ISO TR 278772021.docx

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1、TECHNICA1.REPORTISO/TR27877editionFrst2021.-10Statistica1.ana1.ysisforeva1.uatingtheprecisionofbinarymeasurementmethodsandtheirresu1.tsAna1.yseStatistiquepourreva1.uationde1.afide1.itydesmethodesdemesurebinaireetdeIeursMSUImtSReferencenumberISO/TR27877:2021(E)COPYRIGHTPROTECTEDDOCUMENTISO2021IUirhM*

2、hedbdi1.iUedotherwiseupdhi.o啪InyM1.tta0DmkfifiU81.andonnet8CH-1214Vernier,GenevaPhone：M1.227490111觥曲ite：图洲跳触OQrgPub1.ishedinSwitzer1.andContentsForeword._.v5.3Case4：Histopatho1.ogica1.administrationtesting76Statistica1.ana1.ysisforeva1.uatingtheprecisionofbinarymeasurementmethods6.1.2Overview121.1.5

3、 Case3(b)._._.一.131.1.6 Case156.3 0RDN0V166.3.3Case2(b).186.4 CM-accuracy,196.5 Kappacoefficient.一.20iiiIntroductionviScope1Normativereferences1Termsanddefinitions,andsymbo1.s13.1 Termsanddefinitions132SymboIS3Overview4Examp1.esusedinthisdocument65.1 Case1:1.isteriamonocytogenes65.2 Case2:Humance1.1

4、1.ineactivationtest(h-C1.T)-1.65.4 3:Jntrarachea1.c1.assificationof1.ungcarcinoma5.5 Case5:Humance1.1.1.ineactivationtest(h-C1.AT)-285.6 Case6:Statistica1.mode1.forpredictingchemica1.toxicity8andtheirresu1.ts96.1 ISO5725basedmethod9Case16.13CaSe2（八）126.1.4Case2(b)133（八）6.2Accordanceandconcordance13

5、12（八）6.2.4 Case2(b)166.2.5 Case3（八）1f6.2.6 Case3(b)6.3.1 Overview166.3.2 Case1186.3.4 2（八）6.3.6 Case3(b).196.4.1 Overviewsensitivityandspecificity6.4.2 CaSC4,.206.4.3 Case5206.4.4 Case66.5.1 Overview216.5.2 Case4216.5.3 CaSe522Remarksonthemethodsintroducedinthisdocument227.1 Comparisonbetweenthemath

6、ematica1.expressionsoftheprecisionestimates227.2 Comparisonbetweenthenumerica1.examp1.esoftheprecisionestimates23Bib1.iographyForewordISO(theInternationa1.OrganizationforStandardization)isawor1.dwidefederationofnationa1.standardsBuchugh(ISOtnrhniroibirH)tR,kWpaphngbody1.ntnoi6tat(bW(no!hntartedjmitt

7、eehasbeenestab1.ishedhastherighttoberepresentedonthatcommittee.Internationa1.organizations,governmenta1.andnongovernmenta1.,in1.iaisonwithISO,a1.sotakepartinthework.ISOco1.1.aboratesc1.ose1.ywiththee1.ectrotechnica1.standardization.Internationa1.E1.ectrotechnica1.Commission(IEC)ona1.1.mattersofThepr

8、oceduresusedtodeve1.opthisdocumentandthoseintendedforitsfurthermaintenanceareg殿1.三舟即oSOIEC4kusntwUIbeintheIntroductionand/orontheISO1.istofpatentdec1.arationsreceived(secwww.iso.org/patents).Anytradeusedinthisconstitutenameendorsement,domentisinformationgivenfortheconvenienceofusersanddoesnotForanex

9、p1.anationofthevo1.untarynatureofstandards,themeaningofISOspecifictermsand忠G黜媳隅魏dwan邸邮懒O1.assE鹿ftinwe憎s1R信nBar池ea报聘心黑www.iso.org/iso/foreword.htmr.ndCHfftteeiSO/TC69,App1.icationOfstatistica1.methods,Anyfeedbackorquestionsonthisdocumentshou1.dbedirectedtotheUSeJSnationa1.standardsbody.Acomp1.ete1.is

10、tingofthesebodiescanbefoundIntroductionThedocumentsintheISO5725seriesdefinetheprecisionofquantitativemeasurementmethodstte中CteidereSWiwdKaBsumcaiperttaoentoernfni1.BMnaMpiiecisigdistiibiitinnRhasttek?ropdata1.htMso,reproducibi1.ity.Nowadays,thereisa1.soademandfordea1.ingwithqua1.itativemeasurementme

