Why Metrological Traceability Matters in Medical Laboratory Diagnostics

Area of Science:

• Laboratory Medicine
• Metrology
• Precision Medicine

Background:

• Medical laboratory results are vital for diagnosis, monitoring, and risk stratification.
• Precision medicine increases the demand for high clinical and analytical performance of laboratory tests.
• Metrology concepts are essential for translating clinical needs into reliable tests.

Purpose of the Study:

• To highlight the importance of metrological traceability in laboratory medicine.
• To explain how metrology ensures accurate medical decision-making.
• To demonstrate the role of metrology in data exchange and AI applications.

Main Methods:

• Review of metrology concepts in laboratory medicine.
• Discussion of metrological traceability from test development to clinical interpretation.
• Exploration of metrology's application across various laboratory disciplines.

Main Results:

• Metrological traceability is fundamental for accurate medical decision-making.
• Equivalence of test results is achieved through correct metrology implementation for data exchange.
• Metrology is critical for the reliable use of test results in algorithms and AI.

Conclusions:

• Metrology is an underappreciated science critical to modern laboratory medicine.
• Implementing metrology ensures the quality and comparability of laboratory test results.
• Metrology ultimately benefits patient care and caregiver support through reliable data.