Rapid Paper-based Diagnostics of CT / Trich

 描述(申请人提供)：我们建议使用一种低成本、一次性和高灵敏度的分子诊断设备来快速诊断衣原体(CT)和滴虫病(TRICH)。目前可用的诊断方法包括核酸扩增测试(NAAT)、基于免疫分析的快速诊断测试、培养和显微镜，以及新兴的近患者分子测试，这些方法在成本、时间和灵敏度之间进行了权衡。此前，我们设计了一种纸基微芯片来实现CT的样本到答案诊断，检测极限(LOD)接近或优于当前的黄金标准NAAT方法，速度不到一小时，速度快数十倍。在初步研究中，我们展示了该设备的新概念及其检测其他STI感染的潜在能力，如TRICH。项目成功完成的里程碑是演示了一个集成系统，可以在不到一小时的时间内通过比色读数在CT和TRICH上执行整个纸基多路样品到检测分子诊断过程。为了实现这一目标，我们将在我们的原型设备的基础上构建，该原型设备在快速检测模拟尿液中的CT方面显示出显著的灵敏度，通过实施将导致灵敏度(LOD)的分析和硬件更改，从而能够同时测量尿液中的CT和Trich。这种用于性病POC检测的完全集成和验证的分子诊断将在项目交付时准备好商业化和扩大到临床试验。

 DESCRIPTION (provided by applicant): We propose to rapidly diagnose chlamydia (CT) and trichomoniasis (Trich) with a low cost disposable and highly sensitive molecular diagnostic device. Currently available diagnostic methods including nucleic acid amplification tests (NAATs), immunoassay-based rapid diagnostic tests, culture and microscopy, and emerging near patient molecular tests suffer from the tradeoff between costs, time, and sensitivity. Previously, we designed a paper-based micro-chip to enable sample-to-answer diagnostics of CT, with the limit of detection (LOD) close or superior to the current gold standard NAAT methods, and at a speed of less than an hour, tens of times more rapid. In preliminary studies, we have demonstrated the novel concept of the device and its potential ability to detect other STI infections, such as Trich. The project milestone for successful completion is the demonstration of an integrated system to perform the entire paper-based multiplex sample- to-detection molecular diagnostic process on CT and Trich in less than one hour with a colorimetric readout. To achieve this goal, we will build upon our prototype device, which has shown significant sensitivity in rapidly detecting of CT in simulated urine, by implementing assay and hardware changes that would lead to sensitivity (LOD) that would enable the measurement of both CT and Trich in urine. This fully-integrated and validated molecular diagnostic for POC testing of STDs will be ready for commercialization and scale-up to clinical trials at project delivery.