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.

这项小型企业创新研究（SBIR）II期项目的更广泛的影响/商业潜力解决了新生儿和儿科患者以及脆弱的成年患者的血液凝结和相关出血风险的问题。现有系统将这些患者面临进一步的风险，因为他们无法以低量的血液运作，并且由于对测试样本接触的要求，它们的可靠性较差。提议的非接触技术平台仅使用一滴血液，可以为所有患者对血液服装进行安全可靠的评估，并为开发新生儿筛查测试的凝结异常提供了机会。通过使用1/100的1/100，该技术可以减少新生儿和小儿患者的副作用，这是针对成人医疗保健开发的技术所需的样本量，并改善了重症监护提供者的诊断时间超过3倍。血液凝血分析的分析超过30％，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）II期项目开发了一种用于非接触式血液凝结分析的创新技术，可以整合单滴血液中的光学和粘弹性测量。该技术的基础是通过声学辐射力和测量其物理特性在悬浮期间的变形中测量其物理特性。由于其非接触功能和较低的样品需求，该技术可以迅速（10分钟）和可靠的评估出血/血小板风险，并且对血液凝结和纤维蛋白溶解过程中剪切粘度和弹性的暂时变化敏感。该项目的目的是开发和测试一个在无菌条件下快速，可靠且易于使用的血液滴凝结分析的系统。将通过达到四个目标来实现：1）从标准血液收集管中开发自动样品部署的模块； 2）实施环境控制和样品遏制（“声学弹药筒”）； 3）组装原型设备，并通过改进的工作流和用户友好的界面来开发控制软件； 4）评估原型的可靠性，将其标准化以进行凝结测量并进行初始临床测试。该奖项反映了NSF的法定任务，并使用基金会的知识分子优点和更广泛的影响审查标准，通过评估诚实地表示支持。

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.