Comparing New and Old Screening Tests When a Reference Procedure Cannot Be Performed on All Screenees

Direct determination of the sensitivity and specificity of a screening test requires use of a reference procedure (such as biopsy with histopathologic analysis) that provides an estimate of true disease status. The authors present a method for comparing the accuracy of a new screening test to an old one in situations when it is not feasible to apply the reference procedure to all screenees. This method requires that only those persons who test positive on old or new screening tests be further evaluated with the reference procedure. Ratios of sensitivities and specificities are derived for rapid comparison of the two screening tests. It is shown that McNemar's test can be used for significance testing of the differences in sensitivities and specificities between two screening tests. The required sample size for a study that compares the two tests is determined.