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

SBIR II 期：CoagCare - POC 凝血诊断平台，利用手持式仪表和机械敏感试纸条进行广谱止血监测

• 批准号: 2050272
• 负责人: Ramkumar Abhishek
• 金额: $ 96.88万
• 依托单位: Abram Scientific, Inc.
• 依托单位国家: 美国
• 项目类别: Cooperative Agreement
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-03-15 至 2025-08-31
• 项目状态: 未结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2050272&HistoricalAwards=false
• 关键词: SBIR; Phase; II; CoagCare; POC

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.

这项小型企业创新研究（SBIR）II期项目的更广泛的影响/商业潜力将是开发和商业化新技术，以准确，便携式和廉价的多种血液凝血参数的衡量。常规测试通常对患有心房颤动，深静脉血栓形成或已置换心脏瓣膜等疾病的患者进行。这些情况仅影响美国数百万患者，每年代表2美元的支出。 但是，许多当前的解决方案无法在同一系统或样品上准确或方便地进行多次血液凝结测试，从而给最终用户带来临床上重要的问题，并提高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血液凝结测试能够在单个便携式系统中进行。这可能会导致对医疗专业人员的更便宜，更方便的血液凝血测试，并通过将准确和多个测试带入单个便携式设备来改善医疗结果。这项小型企业创新研究（SBIR）II期项目将开发一项技术，将开发一项技术，将启用首先依赖于单一的电脑（POC）直接的机能（POC），并将其用于分配机械的机能（POC），并将其用于分配机械的机能，并使用机械的机械使用，并将其机械化效果。临床实验室中血液凝结测试的基础的方法。作为一种机械测量，该卡将测量凝血的全血样品的物理特性，并说明诸如血细胞比容的混杂因素。具体而言，该项目的目的是开发POC，手持电池供电的系统，该系统可以在不到10分钟的时间内生成粘弹性曲线和相关的血栓浮动物参数，这比目前的笨重和劳动强度的解决方案具有显着改善，最多可达30分钟或更多时间。除了满足血栓形象需求外，还可以将基于血液样本的流体机械表征（包括凝血酶蛋白时间，部分血栓形成时间和激活的凝结时间）扩展到其他凝血测试。该项目将证明在便携式POC系统中实施了血液凝结测试。该奖项反映了NSF的法定任务，并使用基金会的知识分子优点和更广泛的影响评估标准，被认为值得通过评估来获得支持。