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

这个SBIR第一阶段项目将开发一种新技术，用于准确、便携和廉价地测量多项凝血试验。这类检测包括凝血酶原时间/国际标准化比率(PT/INR)、活化部分凝血活酶时间(APTT)、活化凝血时间(ACT)或血栓弹性成像(TEG)，常规用于患有房颤、深静脉血栓形成或心脏瓣膜置换等疾病的患者。这影响了全球每年价值超过10亿美元的市场，仅在美国就有数百万患者。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项凝血测试，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、更准确和更方便的血液凝块检测；通过将多项凝血测试引入单一便携式设备来改善医疗保健；为依赖较不准确技术的市场带来亟需的创新；并在有可能满足10亿美元全球市场需求的新兴技术格局中促进小企业和就业增长。该项目开发的技术将使首次以条状形式实施直接机械测试，以更紧密地复制作为所有凝血时间测试基础的机械方法。作为一种机械测量，试纸将测量手指刺伤的全血样本的物理性质，以解决影响护理点凝血测试的混杂因素，例如用于PT/INR测量的红细胞压积。作为一种广谱止血平台技术，基于血液样本流体机械性能测量的其他重要凝血测试可被引入便携式护理格式，包括激活部分凝血活酶时间(PT/INR)、激活凝血时间(ACT)或血栓弹性图(TEG)测试。这个第一阶段的项目将证明第二次凝血试验(激活的部分凝血活酶时间)的可行性，实现一个机械的、基于条状的、便携式的护理点(POC)血液凝固平台系统。

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.