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 # | Topic | Use Case | Domains Affected | Example/Decisions | Modeling | Notes |
---|---|---|---|---|---|---|
1 | Updates from Influenza-TAUG | OI, IS | Hemagglutination Inhibition Assay - updates from Influenza-TAUG | Completed | ||
2 | Updates from TB-TAUG v1 and v2 | IS | Interferon-Gamma Response Assays -updates from TB-TAUG V1 and V2 | Completed | ||
3 | Antinuclear Antibody Staining | IS | Open-ended Findings vs Pre-specified Findings Modeling in IS | Completed |
| |
4 | High-Risk HPV Screening Test | MB | Modeling Multi-target Microbial Detection/Identification Test | Completed |
| |
5 | Replication Complement Lentivirus | MB | Replication Competent Lentivirus - Decisions | Example not needed in MB. May be needed in GF? |
| |
6 | System Serology Data | IS | System Serology Examples | |||
7 | Updates from Influenza-TAUG | MB | Flu Antigen Identification Tests | |||
8 | HLA 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 |
| ||
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