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

描述：在美国和世界其他地方，铅中毒是一个严重但可以预防的公共卫生问题。即使在非常低的水平下，摄入铅也会造成不可逆转的损害，特别是在幼儿中，导致智商下降、学习障碍、注意力缺陷障碍、行为问题、发育迟缓和其他个人和社会问题。其结果是健康和幸福感显著下降，教育和医疗成本增加。美国卫生与公众服务部制定了一个雄心勃勃的目标，即消除儿童铅中毒。疾病控制中心最近将需要采取行动的血铅参考水平降低到5微克/分升。然而，血铅水平在5微克/分升及以下无法通过铅护理(R)准确测量，这是我们发明的一种广泛使用的电化学测试，是现有唯一可以在护理点提供血铅测试结果的技术。为了帮助消除儿童铅中毒的努力，我们建议开发一种更好的(更便宜、更容易、更快、更灵敏、更小的体积)来测定儿童在护理地点的血铅水平。我们的研究团队为该项目开发了新材料，并拥有创造传感器样品处理和更准确的电化学铅分析所需的先进技术所需的经验和专业知识。我们第一阶段研究的目的是创造和展示创新生物传感器的效用，这种传感器消除了检测极限为2ug/dL的测试前样本准备的需要(目标1)，以满足当前和新出现的对临床血液样本中铅的精确、选择性和灵敏测量的需求(目标3)。我们将研究影响血铅检测性能和成本的关键变量，同时开展这些目标的研究。我们提出的关键创新是创建和开发一种全新的生物传感器，该传感器可以支持样品较小的血铅的阳极溶出伏安法(ASV)分析，而无需任何测试前样品处理。研究将表明，新的One Touch生物传感器可以提供血铅检测所需的灵敏度、动态范围和准确性，以帮助消除儿童铅中毒。我们三个具体目标的实现将显示提议的新技术的可行性和成本效益，并为进一步开发一种新产品One Touch Lead Care奠定基础，该产品可以以更低的成本和前所未有的简单性在护理点交付结果。该项目的高度意义和影响在于，使用建议的One Touch方法进行的护理点检测将为医生提供关于中毒儿童的即时知识，将父母没有回来跟进的儿童的损失降至最低，并有助于发现和消除毒害儿童的环境铅源。

DESCRIPTION: Lead toxicity is a serious but preventable public health problem in the U.S. and elsewhere in the world. Even at very low levels, ingested lead causes irreversible damage, especially in young children, resulting in decreased IQ, learning disabilities, attention deficit disorders, behavioral problems, stunted growth and other individual and societal problems. The result is significantly decreased health and well-being and increased education and healthcare costs. The U.S. Department of Health and Human Services has established an ambitious goal of eliminating lead poisoning in children. The Centers for Disease Control has recently lowered the reference level of blood lead that calls for action down to 5 ug/dL. However, blood lead levels at and below 5 ug/dL cannot be accurately measured by Lead Care(R), a widely used electrochemical test we invented that is the only existing technology that can deliver blood lead test results at point-of-care. To aid in the effort to eliminate childhood lead poisoning, we propose to develop a better (cheaper, easier, faster, more sensitive, smaller volume) for determining blood lead levels in children at point-of-care. Our research team has developed new materials for this project, and has the experience and expertise needed to create the advanced technology for on-sensor sample handling and more accurate electrochemical lead assays. The Aims of our Phase I research are to create and demonstrate the utility of innovative biosensors that eliminate the need for pre-test specimen preparation (Aim 1) with a limit of detection of 2 ug/dL to meet current and emerging needs (Aim 2) for precise, selective and sensitive measurement of lead in clinical blood specimens (Aim 3). We will research key variables that influence performance and cost of blood lead tests as we carry out research on these Aims. The key innovation we propose is the creation and development of a completely new biosensor, one that can support Anodic Stripping Voltammetry (ASV) assays of blood lead with smaller samples and without any pre- test sample processing. Research will show that the new One Touch biosensors can provide the sensitivity, dynamic range and accuracy needed for blood lead testing to help eliminate lead poisoning in children. Accomplishment of our three Specific Aims will show the feasibility and cost benefits of the proposed new technology and set the stage for further development of a new product, One Touch Lead Care that can deliver results at point-of-care with lower cost and unprecedented simplicity. The high significance and impact of this project lies in the fact that point-of-care tests using the proposed One Touch approach would 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.