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

这个i-Corps项目的更广泛的影响/商业潜力是开发简单和低成本的护理点式微流控分子(DNA/RNA)测试，这些测试旨在分散或低资源环境下使用。目前，传染病的现场检测主要是以纸质试纸的形式进行的。尽管这些试纸测试费用不高，但它们的灵敏度有限。作为替代方法，最灵敏的检测方法需要通过聚合酶链式反应(PCR)检测DNA/RNA，然而，PCR检测通常需要耗时的人工步骤和昂贵的设备。由于成本的原因，聚合酶链式反应通常被限制在集中式实验室，因此一线分散诊所的检测结果可能会延迟数天至数周，因为需要将样本送出进行检测。低成本的核酸检测对于医疗诊断是可取的；现场分子测试的可用性将为医生提供确认传染病诊断的强大工具，并允许以更高的灵敏度进行更快的治疗。该项目将帮助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、更容易获得分子检测和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。这种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力式微流控芯片，这种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)。这使得与传统的微流体相比，微流控测试的成本只有很小的一部分。真空技术还使微流控芯片完全便携和易于运输，这是分散护理点使用的理想选择。还可以利用基于真空的微流控技术进行样品制备。利用这个基于真空的微流控平台，可以在30分钟内直接从人体血液样本中快速定量检测耐药细菌DNA。这些技术特征是为下一代低成本分子诊断分析建立自主、便携、芯片实验室技术的重要基础。

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.