Feasibility of singlicate-based analysis in bridging ADA assay on Meso-Scale Discovery platform: comparison with duplicate analysis

Jiang Z, Kamerud J, You Z et al. | Bioanalysis, 13(14), 1123-1134, (2021) Keywords: • antidrug antibodies • immunogenicity • ligand binding assay • singlicate analysis Aim: To investigate the feasibility of singlicate analysis in anti-drug antibody (ADA) assay by comparing performance characteristics for assays qualified in duplicate and singlicate formats. Materials & methods: We employed modeling to assess and quantify the impact of singlicate to cut point factor (CPF) in scenarios with the duplicate precision from 1–20% and the proportion of well-to-well variance to overall assay variance from 0.01–0.90. The impact to CPF by singlicate is marginal if the...