A manufacturer's approach to development of matrix robust methods.

Abstract

Use of matrix robust methods (MRM) to solve the problem of matrix-induced analytic errors appears to be a sound strategy. The development of MRM, however, is in an infancy stage. The principal barrier is the complexity of the matrix effect that involves interactions of the matrix, the analyte, and the technology base of the test method. Each of these three components has its own set of variables. The present article focuses on concepts and tactics to develop the MRM that appear promising on a path-forward basis. The author believes that the current environment favors probability of successful development of MRM. The quality awareness at all functional levels is high, technically feasible models for the design and development of MRM exist, and commercialization of such a method promises the developer a competitive advantage in the marketplace. The optimum strategy for MRM development appears to be evolutionary, ie, starting with a few critical methods and the samples representing the prevalent matrix types. Success in developing MRM also depends on close cooperation between the developers of the MRM, proficiency testing material, the proficiency testing providers, and the regulatory bodies. The research and development program may also include approaches that detect and/or correct the matrix-caused error(s) both in place of, or as an adjunct to, MRM. With respect to the development of genuine MRM, the author has given a typical development scenario comprising the design specifications, specific experimental approaches, evaluation, market introduction, and postintroduction monitoring of its robustness. The crux of the experimental approach is the response surface co-optimization of reaction conditions for the samples of prevalent matrix types such as the proficiency testing materials. The recommended approach is supported by examples of existing methods that exhibit robustness against certain types of matrices. The author believes that addition of MRM to the clinical chemistry methods repertoire is likely to improve the test result quality. It will also improve proficiency testing performance and patient care while boosting the morale of laboratory personnel.