title: Testing homogeneity of intra-run variance parameters in immunoassay.
abstract: A common assumption in the analysis of immunoassay data is a similar pattern of within-run variation across runs of the assays. One makes this assumption without formal investigation of its validity, despite the widely acknowledged fact that accurate understanding of intra-run variation is critical to reliable calibration inference. We propose a simple procedure for a formal test of the assumption of the homogeneity of parameters that characterize intra-run variation based on representation of standard curve data from multiple assay runs by a non-linear mixed effects model. We examine the performance of the procedure and investigate the robustness of calibration inference to incorrect assumptions about the pattern of intra-run variation.
authors.affiliation: RY33-404, Merck Research Laboratories, Rahway, NJ 07065, USA.
authors.forename: Q
authors.initials: Q
authors.lastname: Zeng
authors.forename: M
authors.initials: M
authors.lastname: Davidian
mesh_terms: D002138:Calibration; D016001:Confidence Intervals; D003851:Deoxyribonucleases / Q000032:analysis; D004797:Enzyme-Linked Immunosorbent Assay / Q000592:standards; D007118:Immunoassay / Q000592:standards*; D016018:Least-Squares Analysis; D015233:Models, Statistical; D009010:Monte Carlo Method; D017711:Nonlinear Dynamics; D011897:Random Allocation; D015203:Reproducibility of Results; D018401:Sample Size
chemical_list: D003851:Deoxyribonucleases