Assessing the Feasibility and Impact of Singlicate-Based Analysis for Clinical ADA Sample Analysis

EBF Open Symposium 2022 -- The traditional approach to generating sample results in ligand-binding assays has been to make 'duplicate' measurements from two adjacent wells on the same immunoassay plate. In recent years, this paradigm has been challenged, primarily for pharmacokinetic assays, by looking back at previously generated bioanalytical data, with the conclusion that the benefits of duplicate over single well 'singlicate' measurement are negligible (Barfield et al. 2020). Feasibility of singlicate analysis for ADA assays has also been evaluated in the method development and the validation space (Stanta et al. 2021; Jiang et al. 2021) where similar conclusions were made. Here we assessed the feasibility and impact of singlicate-based analysis by evaluating sets of clinical ADA sample analysis data in the screening, confirmation and titer tiers of analysis.