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This example is currently in draft.

This example shows findings from an assessment <> with the purpose of determining <>.

Human leukocyte antigen (HLA) typing

This example shows findings from an assessment of genomic variations in drug metabolizing genes with the purpose of determining how variations in those genes affect drug absorption, distribution, metabolism, and excretion (ADME). The method used to summarize nucleotide variation is represented in variable GFANMETH where appropriate. Identifying information for the genomic panel is represented in SPDEVID. Additional information about the genomic panel may be represented in the Medical Device Domains (e.g., DI domain) as needed.

This example shows findings from an assessment of genomic variations in genes associated with HLA typing with the purpose of determining the allele subtypes.


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Study IdentifierDomain AbbreviationUnique Subject IdentifierSponsor Device IdentifierNon-Host Organism IdentifierSequence NumberGroup IDReference IDSponsor-Defined IdentifierLink IDLink Group IDShort Name of Genomic MeasurementName of Genomic MeasurementMeasurement, Test, or Examination DetailResult or Finding in Original UnitsGenomic SymbolGenomic Symbol TypeCopy IdentifierCompletion StatusReason Test Not DoneExternal File PathLaboratory/Vendor NameSpecimen Material TypeMethod of Test or ExaminationRun IDAnalysis MethodBaseline FlagDerived FlagLower Limit of QuantitationRepetition NumberVisit NumberVisit NamePlanned Study Day of VisitDate/Time of Specimen CollectionStudy Day of Specimen CollectionPlanned Time Point NamePlanned Time Point NumberPlanned Elapsed Time from Time Point RefTime Point ReferenceDate/Time of Reference Time Point
STUDYIDDOMAINUSUBJIDSPDEVIDNHOIDGFSEQGFGRPIDGFREFIDGFSPIDGFLNKIDGFLNKGRPGFTESTCDGFTESTGFTSTDTLGFORRESGFSYMGFSYMTYPGFCOPYIDGFSTATGFREASNDGFXFNGFNAMGFSPECGFMETHODGFRUNIDGFANMETHGFBLFLGFDRVFLGFLLOQGFREPNUMVISITNUMVISITVISITDYGFDTCGFDYGFTPTGFTPTNUMGFELTMGFTPTREFGFRFTDTC
Study-123GFS123-001

1
HGA4567

An assessment of the unique pattern of sequence variation of one to many loci associated with a normal or abnormal biological process.VARPROFVariant ProfileALLELE TYPEA*02:TSXZHLA-AGENE WITH PROTEIN PRODUCT1


ACME GenomicsDNASANGER SEQUENCING





-1SCREENING-19/16/2023-2




Study-123GFS123-001

1
HGA4567


VARPROFVariant ProfileALLELE TYPEA*03:ABSAXHLA-AGENE WITH PROTEIN PRODUCT2


ACME GenomicsDNASANGER SEQUENCING















Study-123GFS123-001

1
HGA4567


VARPROFVariant ProfileALLELE TYPEB*18:TXYFHLA-BGENE WITH PROTEIN PRODUCT1


ACME GenomicsDNASANGER SEQUENCING















Study-123GFS123-001

1
HGA4567


VARPROFVariant ProfileALLELE TYPEB*38:01HLA-BGENE WITH PROTEIN PRODUCT2


ACME GenomicsDNASANGER SEQUENCING















Study-123GFS123-001

1
HGA4567


VARPROFVariant ProfileALLELE TYPEC*07:AAEPNHLA-CGENE WITH PROTEIN PRODUCT1


ACME GenomicsDNASANGER SEQUENCING















Study-123GFS123-001

1
HGA4567


VARPROFVariant ProfileALLELE TYPEC*12:AAGWEHLA-CGENE WITH PROTEIN PRODUCT2


ACME GenomicsDNASANGER SEQUENCING















Study-123GFS123-001

1
HGA4567


VARPROFVariant ProfileALLELE TYPEDRB1*07:ACEUAHLA-DRB1GENE WITH PROTEIN PRODUCT1


ACME GenomicsDNASANGER SEQUENCING















Study-123GFS123-001

1
HGA4567


VARPROFVariant ProfileALLELE TYPEDRB1*14:ABZZVHLA-DRB1GENE WITH PROTEIN PRODUCT2


ACME GenomicsDNASANGER SEQUENCING















Study-123GFS123-001

1
HGA4567


VARPROFVariant ProfileALLELE TYPEDRB3*01:XXHLA-DRB3GENE WITH PROTEIN PRODUCT1


ACME GenomicsDNASANGER SEQUENCING















Study-123GFS123-001

1
HGA4567


VARPROFVariant ProfileALLELE TYPEDRB3*HLA-DRB3GENE WITH PROTEIN PRODUCT2NOT DONEDRB3*
ACME GenomicsDNASANGER SEQUENCING















Study-123GFS123-001

1
HGA4567


VARPROFVariant ProfileALLELE TYPEDRB4*01:FVUUHLA-DRB4GENE WITH PROTEIN PRODUCT1


ACME GenomicsDNASANGER SEQUENCING















Study-123GFS123-001

1
HGA4567


VARPROFVariant ProfileALLELE TYPE
HLA-DRB4GENE WITH PROTEIN PRODUCT2NOT DONEDRB4*
ACME GenomicsDNASANGER SEQUENCING















Study-123GFS123-001

1
HGA4567


VARPROFVariant ProfileALLELE TYPE
HLA-DRB5GENE WITH PROTEIN PRODUCT1NOT DONEDRB5*
ACME GenomicsDNASANGER SEQUENCING















Study-123GFS123-001

1
HGA4567


VARPROFVariant ProfileALLELE TYPE
HLA-DRB5GENE WITH PROTEIN PRODUCT2NOT DONEDRB5*
ACME GenomicsDNASANGER SEQUENCING















Study-123GFS123-001

1
HGA4567


VARPROFVariant ProfileALLELE TYPEDQB1*02:ACBXNHLA-DQB1GENE WITH PROTEIN PRODUCT1


ACME GenomicsDNASANGER SEQUENCING















Study-123GFS123-001

1
HGA4567


VARPROFVariant ProfileALLELE TYPEDQB1*05:ACEDBHLA-DQB1GENE WITH PROTEIN PRODUCT2


ACME GenomicsDNASANGER SEQUENCING















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