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Computational and Mathematical Methods in Medicine
Volume 2015, Article ID 128930, 7 pages
Research Article

Efficient Noninferiority Testing Procedures for Simultaneously Assessing Sensitivity and Specificity of Two Diagnostic Tests

1Epidemiology and Biostatistics Program, Department of Environmental and Occupational Health, School of Community Health Sciences, University of Nevada Las Vegas, Las Vegas, NV 89154, USA
2Department of Mathematical Sciences, University of Nevada Las Vegas, Las Vegas, NV 89154, USA
3Division of Health Sciences, University of Nevada Las Vegas, Las Vegas, NV 89154, USA

Received 28 May 2015; Revised 3 August 2015; Accepted 6 August 2015

Academic Editor: Qi Dai

Copyright © 2015 Guogen Shan et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.


Sensitivity and specificity are often used to assess the performance of a diagnostic test with binary outcomes. Wald-type test statistics have been proposed for testing sensitivity and specificity individually. In the presence of a gold standard, simultaneous comparison between two diagnostic tests for noninferiority of sensitivity and specificity based on an asymptotic approach has been studied by Chen et al. (2003). However, the asymptotic approach may suffer from unsatisfactory type I error control as observed from many studies, especially in small to medium sample settings. In this paper, we compare three unconditional approaches for simultaneously testing sensitivity and specificity. They are approaches based on estimation, maximization, and a combination of estimation and maximization. Although the estimation approach does not guarantee type I error, it has satisfactory performance with regard to type I error control. The other two unconditional approaches are exact. The approach based on estimation and maximization is generally more powerful than the approach based on maximization.