Characterization and Validation of Biomarkers by Immunoassays: Quality Requirements, Physical Standards and Data Management in Predictive Medicine

Abstract

In the last 10years, the area of ELISA and protein-chip technology has developed and enthusiastically applied to an enormous variety of biological questions. However, the degree of stringency required in data analysis appears to have been underestimated. As a result, there are numerous published findings that are of questionable quality, requiring further confirmation and/or validation. In the course of feasibility and validation studies a number of key issues in research, development and clinical trial studies must be outlined, including those associated with laboratory design, analytical validation strategies, analytical completeness and data managements. The scope of the following book chapter should provide assistance for defining key parameters in assay evaluation, validation in research and clinical trial projects.