Rapid, Accurate Point-of-Care Test for Gonorrhea and Determination of Antimicrobial Susceptibility

Antimicrobial resistant gonorrheacaused by Neisseria gonorrhoeaeNGhas become an urgent threat for global public healthThe goal of this project is to develop a one hour point of care diagnosticPOCtest capable of identifying NGand determining the infecting strain s susceptibility to antibioticsAI Biosciences plans to achieve this goal by expanding the capability of its POC system being developed for a CLIA waivedmin molecular test for Chlamydia trachomatisCTand NG from urine and swabsWe will upgrade our simplelow cost cartridge to enable processing multiple samples automaticallyThis multi sample enclosed cartridge will have sample wells that each contain antibiotic from major antibiotic groupsi equinolonestetracyclinesand macrolidesWhile the sample is being tested for CT NGaliquoted samples are exposed to these NG treating antibiotics for overminutesIf tested positive for NGthe samples exposed to antibiotics will be processedPhenotypic measurements of antibiotic susceptibility through quantitative measurement of NG growth will then be quantified by rapid nucleic acid amplification assay in the cartridgeThe change in target level after antibiotic exposure will be used to determine the susceptibilityTwo internationally recognized experts in CT NG testing and commercial POC molecular assay will validate our Phase I work