Exact confidence limits for prevalence of a disease with an imperfect diagnostic test

Epidemiol Infect. 2010 Nov;138(11):1674-8. doi: 10.1017/S0950268810000385. Epub 2010 Mar 3.


Estimation of prevalence of disease, including construction of confidence intervals, is essential in surveys for screening as well as in monitoring disease status. In most analyses of survey data it is implicitly assumed that the diagnostic test has a sensitivity and specificity of 100%. However, this assumption is invalid in most cases. Furthermore, asymptotic methods using the normal distribution as an approximation of the true sampling distribution may not preserve the desired nominal confidence level. Here we proposed exact two-sided confidence intervals for the prevalence of disease, taking into account sensitivity and specificity of the diagnostic test. We illustrated the advantage of the methods with results of an extensive simulation study and real-life examples.

MeSH terms

  • Animals
  • Bias
  • Computer Simulation
  • Confidence Intervals
  • Models, Biological*
  • Models, Statistical*
  • Paratuberculosis / diagnosis
  • Paratuberculosis / epidemiology
  • Sensitivity and Specificity
  • Seroepidemiologic Studies
  • Sheep
  • Sheep Diseases / diagnosis
  • Sheep Diseases / epidemiology