Modeling immunogenecity data to establish screening bioassays cut point.

Abstract

The response of immunogenecity anti-drug antibody (ADA) generally includes biological and analytical variability. The nature of biological and analytical variations may lead to a variety of symmetric and asymmetric ADA data. As a result, current statistical methods may yield unreliable results because these methods assume special types of symmetric or asymmetric ADA data. In this paper, we survey and compare parametric models that are useful for analyzing a variety of asymmetric data that have rarely been used to calculate assay cut points. These models include symmetric distributions as limiting case; therefore, they are useful in the analysis of a variety of symmetric data. We also investigate two nonparametric approaches that have received little attention in screening cut point calculations. A simulation study was conducted to compare the performance of the methods. We evaluate the methods using four published different types of data, and make recommendations concerning the use of the methods.