PFI-RP: The rapid and specific detection of infectious pathogens using ultrathin porous membranes as sensors

创新伙伴关系-研究伙伴关系（PFI-RP）项目的更广泛影响/商业潜力源于一项技术的进步，该技术可从唾液、尿液或血液等少量体液中快速检测感染。这种基于膜的传感器技术不需要电子设备或外部读取器，有望实现与当前横向流动分析相同的低成本，但具有更高的灵敏度。重要的是，作为第一个需要特定病原体大小和亲和力的阳性适应症的检测方法，这种方法可以检测到活动性感染，这是目前任何检测方法都无法做到的。对活动性感染的低成本评估将对隔离管理产生影响，特别是在资源匮乏的环境中，那里失去工作或上学的社会负担特别高。相关的应用可能包括区分疾病的病毒源和细菌源的快速测试，这对于快速评估儿童疼痛的原因可能特别有用。这个PFI-RP的一个主要重点是扩大参与，包括PUI机构的教师和本科生作为研究和开发工作的全面参与者。企业家精神和工业将在课堂培训和PFI-RP小组的两周会议中得到充分的代表。这个PFI-RP项目将推进一种新型的基于膜的传感器，用于根据其大小和表面抗原检测生物体液中的感染因子。目前的快速检测方法只检测病原体分子成分的存在，不能区分病原体的感染和非感染状态。除了团队现有的原理验证研究之外，项目计划重点关注商业可行性所需的两个发展：1)将基于膜的传感器集成到具有明显比色读数的手动微流体装置中；2)通过优化孔径和抗原识别，证明膜传感可以推广用于检测不同的病原体/变异。为了实现这些目标，PFI团队组建了一个包括学术界和工业界在内的多机构团队。该团队将使用PET层压板（PETL）和其他低技术含量的材料制造多功能微流体装置，以创造一种足够简单的装置，可以在家中操作。在平行研究中，将建立高灵敏度和特异性检测大型和小型病原体所需的设计原则。这两项任务的成功预计将产生原型和工作流程，从而能够以简单易用的测试格式快速检测一系列传染性病原体。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 Partnerships for Innovation - Research Partnerships(PFI-RP) project derives from the advancement of a technology for the rapid detection of infection from a small quantity of body fluid such as saliva, urine, or blood. Requiring no electronics or external reader, the proposed membrane-based sensor technology is expected to achieve the same low costs as current lateral flow assays, but with greater sensitivity. Importantly, as the first assay to require specific pathogen size and affinity for positive indications, this approach may detect active infections which is not currently done by any assay. The low-cost assessment of active infection would be impactful for quarantine management, particularly in low-resource settings where the societal burden of lost work or school is especially high. Related applications may include rapid tests that distinguish between viral and bacterial sources of illness, which could be particularly useful for the rapid assessments of the cause of sore thoughts in children. A major emphasis in this PFI-RP is to broaden participation by including faculty and undergraduates at PUI institutions as full participants in the research and development efforts. Entrepreneurship and industry will be well-represented in both classroom training and in bi-weekly meetings of the PFI-RP team.This PFI-RP project will advance a novel membrane-based sensor for the detection of infectious agents in biofluids based on both their size and surface antigens. Current rapid assays only detect the presence of molecular components of pathogens and cannot distinguish between their infectious and non-infectious states. The project plan focuses on two developments needed for commercial viability beyond the team’s existing proof-of-principle studies: 1) The integration of the membrane-based sensor into a hand-operated microfluidic device with an obvious colorimetric readout, and 2) The demonstration that membrane ensing can be generalized for detection of different pathogens/variants by optimizing pore size and antigen recognition. To accomplish these objectives, the PFI team put together a multi-institutional team including academia and industry. This team will fabricate versatile microfluidic devices using PET laminates (PETL) and other low-tech materials to create a device simple enough to be operated in the home. In parallel studies, the design principles needed to detect both large and small pathogens with high sensitivity and specificity will be established. Success in both tasks are expected to result in prototypes and workflows enabling the rapid detection of a range of infectious agents in a simple-to-use test format.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.