Rapid Test Kit for Measurement of Urinary Iodine

尿碘快速检测试剂盒

• 批准号: 10088454
• 负责人: BIKAS VAIDYA
• 金额: $ 49.74万
• 依托单位: LYNNTECH, INC.
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-05-01 至 2023-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10088454
• 关键词: Activation Analysis; Address; Adverse effects; Affect; Anions; Area; Biological Markers; Boston; Brain; Brain Injuries; Centers for Disease Control and Prevention (U.S.); Chemicals; Child; Clinical Research; Collaborations; Color; Communities; Community Health; Country; Detection; Diagnostic Reagent Kits; Dietary Iodine; Digestion; Disease; Economics; Ensure; Evaluation; Excision; Feedback; Freezing; General Population; Goals; Growth and Development function; High temperature of physical object; Hour; Human Resources; Impairment; Individual; Inductively Coupled Plasma Mass Spectrometry; Intake; Intelligence quotient; Intervention; Iodides; Iodine; Kinetics; Laboratories; Learning; Letters; Life; Measurement; Measures; Mental Retardation; Mental deficiency; Metabolism; Methods; Micronutrients; Mission; Monitor; Nuclear; Optical Readers; Performance; Persons; Phase; Policy Research; Population; Pregnancy; Pregnant Women; Procedures; Process; Production; Productivity; Program Development; Property; Public Health; Quality of life; Reader; Reagent; Research; Sampling; School-Age Population; Shipping; Site; Small Business Innovation Research Grant; Sodium Chloride; Standardization; Technology; Test Result; Testing; Thyroid Hormones; Training; United States National Institutes of Health; Universities; Update; Urine; Validation; Woman; Women' s Health; aged; chemical reaction; commercialization; cost; cost effective; design; global health; infancy; innovation; instrumentation; iodine deficiency syndrome; medical schools; nutrition; operation; programs; prototype; quality assurance; rapid test; reproductive; scale up; urinary

Iodine is an essential component of the thyroid hormones which are necessary for normal growth, development, and metabolism during gestation, infancy, and throughout life. Iodine deficiency disorders (IDD) affect more than a billion people worldwide, and IDD during pregnancy and infancy are a major cause of intellectual impairment and brain damage. Iodine deficiency, through its effects on the developing brain, has condemned millions of people to a life of few prospects and continued underdevelopment. On a worldwide basis, iodine deficiency is the single most important preventable cause of brain damage. Thus, an accurate assessment of population iodine status is necessary to inform public health policies and clinical research on iodine nutrition. Urinary iodine concentration (UIC) directly reflects dietary iodine intake and is the most common indicator used worldwide to assess population iodine status. Currently used methods for urinary iodine measurement either require expensive instrumentation with qualified personnel (inductively coupled plasma-mass spectrometry, instrumental nuclear activation analysis) or oxidative sample digestion to remove potential interferences prior to analysis by a kinetic colorimetric method originally introduced by Sandell and Kolthoff. The Sandell–Kolthoff method requires hour(s) long sample digestion process involving very harsh chemicals and high temperature and are therefore limited to well-equipped laboratories. This requires shipping frozen urine sample to the central laboratories for analysis, which adds complexity, cost and may take several days to weeks to get test results. Thus, there is a critical need for an easy-to-use and cost-effective method for on-site testing of urinary iodine to support the mission of the global health communities. Lynntech is developing a simple innovative test kit for rapid and accurate measurement of urinary iodine concentration. In a Phase I SBIR study we have developed and demonstrated a rapid test kit consisting of dry test cartridges that only requires three simple steps for measurement of UIC using an inexpensive colorimeter. This test kit incorporates solutions to many challenging steps involved with the quantitation of urinary iodine, including detection of ppb levels of iodide in presence significantly higher concentration of potentially interfering anions and colored compounds, as well as removal of organic matrix. The goal of this Phase II of this SBIR project is to transition the technology into a practical test kit by developing a design for scaled up production of the test cartridges and testing the prototype test kit with large number of urine samples from school-aged children, reproductive-aged women, and pregnant women. The applicability of the test kit will be validated by comparing the results with those obtained by a standard spectrophotometric method. This technology can potentially make a significant impact on public health by making it possible to conveniently measure UIC much more frequently and providing accurate assessment of iodine deficiency at an individual basis.

碘是甲状腺激素的重要组成部分，是妊娠期、婴儿期和整个生命期间正常生长、发育和代谢所必需的。碘缺乏病影响着全世界10亿多人，怀孕和婴儿期的碘缺乏病是智力障碍和脑损伤的主要原因。碘缺乏症通过其对发育中的大脑的影响，使数百万人的生活前景渺茫，并继续处于不发达状态。在全世界范围内，碘缺乏症是脑损伤的最重要的可预防原因。因此，有必要对人口碘营养状况进行准确评估，以便为公共卫生政策和碘营养临床研究提供信息。尿碘浓度（UIC）直接反映了膳食碘摄入量，是世界范围内用于评估人群碘状况的最常用指标。目前使用的尿碘测量方法要么需要昂贵的仪器和合格的人员（电感耦合等离子体质谱法，仪器核活化分析）或氧化样品消化，以消除潜在的干扰，然后通过动力学比色法最初由Sandell和Kolthoff介绍的分析。Sandell-Kolthoff方法需要数小时的样品消化过程，涉及非常苛刻的化学品和高温，因此仅限于设备齐全的实验室。这需要将冷冻的尿液样本运送到中心实验室进行分析，这增加了复杂性，成本，并且可能需要几天到几周的时间才能获得测试结果。因此，迫切需要一种易于使用且具有成本效益的尿碘现场测试方法，以支持全球卫生界的使命。Lynntech正在开发一种简单的创新检测试剂盒，用于快速准确地测量尿碘浓度。在一项I期SBIR研究中，我们开发并展示了一种快速检测试剂盒，该试剂盒由干检测盒组成，使用廉价的比色计仅需三个简单步骤即可测量UIC。该检测试剂盒结合了与尿碘定量相关的许多挑战性步骤的解决方案，包括在存在显著较高浓度的潜在干扰阴离子和有色化合物的情况下检测ppb水平的碘化物，以及去除有机基质。该SBIR项目的第二阶段的目标是通过开发测试盒的规模化生产设计，并使用学龄儿童、育龄妇女和孕妇的大量尿液样本测试原型测试盒，将该技术转化为实用的测试盒。将通过将结果与标准分光光度法所得结果进行比较，验证检测试剂盒的适用性。这项技术可能会对公共卫生产生重大影响，因为它可以更频繁地方便地测量UIC，并在个人基础上提供准确的碘缺乏评估。