ISO TS 04424-2023.docx

TECHNICA1.SPECIFICATIONISO/TS4424editionFirst2O23-12Genomicsinformatics-Datae1.ementsandtheirmetadatafordescribingthetumormutationburden(TMB)informationofc1.inica1.massivepara1.1.e1.DNAsequencingInformatuiuegenomiqueE1.ementsdedonneesetIeursmetadonneespourdecrire1.esinformationsre1.ativesaIachargetumora1.emutationne1.1.e(TMB)dusqUenCQgemassifpara1.1.e1.ed,ADN©ISO2023COPYRIGHTPROTECTEDDOCUMENT©ISO2023IUirhM*hedbdi1.iUedotherwiseupdhi.or啪UIBndttaeDmk<nroni(ncm11ni10tf1.*Mqn1.C6pW11opypMRHt1.onmaytheinternetoranintranet,withoutpriorwrittenpermission.PermissioncanberequestedfromeitherISOattheaddressbe1.oworISO'smemberbodyinthecountryoftherequester.f),WV>fifiHipB1.andonnet8CH-1214Vernier,GenevaPhone：M1.22749O1.11觥ftte:丽丽BQrgPub1.ishedinSwitzer1.andContentsForeword7.2.2Genera1.77.3.2Genera1.8735Referr1.ngdiagnosis.7.5 Performing97.6 Biospecimen1.nfonnationinformation97.7 TMBGenera1.107.8 ReCOmnIeI1.ded一”“一“一“一MM.“一一”'”1088.38.3.1information12iiiIntroductionviScope1Normativereferences1TermsanddefinitionsAbbreviatedterms4Tumormutationburden(TMB)Compositionofe1.ementsfordescribingTMBonthec1.inica1.DNANGSreport6Gener31.6.2 SummarypartFie1.dsandtheirnomenc1.atureofrequireddata67.1 Genera1.67.2 SeqUenC1.ngorder7.2.1 C1.inica1.sequencingordercode7.2.3 Dateandtime77.3 Infdrmationonsubjeccofcare87.3.1 Subjectofcareidentifier7.3.2 SubjdOfCarename.87.3.4 Subjectofcarebirthdate87.3.6 Subjectofcaresex7.4 Informationon1.ega1.1.yauthorizedpersonorderingc1.inica1.sequencing97.4.1 Genera1.97.5.1 Genera1.1.aboratory7.5.2 Basicinformationonperforming1.aboratory97.5.3 Informationonreportgenerator97.5.4 1.ega1.1.yconfirmedpersononsequencingreport7.6.1 Genera1.97.6.2 Typeofspecimen97.7.1 statusresu1.tinformation7.7.2 TMBvaIue107.7.3 TMBstatus10Genera1.treatmentMedication10C1.inica1.tria1.information10Fie1.dsandtheirnomenc1.atureofoptiona1.data11B.1Genero】.118.2Referencegenomeversion12TMBGenera1.8.3.2CriteriaofTMBstatus128.3.3Approachoffi1.teringgerm1.inevariants128.3.58.3.6VMBntrt3g)fiUdMirfdica1.cu1.atingTMBva1.ueCa1.ibratedTMBva1.ue128.4Sequencinginformation138：粒8.4.38.4.4布蚓CingS用哈ci'eQua1.itycontro1.metrics13Sequencingp1.atforminformation138.4.5Ana1.ysisp1.atforminfb11na1.in.14AnnexA(informative)Examp1.estructureofTMBreport16*W*M*N*M*M*M*w*M*iK*W*w*M*MaM*Forewordthrough(1.SOmittees.workofPreparingbody1.ntemationa1.Standardsisnorma1.1.ytechnica1.e1.ectrotechnica1.standardization.Internationa1.E1.ectrotechnica1.Commission(IEC)ona1.1.mattersofdescribedtypesofISO/IECDirectivesrShouIdbePartiCU1.ar,documentwasapprova1.accordancewiththeISO（八）patent(三).attcntion1.akcs1.hcnopossibiHtyconcerningimp1.ementationva1.idityapp1.icabi1.ityinvo1.vec1.aimedcautioncdavai1.ab1.cWWW0iwg/PaUHKdatcstinformation,Whichresponsib1.eidentifyinganypatentconstitutenameendorsement,documentisinformationgivenfortheconvenienceofusersanddoesnotexpressionsre1.ated。即nization(WTO)assessment,asinwe1.1.asinfomationBaierstoTradeadherenceseeThisdocument11jb11nMcs.byTechnica1.CommitteeISO/TC215,Hea1.thinformatics,Subcommitteecomp1.ete1.istingofthesebodiescanbefoundatwww.iscorn/membeFshtm1.2023-A1.1.rightsreservedISO(theInternationa1.OrganizationforStandardization)isawor1.dwidefederationofnationa1.standardsbodiesmemberbodies).TheEachmemberinterestedinsubjectforwhichcarriedoutcommitteehasbeenestab1.ishedhastherighttoberepresentedonthatcommittee.Internationa1.organizations,governmenta1.andnongovernmenta1.,in1.iaisonwithISO,a1.sotakepartinthework.ISOco1.1.aboratesc1.ose1.ywiththeTheproceduresusedtodeve1.opthisdocumentandthoseintendedforitsfurthermaintenancearedifferentinthedocumentPart1.InnoSC1.ThiS【hediffereddrattedincriteriaforeditoria1.ru1.esoftheISO/IECDirectives,Part2(seewww.iso.org/direc1.ives).vofdrawsISOtopositionthatthetheevidence,ofthisordocumentmayofanytheusepatentrightsinrespectthereof.Asofthedateofpub1.icationofthisdocument,ISOhadnotreceivednoticeof（八）PatCnt(三)whichmayberequiredtoimp1.ementthisdocumentHowever,irnp1.ementersaredatabasethatthisatmaythe.ISOsha1.1.behe1.dmayforobtainedfromtheora1.suchpatentrights.AnytradeusedinthisForanexp1.anationofthevo1.untarynatureOfstandards,themeaningofISOspecifictermsandtheWor1.dTradeconformityprincip1.estheTechnica1.about1.SO,s(TBT)1towww.iso.org/iso/foreword.htm1.SC1.fGenomicswaspreparedAnyfeedbackorquestionsonthisdocumentshou1.dbedirectedtotheuser/snationa1.standardsbody.AIntroductionWiththe