LBC – EVIDENCE FOR IMPROVED SENSITIVITY IN THE 为提高灵敏度的LBC–证据

LBC-EVIDENCE

FORIMPROVED

DETECTION

OFHIGHGRADELESIONSTomasSlavikAnatomical

PathologistAmpath

Pretoria

Cytology

LaboratoryIntroduction

“

e1

l

cancer

through

labs’errors"Critical

scrutiny

of

cervical

cancer

screening

failuresfo

m

eding

5

years

(>80

%)-

false

negative

Paptest

(1

%)*=70%-sampling

issue

(cells

notcollected/transferred

onto

slide)二

30

%-interpretative

issue(abnormal

cells

present

butmissed

/misinterpreted)*McCrory

DCetal,AgencyforHealthCare

Policyand

Research,2019eirriueapswPapllono■a:c7rvi98uch

c2

NovissesJourntePapteWall

SSensitivityofasingleconventionalcervicalsmearisassessed

in

the

literature

at50

-60%Faheyetal2019Specificity

>95%AHC

E0100-0200002019paioaHnTdAaPubliUKNPRInitial

LBCstudies

0G'sS:LILB

e

ehc

wio

pi

at

e

inAs

more

studies

were

published,caseosarencren

coramatne

i

eluds,i

ys

dologyimilarmethonuostonceasveerimprnumconventionalcytologymanystudieshadshortcomings

(smallpatientnumbers,splitsample,comparisonofoutcomes,no

reference

standard)YearPrimary

AuthorJo

urnalType

of

Study#TPPTBiopsyEffect

on

HSILStatistical

Significance2003LimayeArch

Pathol

Lab

MedDirect-To-Vial166,384YesIncreased

173%p<0.0012003NICE

StudyReport

to

the

Dept

of

HealthDirect-To-Vial34,813YesIncreased

17%nostatistical

significance2002Scottish

StudyScottish

GroupCSP

SteeringReportDirect-To-Vial30,228YesIncreased

85%p<0.0012001Obwegeser

Acta

CytologyDirect-To-Vial997YesDecreased

15%notstatistically

different2001ClavelBr

JCancerDirect-To-Vial7,932YesIncreased

28%p<0.052000FerrisJFam

PractDirect-To-Vial992YesIncreased

119%p<0.0012000WeintraubDiagn

CytopatholDirect-To-Vial39,864YesIncreased

244%p<0.00119991999YeohDiaz-RosarioHongArchKongPatholMed」Lab

MedDirect-To-VialDirect-To-Vial16,541YesIncreasedIncreased28%103%p<0.0156,339Yesp<0.0011998GuidosDiagn

CytopatholDirect-To-Vial9,583YesIncreased

233%p<0.0011998PapilloActa

CytologyDirect-To-Vial8,541YesIncreased

55%p<0.0012001MonsonegoBr

JCancerSplit

Sample5,428YesIncreased

18%noPvalue

calculated1999HutchinsonCancer

CytopatholSplit

Sample8,636YesIncreased

19%p<0.0011999Ro

bertsMed

JAustSplit

Sample85,732YesIncreased

16%noPvalue

calculated1999WangJ

Formos

Med

AssocSplit

Sample972YesIncreased

31%p<0.0062001BernsteinAm

JObstet

GynecolMeta-analysis221.864Meta

Increased137%tbdDetectionofHighGrade

Disease(HSIL)International

Clinical

DataDataforFDAapproval

(directtovial)2019:ThinPrep(Cytyc)-59%increasedHGSIL+detection2019:Surepath(Tripath)-64

%increasedHGSIL+detectionWeighted

average4

laboratoriesTotal

30,228

in

6

monthsConv%ThinPrep%Unsatisfactory7.31.84Borderline(~ASC

US)3.983.68Mild

dyskaryosis

(LSIL)1.12.12Moderate

+severedyskaryosis

(HSIL)1.12.03Scottish

LBCPilot

Results(2019)PPV

79.5-87.5%87408

Conventional(%)2019-201978064

ThinPrep(%)2019-2019Unsatisfactory13.61.9Negative80.991.7Borderline2.52.6Mild2.02.3

+15%Moderate0.60.8

+33%Severe0.40.6

+50%Others0.10.1EdlinburghLaterstudies(secondaryresearch,*

Austin

M,Ramzyl.ActaCytol2019;42:178-84*

Abulafia

Oetal.GynecolOncol2019:90:137-44Karnon

J

et

al.Health

TechnolAssess2019;8:iii,1-78systematicreviews,meta-analyses)i

i

)LGSIL

+%of7n1o6-1tectsedts,danncrepatiesignificantlyeswith

79366Cdion

LB23

stu24studies;10withreferencestandard(21752

patients)

e

iBfiCc

ithya

7o

rall

increased

sensitivity(8

%)cLpdsweansh2largest

studies(88569

and

74573

patients)found79-96

%increased

HGSIL+detection,aggregatesensitivity

increased

12%withLBCBUT...l

f

udies(onlyConclusionsofhigh,mediumand

lowqualityInadequacycriteriain

studies

differed)tssrele45tabut

ofacceofdiesno.oultlity

ssmaayigh

quremel5

hExtstudiesconflicting

(e.g.LGSILdetectionincreasedinallqualitystudies,HGSILdetection

ii

/low

quality

studies

and

ineuindependentstudincreased

in

medDavey

Eetal,BMJ,2019;335;31consideredtheirprevious

Lancet

LBCstudy=

"inconclusive"with

LBCand

imager-fewer

unsatisysldes

than

CC-improved

detection

of

SIL

(2,8vs2,2%)detects

1,29more

HGSIL/

1000casesscreenedthanCCRenshaw

Aet

al.Arch

Pathol

Lab

Med2019;128:17-22

i

a

o

886LBC)LBCassociatedwithsignificantlylowererror0n2i89815

CC

andarisonProgramgyomloCCytoralorinbgavaerlCervCAPratesindiagnosingpathology

when

comparedwith

CCGovernment

Health

Reviews/TechnologyAssessmentsliit

eHRe

r

(

)ical

Advisory6

%increase

in

biopsy-proven

highgradelesionswith

LBC

cehn/

y

e,

0lt9C)are

Policy

andUK-NICE(2019,2019)-KarnonJet

al.1hPrHfaAeSohplteaenommustraLBCshows"significant

improvement

insensitivity"overCC出

lsrOunllyAsswenseInCsvsnleanser

e

i

5

u

lb

l

o

h

i

r

Lrate

Denmark(Kirschner

B

et

al.Cytopathol2019;17:187-94)Sweden

(Strander

B

etal.Cancer

Cytopathol2019;111:285-91)Cana

ynt

gsstu

s

o

o,4g

r

l

it(

t

4

%u)b9ive20nstheaseeHonms

i%ie6lBChnLcedins

in

20for

Drucaeepgsp4Ass811ianeasedHGSIincrsedofeanceincelyidntvaecer

nosigniftdgeaniestialudanttsst

al=subs),ie%ud8st(rtnoohctcodettwo13484

patients(direct

to

vial)=42

%increase

in

high

grade

lesionsi

efnotm(d

al)=23,3

%increase

in

“cellsyicvnonat

tallgirecrsouspatipic513s6u6s1CC

ONLYCC+LBC30905

cases49041

casesAmpathPretoriaCytopathology

Laboratory-

HGSIL

=1,2

%-HGSIL=1,6%(33

%increase)CONCLUSIONONhueseid

le

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