Micro-Fabricated Complete Blood Counter

描述(申请人提供)：这项第二阶段的SBIR工作将研究和测试一种新型的血液分析系统，该系统利用微电子机械系统(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造一种价格低廉的手持血细胞分析仪，配备一次性一次性血细胞分析仪，能够使用12埃L全血样本进行全血细胞计数。为了实现这一长期目标，第二阶段SBIR的重点是成功地将必要的基于电导和阻抗的细胞计数技术微型化，设计和测试一次性使用的CBC微流控盒，以及测试拟议手持系统的支持电子和微流控接口。该系统将由可编程个人设备助理(PDA)提供动力，用于测试控制、数据收集、原始EI单元数据分析和结果显示。具体来说，将实现三个目标：(1)设计和测试CBC一次性墨盒；(2)设计和测试PDA驱动的电子和分析软件；(3)CBC分析仪系统部件的集成和性能测试。如果成功，这种突破性的医疗设备的最终推出将构成血液学的技术突破，并将为医疗保健提供者提供一个宝贵的替代方案，以取代目前在大多数临床实验室使用的传统血液学分析仪。这种设备的预期好处包括极大地降低测试成本、快速测试结果、就近患者护理和便携性，以及提高诊断和治疗效率。这一新的医疗设备系统有可能显著降低CBC设备和每次检测的成本，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)，在全球范围内具有更大的成本节约潜力。这种新的微制造平台技术及其第一次产品应用(即带有一次性墨盒的手持式CBC分析仪)是同类产品中唯一已知的商业努力。廉价、便携式血液学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，从而构成血液学方面的重大突破。这一突破将通过其一次性使用的测试墨盒显著提高测试效率，并将使在床边、偏远地点或医疗资源有限的地区对患者进行快速测试成为可能。最后，这种新的医疗点系统可以显著降低当前的CBC设备和每次检测的成本，从而在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产生更大的影响。

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¿L 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.