ArticleThe AAPS journal2026
Minimum Significant Ratio for Defining Treatment-Boosted ADA Responses Using Signal-to-Noise as an Alternative to Titer.
Article in The AAPS journal, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Signal-to-noise ratio (S/N) has emerged as a practical alternative to endpoint titer for evaluating anti-drug antibody (ADA) response magnitude. When titration is not performed, a scientifically justified threshold is needed to interpret longitudinal increases in S/N, particularly for identifying treatment-boosted ADA responses in subjects with pre-existing ADA. In conventional titer-based assessments, treatment-boosted responses are typically defined by an increase of two dilution steps relative to the pre-dose titer. In the absence of titer testing, an alternative threshold is needed to determine whether a post-dose/pre-dose increase in S/N exceeds expected analytical variability. This study evaluated minimum significant ratio (MSR) as a project-specific, analytical variability-based threshold for treatment-boosted ADA response classification using S/N. Two MSR calculation approaches were assessed across 11 validated clinical ADA assays representing diverse assay formats, therapeutic modalities, and analytical platforms. MSR
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