The invisible bridge: how harmonization closes the gap between impossible standardization and clinical necessity

Area of Science:

• Clinical laboratory science
• Medical diagnostics
• Metrology in healthcare

Background:

• Clinical laboratory testing is crucial in medicine, but inter-method result variability poses a significant challenge.
• Standardization and harmonization are essential for reliable and comparable diagnostic results across different laboratory methods and platforms.

Purpose of the Study:

• To review current approaches for standardizing and harmonizing clinical laboratory test results.
• To examine the roles of ISO 17511 and ISO 21151 in achieving metrological traceability and harmonization.
• To discuss the infrastructure and efforts by international organizations like IFCC, JCTLM, and ICHCLR.

Main Methods:

• Review of international standards (ISO 17511, ISO 21151) for calibration hierarchies and harmonization protocols.
• Analysis of infrastructure developed by international organizations (IFCC, JCTLM, ICHCLR).
• Examination of successful applications and remaining challenges in inter-method comparability.

Main Results:

• Standardization via metrological traceability is ideal, but harmonization is necessary when reference materials/methods are unavailable.
• International collaborations have improved inter-method comparability for various clinical assays.
• Significant challenges persist, especially in markets with high platform diversity.

Conclusions:

• Achieving widespread harmonization requires developing commutable reference materials, advanced calibration algorithms, and quality monitoring systems.
• Future efforts must focus on scalable solutions to maintain global comparability while accommodating regional testing variations.
• Continued international collaboration is vital for advancing standardization and harmonization in clinical laboratory testing.