• Users have inquired on whether certain immunogenicity study data that have been mapped to LB, such as the anti-microbial interferon gamma response assay (which measures a person’s immune reactivity toward a pathogen/antigen, not therapy), should be reconsidered for IS. The IG3.4 IS domain scope now would allow the transition of such data from LB to IS, with the support of IS domain standard variables, whereas this data was previously represented by LB using supplemental qualifiers to map key information, this was not ideal.
    • Based on user feedback, this data had been mapped to IS, in spite of the guidance provided by the IGs and TAUGs.
      • move the IFNg response assay data in TB-TAUG from LB to IS for 4.0.
  • Add this - When modeling allergy testing-specific immune response data:
    1. if mapping specimen-based, systemic allergy data (i.e. anti-allergen antibodies) – use IS.
    2. If mapping a “wanted, expected”, localized, surface immune response (specifically skin response) to an allergen/intervention (i.e. dermal allergen tests) – use SR.
    3. If mapping a “unwanted, unexpected” finding about a reactogenicity event (i.e. vaccine-related events, such as injection site AE) – use FACE or FAAE.





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