SBIR Phase I: CoagCare-A POC Blood Coagulation Diagnostic Platform That Utilizes A Hand-held Meter and Mechanically Sensitive Test Strips for Broad Spectrum Hemostasis Monitoring

SBIR一期项目的广泛/商业影响将使一种新技术商业化，该技术可用于精确、便携和廉价的凝血测试测量，这些测试通常用于患有房颤、深静脉血栓形成或机械心脏瓣膜置换术的患者。仅在美国，这些疾病就影响着数百万患者，而全球每年的市场价值超过30亿美元。然而，许多现有技术无法在同一系统上准确、便捷地进行多项凝血检查，给患者带来了临床显著问题，也增加了常规检测的成本和不便。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、更方便的血凝块检测；通过在一个便携式设备上进行准确和多次血液凝固测试来改善医疗保健；给依赖旧技术的设备带来竞争；在新兴技术领域培育小企业和就业增长，这一领域有潜力解决30亿美元的全球市场。拟议的项目将使其能够首次实施护理点（POC）直接机械测试，以仪表和试纸的形式，更紧密地复制临床实验室中所有凝血测试的基本机械方法。作为一种机械测量，试纸将测量凝血全血样本的物理特性，并考虑影响护理点凝血试验的混杂因素，如凝血酶原时间/国际标准化比率测量的红细胞压积。作为一种广谱止血平台技术，多种凝血试验可被引入便携式护理点格式，包括血栓弹性成像（TEG）、活化部分凝血酶活时间（aPTT）、活化凝血时间（ACT）和凝血酶原时间/国际标准化比率（PT/INR）试验。该SBIR一期项目将论证商业化凝血试验的可行性，实现机械式、试纸式、便携式POC凝血平台系统。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

The broader/commercial impact of this SBIR Phase I project will commercialize a new technology for accurate, portable, and inexpensive measurement of blood clotting tests routinely performed on patients who suffer from conditions such as atrial fibrillation, deep vein thrombosis, or have a mechanical heart valve replacement. These conditions affect millions of patients in the US alone in an annual market worth more than $3 B worldwide. However, many of the state-of-practice technologies 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 routine testing. 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 cheaper and more convenient blood clot testing for medical professionals and millions of patients; improve medical care by bringing accurate and multiple blood clotting tests to a single portable device; bring competition to devices which rely on older technologies; and foster small business and job growth in an emerging technology landscape that has the potential to address a 3 billion dollar, worldwide market. The proposed project will enable the first-of-its-kind implementation of a point of care (POC) direct, mechanical test in a meter and strip format, to more closely replicate the mechanical methods which fundamentally underlie all blood clotting tests in the clinical laboratory. As a mechanical measurement, the strip will measure physical properties of the clotting whole blood sample and account for the confounding factors affecting point of care blood clotting tests, such as hematocrit for prothrombin time / international normalized ratio measurement. As a broad-spectrum hemostasis platform technology, multiple blood coagulation tests can be brought to the portable point of care format, including thromboelastography (TEG), activated partial thromboplastin time (aPTT), activated clotting time (ACT), and prothrombin time / international normalized ratio (PT/INR) tests. This SBIR Phase I project will demonstrate the feasibility of a commercial blood coagulation test, realizing a mechanical, strip-based, portable POC blood coagulation platform 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.