Sample size consideration for immunoassay screening cut-point determination.

Past decades have seen a rapid growth of biopharmaceutical products on the market. The administration of such large molecules can generate antidrug antibodies that can induce unwanted immune reactions in the recipients. Assessment of immunogenicity is required by regulatory agencies in clinical and nonclinical development, and this demands a well-validated assay. One of the important performance characteristics during assay validation is the cut point, which serves as a threshold between positive and negative samples. To precisely determine the cut point, a sufficiently large data set is often needed. However, there is no guideline other than some rule-of-thumb recommendations for sample size requirement in immunoassays. In this article, we propose a systematic approach to sample size determination for immunoassays and provide tables that facilitate its applications by scientists.