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
• 负责人: ROBERT W HENKENS
• 金额: $ 13.73万
• 依托单位: ALDERON BIOSCIENCES, INC.
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-05 至 2014-08-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8589447
• 关键词: AA Spectrophotometry; Attention Deficit Disorder; Bedside Testings; Biological Assay; Biosensor; Blood; Blood Cells; Blood capillaries; Blood specimen; Caring; Cells; Centers for Disease Control and Prevention (U.S.); Chemicals; Child; Childhood; Clinical; Costs and Benefits; Cytolysis; Detection; Development; Diagnostic; Early Diagnosis; Enrollment; Environment; Future; Goals; Growth; Guidelines; Health; Health Care Costs; Health Services; Household; Housing; Individual; Juvenile Delinquency; Knowledge; Laboratories; Laws; Lead; Lead Poisoning; Learning; Learning Disabilities; Life; Measurement; Measures; Medicaid; Natural graphite; New Jersey; Parents; Performance; Personal Satisfaction; Phase; Poison; Poisoning; Polymers; Preparation; Problem behavior; Process; Public Health; Rage; Reference Standards; Reporting; Research; Sampling; Services; Source; Specimen; Staging; System; Technology; Test Result; Testing; Touch sensation; United States Dept. of Health and Human Services; Work; blood lead; capillary; commercialization; consumer product; cost; criminal behavior; design; education cost; experience; improved; innovation; lead exposure; meetings; new technology; point of care; prototype; public health relevance; remediation; research and development; sensor

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.

铅中毒在美国和世界其他地方是一个严重但可预防的公共卫生问题。即使摄入的铅含量很低，也会造成不可逆转的损害，特别是对幼儿，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。其结果是健康和福祉显着下降，教育和医疗保健成本增加。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。疾病控制中心最近将要求采取行动的血铅参考水平降低到5 ug/dL。然而，低于5 ug/dL的血铅水平无法通过Lead Care（R）准确测量，Lead Care是我们发明的一种广泛使用的电化学测试，是唯一可以在护理点提供血铅测试结果的现有技术。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，更灵敏，体积更小）用于在护理点确定儿童血铅水平。我们的研究团队为该项目开发了新材料，并拥有创建传感器上样品处理和更准确的电化学铅测定所需的先进技术的经验和专业知识。我们的第一阶段研究的目的是创建和展示创新的生物传感器的效用，消除了检测限为2 μ g/dL的测试前样本制备的需要（目标1），以满足当前和新兴的需求（目标2），以精确，选择性和灵敏度测量临床血液样本中的铅（目标3）。我们将研究影响血铅测试的性能和成本的关键变量，因为我们对这些目标进行研究。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，这种生物传感器可以支持阳极溶出伏安法（ASV）测定血铅，样品较小，无需任何预测试样品处理。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、动态范围和准确度，以帮助消除儿童铅中毒。我们的三个特定目标的实现将显示拟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可以以更低的成本和前所未有的简单性在护理点提供结果。该项目的重要意义和影响在于，使用提议的“一触即得”方法进行的即时检测将使医生能够立即了解中毒儿童的情况，最大限度地减少父母不返回接受随访的儿童的损失，并有助于发现和消除毒害儿童的环境铅源。