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Reference measurement systems in clinical chemistry.
Linda M Thienpont1, Katleen Van Uytfanghe, André P De Leenheer
1Laboratorium voor Analytische Chemie. Fac. Farmaceutische Wetenschappen, Universiteit Gent, Harelbekestraat 72, B-9000, Ghent, Belgium. linda.thienpont@rug.ac.be
Summary
Establishing measurement traceability in clinical chemistry is crucial. This review discusses methods for SI-traceability and International Unit (IU) traceability, highlighting challenges and the need for global consensus.
Area of Science:
- Clinical Chemistry
- Metrology
- Measurement Science
Background:
- Traceability of measurements is a high priority in clinical chemistry.
- Standardization ensures accuracy and comparability of laboratory results.
Purpose of the Study:
- Critically discuss current recommendations for establishing measurement traceability.
- Differentiate between SI-traceability and International Unit (IU) traceability.
Main Methods:
- Literature review of current recommendations on traceability.
- Analysis of reference measurement systems and standardization processes.
Main Results:
- SI-traceability requires a metrological basis, SI units, material standards, and calibration hierarchies.
- IU-traceability is used for analytes lacking unequivocal entities, with processes varying based on analyte history.
- Special attention is needed for 'free analytes' and 'analyte families'.
Conclusions:
- SI-traceability is straightforward for some analytes (e.g., cortisol).
- IU-traceability (e.g., hCG) involves phased standardization based on analyte discovery and characterization.
- Development of an SI-based reference measurement system is realistic, requiring global consensus.