Traceability as a unique tool to improve standardization in laboratory medicine

Area of Science:

• Laboratory Medicine
• Metrology
• Clinical Diagnostics

Background:

• Standardization of measurements is critical for comparable laboratory medicine results.
• Achieving standardization requires reliable transfer of measurement values from higher levels to routine clinical methods.
• The reference measurement system (RS) provides this structure, based on metrological traceability.

Purpose of the Study:

• To outline the essential components and implementation of a reference measurement system for laboratory diagnostics.
• To highlight the role of metrological traceability in achieving accurate and comparable clinical laboratory results.
• To emphasize the importance of international cooperation and validation in standardization efforts.

Main Methods:

• Establishing a comprehensive reference measurement system (RS) including reference measurement procedures and materials.
• Defining measurands based on clinical use and establishing networks of reference laboratories.
• Leveraging international collaboration, such as the Joint Committee on Traceability in Laboratory Medicine (JCTLM), for publicly available resources.

Main Results:

• The development of a hierarchical structure for measurement value transfer.
• Public availability of higher-order reference materials, methods, and reference laboratories through JCTLM.
• The necessity of clinical validation for routine methods (IVD products) post-RS implementation.

Conclusions:

• A well-defined reference measurement system is essential for the standardization of laboratory medicine.
• International collaboration and the use of metrological traceability are key to successful standardization.
• Post-implementation clinical validation and ongoing performance surveillance of IVD products are critical for maintaining measurement accuracy.