SBIR Phase I: Development of a rapid, point-of-care coagulation test for the investigation and treatment of COVID-19-related coagulopathy.

该小型企业创新研究（SBIR）I期项目的更广泛影响/商业潜力是开发一种快速的即时医疗设备，可以精确管理凝血（凝血）障碍和治疗。 拟议的技术将支持开发全自动读取器系统，沿着一次性检测盒，以实现对有凝血问题的COVID-19患者的临床检测。由于COVID-19疾病期间发生的严重炎症，这些患者通常需要频繁检测凝血障碍。该技术将快速识别更容易形成血栓的患者，并有助于评估其当前治疗方案的有效性;这将产生超越当前流行病的影响。这一小型企业创新研究（SBIR）第一阶段项目允许确定凝血因子特异性抑制和/或缺陷，并实时监测对治疗的反应。可用于使用精确医学方法进行抗凝剂管理的即时、便携式、小体积凝血测定的开发将能够鉴定凝血因子特异性抑制，并且因此被证明是诊断和治疗凝血障碍的重要工具。该诊断也将能够用于非COVID-19抗凝剂管理，帮助在紧急情况和手术环境以及其他高风险患者（如新生儿）中识别和量化抗凝剂。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 impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is the development of a rapid, point-of-care device that allows for the precision management of blood clotting (coagulation) disorders and therapies. The proposed technology will support the development of a fully-automated reader system, along with single-use disposable cartridges, to enable clinical testing of COVID-19 patients with blood clotting issues. Due to the severe inflammation that occurs during COVID-19 disease, these patients often require frequent testing for blood clotting disorders. The proposed technology will rapidly identify patients that are more likely to form blood clots, and it can help evaluate the effectiveness of their current regimens; this will have impact beyond the current pandemic.This Small Business Innovation Research (SBIR) Phase I project allows for the determination of coagulation factor-specific inhibition and/or deficiency and real-time monitoring of response to treatment. The development of a point-of-care, portable, small volume coagulation assay that can be used for anticoagulant management using a precision-medicine approach would enable the identification of coagulation factor-specific inhibition, and, therefore, prove to be an essential tool in the diagnosis and treatment of coagulation disorders. This diagnostic would also be able to be used in non-COVID-19 anticoagulant management, aiding the identification and quantification of anticoagulants in an emergency and surgical setting and in other high-risk patients, such as neonates.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.