Rapid Test Kit for Measurement of Urinary Iodine

尿碘快速检测试剂盒

• 批准号: 9907578
• 负责人: BIKAS VAIDYA
• 金额: $ 53.84万
• 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 2022-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9907578
• 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; 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; 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.

碘是甲状腺骑术的重要组成部分，这对于在妊娠，婴儿期和整个生命期间正常生长，发育和代谢所必需。碘缺陷障碍（IDD）在全球范围内影响超过十亿人，而在怀孕和婴儿期间IDD是智力障碍和脑损伤的主要原因。碘缺陷通过其对发展中的大脑的影响，谴责了数百万的人的前景，并且持续不断发育。在全球范围内，碘缺陷是造成脑损伤的最重要的最重要的原因。这是对人口碘状况的准确评估，对于公共卫生政策和碘营养的临床研究是必要的。尿碘浓度（UIC）直接反映饮食碘的摄入量，是全球评估碘状况的最常见指标。当前使用的碘碘测量方法要么需要昂贵的仪器，要么具有合格人员（电感耦合的等离子 - 质量光谱法，仪器核激活分析）或氧化样品消化，以在通过Sandell和Kolthoff最初引入的动力学混合方法进行分析之前去除潜在的接口。 Sandell – Kolthoff方法需要小时长的样品消化过程，涉及非常危险的化学物质和高温，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央实验室进行分析，这增加了复杂性，成本，并且可能需要几天到几周才能获得测试结果。这是迫切需要一种易于使用且具有成本效益的方法来对尿碘的现场测试来支持全球卫生社区的使命。 Lynntech正在开发一个简单的创新测试套件，以快速准确地测量尿碘浓度。在I期SBIR研究中，我们开发了一个快速的测试套件，该试剂盒由干燥的测试弹药筒组成，该盒仅需要使用廉价的比色表来测量UIC的三个简单步骤。该测试试剂盒结合了与尿碘定量有关的许多挑战步骤的解决方案，包括在存在的情况下检测PPB水平的碘化物水平明显更高的潜在干扰阴离子和有色化合物以及去除有机基质。该SBIR项目的II阶段的目的是通过开发用于扩大测试弹药筒的生产的设计，并用大量的尿液样本从学龄儿童，生殖型妇女和孕妇对原型测试套件进行测试，并测试原型测试套件，并测试原型测试套件，并测试原型测试套件，并测试原型测试套件。测试套件的适用性将通过将结果与通过标准分光光度法获得的结果进行比较来验证。这项技术可以通过使您可以更频繁地衡量UIC并在单独的基础上进行准确评估碘缺陷，从而对公共卫生产生重大影响。