Standardizing units of measurement for medicinal biomarkers across healthcare systems and countries
Critical review
Keywords:
Standardization, Harmonization, Laboratory medicine, Traceability, Quality assuranceAbstract
Background: In the field of laboratory medicine, the terms "standardization" and "harmonization" are often used interchangeably, as they both aim to achieve the same outcome: ensuring that measurement results from different routine measurement procedures are equivalent over time and space, in accordance with specific analytical and clinical quality requirements. However, these phrases delineate two separate but interconnected ideas grounded on the principles of traceability. Aim of Work: The aim of this review is to clarify the distinction between the concepts of standardization and harmonization in laboratory medicine, and to highlight the importance of these efforts in improving patient care. Methods: This review synthesizes the existing literature on the concepts of standardization and harmonization in laboratory medicine, their underlying principles, and their practical applications. Results: The term "standardization" refers to the process of ensuring that measurement results are comparable and can be traced back to the International System of Units (SI) using a high-quality primary reference material and/or a reference measurement method (RMP). The term "harmonization" is often used when there are no high-level main reference materials or reference measurement procedures available, but the results obtained are nonetheless comparable.
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