One-Step Rapid Screening for Childhood Lead Poisoning

描述（由申请人提供）：美国疾病控制与预防中心指出，铅中毒是头号环境健康问题，影响着美国的儿童，因为每六个高危儿童中就有一个受到铅中毒的影响，铅中毒被认为是认知和行为障碍的一个来源。只有25%的美国高危儿童接受了检测。在美国，原子吸收仪器完成了80%的血铅检测，但这项技术不太可能变得更容易获得，因为它仅限于复杂的实验室，需要熟练的操作人员。这个拟议的多阶段项目的目标是开发一种创新的“一步”电化学血铅检测技术，以满足高危人群的经济、性能和后勤需求。根据第一阶段工作的可行性，我们将配置一个传感器，该传感器将接受未测量的、未经处理的样品，并在大约3分钟内产生定量血铅结果。市场对一步式、免除CLIA的血铅检测系统的需求将增加铅检测的数量，并最终将每个结果的成本降低到3美元以下。我们还将致力于提高电化学血铅分析性能，并扩大动态响应范围，以满足美国和全球的需求。我们将结合仪器和传感器功能，允许用户测试未测量和未经处理的全血，并获得准确，精确的结果。整个项目的预期结果将是技术将允许在美国和世界范围内进行更多的铅测试。

DESCRIPTION (provided by applicant): The CDC states that lead poisoning is the number one environmental health problem, affecting children in the US because it affects one of every six at-risk children and it is acknowledged to be a source of cognitive and behavioral impairment. Only 25% of the at-risk US children are tested. Atomic absorption instruments do 80% of blood lead tests in the US, but this technology is not likely to become substantially more accessible because it is limited to sophisticated labs and requires skilled operators. The objective of this proposed multi-phase project is to develop an innovative "one-step" electrochemical blood lead testing technology that will satisfy the economic, performance, and logistical needs of at-risk populations. As shown feasible in Phase I work, we will configure a sensor that will accept an unmeasured, untreated sample and an assay that will produce a quantitative blood lead result in about 3 minutes. The market-need for a one-step, CLIA waived blood lead system will increase the amount of lead testing done and ultimately lower the cost per result to < $3. We will also work to improve electrochemical blood lead analysis performance and extend the dynamic response range to meet U.S. and worldwide needs. We will incorporate instrument and sensor features that would allow users to test unmeasured and untreated whole blood and obtain an accurate, precise result. The expected result of the overall project will be technology that will allow substantially more lead testing in the United States and worldwide. Within the guidelines of permissible levels of childhood blood lead levels there are as many as 10 million children at risk, but only 2.5 million are tested. Expensive atomic absorption instruments do 2 million of these tests at a cost of $1 to $3 per reportable result. Much less expensive instruments are used for point of- care electrochemical tests but presently cost $4 to $6 per reportable result. Atomic absorption cannot easily increase the number of blood lead tests done because it is logistically inaccessible to 80% of the US target population and nearly 100% of the target international population. The genuine potential in the US blood lead market (7.5 million tests) lies with cost-effective and rapid electrochemical measurement. The proposed high-performance, low-cost electrochemical technology will be extremely competitive for the $7.5 million available US market and the potentially much larger international market.