Describe the systematic procedure with a decision-tree for application of the lean approach as an alternative to reporting ADA results including titers Discuss the risks and benefits for reporting by the lean 1-tier approach Describe a measurement where saturation of the S/N responses could limit its utility of the lean 1-tier reporting for interpretation of immunogenicity especially in patients.
Learning Objectives:
To identify assay circumstances where S/N values can be suitable as an alternative as reporting titers
To apply and interpret S/N results as an alternative to reporting titers
To provide a systematic approach for implementation of S/N
