Aim: Describe the statistical tools for the evaluation of a diagnostic test.
Material and methods: Description of the methods and practical examples based on published data.
Results: The following methods are described: 1) reproducibility of a measurement, both for a qualitative and a quantitative result, 2) comparison of a new diagnostic test to a reference test, 3) comparison of two diagnostic tests, 4) sample size computation.
Conclusion: The tools required to evaluate diagnostic tests rigorously are available and simple. They should be used more often.