SBIR Phase II: CoagCare-A POC Blood Coagulation Diagnostic Platform That Utilizes A Hand-held Meter and Mechanically Sensitive Test Strips for Broad Spectrum Hemostasis Monitoring

这个小型企业创新研究(SBIR)第二阶段项目的更广泛的影响/商业潜力将是开发一种新技术并将其商业化，用于准确、便携和廉价地测量多种凝血参数。常见的测试通常在患有心房颤动、深静脉血栓形成或接受过心脏瓣膜置换术的患者身上进行。这些疾病仅在美国就影响了数百万患者，每年花费20亿美元。然而，目前的许多解决方案不能准确或方便地在同一系统或样本上执行多项凝血测试，这给最终用户带来了临床上的重大问题，并增加了常规执行这些测试的成本和不便。该项目中的技术将使各种凝血测试能够在单一的便携式系统中进行。这可能会为医疗专业人员带来更便宜、更方便的凝血测试，并通过将准确和多项测试带到单个便携式设备中来改善医疗结果。这项小型企业创新研究(SBIR)第二阶段项目将开发一种技术，该技术将实现同类产品中第一次实施护理点(POC)直接机械测试，以仪表和一次性卡的形式，更紧密地复制支持临床实验室凝血测试的机械方法。作为一种机械测量，该卡将测量凝结的全血样本的物理性质，并考虑混杂因素，如红细胞压积。具体地说，该项目的目标将是开发一种POC、手持、电池操作的系统，该系统能够在不到10分钟的时间内生成粘弹性曲线和相关的血栓弹性成像参数，这是对目前笨重和劳动密集型解决方案的重大改进，周转时间长达30分钟或更长。除了满足血栓弹性成像的需求外，建议的广谱便携式止血平台还可以扩展到基于血液样本的流体力学特性的其他凝血测试，包括凝血酶原时间、部分凝血活酶时间和激活凝血时间。该项目将展示在便携式POC系统中实施凝血测试。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project will be to develop and commercialize a new technology for accurate, portable, and inexpensive measurement of multiple blood clotting parameters. Common tests are routinely performed on patients who suffer from conditions like atrial fibrillation, deep vein thrombosis, or have had heart valve replacement. These conditions affect millions of patients in the US alone and represent $2 B of spending annually. However, many current solutions cannot accurately or conveniently perform multiple blood clotting tests on the same system or sample, causing clinically significant problems for end-users and raising the cost and inconvenience of performing these tests routinely. The technology in this project will enable various blood clotting tests to be performed in a single portable system. This will potentially lead to cheaper and more convenient blood coagulation testing for medical professionals and improve medical outcomes by bringing accurate and multiple tests to a single portable devices.This Small Business Innovation Research (SBIR) Phase II project will develop a technology that will enable the first-of-its-kind implementation of a point of care (POC) direct, mechanical test in a meter and single-use disposable card format, to more closely replicate the mechanical methods that underpin blood clotting tests in the clinical laboratory. As a mechanical measurement, the card will measure physical properties of a clotting whole blood sample and account for confounding factors, such as hematocrit. Specifically, the objective of the project will be to develop a POC, hand-held, battery-operated system that can enable the generation of a viscoelastic curve and associated thromboelastography parameters in less than 10 minutes, a significant improvement over current bulky and labor-intensive solutions with turnaround times of up to 30 minutes or more. Beyond addressing the thromboelastography needs, the proposed broad-spectrum portable hemostasis platform can be extended to other coagulation tests based on fluid mechanical characterization of a blood sample, including prothrombin time, partial thromboplastin time, and activated clotting time. This project will demonstrate the implementation of a blood coagulation test in a portable POC system.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.