[Development of a Web-based Program to Calculate Sample Size for Evaluating the Performance of In Vitro Diagnostic Kits.].

Background: Many studies evaluating the performance of in vitro diagnostic kits have been criticized for the lack of reliability. To attain reliability those evaluation studies should be preceded by sample size calculation ensuring statistical power. This study was intended to develop a web-based system to estimate the sample size, which was often neglected because it would require expert knowledge in statistics.