Point-of-Care Tests for Blood Lead Levels in Children

儿童血铅水平的即时检测

基本信息

  • 批准号:
    8910769
  • 负责人:
  • 金额:
    $ 45.35万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2013
  • 资助国家:
    美国
  • 起止时间:
    2013-09-05 至 2017-07-31
  • 项目状态:
    已结题

项目摘要

DESCRIPTION (provided by applicant): Lead poisoning harms millions of people, yet is an entirely preventable health problem. The objective of this SBIR on "Point-of-Care Tests for Blood Lead Levels in Children" is to develop a significantly better blood lead test to identify and protect those at risk. Even at very low levels, ingested lead causes irreversible brain damage in developing children, resulting in decreased IQ, learning disabilities, attention deficit disorders, and behavioral problems. Because of these aspects of significantly decreased health and well being and increased education and healthcare costs, the U.S. Department of Health and Human Services has set an ambitious goal - the elimination of childhood lead poisoning through wide-spread screening. To aid in this effort, Alderon Biosciences proposes to develop a new, point-of-care test for determining blood lead levels that is cheaper, easier, faster, more sensitive, and uses smaller volumes. Alderon has the resources and expertise (laboratories, research scientists, engineers and commercial partners) to develop and commercialize the new product. The key innovations of our approach, proven feasible in Phase I and to be further developed in Phase II, will allow for accurate and highly sensitive point-of-care measurement of blood lead levels at lower cost, with smaller instruments and samples and without pre-test sample processing. Four Specific Aims will guide our research on 'next generation' point-of-care tests to meet the need for improved blood lead testing. Aim 1 research will develop new sensors and readers for more facile tests that eliminate the need for costly pre-test specimen preparation. Aim 2 research will focus on test performance, aiming at 2 min tests, capable of measurements that have accuracy and precision equal to graphite furnace atomic absorption spectrometry (GFAAS) for blood lead levels ranging from 65 ug/dL down to 1.5 ug/dL. Aim 3 research will show test utility at point-of-care for accurate, precise, and sensitive measurement of lead in clinical blood specimens. Building on these results, in Aim 4 we will fabricate the prototype test system and prepare a comprehensive report, technical specifications and plans to be used for guiding manufacture and clinical trials in Phase III commercialization of the product. Accomplishment of the four Specific Aims will thus set the stage for commercialization of a new 'next generation' product for blood lead testing that can deliver results that identify and protect children at risk at lower cost and with unprecedented simplicity. High project significance and impact lies in the lower cost and simplicity of the tests, which would extend testing into more resource poor settings in the U.S. and around the world, provide doctors with immediate knowledge of poisoned children, minimize loss of children whose parents do not return for followup, and aid in discovery and elimination of environmental lead sources that poison children.
描述(由申请人提供):铅中毒危害数百万人,但这是一个完全可以预防的健康问题。这项关于“儿童血铅水平的即时检测”的SBIR的目的是开发一种更好的血铅检测, 保护那些有风险的人。即使是非常低的水平,摄入的铅也会对发育中的儿童造成不可逆转的脑损伤,导致智商下降、学习障碍、注意力缺陷障碍, 和行为问题。由于这些方面的显着下降的健康和福祉和增加的教育和医疗保健成本,美国卫生和人类服务部已经制定了一个雄心勃勃的目标-通过广泛的筛查消除儿童铅中毒。为了帮助这一努力,Alderon Biosciences建议开发一种新的即时检测方法来确定血铅水平,这种方法更便宜,更容易,更快,更灵敏,使用更小的体积。Alderon拥有开发和商业化新产品的资源和专业知识(实验室、研究科学家、工程师和商业合作伙伴)。我们的方法的关键创新在第一阶段被证明是可行的,并将在第二阶段进一步发展,将允许以更低的成本,更小的仪器和样本,无需预测试样本处理,准确和高度灵敏的即时血铅水平测量。四个具体目标将指导我们对“下一代”即时检测的研究,以满足改善血铅检测的需求。目标1研究将开发新的传感器和阅读器,用于更简单的测试,消除了昂贵的测试前样品制备的需要。目标2研究将侧重于测试性能,目标是2分钟测试,能够测量准确度和精密度等同于石墨炉原子吸收光谱法(GFAAS)的血铅水平,范围从65 ug/dL下降到1.5 ug/dL。目的3研究将显示在床旁的检测实用性,准确,精密,灵敏的测量临床血液标本中的铅。在这些结果的基础上,在目标4中,我们将制造原型测试系统,并准备一份全面的报告、技术规范和计划,用于指导产品III期商业化的生产和临床试验。因此,四个具体目标的实现将为新的“下一代”血铅检测产品的商业化奠定基础,该产品可以提供识别和保护 以更低的成本和前所未有的简单方式为面临风险的儿童提供服务。高项目的意义和影响在于测试的低成本和简单性,这将把测试扩展到美国和世界各地资源更贫乏的环境中,为医生提供中毒儿童的即时知识,最大限度地减少父母不返回随访的儿童的损失,并帮助发现和消除毒害儿童的环境铅源。

项目成果

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ROBERT W HENKENS其他文献

ROBERT W HENKENS的其他文献

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{{ truncateString('ROBERT W HENKENS', 18)}}的其他基金

Biosensor Assays for Diagnosis of Chronic HCV Infection
用于诊断慢性 HCV 感染的生物传感器测定
  • 批准号:
    8646475
  • 财政年份:
    2014
  • 资助金额:
    $ 45.35万
  • 项目类别:
Point-of-Care Tests for Blood Lead Levels in Children
儿童血铅水平的即时检测
  • 批准号:
    8777702
  • 财政年份:
    2013
  • 资助金额:
    $ 45.35万
  • 项目类别:
Point-of-Care Tests for Blood Lead Levels in Children
儿童血铅水平的即时检测
  • 批准号:
    8589447
  • 财政年份:
    2013
  • 资助金额:
    $ 45.35万
  • 项目类别:
Printed Disposable Sensor for Quantitative HIV RNA Measurement of Viral Load
用于定量测量病毒载量的 HIV RNA 的印刷一次性传感器
  • 批准号:
    7229174
  • 财政年份:
    2008
  • 资助金额:
    $ 45.35万
  • 项目类别:
Pseudo Target Amplification Diagnostics
伪目标扩增诊断
  • 批准号:
    7322835
  • 财政年份:
    2008
  • 资助金额:
    $ 45.35万
  • 项目类别:
Pseudo Target Amplification Diagnostics
伪目标扩增诊断
  • 批准号:
    7591674
  • 财政年份:
    2008
  • 资助金额:
    $ 45.35万
  • 项目类别:
Electrochemical Quantification of HCV RNA
HCV RNA 的电化学定量
  • 批准号:
    6934898
  • 财政年份:
    2005
  • 资助金额:
    $ 45.35万
  • 项目类别:
Electrochemical RT activity assay for measuring HIV load
用于测量 HIV 负荷的电化学 RT 活性测定
  • 批准号:
    7031579
  • 财政年份:
    2005
  • 资助金额:
    $ 45.35万
  • 项目类别:
Electrochemical RT Activity Assay for Measuring HIV Load
用于测量 HIV 负荷的电化学 RT 活性测定
  • 批准号:
    8015016
  • 财政年份:
    2005
  • 资助金额:
    $ 45.35万
  • 项目类别:
Electrochemical RT activity assay for measuring HIV load
用于测量 HIV 负荷的电化学 RT 活性测定
  • 批准号:
    6947104
  • 财政年份:
    2005
  • 资助金额:
    $ 45.35万
  • 项目类别:

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