Assessing biomarker stability and assay performance parameters for the use of biomarkers in mental disorders; A study of early stage biomarker assay method development

Abstract

Within the field of psychiatry, the development of biomarker based assay methods is relatively young. Recent efforts focused on combining several biomarkers within a panel to increase discriminative power. However, most biomarker panels have failed to advance to the stage of clinical application. An important prerequisite is a proper sampling and storage procedure, based on a priori identified stability properties of all biomarker/body fluid combinations present in the panel. Second, is the performance requisites of the assays in use, such as Enzyme-Linked Immunosorbent Assays (ELISA), in order to assure reliable results within and between runs. In this study, we analyzed 24 biomarker assays in 32 biomarker/body fluid combinations identified clinically relevant for prediction of MDD. Each biomarker body fluid combination was tested for stability and assay performance. We found hampering stability in almost all cases except three biomarkers in urine and three in serum. By having identified stability properties adequate measures can be taken to avoid interpretation mistakes. By having identified performance properties decisions in an early stage can be taken to assay implementation. This study indicates that a good starting point for biomarker panel assay development is the investigation of stability for each biomarker/body fluid combination. In addition, assay performance plays an important role in the correct interpretation of those results. Along the way of assay development, other quality assurance parameters might be implemented focused on a fit for purpose principle ultimately providing reliable data necessary for diagnostical method implementation.