Abstract:The traditional concept of describing the validity of a diagnostic test neglects the presence of chance agreement between test result and true (disease) status. Sensitivity and specificity, as the fundamental measures of validity, can thus only be considered in conjunction with each other to provide an appropriate basis for the evaluation of the capacity of the test to discriminate truly diseased from truly undiseased subjects. In this paper, chance-corrected analogues of sensitivity and specificity are presented as supplemental measures of validity, which pay attention to the problem of chance agreement and offer the opportunity to be interpreted separately. While recent proposals of chance-correction techniques, suggested by several authors in this context, lead to measures which are dependent on disease prevalence, our method does not share this major disadvantage. We discuss the extension of the conventional ROC-curve approach to chance-corrected measures of sensitivity and specificity. Furthermore, point and asymptotic interval estimates of the parameters of interest are derived under different sampling frameworks for validation studies. The small sample behavior of the estimates is investigated in a simulation study, leading to a logarithmic modification of the interval estimate in order to hold the nominal confidence level for small samples.
Validation and Measurement Uncertainty Assessment of a Microbiological Method Using Generalized Pivotal Quantity Procedure and Monte-Carlo Simulation