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

该SBIR I期项目的更广泛/商业影响将使一种新技术商业化，该技术用于对患有房颤、深静脉血栓形成或机械心脏瓣膜置换术等疾病的患者进行常规凝血试验的准确、便携和廉价测量。这些疾病仅在美国就影响了数百万患者，全球每年的市场价值超过30 B美元。然而，许多最先进的技术不能准确或方便地在同一系统上进行多种凝血测试，这给患者带来了临床上的重大问题，并增加了常规测试的成本和不便。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，更方便的血液凝块测试;通过将准确和多种血液凝块测试引入单个便携式设备来改善医疗保健;为依赖旧技术的设备带来竞争;并在新兴技术领域促进小企业和就业增长，有可能解决30亿美元的全球市场。该项目将首次以血糖仪和试纸的形式实施即时护理（POC）直接机械测试，以更接近地复制临床实验室中所有凝血测试的基本机械方法。作为机械测量，试纸将测量凝血全血样本的物理特性，并考虑影响床旁凝血试验的混杂因素，例如凝血酶原时间/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，可将多种凝血测试引入便携式床旁模式，包括血栓弹力图（TEG）、活化部分凝血活酶时间（aPTT）、活化凝血时间（ACT）和凝血酶原时间/国际标准化比值（PT/INR）测试。该SBIR第一阶段项目将证明商业化血液凝固测试的可行性，实现一个机械的、基于条带的、便携式POC血液凝固平台系统。该奖项反映了NSF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.