SBIR Phase II: Innovative Platform for Low Volume Blood Coagulation Analysis

SBIR II 期：低容量凝血分析的创新平台

• 批准号: 2134020
• 负责人: Nithya Kasireddy
• 金额: $ 99.89万
• 依托单位: Levisonics Inc.
• 依托单位国家: 美国
• 项目类别: Cooperative Agreement
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-03-01 至 2025-02-28
• 项目状态: 未结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2134020&HistoricalAwards=false
• 关键词: SBIR; Phase; II; Innovative; Platform

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project addresses the problem of blood clotting and associated bleeding risks in neonatal and pediatric patients as well as vulnerable adult patients. Existing systems put these patients at further risk because they cannot operate with low volumes of blood, and because they are less reliable owing to the requirement for test sample contact. Using only a single drop of blood, the proposed non-contact technology platform enables safe and reliable assessment of blood clotting for all patients and provides an opportunity for development of newborn screening tests for coagulation abnormalities. This technology can reduce side effects for neonatal and pediatric patients by using 1/100th the sample volume required by technologies developed for adult healthcare and improve diagnostic response time for critical care providers by more than 3x. This technology could decrease the cost of blood coagulation analysis by over 30%, thus allowing for patients in the United States to save $1.1 billion annually.This Small Business Innovation Research (SBIR) Phase II project develops an innovative technology for non-contact blood coagulation analysis that integrates photo-optical and viscoelastic measurements in a single drop of blood. The basis of the technology is to levitate a small sample in a host fluid (air) by the acoustic radiation force and measure its physical properties under deformation during levitation. Due to its non-contact feature and low sample volume requirement, this technology can rapidly (10 minutes) and reliably assess bleeding/thrombotic risks and is sensitive to temporal changes in shear viscosity and elasticity during blood clotting and fibrinolysis. The goal of this project is to develop and test a system for fast, reliable, and easy-to-use drop-of-blood coagulation analysis under sterile conditions. This goal will be achieved by meeting four objectives: 1) develop the module for automatic sample deployment from standard blood collection tubes; 2) implement environmental control and sample containment (“acoustic cartridge”); 3) assemble prototype devices and develop the control software with improved workflow and a user-friendly interface; and 4) assess prototype reliability, standardize it for coagulation measurements, and conduct initial clinical testing.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.

这一小型企业创新研究（SBIR）II期项目的更广泛影响/商业潜力解决了新生儿和儿科患者以及脆弱成人患者的凝血问题和相关出血风险。现有的系统使这些患者处于更大的风险中，因为它们不能在低容量的血液下操作，并且因为它们由于需要测试样品接触而不太可靠。仅使用一滴血，拟议的非接触式技术平台就可以安全可靠地评估所有患者的凝血情况，并为开发新生儿凝血异常筛查测试提供了机会。这项技术可以减少新生儿和儿科患者的副作用，使用成人医疗保健技术所需的1/100的样本量，并将重症监护提供者的诊断响应时间缩短3倍以上。这项技术可以将血液凝固分析的成本降低30%以上，从而使美国的患者每年节省11亿美元。这项小型企业创新研究（SBIR）第二期项目开发了一种用于非接触式血液凝固分析的创新技术，该技术在一滴血液中集成了光光学和粘弹性测量。该技术的基础是通过声辐射力将小样品悬浮在宿主流体（空气）中，并在悬浮期间测量其变形下的物理性质。由于其非接触特性和低样本量要求，该技术可以快速（10分钟）可靠地评估出血/血栓形成风险，并且对血液凝固和纤维蛋白溶解过程中剪切粘度和弹性的时间变化敏感。该项目的目标是开发和测试一种系统，用于在无菌条件下快速，可靠和易于使用的血液凝固分析。这一目标将通过满足四个目标来实现：1）开发标准采血管自动样本部署模块; 2）实施环境控制和样本遏制3）组装原型装置，并开发控制软件，改进工作流程和用户友好界面;以及4）评估原型可靠性，将其标准化用于凝血测量，该奖项反映了NSF的法定使命，并通过使用基金会的智力价值进行评估，更广泛的影响审查标准。

项目成果

Drop-of-sample rheometry of biological fluids by noncontact acoustic tweezing spectroscopy

非接触式声镊光谱法对生物体液进行滴样流变测量

• DOI: 10.1039/d2lc00356b
• 发表时间: 2022
• 期刊: Lab on a Chip
• 影响因子: 6.1
• 作者: Kasireddy, Nithya;Orie, Jeremy C.;Khismatullin, Damir B.
• 通讯作者: Khismatullin, Damir B.