Micro-Fabricated Complete Blood Counter

微型全血计数器

• 批准号: 7157040
• 负责人: Harold Edward Ayliffe
• 金额: $ 35.23万
• 依托单位: E.I. SPECTRA, LLC
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-04-01 至 2008-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7157040
• 关键词: bioengineering /biomedical engineering; biomedical equipment development; blood cell count; computer program /software; computer system design /evaluation; consumable /disposable biomedical equipment; electrical impedance; erythrocytes; hematology; human tissue; leukocytes; microfluidics; miniature biomedical equipment; monitoring device; platelets; portable biomedical equipment; radiowave radiation

DESCRIPTION (provided by applicant): This Phase II SBIR effort will research and test a novel system for blood analysis that utilizes micro-electro- mechanical systems (MEMS) fabricated chips and radio-frequency electric impedance (EI) interrogation signals to differentiate blood cell types. The project's long-term objective is to create an inexpensive handheld hematology analyzer with single-use disposable cartridges capable of performing a complete blood count (CBC) using a 12 muL sample of whole blood. In pursuit of this long term objective, this Phase II SBIR focuses on successfully miniaturizing the necessary conductance and impedance-based cell counting technologies, design and testing of the single-use CBC microfluidic cartridges, as well as testing the supporting electronics and micro-fluidics interfaces for the proposed handheld system. The system will be powered by a programmable personal device assistant (PDA) for test control, data collection, analysis of raw EI cell data, and results display. Specifically, three aims will be pursued: (1) design and testing of a CBC disposable cartridge; (2) design and testing of the PDA driven electronics and analysis software; and (3) integration and performance testing of the CBC analyzer system components. If successful, the eventual introduction of such a groundbreaking point-of-care device would constitute a technological breakthrough in hematology and will offer health care providers a valuable alternative to the traditional hematology analyzers currently used in most clinical laboratories. Anticipated benefits from such a device include dramatically lower test costs, rapid test results, next-to-patient care & portability, and increased efficiency in diagnosis and treatment. This new point-of-care system has the potential to significantly reduce the CBC equipment and per-test cost and could result in millions of dollars saved in the US healthcare industry alone (2004 US CBC market estimated at $12 billion), with even greater worldwide cost savings potential. This new micro-fabricated platform technology and its first product application (i.e., a handheld CBC analyzer with disposable cartridges) is the only known commercial effort of its kind. The successful completion of an inexpensive, portable handheld hematology analyzer would constitute a significant breakthrough in hematology by offering healthcare providers a less expensive, simpler platform to conduct the most common blood diagnostic test currently performed in the US. Such a breakthrough will dramatically improve testing efficiencies with its single-use, disposable test cartridges and will make it possible to rapidly test patients at bedside, in remote locations, or in areas with limited healthcare resources. Finally, this new point-of-care system could significantly reduce current CBC equipment and per-test costs, thereby resulting in millions of dollars saved in the US healthcare and insurance industries (2004 US CBC market estimated at $12 billion), with even greater worldwide healthcare impacts in developing countries.

描述（由申请人提供）：第二阶段 SBIR 工作将研究和测试一种新型血液分析系统，该系统利用微机电系统 (MEMS) 制造的芯片和射频电阻抗 (EI) 询问信号来区分血细胞类型。该项目的长期目标是创建一种廉价的手持式血液分析仪，配备一次性试剂盒，能够使用 12 µL 全血样本进行全血细胞计数 (CBC)。为了实现这一长期目标，第二阶段 SBIR 重点关注成功小型化必要的电导和基于阻抗的细胞计数技术、一次性 CBC 微流体盒的设计和测试，以及测试拟议手持系统的支持电子和微流体接口。该系统将由可编程个人设备助理 (PDA) 提供支持，用于测试控制、数据收集、原始 EI 电池数据分析和结果显示。具体来说，将追求三个目标：（1）CBC一次性试剂盒的设计和测试； (2) PDA驱动电子和分析软件的设计和测试； (3) CBC分析仪系统组件的集成和性能测试。如果成功，这种突破性的即时护理设备的最终推出将构成血液学领域的技术突破，并将为医疗保健提供者提供目前大多数临床实验室使用的传统血液分析仪的宝贵替代品。这种设备的预期好处包括显着降低测试成本、快速获得测试结果、就近患者护理和便携性以及提高诊断和治疗效率。这种新的护理点系统有可能显着降低 CBC 设备和每次测试的成本，并且仅在美国医疗保健行业就可以节省数百万美元（2004 年美国 CBC 市场估计为 120 亿美元），全球范围内的成本节约潜力更大。这种新的微制造平台技术及其首个产品应用（即带有一次性试剂盒的手持式 CBC 分析仪）是同类产品中唯一已知的商业成果。廉价、便携式手持式血液分析仪的成功完成将为医疗保健提供者提供一个更便宜、更简单的平台来进行目前在美国进行的最常见的血液诊断测试，从而构成血液学领域的重大突破。这一突破将极大地提高一次性测试盒的测试效率，并使在床边、偏远地区或医疗资源有限的地区快速测试患者成为可能。最后，这种新的护理点系统可以显着降低当前的 CBC 设备和每次测试的成本，从而为美国医疗保健和保险行业节省数百万美元（2004 年美国 CBC 市场估计为 120 亿美元），对发展中国家的全球医疗保健影响更大。