title: Informative prior distributions for ELISA analyses.
abstract: Immunoassays are capable of measuring very small concentrations of substances in solutions and have an immense range of application. Enzyme-linked immunosorbent assay (ELISA) tests in particular can detect the presence of an infection, of drugs, or hormones (as in the home pregnancy test). Inference of an unknown concentration via ELISA usually involves a non-linear heteroscedastic regression and subsequent prediction, which can be carried out in a Bayesian framework. For such a Bayesian inference, we are developing informative prior distributions based on extensive historical ELISA tests as well as theoretical considerations. One consideration regards the quality of the immunoassay leading to two practical requirements for the applicability of the priors. Simulations show that the additional prior information can lead to inferences which are robust to reasonable perturbations of the model and changes in the design of the data. On real data, the applicability is demonstrated across different laboratories, for different analytes and laboratory equipment as well as for previous and current ELISAs with sigmoid regression function. Consistency checks on real data (similar to cross-validation) underpin the adequacy of the suggested priors. Altogether, the new priors may improve concentration estimation for ELISAs that fulfill certain design conditions, by extending the range of the analyses, decreasing the uncertainty, or giving more robust estimates. Future use of these priors is straightforward because explicit, closed-form expressions are provided. This work encourages development and application of informative, yet general, prior distributions for other types of immunoassays.
authors.affiliation: Physikalisch-Technische Bundesanstalt, Abbestr. 2-12, 10587 Berlin, Germany Katy.Klauenberg@ptb.de.
authors.forename: Katy
authors.initials: K
authors.lastname: Klauenberg
authors.affiliation: Physikalisch-Technische Bundesanstalt, Abbestr. 2-12, 10587 Berlin, Germany.
authors.forename: Monika
authors.initials: M
authors.lastname: Walzel
authors.affiliation: Physikalisch-Technische Bundesanstalt, Abbestr. 2-12, 10587 Berlin, Germany.
authors.forename: Bernd
authors.initials: B
authors.lastname: Ebert
authors.affiliation: Physikalisch-Technische Bundesanstalt, Abbestr. 2-12, 10587 Berlin, Germany.
authors.forename: Clemens
authors.initials: C
authors.lastname: Elster
mesh_terms: D001499:Bayes Theorem; D056808:Biostatistics; D002138:Calibration; D003198:Computer Simulation; D004797:Enzyme-Linked Immunosorbent Assay / Q000706:statistics & numerical data*; D005260:Female; D006801:Humans; D015233:Models, Statistical; D017711:Nonlinear Dynamics; D016011:Normal Distribution; D011247:Pregnancy
keywords: 4-parametric logistic function; Bayesian inference; CCQM-P58.1; ELISA; Heteroscedastic variance; Immunoassay; Informative prior; Metrology; Non-linear modeling; Prior knowledge