaconessMedicalCenter
Boston,Massachusetts,USA
LindaA.Miller,PhD
GlaxoSmithKline
Collegeville,Pennsylvania,USA
Acknowledgment
CLSIandtheConsensusCommitteeonMicrobiologygratefullyacknowledgethefollowingindividuals
fortheirhelpinpreparingthisdocument:
JanaM.Swenson,MMSc
Consultant
ChattahoocheeHills,Georgia,
USA
MariaM.Traczewski,BS,
MT(ASCP)
TheClinicalMicrobiology
Institute
Wilsonville,Oregon,USA
5
January2014M100-S24
WorkingGrouponMethodology
StephenG.Jenkins,PhD,
D(ABMM),F(AAM)
Co-Chairholder
NewYorkPresbyterianHospital
NewYork,NewYork,USA
BrandiLimbago,PhD
Co-Chairholder
CentersforDiseaseControland
Prevention
Atlanta,Georgia,USA
SethT.Housman,PharmD,MPA
CenterforAnti-InfectiveResearch
andDevelopment,HartfordHospital
Hartford,Connecticut,USA
LauraM.Koeth,MT(ASCP)
LaboratorySpecialists,Inc.
Westlake,Ohio,USA
SandraS.Richter,MD,D(ABMM)
ClevelandClinic
Cleveland,Ohio,USA
DarcieE.Roe-Carpenter,PhD,CIC,
CEM
SiemensHealthcareDiagnosticsInc.
WestSacramento,California,USA
KatherineSei
SiemensHealthcareDiagnosticsInc.
WestSacramento,California,USA
RibhiM.Shawar,PhD,D(ABMM)
FDACenterforDevicesand
RadiologicalHealth
SilverSpring,Maryland,USA
JohnD.Turnidge,MD
SAPathologyAtWomen’sand
Children’sHospital
NorthAdelaide,Australia
MelvinP.Weinstein,MD
RobertWoodJohnsonMedical
School
NewBrunswick,NewJersey,USA
RomneyM.Humphries,PhD,
D(ABMM)
UCLADavidGeffenSchoolof
Medicine
LosAngeles,California,USA
SusanSharp,PhD,D(ABMM),
F(AAM)
KaiserPermanente-NW
Portland,Oregon,USA
TextandTableWorkingGroup
JanaM.Swenson,MMSc
Co-Chairholder
Consultant
ChattahoocheeHills,Georgia,USA
MariaM.Traczewski,BS,MT(ASCP)
Co-Chairholder
TheClinicalMicrobiologyInstitute
Wilsonville,Oregon,USA
JanetA.Hindler,MCLS,MT(ASCP)
UCLAMedicalCenter
LosAngeles,California,USA
DyanLuper,BS,MT(ASCP)SM,MB
BDDiagnosticSystems
Sparks,Maryland,USA
LindaM.Mann,PhD,D(ABMM)
Consultant
Sacramento,California,USA
SusanD.Munro,MT(ASCP),CLS
Consultant
Campbell,California,USA
FlaviaRossi,MD
UniversityofSaoPaulo
SaoPaulo,Brazil
JeffSchapiro,MD
KaiserPermanente
Alamo,California,USA
DaleA.Schwab,PhD,D(ABMM)
QuestDiagnostics,NicholsInstitute
SanJuanCapistrano,California,USA
RichardB.Thomson,Jr.,PhD
EvanstonHospital,NorthShore
UniversityHealthSystem
Evanston,Illinois,USA
MaryK.York,PhD,ABMM
MKYMicrobiologyConsulting
WalnutCreek,California,USA
6
Vol.34No.1M100-S24
QualityControlWorkingGroup
StevenD.Brown,PhD,ABMM
Co-Chairholder
Consultant
Wilsonville,Oregon,USA
StephenHawser,PhD
IHMAEuropeSàrl
Epalinges,Switzerland,USA
RossMulder,MT(ASCP)
bioMérieux,Inc.
Hazelwood,Missouri,USA
SharonK.Cullen,BS,RAC
Co-Chairholder
SiemensHealthcareDiagnosticsInc.
