This Small Business Innovation Research (SBIR) Phase I project proposes the development of a new test to diagnose pathogenic microorganisms causing sexually transmitted infections at the point-of-care in near-real time. The technical approach is based on a novel implementation of impedance sensing to monitor bacterial growth with exceptional sensitivity and stability combined with a well-established immuno-capture technique. The method avoids the need for grown cultures and enables both identification and antibiotic susceptibility to be obtained directly from clinical samples within a few hours with a simple and easy-to-use low cost device ideally suited for mass production. Implementation of the proposed technology will reduce the time from sample collection to complete diagnosis of infectious agent by days compared to currently used methods and enable the prescription of targeted antibiotic therapies. Feasibility of the proposed diagnostic tool will be demonstrated initially with the organism Neisseria gonorrhoeae within a 6-month Phase I effort and is readily applicable to other sexually transmitted infections (STI) organisms.
If successful this project will make a practical and affordable method for rapidly determining the antibiotic susceptibility of pathogens associated with STI more available therefore having significant impact on public health allowing better management of effective policies. Antibiotic susceptibility testing of STI is not routinely performed, in part, because of the time consuming nature of testing for antibiotic resistance. The availability of a rapid and affordable diagnostic test that could be performed at the point-of-care would improve patient outcomes enabling the prescription of targeted antibiotic therapies and reducing the spread of antibiotic resistance.
