I-Corps: Rapid, low-cost, microfluidic chips for molecular point-of-care diagnostics

这个I-Corps项目更广泛的影响/商业潜力是开发简单和低成本的护理点微流体分子（DNA/RNA）测试，旨在用于分散或低资源环境。目前，传染病的即时检测主要以试纸形式进行。虽然这些试纸测试是廉价的，但它们具有有限的灵敏度。作为替代方案，最敏感的检测方法需要通过聚合酶链反应（PCR）进行DNA/RNA检测，然而PCR检测通常需要耗时的手动步骤和昂贵的设备。由于成本的原因，PCR一般局限于集中实验室，因此一线分散诊所的检测结果可能会延迟数天到数周，因为样本需要送出去检测。低成本的核酸检测对于即时诊断是理想的;现场分子检测的可用性将为医生提供一个强大的工具来确认传染病的诊断，并允许更快的治疗和更高的灵敏度。该项目将有助于确定部署该技术的最佳产品市场战略，并指导设备的开发，这些设备将对更好的患者管理，增加分子检测的可及性以及更快地应对流行病产生积极影响。该I-Corps项目基于为现场核酸检测开发的几项专利微流控技术。微流控芯片旨在将分子测试设置成本降低100倍。关键技术包括基于真空的自供电微流控芯片，不需要传统微流控装置中常见的任何昂贵设备（如外部泵、控制器、阀门或电源）。这使得微流体测试与常规微流体相比成本仅为一小部分。真空技术还使微流控芯片完全便携，易于运输，非常适合分散式护理点使用。还可以使用基于真空的微流体技术进行样品制备。 使用这种基于真空的微流体平台，可以在30分钟内直接从人体血液样品中快速定量数字核酸检测耐药细菌DNA。这些技术特征是构建自主、便携、芯片实验室技术的重要组成部分，用于下一代低成本分子诊断检测。

The broader impact/commercial potential of this I-Corps project is the development of simple and low-cost point-of-care microfluidic molecular (DNA/RNA) tests that are designed to be used in decentralized or low-resource settings. Currently, point-of-care tests for infectious diseases are predominately done in a paper dipstick format. Although these dipstick tests are inexpensive, they have limited sensitivity. As an alternative, the most sensitive detection method entails DNA/RNA detection by polymerase chain reaction (PCR), however PCR testing often requires time-consuming manual steps and costly equipment. Because of its cost, PCR is generally confined to centralized laboratories, so front-line decentralized clinics can suffer days to weeks of delay in testing results because samples need to be sent out for testing. Low-cost nucleic acid detection is desirable for point-of-care diagnostics; The availability of an on-site molecular tests will give doctors a powerful tool to confirm diagnosis of infectious diseases and allow faster treatment with higher sensitivity. This project will help confirm the best product-market strategy to deploy the technology, and guide the development of devices that makes positive impact for better patient management, increased accessibility to molecular testing, and a faster response to epidemics.This I-Corps project is based on several patented microfluidic technologies developed for on-site nucleic acid detection. The microfluidic chip is designed to reduce molecular testing setup costs by 100X. The key technologies include vacuum based self-powered microfluidic chips that do not require any costly equipment often necessary seen in conventional microfluidic setups (such as external pumps, controllers, valves, or power sources). This allows the microfluidic test to be a fraction of the cost compared to conventional microfluidics. The vacuum technology also makes the microfluidic chips fully portable and easily transportable, which is ideal for decentralized point-of-care use. It was also possible to perform sample preparation with the vacuum based microfluidic technology. Using this vacuum based microfluidic platform, it is possible for rapid quantitative digital nucleic acid detection of drug resistant bacteria DNA directly from human blood samples within 30 minutes. These technical features are important building blocks for building autonomous, portable, lab-on-chip technologies for a future generation of low-cost molecular diagnostic assays.