Methodology in Diagnostic Laboratory Test Research in Clinical Chemistry and Clinical Chemistry and Laboratory Medicine (Evidence-Based Laboratory Medicine and Test Utilization‪)‬

The recently published STARD initiative concerning the publication of studies on diagnostic accuracy is an important step forward in improving the quality of diagnostic investigation. Its relevance is even greater if we consider the many challenges of research on diagnostic tests and that application of epidemiologic principles to the field of clinical diagnosis has been less developed than other clinical areas, or perhaps less effective (1, 2). In 1996, Reid et al. (3) pointed out serious methodologic limitations of research on diagnostic tests published in the most prestigious international scientific clinical journals. More recently, serious methodologic limitations have been brought to light in reports on genetic testing (4,5).