ISO TS 04424-2023.docx
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1、TECHNICA1.SPECIFICATIONISO/TS4424editionFirst2O23-12Genomicsinformatics-Datae1.ementsandtheirmetadatafordescribingthetumormutationburden(TMB)informationofc1.inica1.massivepara1.1.e1.DNAsequencingInformatuiuegenomiqueE1.ementsdedonneesetIeursmetadonneespourdecrire1.esinformationsre1.ativesaIachargetu
2、mora1.emutationne1.1.e(TMB)dusqUenCQgemassifpara1.1.e1.ed,ADNISO2023COPYRIGHTPROTECTEDDOCUMENTISO2023IUirhM*hedbdi1.iUedotherwiseupdhi.or啪UIBndttaeDmkfifiHipB1.andonnet8CH-1214Vernier,GenevaPhone:M1.22749O1.11觥ftte:丽丽BQrgPub1.ishedinSwitzer1.andContentsForeword7.2.2Genera1.77.3.2Genera1.8735Referr1.
3、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.DNAN
4、GSreport6Gener31.6.2 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 I
5、nformationon1.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.tinformat
6、ion7.7.2 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.at
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- ISO TS 04424-2023 04424 2023
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