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.

该SBIR I期项目将开发一项新技术，以对多个血液凝血测试进行准确，便携式和廉价的测量。此类测试包括凝血酶原时间 /国际归一化比率（PT / INR），激活的部分血小板塑料时间（APTT），激活的凝结时间（ACT）或血栓射击（TEG）（TEG）（TEG），并经常在患有诸如肉眼纤维化，深静脉血栓形成或患有心脏的病情上遭受痛苦的患者。仅在美国，全球价值超过10亿美元的市场就会影响数百万的患者。但是，当前市场上目前使用的许多技术无法准确或方便地在同一系统上进行多次血液凝结测试，从而导致患者临床上的重要问题，并提高常规执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各种血液凝结测试能够在单个便携式测试条纹系统中进行。这可能会导致对医疗专业人员和数百万患者的便宜，更准确，更方便的血凝块测试；通过将多个血液凝结测试带到单个便携式设备中来改善医疗保健；将急需的创新带入一个依赖较少准确技术的市场；并在新兴技术领域中促进小型企业和工作增长，有可能解决数十亿美元的全球市场。该项目中开发的技术将使以剥离形式进行直接机械测试的首先实施，以更加紧密地复制机械方法，从根本上讲，这根本上是所有血液凝结时间测试的基础。作为一种机械测量，该条带将测量手指 - 纸，全血样品的物理特性，以说明影响护理血液凝结测试的混杂因素，例如用于PT/INR测量的血细胞比容。作为一种广谱止血平台技术，基于测量血液样品的流体机械性能的其他重要血液凝血测试可以将其带入便携式护理点格式，包括激活的部分（APTT）凝血纤维素时间（PT/INR），激活的凝结时间（ACT）ACT（ACT）ACT（ACT）ACT（ACT）测试（TEG）测试（TEG）测试（TEG）。该阶段I项目将证明第二次血液凝结测试（激活的部分血小板蛋白时间）的可行性，并实现了机械，基于条带的，便携式的护理（POC）血液凝结平台系统的可行性。