Sivakumar Sasidharan, Makhija Ishika, Bhagat Ruchika, Maurya Saanvi, Chatterjee Nabendu Sekhar, Bansal Savita, Chandra Nilesh
Discovery Research Division, Indian Council of Medical Research, ICMR Headquarters, Ansari Nagar, New Delhi 110029, India.
Institute of Home Economics, University of Delhi, Hauz Khas, New Delhi, Delhi 110016, India.
Clin Chim Acta. 2026 Jan 1;578:120539. doi: 10.1016/j.cca.2025.120539. Epub 2025 Aug 7.
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.
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.
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.
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.
生物参考区间(RIs)是临床诊断中的基本工具,传统上源自地理和种族同质化的人群,主要是西方血统。这种通用的参考区间往往无法考虑到由遗传、环境和生活方式因素引起的差异,这些因素会影响临床决策并导致健康不平等,特别是在非洲、印度和许多其他东南亚国家。本范围综述调查了一系列生物标志物基于种族的参考区间差异,以突出特定人群参考区间的重要性。
遵循乔安娜·布里格斯研究所(JBI)指南,本范围综述研究了多种生物标志物基于种族的参考区间差异的文献,包括血管性血友病因子、C反应蛋白、促甲状腺激素、白蛋白、肌酐等。通过检索截至2024年12月30日的MEDLINE(通过PubMed)、Embase、Scopus和科学网来识别研究。使用人群-概念-背景(PCC)框架确定纳入标准,重点是分析特定种族差异的观察性研究。使用CADIMA软件进行数据提取和图表绘制,由两位作者进行独立审查以确保一致性。
在4514篇文章中,共有15项研究符合纳入标准,涵盖多民族人群。各民族之间观察到生物标志物水平存在显著差异,凸显了通用参考区间的不足。显著差异包括血脂谱、维生素B12和抗苗勒管激素水平的差异。区域分布分析突出了代表性不足的种族人群研究中的差距。
本综述强调了特定种族参考区间对于提高诊断准确性和促进公平医疗结果的迫切需求。进一步的研究应侧重于开发用于建立包容性和代表性参考区间的稳健方法。