Quality Management in Clinical Application of Mass Spectrometry Measurement Systems

Vogeser, M.; Seger, C.

Given the increasing application of quantitative MS methods (with stable isotope internal standardization) to clinical samples, aspects of quality and risk management must be considered for the assays to ultimately be fit for diagnostic purposes. These aspects are extensively weighed in Vogeser and Segers recent review article. Addressed therein are pre-implementation strategies, quality assurance tools, validation approaches, assay assessment, and regulatory practices.