CLSIM100-S24英文版 抗菌药物敏感性试验执行标准;第二十四版资料增刊

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

technology?CLSIwantstohearfromyou.Wearealwayslookingforvolunteers.Bydonatingyourtimeand

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