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

IF 2.9 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinica Chimica Acta Pub Date : 2025-07-25 DOI:10.1016/j.cca.2025.120516

Kaiduo Xu, Xuanchang Bai, Haijian Zhao, Weiyan Zhou, Chuanbao Zhang

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引用次数: 0

Abstract

Clinical laboratory testing plays a pivotal role in modern medicine, yet result variability across methods remains a major challenge. This review examines current approaches for achieving standardized and harmonized test results, with particular focus on ISO 17511's calibration hierarchies and ISO 21151 harmonization protocols. While standardization through metrological traceability to higher-order references remains ideal, many analytes require harmonization when reference materials or methods are unavailable. Key international organizations including IFCC, JCTLM, and ICHCLR have developed infrastructure supporting these efforts. Successful applications demonstrate significant improvements in inter-method comparability for various clinical assays. However, substantial challenges remain in achieving widespread harmonization, particularly in markets with high platform diversity. Addressing these limitations requires expanded development of commutable reference materials, advanced calibration algorithms, and robust quality monitoring systems. Future efforts focus on scalable solutions that maintain global comparability while addressing regional testing variations.

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无形的桥梁：协调如何弥合不可能的标准化与临床需要之间的差距。

临床实验室检测在现代医学中发挥着关键作用，但不同方法的结果差异仍然是一个主要挑战。本文审查了目前实现标准化和协调测试结果的方法，特别关注ISO 17511的校准层次结构和ISO 21151协调协议。虽然通过计量溯源到高阶参考的标准化仍然是理想的，但当参考材料或方法不可用时，许多分析物需要协调。包括IFCC、JCTLM和ICHCLR在内的主要国际组织已经开发了支持这些努力的基础设施。成功的应用证明了不同临床分析方法间可比性的显著改善。然而，在实现广泛的协调方面仍然存在重大挑战，特别是在平台高度多样化的市场中。解决这些限制需要扩展可交换参考材料的开发，先进的校准算法和强大的质量监测系统。未来的工作重点是可扩展的解决方案，在解决区域测试差异的同时保持全球可比性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Clinica Chimica Acta 医学-医学实验技术

CiteScore

10.10

自引率

2.00%

发文量

1268

审稿时长

23 days

期刊介绍： The Official Journal of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Clinica Chimica Acta is a high-quality journal which publishes original Research Communications in the field of clinical chemistry and laboratory medicine, defined as the diagnostic application of chemistry, biochemistry, immunochemistry, biochemical aspects of hematology, toxicology, and molecular biology to the study of human disease in body fluids and cells. The objective of the journal is to publish novel information leading to a better understanding of biological mechanisms of human diseases, their prevention, diagnosis, and patient management. Reports of an applied clinical character are also welcome. Papers concerned with normal metabolic processes or with constituents of normal cells or body fluids, such as reports of experimental or clinical studies in animals, are only considered when they are clearly and directly relevant to human disease. Evaluation of commercial products have a low priority for publication, unless they are novel or represent a technological breakthrough. Studies dealing with effects of drugs and natural products and studies dealing with the redox status in various diseases are not within the journal''s scope. Development and evaluation of novel analytical methodologies where applicable to diagnostic clinical chemistry and laboratory medicine, including point-of-care testing, and topics on laboratory management and informatics will also be considered. Studies focused on emerging diagnostic technologies and (big) data analysis procedures including digitalization, mobile Health, and artificial Intelligence applied to Laboratory Medicine are also of interest.