Measurement uncertainty for practical use – applied in hematology

IF 2.9 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinica Chimica Acta Pub Date : 2025-08-08 DOI:10.1016/j.cca.2025.120546

Wytze P. Oosterhuis , Abdurrahman Coskun , Sverre Sandberg , Parvana Mikailova , Elvar Theodorsson , on behalf of the EFLM Committee: Practical Guide to Implement Measurement Uncertainty

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Abstract

Uncertainty of measurements in clinical laboratories should be monitored, reported, and documented as required by accreditation standards. The conceived complexity of calculation methods described by current guidelines such as ISO 20914 favors a more pragmatic, utilitarian approach. For that reason an alternative approach was applied for measurement uncertainty (MU) calculations in a conglomerate of seven laboratories with eleven measurement systems. MU was based on internal quality control results and for the routine hematological parameters. Graphical and variance component analysis was used to identify factors causing diverging results. MU for hematological tests, but not for all derived parameters were within the MU-APS limits (MAU) based on biological variation. It was demonstrated that MU of a diverging measuring system in the conglomerate could be improved by a correction procedure. In conclusion, that MU could be derived for hematological tests in a conglomerate of laboratories. All the parameters of cellular counting (except indices) were within the specifications based on biological variation. Factors causing deviating results within the conglomerate could be identified and significantl improved.

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实际应用的测量不确定度。应用于血液学。

临床实验室测量的不确定度应按照认可标准的要求进行监测、报告和记录。当前的指导方针（如ISO 20914）所描述的计算方法的复杂性倾向于更实用、更实用的方法。由于这个原因，在一个由7个实验室和11个测量系统组成的集团中，测量不确定度（MU）的计算采用了另一种方法。MU以内部质控结果和常规血液学参数为基础。采用图形分析和方差成分分析来确定导致结果分歧的因素。血液学试验的MU，但并非所有衍生参数都在基于生物学变异的MU- aps限值（MAU）内。结果表明，砾岩中发散测量系统的MU可以得到充分的校正。总之，该MU可用于血液学试验的综合实验室。细胞计数参数在生物学变异的规范范围内。可以识别并充分纠正导致砾岩内部结果偏差的因素。

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.