11、thodsandtheirresu1.ts,whichoutputbinarydata,categorica1.data.etc.However,theISO5725seriesisnotsuitab1.emathematica1.1.yforana1.yzingsuchdata.Severa1.existingstudiesproposestatistica1.methodsfordea1.ingwithbinaryand/orcategorica1.data,butnoguidancedocumentsareavai1.ab1.esofar.Hence,thisdocumentsummar

12、iesvariousmethodstoand肘&出摘WBrCC阳MnCI临的用饼砸回触海艇IhOdSandtheirresu1.ts.whicharethemostessentia1.Statistica1.ana1.ysisforeva1.uatingtheprecisionofbinarymeasurementmethodsandtheirresu1.ts1 Scopemeasuredva1.uesprovidedTheeach1.aboratoryparticipatingintoco1.1.aborativestudy.typesarebasedtype,samp1.es.presen

13、ted,respective1.y.invo1.vcd.Forthefirstandsecondtypesofmethods,fiveandthreecasesare2 Normativereferencesconstitutesrequirements1.atesteditiondocument.referencedreferences.(inc1.udingamendments)app1.ics.app1.ies.probabi1.ityprincip1.esanddefinitions3 Termsanddefinitions,andsymbo1.s3.1 Termsanddefinit

14、ionsthefo1.1.owingapp1.y.ISOOn1.inebrowsingp1.atfonn:avai1.ab1.eat4Ups/WWWT0rFgobp3.1.1accordanceproposedReferenceconceptcorrespondstothedefinitionofwrepeacab1.1.ityMinISO5725andwasorigina1.1.yThisdocumentintroducesfivestatistica1.methodsforeva1.uatingtheprecisionofbinarymeasurementmethcdsandtheirre

15、su1.ts,byfivemethodshedividedatwotypes.BothInthefirstoneach1.aboratoryrepeated1.ymeasuresasing1.esamp1.e.Thesamp1.esmeasuredbythe1.aboratoriesarenomina1.1.yidentica1.Thesecondtypeisanextensionofthefirsttype,wheretherearesevera1.1.eve1.sofForeachstatistica1.method,thisdocumentbrief1.ysummarizesitsthe

16、oryandexp1.ainshowtoestimatetheproposedprecisionmeasures.Somerea1.casesarei1.1.ustratedtohe1.pthereadersunderstandtheeva1.uationproceduresFina1.1.y,thisdocumentcomparesthefivestatistica1.methods.Thefo1.1.owingdocumentsarereferredtointhetextinsuchawaythatsomeora1.1.oftheircontentundatedreferences,the

17、ofthisoftheFordateddocumenton1.ytheanyeditioncitedForISO3534-1.rStatisUcs-Vocabu1.aryandsymbo1.s-Part1:Genera1.statistica!termsandtermsusedinISO5725fAccuracy(truenessandprecision)ofmeasurementmethodsandresu1.tsPart1：Genera1.Forthepurposesofthisdocument,thetermsanddefinitionsgiveninISO3534-1andISO572

18、51andISOandIECmaintainte11nino!ogica)databasesforuseinstandardizationatthefo1.1.owingaddresses：IECE1.ectropedia:avai1.ab1.eathttps:/www.e1.ectropedia.org/probabi1.itythattwobinarymeasuredva1.uesbeidentica1.whentheyaretakenfromthesame1.aboratoryNote1tobyentry：The3.3.1.2concordanceproposedReferencecon

19、ceptcorrespondstothedefinitionof,reproducibi1.ity*inISO5725andwasorigina1.1.y3.1.30RDN0V3.1.41toentry:Theconceptwasorigina1.1.yproposedbyReference(4j.t11epositiveTP3.1.StruenegativeTN3.1.6fa1.sepositiveFP3.1.7fa1.senegativeFN3.1.8confusionmatrix3.1.9CM-accuracygenera1.1.ycntry:Howcver,CM-accuracisCM

20、accuracyaccuracyaccuracj-machincmachinc1.earningfie1.dnot3.1.10sensitivityprobabi1.itythattwobinarymeasuredva1.uesbeidentica1.whentheyarctakenfromdifferent1.aboratoriesNote1tobyentry:The3.statistica1.methodforeva1.uatingtheprecisionofordina1.-sca1.emeasurementmethodsandtheirresu1.tsbasedonanordina1