WestSacramento,California,USA
WilliamB.Brasso
BDDiagnosticSystems
Sparks,Maryland,USA
PatriciaS.Conville,MS,MT(ASCP)
FDACenterforDevicesandRadiological
Health
SilverSpring,Maryland,USA
JanetA.Hindler,MCLS,MT(ASCP)
UCLAMedicalCenter
LosAngeles,California,USA
MichaelD.Huband
AstraZenecaPharmaceuticals
Waltham,Massachusetts,USA
RonaldN.Jones,MD
JMILaboratories
NorthLiberty,Iowa,USA
ErikaMatuschek,PhD
ESCMID
Vãxjõ,Sweden
SusanD.Munro,MT(ASCP),CLS
Consultant
Campbell,California,USA
RobertP.Rennie,PhD
UniversityofAlbertaHospital
Edmonton,Alberta,Canada
FrankO.Wegerhoff,PhD,
MSc(Epid),MBA
Seattle,Washington,USA
Staff
ClinicalandLaboratoryStandardsInstitute
Wayne,Pennsylvania,USA
LuannOchs,MS
SeniorVicePresident–Operations
TracyA.Dooley,MLT(ASCP)StaffLiaison
MeganL.Tertel,MAEditor
JoanneP.ChristopherAssistantEditor
7
January2014M100-S24
8
Vol.34No.1M100-S24
Contents
Abstract
1
Committee
Membership
5
Summary
of
Major
Changes
in
This
Document
13
Cefepime
Breakpoint
Change
for
Enterobacteriaceae
and
Introduction
of
the
Susceptible-Dose
Dependent
(SDD)
Interpretive
Category
18
Summary
of
CLSI
Processes
for
Establishing
Interpretive
Criteria
and
Quality
Control
Ranges
22
CLSI
Reference
Methods
vs
Commercial
Methods
and
CLSI
vs
FDA
Interpretive
Criteria
(Breakpoints)
23
Subcommittee
on
Antimicrobial
Susceptibility
Testing
Mission
Statement
26
Instructions
for
Use
of
Tables
27
Table1A.SuggestedGroupingsofAntimicrobialAgentsWithFDAClinicalIndicationsThatShould
BeConsideredforRoutineTestingandReportingonNonfastidiousOrganismsbyClinical
MicrobiologyLaboratoriesintheUnitedStates38
Table
1B.
Suggested
Groupings
of
Antimicrobial
Agents
With
FDA
Clinical
Indications
That
Should
Be
Considered
for
Routine
Testing
and
Reporting
on
Fastidious
Organisms
by
Clinical
Microbiology
Laboratories
in
the
United
States
44
Table
1C.
Suggested
Groupings
of
Antimicrobial
Agents
That
Should
Be
Considered
for
Routine
Testing
and
Reporting
on
Anaerobic
Organisms
48
Tables2A–2J.ZoneDiameterandMinimalInhibitoryConcentration(MIC)InterpretiveStandards
for:
2A.
Enterobacteriaceae
50
2B-1.
Pseudomonas
aeruginosa
58
2B-2.
Acinetobacter
spp
62
2B-3.
Burkholderia
cepacia
64
2B-4.
Stenotrophomonas
maltophilia
65
2B-5.
Other
Non-
Enterobacteriaceae
66
2C.
Staphylococcus
spp.
68
2D.
Enterococcus
spp.
76
2E.
Haemophilus
influenzae
and
Haemophilus
parainfluenzae
80
9
January2014M100-S24
Contents(Continued)
2F.
Neisseria
gonorrhoeae
84
2G.
Streptococcus
pneumoniae
88
2H-1.
Streptococcus
spp.
β
-Hemolytic
Group
94
2H-2.
Streptococcus
spp.
Viridans
Group
98
2I.
Neisseria
meningitidis
102
2J.
Anaerobes
106
Table
3A.
Screening
and
Confirmatory
Tests
for
Extended-Spectrum
β
-Lactamases
(ESBLs)
in
Klebsiella
pneumoniae,
Klebsiella
oxytoca,
Escherichia
coli,
and
Proteus
mirabilis
110
Table
3B.
Confirmatory
Test
for
Suspected
Carbapenemase
Production
in
Enterobacteriaceae
114
Table
3C.
Screening
and
Confirmatory
Tests
for
Suspected
Carbapenemase
Production
in
Enterobacteriaceae
When
Using
Interpretive
Criteria
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