title: Assessing equivalence of two assays using sensitivity and specificity.
abstract: The equivalence of two assays is determined using the sensitivity and specificity relative to a gold standard. The equivalence-testing criterion is based on a misclassification rate proposed by Burdick et al. (2005) and the intersection-union test (IUT) method proposed by Berger (1982). Using a variance components model and IUT methods, we construct bounds for the sensitivity and specificity relative to the gold standard assay based on generalized confidence intervals. We conduct a simulation study to assess whether the bounds maintain the stated test size. We present a computational example to demonstrate the method described in the paper.
authors.affiliation: Statistics Department, Schering Plough Research Institute, Kenilworth, NJ, USA.
authors.forename: Jorge
authors.initials: J
authors.lastname: Quiroz
authors.forename: Richard K
authors.initials: RK
authors.lastname: Burdick
mesh_terms: D000704:Analysis of Variance; D000818:Animals; D001681:Biological Assay / Q000379:methods / Q000592:standards / Q000706:statistics & numerical data*; D003198:Computer Simulation; D016001:Confidence Intervals; D003627:Data Interpretation, Statistical; D006801:Humans; D015233:Models, Statistical; D009010:Monte Carlo Method; D012015:Reference Standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity