A proof-of-concept practical approach for achieving equivalent results from non-harmonized measurement methods while awaiting harmonization: The CA 125 example

IF 3.2 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinica Chimica Acta Pub Date : 2025-05-15 DOI:10.1016/j.cca.2025.120355

Hikmet Can Çubukçu , Oğuzhan Zengi , Hamit Hakan Alp , Murat Cihan , Kamil Taha Uçar , Marc Thelen , Mauro Panteghini

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引用次数: 0

Abstract

Background

Laboratory test results are crucial for clinical decisions, yet inconsistencies arise when measurements are not harmonized due to the lack of suitable higher-order references. This study introduces an approach to improve result comparability across different measurement systems, applicable until full metrological harmonization of the measurand is achieved.

Methods

A linear transformation formula was developed, utilizing the 2.5th and 97.5th percentiles of data from source and target methods, to adjust source method results. The feasibility of this formula was tested using carbohydrate antigen 125 (CA 125) data from two commercial assays provided by Roche Diagnostics and Abbott Diagnostics. Method comparison statistics, including difference plots and Passing-Bablok regression, were used to evaluate the transformation’s effectiveness before and after adjustment. A web application, “Result Transformer,” was developed to facilitate the application of the transformation process.

Results

Prior to transformation, the median relative difference between the Roche and Abbott CA 125 assays was 37.7% (95% CI: 34.5–40.8%), exceeding acceptable bias. Passing-Bablok regression yielded a slope of 1.450 (95% CI: 1.400–1.485) and an intercept of −0.83 kU/L (95% CI: −1.50 to −0.29). After adjustment using the proposed approach, the median relative difference decreased to 6.0% (95% CI: 4.3–7.7%), falling within the desirable acceptable bias goal. The slope and intercept of the regression equation improved to 1.075 (95% CI: 1.039–1.102) and −0.12 kU/L (95% CI: −0.71 to 0.19), respectively.

Conclusion

The proposed transformation method effectively improved the comparability of results from different assays, permitting a more consistent test result interpretation during patient follow-up.

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在等待协调时，从非协调测量方法获得等效结果的概念验证实用方法：ca125示例

实验室检测结果对临床决策至关重要，但由于缺乏合适的高阶参考，当测量不协调时，就会出现不一致。本研究介绍了一种提高不同测量系统结果可比性的方法，适用于测量的完全计量协调。方法利用源法和目标法中2.5和97.5%的数据，建立线性变换公式，对源法结果进行调整。使用罗氏诊断和雅培诊断提供的两种商业测定法的碳水化合物抗原125 （CA 125）数据对该配方的可行性进行了测试。方法采用差异图和pass - bablok回归等比较统计方法对调整前后的改造效果进行评价。开发了一个web应用程序“Result Transformer”，以促进转换过程的应用。结果转化前，罗氏和雅培CA 125检测的中位相对差异为37.7% (95% CI: 34.5-40.8%)，超过可接受偏差。Passing-Bablok回归的斜率为1.450 (95% CI: 1.400-1.485)，截距为- 0.83 kU/L （95% CI: - 1.50至- 0.29）。使用建议的方法调整后，中位相对差降至6.0% (95% CI: 4.3-7.7%)，落在理想的可接受偏倚目标之内。回归方程的斜率和截距分别提高到1.075 （95% CI: 1.039 ~ 1.102）和- 0.12 kU/L （95% CI: - 0.71 ~ 0.19）。结论所提出的转化方法有效地提高了不同检测结果的可比性，使患者随访时的检测结果解释更加一致。

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.