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Ground Rules for Examples; examples must be:

  • "Real-life" submission use cases (i.e., not theoretical)
  • Should be actual dummied collection if possible; otherwise other materials are fine.
Row #TopicUse CaseDomains AffectedExample/DecisionsModelingNotes
1Updates from Influenza-TAUG
OI, ISHemagglutination Inhibition Assay - updates from Influenza-TAUGCompleted
2Updates from TB-TAUG v1 and v2
ISInterferon-Gamma Response Assays -updates from TB-TAUG V1 and V2Completed
3Antinuclear Antibody Staining 
ISOpen-ended Findings vs Pre-specified Findings Modeling in ISCompleted
4High-Risk HPV Screening Test
MBModeling Multi-target Microbial Detection/Identification TestCompleted
5Replication Complement Lentivirus
MBReplication Competent Lentivirus - Decisions

Example not needed in MB.

May be needed in GF?

  • GF team has a similar topic, need to notify Chris that the MB team has created controlled terminology for this topic and the decision it to model this data in MB.
6System Serology Data
ISSystem Serology Examples

7Updates from Influenza-TAUG
MBFlu Antigen Identification Tests

8HLA Antibodies

HLA-DPA1*01:03 Allele Antibody

HLA-DPB1*04:01 Allele Antibody

HLA-DPB1*04:01 Allele Antibody

HLA-DPB1*04:01 Allele Antibody

IS

  • The antibodies targeting HLA antigens belong in IS, like HLA-A32 Antibody, HLA-DQB5 Antibody, but what are these things?
  • GF team has a similar topic, need to work with Chris to see which team/domain this data fall under.





















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