21、dispersionmeasureNotecorrectmeasuredva1.ueinpositiveresu1.ts,thatis,thecasewhereboththemeasuredandthecorrectresu1.tsarepositivecorrectmeasuredva1.ueinnegativeresu1.ts,thatis,thecasewhereboththemeasuredandthecorrectresu1.tsarenegativeincorrectmeasuredva1.ueinpositiveresu1.ts,thatis,thecasewheretheme

22、asuredva1.ueispositivebutthecorrectoneisnegativeincorrectmeasuredva1.ueinnegativeresu1.ts,thatis,thecasewherethemeasuredva1.ueisnegativebutthecorrectoneispositive22matrixshowingthenumbersoftruepositives,truenegatives,fa1.sepositivesandfa1.senegativesstatisticforindicatingthecapabi1.ityoftwo-c1.assc1

23、assifications,definedbythepercentageofcorrectmeasuredva1.uesNote1toused.ThetermthisdocumentUscsidcntica1.totheterminsteadofinthethe1.earningficki,andisdistinguishbetweenthetermaccuracyinISO5725andtheterminthemachine1.earningfie1.d.Inthisdocment,theprefixCMstandsforconfusionmatrixesbecauseCM-accurac

24、ycanbeca1.cu1.atedbasedonthose.statisticforindicatingthecapabi1.ityoftwo-c1.assc1.assifications,definedbythepercentageofcorrectpositivemeasuredva1.ues3.1.11specificitystatisticorindicatingthecapabi1.ityofIwo-c1.assc1.assifications,definedbythepercentageofcorrecty滔野emeasuredva1.uesCM-precisionstatist

25、icforindicatingthecapabi1.ityoftwo-c1.assc1.assifications,definedbythepercentageofcorrectmeasuredva1.uesinpositivemeasuredva1.uesNmeeMpfH11evBrxBMttuwmwnuses1.dMiJwthote11nctsidIecisirtwiachthertwQ1.nh,1.fietnHfft1.dnotdistinguishbetweenthetermprecisioninISO5725andtheterminthemachine1.earningfie1.d.

26、Inthisdocument.史,/fixCMstandsforconfusionmatrixesbecauseCM-precisioncanbeca1.cu1.atedbasedonthose.F-measurestatisticforindicatingthecapabi1.ityoftwo-c1.assc1.assifications,definedbytheharmonicmean法俾nsensitivityandCM-precisionkappacoefficientstatisticforindicatingthecapabi1.ityoftwo-c1.assc1.assifica

27、tions,definedbytherat100fCM-accuracyminusthepossibi1.ityofthecorrectnessoccurringbychancetooneminusthepossibi1.ityofthecorrectnessoccurringbychanceNoreduced研ry：Rfifetsce)p15etH俳Hhidhmkesba?JPaMiefficmtPoSsjf)ihtyWttnfcdtiwrCtn啜由，MtagraCy,origina1.1.y3.2Symbo1.s1.nnumberOf1.aboratoriesparticipatingin

28、aco1.1.aborativestudy.numberofrepetitionsineach1.aboratoryparticipatinginaco1.1.aborativestudyjsuffixdescribinga1.aboratory,andi1.J1,suffixdescribingarepetition,andjn二J1.1.,yducibi1.it)varianceintheISO5725basedmethodchatis,ffawfWrWithin-Iabora1.oryvarianceOf1.aboratoryJinORDANOVArepeatabi1.ityvarian

29、ceinORDANOVA:=+20reprodudbi1.itjvarianceinORDANOVA,thatis.fGOrov.：2Pprobabi1.ityofobtainingameasuredVaI1.Ie型=1Of1.abora1.oryiarithmeticmeanofPi,thatis,P1.=()f71-1HGnu1.1.hypothesisofastatistica1.testi)2teststatisticofachi-squaredtestcaccordanceofReference3methodconcordanceofReference3methodestimateo

30、fX4OverviewThisdocumentdea1.swiththefo1.1.owingfivemethods.a) ISO5725-basedmethod(proposedbyReference13);b) accordanceandconcordance(proposedbyReference(3);d)CM-accuracyrsensitivityandspecificity;measuresoneidentica1.structuredependstimes,method.datamethodssummarizedc),inTab1.e1.aboratoryinsteadofNo

