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.

PUBLIC HEALTH RELEVANCE: Micro Analysis Integration proposes a novel integrated device for rapid, sensitive, and low cost diagnostics of chlamydia (CT) and trichomoniasis (Trich). The integrated device will allow molecular sample preparation and colorimetric readout of CT / Trich DNA signature, with the sensitivity similar to a benchtop quantitative Polymerase Chain Reaction diagnostics (gold standard) system, but much lower cost and higher speed at the same time. Successful completion of this work will allow us to proceed to more rigorous clinical testing of the proposed device for the ultimate use in primary care settings.