Harmonisation of Measurement Procedures: how do we get it done?

Area of Science:

• Clinical Chemistry
• Laboratory Medicine
• Metrology

Background:

• Comparable clinical laboratory measurement results are essential for accurate disease identification and management.
• Harmonisation aims to achieve result comparability across different measurement procedures, locations, and times.
• Standardisation, a subset of harmonisation, relies on calibration traceability to SI units via reference measurement procedures.

Purpose of the Study:

• To explain calibration traceability and the principles of harmonisation for measurands lacking a reference measurement procedure.
• To discuss the value and importance of harmonisation in clinical laboratory science.
• To highlight barriers to harmonisation and current global efforts to improve it.

Main Methods:

• Review of calibration traceability principles.
• Focus on harmonisation strategies for measurands without higher-order reference procedures.
• Discussion of commutable reference materials and existing harmonisation barriers.

Main Results:

• Harmonisation is crucial for ensuring clinical laboratory result comparability when full standardisation is not feasible.
• Commutable reference materials are vital for successful harmonisation.
• Significant barriers hinder current harmonisation efforts.

Conclusions:

• Harmonisation provides a framework for achieving comparable results for individual measurands, even without a reference measurement procedure.
• Addressing barriers and advancing global collaborative efforts are necessary to improve the state of laboratory measurement harmonisation.
• Continued focus on harmonisation principles is key to enhancing the reliability of clinical laboratory diagnostics.