31、wadays,thcd)probabi1.ityforthisdocumcnt(POD)dca1.sapproachon1.yc1.assica1.methods.mcasurcdsomcva1.ucszTab1.e1Dataformatformethodsa)rb)andc)va1.ues,respective1.y.2AnotherexpressionofTab1.e1Tab1.e3Dataformatformethodsd)ande)NOTEarcnn-neativeintegers.Theestimateofaccordanceofeach1.aboratoryisshownin-Ta

32、b1.e-22;therefore.H0,87.Sincen=10,aoddsratios(CORs),werewasasor1 ha)noror(24)BecausetheP版IUe前t褥FiSher1.exacttestis0,01,Wo:COR=1isrejectedwith5-significance15TheCORistheoddsratiowhenthecontingencytab1.eshowninTab1.e20isconsidered;therefore,ifCOR=.COR=1COR,theFishersexactiforthe1,thentestused.NOTE2Att

33、ributeNumbcrofpairsTota1.ofthesamee1.ementsofdifferente1.ements100：1001.OOa.100*C100100a叫）20010Pc)1.aboratoryUb1.1.ab21.ab3Ub41.abS1.ab61.ab7Ub81.ab91.ab10SinvtaidaCstio111.ydejendonsnsitivity,IiedifYereICeenCaida1.snotSuhabeforanTheestimateofaccordanceofeach1.aboratoryisshowninTab1.e21;therefore,.=

34、088(25)Sincethenumberofpositivemeasuredva1.uesina1.1.1.aboratoriesn(,is46,theestimateofconcordance2 as(46SC=(26)Then,(27)BecausethePva1.ueoftheFishersexacttestis0.34,Ho1:COR=isnotrejectedwith5%significancAttributeNumberofpairsTota1.ofthesamee1.ementsofdifferente1.ements100；1001.OOaa100；1001.OO*CW)20

35、呼1.aboratory1.akZ1.ab31.ab41.abS1.ab61.ab71.ab81.ab91.ab1.OI4ZHAi1.eve1.;thus,abetween-1.aboratoryvarianceispresentfromtheviewpointofstatistics.CHO,64andCORH1,5.1.aboratory1.ab1.1.ab21.ab31.ab41.ab5A,1.aboratory1.ab11.ab21.ab31.ab41.ab51.aboratory1.ab1.1.ab21.ab31.ab4Ub5AA1C=I1O.Inthiscaseo1.kBF1-Ws

36、n*既d三W4at0nw9nes0.Itisnatura1.toconsiderthatanybetveen-1.aboratoA，yVariati,Reference4app1.iedthesamemethodasReference13.Moreprecise1.y,theyintroduce,theAtatiStiCIandprovedthefo1.1.owingre1.ationships:(37)Then,proposedthatthenu1.1.hypothesisisrejectedif(38)whereI：12standsforthecritica1.va1.ueofthechi

37、squarestatisticNOTE1Thc1.rcproducibiIityvariancecanbeestimatedasfo1.1.ows,too:11.42*dm三fn4iG?N-/=1f=1.f=1.相.1当乐*)WOaW6dyTheidfci1.1.MthWJftaWJU1.HKdWhbmCrRW的mtt1.BgtfvHY4注四州喃#3HyC等吸ed11pBotafMiP1.5|)*isnotsatisfied,theFisher,sexacttestcanbeusedinstead.6.3.2Case1Theestimatedprobabi1.ityPtofeachIabOr

38、atOryis1.istedinTab1.e15;therefore,p=092.Since=IOaniITsPSrti“阚Uninktd4)Ud咏inaboratOry,between-1.aboratoryandreproducibi1.ityvariances.,H110I1.110IJ11IOU卜(卜IhJ1.1.1.1,fIpH1.U1.Hh1I1.1I,-,NIk.1.D州IH10,101101t)+1)(1U(40)”90,922+(1,00,92)2+(1,0O192)2+1,00,922()“仿21(,0g(09/0092/，060092：/fH010,10I222I(41).01,(P92(92)+(1,)(j)1,00,92Iand2=4(,92(10,92)HQ29.(42)6.3.3 Case2（八）Theestimatedprobabi1.ity-pofeach1.aboratoryis1.istedinTab1.e16;therefore,A,pH087.Since1.=5andn=3rtheestimatesofthe