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Multi-Tiered Assay Strategy

Meaning

A multi-tiered assay strategy is a systematic, sequential approach to clinical or bioanalytical testing, where samples are first screened using a high-throughput, sensitive primary assay, and then positive or equivocal results are subjected to one or more subsequent, more specific, and confirmatory assays. This rigorous methodology is commonly employed in immunogenicity testing for biologic hormonal therapies to accurately distinguish between true positive immune responses and non-specific assay interference. The strategy ensures both efficiency in screening large cohorts and high confidence in the final, clinically actionable results. Implementing this approach minimizes misclassification and enhances diagnostic accuracy.