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，甲状腺激素是妊娠期、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 (IDD) 影响着全世界超过 10 亿人，而妊娠期和婴儿期的 IDD 是最常见的疾病。碘缺乏是导致智力障碍和脑损伤的一个主要原因，它对发育中的大脑造成影响，导致数百万人的生活前景渺茫，并且持续发育不全。因此，准确评估人群碘状况对于为公共健康政策和碘营养临床研究提供信息是必要的。尿碘浓度（UIC）直接反映膳食碘摄入量，是全球最常用的碘营养指标。目前使用的尿碘测量方法要么需要配备合格人员的昂贵仪器（电感耦合等离子体质谱法、仪器核活化分析），要么需要氧化样品消化以消除潜在的碘含量。最初由 Sandell 和 Kolthoff 引入的动力学比色法进行分析之前存在干扰。 Sandell-Kolthoff 方法需要数小时的样品消解过程，涉及非常刺激的化学品和高温，因此仅限于设备齐全的实验室。将冷冻尿液样本送到中心实验室进行分析，这增加了复杂性和成本，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现场方法。测试Lynntech 正在开发一种简单的创新测试套件，用于快速、准确地测量尿碘浓度。在 I 期 SBIR 研究中，我们开发并展示了一种由干测试组成的快速测试套件。使用廉价的比色计仅需三个简单步骤即可测量 UIC。该测试套件包含了涉及尿碘定量的许多具有挑战性的步骤的解决方案，包括检测 ppb 水平的碘化物。 SBIR 项目第二阶段的目标是通过开发扩大生产的设计，将该技术转变为实用的测试套件。测试盒并用学龄儿童、育龄妇女和孕妇的大量尿液样本测试原型测试套件。通过将结果与标准分光光度法获得的结果进行比较，验证测试套件的适用性。该技术可以。通过更频繁地方便地测量 UIC 并提供个人碘缺乏的准确评估，可能对公共健康产生重大影响。