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

这个小企业技术转让（STTR）第一阶段项目的更广泛的影响/商业潜力是一种生物传感技术，可以实现高度灵敏的定量护理点诊断。一旦经过验证，所提出的生物传感器、一次性传感器芯片/盒和电子读出模块可以使用现有的医疗设备制造能力容易地大规模生产。该技术可能会对患者的健康和福利产生影响。近期目标是检查白细胞介素蛋白监测，用于细胞因子释放综合征的早期检测，细胞因子释放综合征是在接受免疫疗法治疗、器官移植、传染病、败血症等的患者中发展的潜在危及生命的健康并发症。该小企业技术转让（STTR）第一阶段项目是低成本、磁性生物传感器技术的概念验证示范，该技术可以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。所提出的生物传感器将适用于定量检测血液中的白细胞介素蛋白，用于细胞因子释放综合征的早期诊断。该技术将磁性传感集成到无处不在的侧流检测（LFA）格式（用于妊娠试验）中，利用磁性纳米颗粒作为生物分子相互作用的报告者。这些测试非常适合即时护理应用，快速方便地获得低成本的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的实验室相媲美的临床相关的定量数据，同时保留LFA测试在低成本和易用性方面的优势。具有蛤壳式设计的一次性芯片基于通常的LFA卡匣设计。一次性芯片将由低成本的印刷电路板（PCB）生产和组装，预计LFA测试的成本仅增加几美分。一个低成本的便携式阅读器，能够进行高灵敏度的定量读数，将建立从传统的现成的电子元件。这一奖项反映了NSF的法定使命，并已被认为是值得的支持，通过评估使用该基金会的智力价值和更广泛的影响审查标准。

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.