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

在美国和世界其他地方，铅中毒是一种严重但可预防的公共卫生问题。即使铅含量极低，摄入铅也会造成不可逆转的损害，特别是对幼儿造成损害，导致智商下降、学习障碍、注意力缺陷障碍、行为问题、发育迟缓以及其他个人和社会问题。其结果是健康和福祉显著下降，教育和保健费用增加。美国卫生与公众服务部制定了消除儿童铅中毒的宏伟目标。美国疾病控制中心（Centers for Disease Control）最近将需要采取行动的血铅参考水平降至5微克/分升。然而，铅护理(R)不能准确测量5 ug/dL及以下的血铅水平，铅护理(R)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，我们建议开发一种更好的（更便宜、更容易、更快、更敏感、体积更小）在护理点测定儿童血铅水平的方法。我们的研究团队已经为这个项目开发了新材料，并拥有创造先进的传感器样品处理技术和更准确的电化学铅分析所需的经验和专业知识。我们第一阶段研究的目的是创建和展示创新生物传感器的实用性，该传感器消除了测试前标本制备（目标1）的需要，检测限为2 ug/dL，以满足当前和新出现的需求（目标2），以精确，选择性和敏感地测量临床血液标本中的铅（目标3）。在开展这些目标的研究时，我们将研究影响血铅测试性能和成本的关键变量。我们提出的关键创新是创造和开发一种全新的生物传感器，这种传感器可以支持小样本的阳极溶出伏安法（ASV）血铅分析，而无需任何测试前样品处理。研究表明，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。实现我们的三个具体目标将展示所提议的新技术的可行性和成本效益，并为进一步开发新产品奠定基础，One Touch Lead Care可以在护理点以更低的成本和前所未有的简单性提供结果。该项目的高度重要性和影响在于，采用拟议的一触式方法进行的即时检测将使医生立即了解中毒儿童的情况，最大限度地减少父母不回来随访的儿童的损失，并有助于发现和消除导致儿童中毒的环境铅源。

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.