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SBIR Phase I: Sensitive and Rapid Endotoxin Assays via a Unique Optical Biosensor-Based Limulus Amoebocyte Lysate Test

SBIR 第一阶段：通过独特的基于光学生物传感器的鲎变形细胞裂解物测试进行灵敏、快速的内毒素测定

基本信息

批准号：
2014915
负责人：
Nikolay Akimov
金额：
$ 22.42万
依托单位：
SAFEBIOSENSE LLC
依托单位国家：
美国
项目类别：
Standard Grant
财政年份：
2020
资助国家：
美国
起止时间：
2020-05-15 至 2021-09-30
项目状态：
已结题

来源：
https://www.nsf.gov/awardsearch/showAward?AWD_ID=2014915&HistoricalAwards=false
关键词：
SBIR Phase Sensitive Rapid Endotoxin

项目摘要

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to explore an innovative, highly sensitive, rapid, compact and inexpensive system for detection of contaminants known as endotoxins. If pharmaceutical products or implantable medical devices contaminated with endotoxins come into contact with the bloodstream, they can cause a rapid rise in core body temperature followed by a severe shock, possibly fatal even before the problem is diagnosed. An estimated 70 million endotoxin tests are performed each year in the US alone. However, the conventional methods suffer from limited sensitivity and speed or chemical interference issues. The proposed project will advance the development of an endotoxin detection system using a novel optical biosensor for quick, precise detection of low levels. The proposed system can potentially be applied to sepsis diagnosis in acute care.The proposed SBIR Phase I project will address endotoxin testing for pharmaceutical quality control. The proposed approach will use a different physical parameter, refractive index (RI), to sensitively monitor the early onset of the gel-forming process in a mixture of analyte solution and Limulus Amoebocyte Lysate (LAL). Endotoxin concentrations will be correlated with the changes in RI due to the coagulation of LAL. A unique photonic-crystal biosensor will be used to monitor changes in RI with high speed (5 min.) and high sensitivity (0.000025 EU/mL), 200 times higher than the state of practice. This crystal will be used in a total internal reflection (PC-TIR) configuration, with an imaging system to monitor the sensor's state. The project will conduct rapid prototype iterations through 3D printing. Technical objectives include: (1) design and construct a prototype; (2) conduct verification and validation in the presence of typical interfering species; (3) evaluate assay speeds for testing of radiopharmaceuticals with a short half-life.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.

这个小企业创新研究（SBIR）第一阶段项目的更广泛的影响/商业潜力是探索一种创新的、高度敏感的、快速的、紧凑的和廉价的系统来检测被称为内毒素的污染物。如果被内毒素污染的药品或植入式医疗设备与血液接触，它们可能导致核心体温迅速上升，随后出现严重休克，甚至在问题被诊断出来之前就可能致命。据估计，每年仅在美国就进行7000万次内毒素检查。然而，传统的方法存在灵敏度和速度有限或化学干扰问题。拟议的项目将推进内毒素检测系统的发展，该系统使用一种新型光学生物传感器来快速，精确地检测低水平的内毒素。提出的系统可以潜在地应用于败血症的诊断在急性护理。拟议的SBIR一期项目将解决用于药品质量控制的内毒素检测。所提出的方法将使用不同的物理参数，折射率（RI），以灵敏地监测分析物溶液和鲎试剂（LAL）混合物中凝胶形成过程的早期开始。内毒素浓度将与LAL凝固引起的RI变化相关。一种独特的光子晶体生物传感器将用于监测RI的变化，其速度快（5分钟），灵敏度高（0.000025 EU/mL），比实际状态高200倍。该晶体将用于全内反射（PC-TIR）配置，并配有成像系统来监控传感器的状态。该项目将通过3D打印进行快速原型迭代。技术目标包括：(1)设计并构建原型；(2)在存在典型干扰物质的情况下进行验证和验证；(3)评价半衰期短的放射性药物的检测速度。该奖项反映了美国国家科学基金会的法定使命，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。