Regression analysis on serial dilution data from virus validation robustness studies

In: Statistica Neerlandica: journal of the Netherlands Society for Statistics and Operations Research, Volume 63, Issue 3, p. 245-257

Abstract

To ensure the safety of plasma‐derived medicinal products, the Dutch Blood Supply Foundation (Sanquin) performs virus validation experiments. Data from these experiments are based on serial dilution assays. Regression analysis on assay data faces several problems: only a small number of data points are available, data contain censoring and are subject to sampling error. Furthermore, the process variability inherent to the experiments is not evident. In this paper we address these problems by introducing a regression model for serial dilution data and by analyzing how validation experiments and simulation techniques can help elucidate various sources of variability the experiments are subject to. These are then incorporated into the regression model.