STTR Phase I: Low-Cost Quantitative Lateral Flow Assay for Cytokine Release Syndrome Detection in Point-of-Care/Point-of-Need Settings

这项小型企业技术转让（STTR）第一阶段项目的更广泛影响/商业潜力是一种生物传感技术，可以实现高灵敏度、定量、即时诊断。一旦经过验证，提议的生物传感器、一次性传感器芯片/墨盒和电子读出模块可以利用现有的医疗设备制造能力轻松批量生产。这项技术可能对病人的健康和福利产生影响。近期目标是检测白细胞介素蛋白监测，以早期发现细胞因子释放综合征，这是一种可能危及生命的健康并发症，发生在接受免疫治疗、器官移植、传染病、败血症等患者中。其他应用包括癌症或癌症复发的早期检测，干眼病，现有和新出现的传染病，生物威胁等。这个小型企业技术转让（STTR）第一阶段项目是低成本的概念验证演示，磁性生物传感器技术可能使分析实验室能够在护理点进行可靠的生物标志物检测和定量。提出的生物传感器将适用于血液中白细胞介素蛋白的定量检测，用于细胞因子释放综合征的早期诊断。该技术利用磁性纳米颗粒作为生物分子相互作用的报告，将磁传感集成到无处不在的横向流动测定（LFA）格式（用于妊娠试验）中。这些测试非常适合于即时护理应用，在这种应用中，快速方便地获得低成本诊断工具有助于改善患者护理。该项目的基本原理是，拟议的生物传感器可以提供与最先进实验室相媲美的临床相关定量数据，同时保留LFA测试在低成本和易于使用方面的优势。其翻盖式设计的一次性芯片建立在通常的LFA卡式设计之上。这种一次性芯片将由低成本的印刷电路板（PCB）制造制造和组装，预计LFA测试的成本只会增加几美分。一种低成本的便携式阅读器，能够用传统的现成的电子元件进行超高灵敏度的定量读数。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。

The broader impact/commercial potential of this Small Business Technology Transfer (STTR) Phase I project is a biosensing technology that may enable highly sensitive, quantitative, point-of-care diagnostics. Once validated, the proposed biosensor, disposable sensor chips/cartridges, and electronic readout modules can be readily mass-produced using existing medical device manufacturing capacities. The technology may have an impact on the health and welfare of patients. The immediate goal is to examine interleukin protein monitoring for early detection of cytokine release syndrome, a potentially life-threatening health complication that develops in patients undergoing immunotherapy treatment, organ transplant, infectious disease, sepsis, etc. Additional applications include early detection of cancers or cancer recurrence, dry eye disease, existing and emerging infectious disease, biothreats, etc.This Small Business Technology Transfer (STTR) Phase I project is a proof-of-concept demonstration of a low-cost, magnetic biosensor technology that may enable analytical laboratory capabilities for reliable biomarker detection and quantitation at the point of care. The proposed biosensor will be adapted for quantitative detection of interleukin proteins in blood for early diagnostics of cytokine release syndrome. The technology integrates magnetic sensing into the ubiquitous lateral flow assay (LFA) format (used in pregnancy tests) utilizing magnetic nanoparticles as reporters of biomolecular interactions. The tests are well-suited for point-of-care applications where rapid and convenient access to low-cost diagnostic tools helps improve patient care. The rationale for this project is that the proposed biosensors can provide clinically-relevant quantitative data rivaling those of state-of-the-art laboratories while preserving the advantages of LFA tests in terms of low cost and ease of use. The disposable chip with its clam-shell design builds upon the usual LFA cassette design. The disposable chip will be produced and assembled from low-cost printed circuit board (PCB) manufacturing and is expected to add only cents to the cost of an LFA test. A low-cost portable reader capable of ultrahigh sensitivity quantitative readings will be built from conventional off-the-shelve electronic components.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.