Micro Analysis Integration LLC — Department of Health and Human Services SBIR Phase I: NIAID

Description

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