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.

这个SBIR一期项目将开发一种新技术，用于精确、便携和廉价地测量多种凝血试验。这些试验包括凝血酶原时间/国际标准化比率（PT/INR）、活化部分凝血酶时间（aPTT）、活化凝血时间（ACT）或血栓弹性成像（TEG），通常用于房颤、深静脉血栓形成或心脏瓣膜置换术患者。仅在美国就有数百万患者受到影响，而全球每年的市场价值超过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进行多项凝血检查，这给患者带来了重大的临床问题，并增加了常规进行这些检查的成本和不便。这个项目中的技术从根本上使这些不同的凝血测试能够在一个单一的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；通过将多种血液凝固测试纳入一个便携式设备来改善医疗服务；将急需的创新带到依赖于不太精确技术的市场；在新兴技术领域培育小企业和就业增长，这一领域有潜力开拓价值10亿美元的全球市场。在这个项目中开发的技术将首次实现直接的机械测试，以试纸的形式，更紧密地复制所有凝血时间测试的基本机械方法。作为一种机械测量，试纸将测量手指刺破的全血样本的物理特性，以解释影响护理点凝血试验的混杂因素，例如PT/INR测量的红细胞压积。作为一种广谱止血平台技术，其他重要的血液凝固试验，是基于测量血液样本的流体力学特性，可以带到便携式护理点格式，包括活化部分（aPTT）凝血活素时间（PT/INR），活化凝血时间（ACT），或血栓弹性图（TEG）测试。本一期项目将论证二次凝血试验（活化部分凝血活素时间）的可行性，实现机械、试纸、便携式护理点（POC）凝血平台系统。