Immunogenicity Assay Cut-Point Drift Across a Multi-Year Programme: A Short Communication
DOI:
https://doi.org/10.5281/zenodo.22649429Keywords:
Immunogenicity Assay Cut-Point Drift Across a Multi-Year Programme, Translational medicine; Evidence synthesis; Clinical implementation; Health services researchAbstract
Immunogenicity Assay Cut-Point Drift Across a Multi-Year Programme is an area of active development in translational
medicine, with evidence that has accumulated unevenly across its component questions. We review the current evidence base for
immunogenicity assay cut-point drift across a multi-year programme, spanning analytical, clinical, implementation, governance,
and economic dimensions, focusing on where practice has converged and where it continues to vary, and set out the practical
considerations relevant to a service considering its adoption. We conclude that selective, context-specific use is best supported by
the evidence currently available, rather than uniform adoption or avoidance
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