Marc Thelen

A roadmap for standardization of serum albumin measurements

Abstract Albumin measurements in serum have important diagnostic and prognostic roles. However, non-standardized measurement procedures are still used in medical laboratories. An agreed approach for the implementation of metrological traceability to the International System of Un...

Model 1b analytical performance specifications – report on the Prague 2025 workshop

diagnostic medical devices (IVD MD) meet regulatory and quality standards before market release; for external quality assurance assessments; for quality control, monitoring reagent lot-to-lot variability, and allowing preanalytical variation assessments in labs; and for guiding p...