SBIR Phase I: Optical Platform for Point-of-Care Analysis With a Single Drop of Blood

SBIR第一阶段项目将开发一种即时（POC）血液化学检测，可以用一滴血同时测量多种分析物。血液化学测试是医生最常订购的测试。这种用于血液化学测试的芯片实验室和相关分析仪将通过提高医疗保健服务质量和降低成本而造福社会。这个装置的微创手术减少了：由针头引起的恐惧和不适，样品采集所需的技能水平，以及与分析前测试步骤相关的错误。那个装置的受专利保护的光电二极管技术，利用色谱来测量浓度，使其与竞争POC设备所使用的电化学技术区分开来。简而言之，光电二极管技术具有较低的制造复杂性，需要少得多的血液，具有更稳健的输出，并且可以同时测试更多的分析物。最初的目标应用将是新生儿血液化学检测，因为迫切需要最大限度地减少采血量。一旦该技术在新生儿市场获得临床认可，该简单易用的平台将扩展到其他应用，包括急性护理中心、急救人员、初级保健、军事护理和救灾组织。该平台还将扩展到测试许多其他分析物，并应有助于在此过程中创造许多新的美国就业机会。拟议中的基于光电二极管的芯片实验室设备将能够用一滴血同时测试各种分析物，这是商业POC设备所无法实现的。这种创新的光电二极管技术与电化学技术相比有几个优点。首先，与电化学传感器相比，光电二极管技术可以实现极小的样品体积要求（6-10 μ L vs. 65-100 μ L），并且无需混合试剂。第二，使用光电二极管大大简化了制造复杂性，因为它需要更少的层，更少的原材料和更简单的制造步骤。第三，光电二极管技术通过使用可见光谱上的多个波长的组合而不是如电化学技术中使用的单个电流输出来提供更鲁棒的输出。最后，该平台技术将产生独特的多重分析物组合，包括第一个仅需一滴血的手持式基本代谢组（BMP）测试。第一阶段SBIR的主要目标是证明这种微分配的芯片实验室系统评估临床样本的可行性。在这个为期一年的项目中，目标1将开发自动化传感器制造方法。目标2将确认开发的芯片实验室在FDA要求的非临床试验中定量血清样本中分析物的性能，并与FDA批准的POC分析仪进行比较。

This SBIR Phase I project will develop a point-of-care (POC) blood chemistry test that can measure multiple analytes simultaneously with a single drop of blood. Blood chemistry tests are the most frequently ordered tests by physicians. This proposed lab-on-a-chip and associated analyzer for blood chemistry tests will benefit society by improving the quality of health care delivery and reducing costs. This device?s minimally invasive procedure reduces: fear and discomfort caused by needles, level of skill needed for sample collection, and errors associated with pre-analytical testing steps. The device?s patent-protected optode technology, which utilizes the color spectrum to measure concentrations, differentiates it from electrochemical technology, which is used by competing POC devices. Briefly, optode technology has lower manufacturing complexity, requires much less blood, has a more robust output, and can test more analytes simultaneously. The initial target application will be neonatal blood chemistry testing because of a strong need to minimize blood draw volumes. Upon clinical acceptance of the technology in the neonatal market, the simple-to-use platform will be expanded to other applications, including acute care centers, first responders, primary care, military care, and disaster relief organizations. This platform will also be expanded to test many other analytes, and should help create many new U.S. jobs in the process.The proposed optode-based lab-on-a-chip device will be capable of testing various analytes simultaneously with a single drop of blood, which has not been achieved by commercial POC devices. This innovative optode technology has several advantages over electrochemical technology. First, the optode technology enables extremely small sample volume requirements compared to electrochemical sensors (6-10 ìL vs. 65-100 ìL) and eliminates the need for mixing of reagents. Second, fabrication complexity is greatly simplified using optodes because it requires less layers, less raw materials, and simpler manufacturing steps. Third, optode technology provides a more robust output by using a combination of multiple wavelengths on the visual light spectrum and not a single current output as used in electrochemical technology. Finally, this platform technology will result in unique multiplex analyte combinations, including the first ever handheld basic metabolic panel (BMP) test that requires just a single drop of blood. The primary goal of thisPhase I SBIR is to demonstrate feasibility of this micro-dispensed, lab-on-a-chip system to evaluate clinical samples. In this one-year project, Objective 1 will develop automated sensor manufacturing methods. Objective 2 will confirm the performance of the developed lab-on-a-chip to quantify analytes in sera samples in FDA-required non-clinical tests and when compared to an FDA-approved, POC analyzer.