A Rapid, Point-of-Care Diagnostic to Identify Viable Sexually Transmitted Infections, Reduce Overtreatment, and Prevent Emerging Antibiotic Resistance

ABSTRACT A Rapid, Point-of-Care Diagnostic to Identify Viable Sexually Transmitted Infections, Reduce Overtreatment, and Prevent Emerging Antibiotic Resistance Rates of sexually transmitted infections (STIs) have climbed to record highs and concern about antimicrobial- resistant and multidrug-resistant STIs is growing. The majority of bacterial STIs do not cause overt symptoms and frequent, asymptomatic screening is thus conducted for select, high risk groups to increase awareness of infection, provide proper treatment, and reduce transmission. Although nucleic acid amplification tests (NAAT) are the preferred test method for many STIs due to their high sensitivity and relatively quick results, they currently lack the ability to differentiate active (viable) infection from resolved (non-viable) infection and/or latent pathogen DNA from an exposure that did not cause infection. Over-estimation of true STI positivity from NAAT may lead to overtreatment and the emergence of antimicrobial resistant STI strains. There is an urgent need for better testing strategies that can differentiate viable infection from a non-viable NAAT result to preserve front-line antibiotic treatments and promote stewardship. We propose to develop a panel of novel STI viability PCR (V-PCR) assays, which will be fully automated using Baebies’ proven digital microfluidic (DMF) technology. Our solution will utilize a simple, CLIA-waived workflow— designed for operation by minimally trained users in distributed settings—to provide multiplexed STI pathogen detection with viability data in under 20 minutes. Results will enable clinicians to diagnose infection and confidently select appropriate treatment within a single patient visit. In Phase I, we will develop V-PCR assays for Chlamydia trachomatis and Neisseria gonorrhoeae, first using a microtiter plate format and then complete hardware modifications to automate the V-PCR tests on our existing DMF analyzer before demonstrating technical feasibility with vaginal swab samples. In Phase II, we will optimize the time-to-result of the assays, identify reagent formulations to optimize stability of the V-PCR reagents, evaluate the analytical performance and clinical concordance of the DMF tests, and conduct an external clinical concordance study with potential lead users. At the conclusion of Phase II, our test will be ready for outcome evaluations, which will catalyze adoption of this revolutionary technology. The final commercialized product will represent a paradigm shift in testing for STIs that will enable providers to confidently prescribe STI treatment, only when needed, with significantly shorter wait times and improved sensitivity compared to culture-based methods. Our product has the potential to reduce overtreatment of non-viable NAAT-positive cases, slow or prevent the emergence of new antibiotic resistance, and preserve the efficacy of front-line antibiotic treatments.