Comparison of quantitative diagnostic tests: type I error, power, and sample size

For a quantitative laboratory test the 0.975 fractile of the distribution of reference values is commonly used as a discrimination limit, and the sensitivity of the test is the proportion of diseased subjects with values exceeding this limit. A comparison of the estimates of sensitivity between two tests without taking into account the sampling variation of the discrimination limits can increase the type I error to about seven times the nominal value of 0.05. Correct statistical procedures are considered, and the power and required sample size are studied for Gaussian and log-Gaussian distributions of diagnostic test values. The results may be useful for the planning phase of studies to evaluate quantitative diagnostic tests.