Profile-likelihood inference for highly accurate diagnostic tests

We consider profile-likelihood inference based on the multinomial distribution for assessing the accuracy of a diagnostic test. The methods apply to ordinal rating data when accuracy is assessed using the area under the receiver operating characteristic (ROC) curve. Simulation results suggest that the derived confidence intervals have acceptable coverage probabilities, even when sample sizes are small and the diagnostic tests have high accuracies. The methods extend to stratified settings and situations in which the ratings are correlated. We illustrate the methods using data from a clinical trial on the detection of ovarian cancer.