ISO TR 27877-2021.docx
TECHNICA1.REPORTISO/TR27877editionFrst2021.-10Statistica1.ana1.ysisforeva1.uatingtheprecisionofbinarymeasurementmethodsandtheirresu1.tsAna1.yseStatistiquepourreva1.uationde1.afide1.itydesmethodesdemesurebinaireetdeIeursMSUImtSReferencenumberISO/TR27877:2021(E)COPYRIGHTPROTECTEDDOCUMENT©ISO2021IUirhM*hedbdi1.iUedotherwiseupdhi.o啪InyM1.tta0Dmk<nroni(ncm11ni10tf1.*Mqn1.C6pW11opypMRationmaytheinternetoranintranet,withoutpriorwrittenpermission.PermissioncanberequestedfromeitherISOattheaddressbe1.oworISO'smemberbodyinthecountr)oftherequester.f),WV>fifiU81.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 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:Humance1.1.1.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)6.2Accordanceandconcordance1312(八)6.2.4 Case2(b)166.2.5 Case3(八)1f>6.2.6 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 Comparisonbetweenthemathematica1.expressionsoftheprecisionestimates227.2 Comparisonbetweenthenumerica1.examp1.esoftheprecisionestimates23Bib1.iographyForewordISO(theInternationa1.OrganizationforStandardization)isawor1.dwidefederationofnationa1.standardsBuchugh(ISOtnrhniroibirH)tR¼,kWpaphngbody1.ntnoi6tat(bW(no!hntart>edj<mitteehasbeenestab1.ishedhastherighttoberepresentedonthatcommittee.Internationa1.organizations,governmenta1.andnongovernmenta1.,in1.iaisonwithISO,a1.sotakepartinthework.ISOco1.1.aboratesc1.ose1.ywiththee1.ectrotechnica1.standardization.Internationa1.E1.ectrotechnica1.Commission(IEC)ona1.1.mattersofTheproceduresusedtodeve1.opthisdocumentandthoseintendedforitsfurthermaintenanceareg殿1.三舟即oSOIEC<M三WM1.not腕田监帅螂脚H礴眼网Tgccordance曲Fhtheeditoria1.ru1.esoftheSOIECDirectives,Part2(seewww.is.orgdircctivcs).R曲拈OnHggd限fe榴n捣嫂期叫脚&ns1.雅翩院R时做赧府docf1.瓶棉搬由银赧.subjectofanypatentrightsidentifiedduringthedeve1.opmentCfh>4k¼usntwUIbeintheIntroductionand/orontheISO1.istofpatentdec1.arationsreceived(secwww.iso.org/patents).Anytradeusedinthisconstitutenameendorsement,domentisinformationgivenfortheconvenienceofusersanddoesnotForanexp1.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.ndC®HfftteeiSO/TC69,App1.icationOfstatistica1.methods,Anyfeedbackorquestionsonthisdocumentshou1.dbedirectedtotheUSeJSnationa1.standardsbody.Acomp1.ete1.istingofthesebodiescanbefoundIntroductionThedocumentsintheISO5725seriesdefinetheprecisionofquantitativemeasurementmethodstte中CteidereSWiwdKaBsumcaiperttaoentoernfni1.BMnaMpiiecisigdistiibiitinnRhasttek?ropdata1.htMso,reproducibi1.ity.Nowadays,thereisa1.soademandfordea1.ingwithqua1.itativemeasurementmethodsandtheirresu1.ts,whichoutputbinarydata,categorica1.data.etc.However,theISO5725seriesisnotsuitab1.emathematica1.1.yforana1.yzingsuchdata.Severa1.existingstudiesproposestatistica1.methodsfordea1.ingwithbinaryand/orcategorica1.data,butnoguidancedocumentsareavai1.ab1.esofar.Hence,thisdocumentsummariesvariousmethodstoand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.presented,respective1.y.invo1.vcd.Forthefirstandsecondtypesofmethods,fiveandthreecasesare2 Normativereferencesconstitutesrequirements1.atesteditiondocument.referencedreferences.(inc1.udingamendments)app1.ics.app1.ies.probabi1.ityprincip1.esanddefinitions3 Termsanddefinitions,andsymbo1.s3.1 Termsanddefinitionsthefo1.1.owingapp1.y.ISOOn1.inebrowsingp1.atfonn:avai1.ab1.eat4Ups/WWWT0rFgobp3.1.1accordanceproposedReferenceconceptcorrespondstothedefinitionofwrepeacab1.1.ityMinISO5725andwaso