SBIR Phase I: CoagCare: Unified POC Blood Coagulation Diagnostic Platform Using Mechanically Sensitive Test Strips

SBIR 第一阶段：CoagCare：使用机械敏感试纸的统一 POC 凝血诊断平台

• 批准号: 1746287
• 负责人: Norimasa Yoshimizu
• 金额: $ 22.49万
• 依托单位: Abram Scientific, Inc.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-01-01 至 2018-09-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1746287&HistoricalAwards=false
• 关键词: SBIR; Phase; CoagCare; Unified; POC

This SBIR Phase I project will develop a new technology for accurate, portable, and inexpensive measurement of multiple blood clotting tests. Such tests include prothrombin time / international normalized ratio (PT/INR), activated partial thromboplastin time (aPTT), activated clotting time (ACT), or thromboelastography (TEG) and are routinely performed on patients who suffer from conditions such as atrial fibrillation, deep vein thrombosis, or have had heart valve replacement. This affects millions of patients in the US alone for a market worth more than a billion dollars worldwide every year. However, many of the technologies currently used in the market cannot accurately or conveniently perform multiple blood clotting tests on the same system, causing clinically significant problems for patients and raising the cost and inconvenience of routinely performing these tests. The technology in this project fundamentally enables these various blood clotting tests to be performed in a single portable, test-strip system. This will potentially lead to less expensive, more accurate, and more convenient blood clot testing for medical professionals and millions of patients; improve medical care by bringing multiple blood clotting tests to a single portable device; bring much-needed innovation to a market which has relied on less accurate technologies; and foster small business and job growth in an emerging technology landscape that has the potential to address a billion dollar, worldwide market. The technology developed in this project will enable the first-of-its-kind implementation of a direct, mechanical test in a strip form, to more closely replicate the mechanical methods which fundamentally underlie all blood clotting time tests. As a mechanical measurement, the strip will measure physical properties of a finger-prick, whole blood sample to account for the confounding factors affecting point of care blood clotting tests, such as hematocrit for PT/INR measurement. As a broad-spectrum hemostasis platform technology, other significant blood coagulation tests, which are based on measurement of fluid mechanical properties of the blood sample, can be brought to the portable point of care format including activated partial (aPTT) thromboplastin time (PT/INR), activated clotting time (ACT), or thromboelastogram (TEG) testing. This Phase I project will demonstrate the feasibility of a second blood coagulation test (activated partial thromboplastin time), realizing a mechanical, strip-based, portable point-of-care (POC) blood coagulation platform system.

该 SBIR 第一阶段项目将开发一种新技术，用于准确、便携且廉价地测量多种凝血测试。此类测试包括凝血酶原时间/国际标准化比值 (PT/INR)、活化部分凝血活酶时间 (aPTT)、活化凝血时间 (ACT) 或血栓弹力图 (TEG)，并且通常对患有房颤、深静脉血栓形成或接受过心脏瓣膜置换术等疾病的患者进行。仅美国就有数百万患者受到影响，全球市场每年价值超过 10 亿美元。然而，目前市场上使用的许多技术无法在同一系统上准确或方便地执行多次凝血测试，这给患者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。该项目中的技术从根本上使这些不同的凝血测试能够在单个便携式试纸系统中进行。这可能会为医疗专业人员和数百万患者带来更便宜、更准确、更方便的血凝块检测；通过在单个便携式设备上进行多项凝血测试来改善医疗护理；为依赖不太精确技术的市场带来急需的创新；并在新兴技术领域促进小型企业和就业增长，该领域有潜力满足价值十亿美元的全球市场。该项目开发的技术将首次实现条带形式的直接机械测试，以更精确地复制所有凝血时间测试的根本基础机械方法。作为一种机械测量，试纸将测量指尖刺破的全血样本的物理特性，以考虑影响护理点凝血测试的混杂因素，例如用于 PT/INR 测量的血细胞比容。作为一种广谱止血平台技术，其他基于血样流体机械特性测量的重要凝血测试可以采用便携式护理形式，包括活化部分（aPTT）凝血活酶时间（PT/INR）、活化凝血时间（ACT）或血栓弹力图（TEG）测试。该一期项目将论证二次凝血测试（活化部分凝血活酶时间）的可行性，实现机械式、条带式、便携式即时护理（POC）凝血平台系统。