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

SBIR第一阶段项目将开发一种新技术，用于准确，便携和廉价的多种凝血测试测量。这些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），并定期对患有房颤，深静脉血栓形成或心脏瓣膜置换术等疾病的患者进行。这仅在美国就影响了数百万患者，每年全球市场价值超过10亿美元。然而，目前市场上使用的许多技术不能准确或方便地在同一系统上进行多种凝血测试，这对患者造成了临床上的重大问题，并增加了常规进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。这将为医疗专业人员和数百万患者带来更便宜、更准确、更方便的血液凝块测试;通过将多种血液凝块测试引入单个便携式设备来改善医疗保健;为依赖不太准确技术的市场带来急需的创新;并在新兴技术领域促进小企业和就业增长，这有可能解决全球十亿美元的市场。该项目开发的技术将首次以条状形式实现直接的机械测试，以更接近地复制所有凝血时间测试的基本机械方法。作为机械测量，试纸将测量手指针刺全血样本的物理特性，以考虑影响床旁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，其他基于血液样本流体机械性能测量的重要凝血测试可以采用便携式护理点格式，包括活化部分（aPTT）凝血活酶时间（PT/INR）、活化凝血时间（ACT）或血栓弹性图（TEG）测试。该I期项目将证明第二次凝血试验（活化部分凝血活酶时间）的可行性，实现机械、基于条带的便携式床旁（POC）凝血平台系统。

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.