Ethnicity-based variations in biological reference interval- A systematic scoping review.

IF 2.9 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinica Chimica Acta Pub Date : 2026-01-01 Epub Date: 2025-08-07 DOI:10.1016/j.cca.2025.120539

Sasidharan Sivakumar, Ishika Makhija, Ruchika Bhagat, Saanvi Maurya, Nabendu Sekhar Chatterjee, Savita Bansal, Nilesh Chandra

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引用次数: 0

Abstract

Background: Biological reference intervals (RIs) are fundamental tools in clinical diagnostics, traditionally derived from geographically and ethnically homogeneous populations, predominantly of Western origin. Such generalized RIs often fail to account for variations arising from genetic, environmental, and lifestyle factors, which can impact clinical decision-making and contribute to health inequities, particularly in countries across Africa, India, and many other Southeast Asian nations. This scoping review investigates ethnicity-based variations in RIs for a range of biomarkers to highlight the importance of population-specific RIs.

Methods: Adhering to the Joanna Briggs Institute (JBI) guidelines, this scoping review examined the literature on ethnicity-based RI variations across multiple biomarkers, including Von Willebrand factor, C-reactive protein, thyroid-stimulating hormone, albumin, creatinine, and more. Studies were identified via searches in MEDLINE (via PubMed), Embase, Scopus, and Web of Science up to December 30, 2024. Eligibility was determined using the Population-Concept-Context (PCC) framework, focusing on observational studies analysing ethnicity-specific differences. Data extraction and charting were performed using CADIMA software, with independent review by two authors to ensure consistency.

Results: Out of 4,514 articles, a total of 15 studies met the inclusion criteria, encompassing multi-ethnic populations. Significant variations in biomarker levels were observed across ethnic groups, highlighting the inadequacy of generalized RIs. Notable differences included variations in lipid profiles, vitamin B12, and anti-Mullerian hormone levels. Regional distribution analysis highlighted gaps in research from underrepresented ethnic populations.

Conclusion: This review emphasizes the critical need for ethnicity-specific RIs to improve diagnostic accuracy and promote equitable healthcare outcomes. Further research should focus on developing robust methodologies for establishing inclusive and representative RIs.

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基于种族的生物参考区间差异——系统范围综述。

背景：生物参考区间（RIs）是临床诊断的基本工具，传统上来源于地理和种族同质的人群，主要来自西方。这种普遍化的RIs通常无法解释由遗传、环境和生活方式因素引起的变异，这些因素可能影响临床决策并导致卫生不公平，特别是在非洲、印度和许多其他东南亚国家。本综述调查了一系列生物标志物的RIs基于种族的差异，以强调人群特异性RIs的重要性。方法：根据乔安娜布里格斯研究所（JBI）的指导方针，本综述检查了基于种族的RI在多种生物标志物上的变化，包括血管性血淋病因子、c反应蛋白、促甲状腺激素、白蛋白、肌酐等。截至2024年12月30日，通过MEDLINE（通过PubMed）、Embase、Scopus和Web of Science的搜索确定了研究。使用人口-概念-背景（PCC）框架确定资格，重点关注分析种族特异性差异的观察性研究。数据提取和制图使用CADIMA软件，由两位作者独立审查以确保一致性。结果：在4,514篇文章中，共有15项研究符合纳入标准，涵盖了多民族人群。在不同种族的人群中观察到生物标志物水平的显著差异，突出了广义RIs的不足。显著差异包括脂质谱、维生素B12和抗苗勒管激素水平的变化。区域分布分析突出了来自代表性不足的少数民族人口的研究差距。结论：本综述强调了对种族特异性RIs的迫切需要，以提高诊断准确性和促进公平的医疗保健结果。进一步的研究应侧重于发展强有力的方法，以建立包容性和代表性的RIs。

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.