Interval estimation for concentration in the ELISA setting

Abstract

Enzyme-linked immunosorbent assays (ELISAs) are often used to quantify the concentration of biological substances. In a typical analysis only a point estimate of the concentration will be presented as interval estimation continues to present challenges for non-linear dose-response models. In this setting, interval estimates calculated using a Wald approach can suffer from poor coverage and have limits that fall outside parameter boundaries. Here we compare profile likelihood interval estimation procedures to Wald type intervals for the interval estimation of a concentration in the ELISA setting. Through a comprehensive simulation study, it is shown that profile likelihood methods result in interval estimates with superior coverage and that are more robust to differences in assay design when compared to Wald based approaches.

Keywords: Concentration estimation; ELISA; ELISA statistics; Host cell proteins; Interval estimation; Profile likelihood.