在孟加拉国农村育龄妇女和孕妇中进行的双盲、随机、对照微量营养素剂量反应（MiNDR）试验中微量营养素生物标志物的选择和测定方法及性能

IF 3.2 Q2 NUTRITION & DIETETICS

Current Developments in Nutrition Pub Date : 2025-10-01 DOI:10.1016/j.cdnut.2025.107546

Sulagna Bandyopadhyay , Anjan Kumar Roy , Sarah Baker , Katherine K. Stephenson , Ximing Ge , Yuwei Wang , Khalid Bin Ahsan , Eleonor Zavala , Hasmot Ali , Rezwanul Haque , Lee Shu Fune Wu , Brooke Langevin , Mathangi Gopalakrishnan , Towfida Jahan Siddiqua , S.M. Tafsir Hasan , Parul Christian , Kerry J Schulze

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引用次数: 0

摘要

背景：微量营养素生物标志物评估的综合文献，捕捉从缺乏到过量的状态，仍然有限，特别是在多种微量营养素补充（MMS）试验的背景下。在孟加拉国农村育龄妇女和孕妇的两项平行生物功效试验中，我们记录了生物标志物的选择、分析前和分析方法、分析性能评估和生物标志物解释，以模拟MMS的剂量-反应效应。方法在野外和2个实验室进行生物标志物测定的盲法分析。自动化临床化学分析仪用于测量维生素D、B12、叶酸、铁、炎症、碘和骨转换等常规血清和血浆生物标志物。采用超高效液相色谱法（UPLC）测定血浆维生素A、E、B2、B6和尿液维生素B1、B2、B3。采用电感耦合等离子体质谱（ICP-MS）分析血清矿物质板。尿碘和维生素B1、B2、B12、铁和硒的功能测定采用96孔板法。对静脉血中的血红蛋白进行即时检测，而对血浆中的肝肾功能、葡萄糖和脂质进行检测。结果报告了生物标志物测定的检测限和定量限。对于主要结果生物标志物，自动分析仪、ICP-MS和96孔板的质量控制（QC）材料的测定间变异系数为4%-10%，UPLC测定的测定间变异系数为2%-11%（如有）。三分之二的主要结果生物标志物的测量可以使用既定的外部QC材料进行评估，以确保分析性能。结论剂量-反应MMS试验中微量营养素生物标志物分析的详细描述为设计未来涉及脆弱人群微量营养素状况综合评估的研究提供了有用的框架。基于uplc的B1， B2和B3维生素，以及B1， B2和硒的动力学分析需要外部质量保证工具。

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Micronutrient Biomarker Selection and Assay Methods and Performance in Double-Blind, Randomized, Controlled Micronutrient Dose Response (MiNDR) Trials among Women of Reproductive Age and Pregnant Women in Rural Bangladesh

Background

Comprehensive documentation of micronutrient biomarker assessments, capturing status from deficiency to excess, remains limited, specifically in the context of multiple micronutrient supplementation (MMS) trials.

Objectives

We document biomarker selection, preanalytical and analytical methods, assay performance evaluation, and biomarker interpretation for modeling the dose–response effects of MMS in 2 parallel bioefficacy trials among women of reproductive age and pregnant women in rural Bangladesh.

Methods

Blinded analysis of biomarker assays is being performed in the field and at 2 laboratories. Automated clinical chemistry analyzers are used to measure conventional serum and plasma biomarkers of vitamin D, B12, folate, iron, inflammation, iodine, and bone turnover. Plasma vitamers of A, E, B2, and B6, and urinary B1, B2, and B3 are measured by ultra-performance liquid chromatography (UPLC). A serum mineral panel is analyzed by inductively coupled plasma mass spectrometry (ICP-MS). Urinary iodine and functional assays for vitamin B1, B2, and B12, iron, and selenium are measured using 96-well plate methods. Point-of-care tests are performed for hemoglobin in venous blood, whereas liver and kidney function, glucose, and a lipid panel are performed in plasma.

Results

Limits of detection and quantitation for biomarker assays are reported. Interassay coefficient of variations of quality control (QC) materials for primary outcome biomarkers are 4%–10% for automated analyzers, ICP-MS, and 96-well plate, and 2%–11% for UPLC assays, where available. Measurements of two-thirds of the primary outcome biomarkers could be evaluated using established external QC materials to ensure assay performance.

Conclusions

The detailed account of micronutrient biomarker assays in the dose–response MMS trials provides a useful framework for designing future research involving comprehensive assessments of micronutrient status in vulnerable populations. External quality assurance tools are warranted for UPLC-based B1, B2, and B3 vitamers, and for kinetic assays of B1, B2, and selenium.

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