User-friendly and robust paper-based device for in-field diagnostic of infectious diseases

传染病的早期检测需要快速、便携和高灵敏度的分子诊断平台。该项目旨在创建一种护理点(POC)设备，简化在农村低资源地区监测和消除传染病的工作。已经开发了基于微流控的低成本纸基设备，但目前没有一种设备满足世界卫生组织提供的有效POC测试的“有保证”标准(负担得起、敏感、特定、用户友好、快速和坚固、无设备和可交付给最终用户)。即使目前的检测方法可以检测到极低浓度的感染性生物，但其有限的稳健性限制了它们在临床和社区中的实际使用，这是因为基本试剂(如酶)在具有挑战性的野外条件下、在实验室环境之外会降解。在这个项目中，我们将开发新的放大方法，包括机载试剂储存和样品处理，并将它们集成到纸张基材上，以提供“可靠的”设备。新的能力将使用添加剂制造进行原型制作，并使用模型样本(缓冲区中的人造DNA/RNA)进行测试，以建立概念验证，然后是添加的真实样本。根据进展和国际旅行限制，这些设备可能会被带到我们在非洲的合作伙伴那里进行实地评估。

Early detection of infectious diseases requires rapid, portable and highly sensitive molecular diagnostic platforms. This project aims at creating a point-of-care (POC) device that simplifies the efforts in monitoring and eliminating infectious diseases in rural low-resource areas. Low-cost, paper-based devices based on microfluidics have been developed but none currently meet the "ASSURED" criteria for effective POC testing provided by World Health Organization (Affordable, Sensitive, Specific, User-friendly, Rapid and robust, Equipment-free and Deliverable to end-users). Even if current tests can detect very low concentrations of infectious organisms, their limited robustness restricts their practical use in the clinics and in communities, due to the degradation of essential reagents (such as enzymes) in challenging field conditions, outside of the laboratory environment. In this project, we will develop new amplification methods, including on-board reagent storage and sample processing and integrate them onto paper substrates to deliver "ASSURED" devices. The new capabilities will be prototyped using additive manufacturing and tested using model samples (artificial DNA/RNA in buffers) to establish proof-of-concept, followed by spiked real samples. Depending on progress and international travel restrictions, the devices will potentially be brought to our partners in Africa for evaluation in the field.