The integrated multivariate approach for the development of dry reagent strips for quantitative clinical analysis

The paper describes the development and the optimization of a visually and metrically evaluable dry reagent strip for quantitative clinical analysis of blood glucose based upon an enzymatic oxidation connected with a following colour coupling reaction. In contrast to classical experimental strategies, multivariate statistical methods were used to design a complex biochemical system with optimal properties. Former experiments were evaluated by means of factor analysis and the relations between the 12 biochemical variables and the 6 strip properties were studied. The mathematical discrimination between biochemically more and less relevant variables allowed a reduction of the number of experiments by a statistically reasonable design of additional selected experiments. By application of a pattern recognition technique and multivariate linear regression the data space and the variables' space were analysed. A following multivariate prediction using the partial least-squares technique yielded a glucose test strip with high reproducibility and long-term thermal stability.