Journal
JOURNAL OF BIOPHARMACEUTICAL STATISTICS
Volume 17, Issue 3, Pages 433-443Publisher
TAYLOR & FRANCIS INC
DOI: 10.1080/10543400701199551
Keywords
equivalence studies; generalized confidence intervals; intersection-union test (IUT); misclassification rates; sensitivity and specificity; variance components
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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.
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