The role of laboratory medicine in healthcare: quality requirements of immunoassays, standardisation and data management in prospective medicine

Abstract

In the last 10 years, 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 review should provide assistance for defining key parameters in assay evaluation and validation in research and clinical trial projects in prospective medicine.

Fig. 1

A schematic of evaluation: Typical assay performance parameters addressed in assay validation and test validation processes for immunoassays, for ato make the assay scientifically defendable method taken modified from [11]. The shown benchmarks represent an estimate for multiple types of immunological assays and strongly depends on the assay method and the intended use

Fig. 2

A scheme of evaluation: Typical assay performance parameters addressed in assay validation and test validation processes for immunoassay, taken modified from [11]. The shown benchmarks represent an estimate for multiple types of immunological assay and strongly depends on the assay method and the intended use