Singlicate analysis in ADA assays: comparing assay performance in duplicate and singlicate formats.

Singlicate anti-drug antibody (ADA) analysis is gaining recognition as a promising approach to optimize immunogenicity assessment. It offers significant benefits in terms of cost-effectiveness and aligns with patient-centric principles. However, its successful implementation requires a thorough understanding of its impacts on assay performance. In this perspective, we review recent case studies comparing singlicate and duplicate formats, focusing on cut point factors and sample result agreement, and seek to discuss how singlicate influences assay cut points and explore considerations for low positive control criteria under singlicate conditions. Furthermore, we propose a strategy for implementing singlicate analysis in both new and existing ADA assays, hoping to contribute to ongoing discussions in this area.