Rapid Cell-Based UTI Diagnosis and Antibiotic Selection Test

. Bacterial infection and antibiotic resistance are major healthcare issues facing the world. Designing rapid tests to tackle these challenges is critical. For example, urinary tract Infections, UTIs, approximately affect 150 million people worldwide annually. A bacterial load ≥ 100,000 cfu/mL in urine is a clinical indication of a patient suffering from a UTI. Current gold standard diagnosis is largely based on urine analysis and urine culture to verify the presence of bacteria. This requires a clinical lab and takes 1-3 days to get the final diagnosis. Existing point-of- care (POC) platforms such as those based on leukocyte esterase reagent strips and nitrite testing, which form part of urine analysis are an indirect measurement of infection, have low sensitivity and specificity, and do not provide any information about the bacterial load, which could be critical in the treatment decision. Gold standard treatment for UTIs involves antibiotics, which are in general very effective in resolving the infection. However, the misuse and abuse of antibiotics has led to a growing number of cases of antibiotic resistance in patients with UTI. Thus, hand in hand with the need for better UTI tests, there is also a growing need for tests which can screen for the presence of antimicrobial resistant (AMR) bacteria in patients suffering from UTI. For example, a bacterial load of <100,000 cfu/mL and without a prior history of UTI does not warrant antibiotic treatment whereas with a prior history of UTI and any co-morbidities does warrant an antibiotic treatment. Therefore, companion tests that would give information on bacterial load and rapidly screen for AMR bacteria present in the urine sample of patients, which would be critical for diagnosis, therapy decision, and follow-up culture test is ideal. To address this need we have formulated the following hypothesis: The development of a rapid test that will diagnose UTI specifically by measuring bacterial load in urine as well as screen for the presence of AMR bacteria will aid in making accurate clinical diagnosis and treatment decisions. In this work, we propose the development of two distinct diagnostic tests, both utilizing bioluminescent Photobacterium. To achieve our goal, we will pursue three specific aims, namely Specific Aim 1: Develop a bioluminescence-based test for quantitative detection of UTI-causing pathogens in urine using a microtiter plate reader and handheld luminometer; Specific Aim 2: Develop a bioluminescence-based test to screen for AMR bacteria in urine samples from UTI-diagnosed patients; and Specific Aim 3: Perform Pilot Studies with Clinical Samples. Our proposed non-culture, non- amplification, non-molecular approach will result in advances in the rapid diagnosis of UTI and the choosing of a therapeutic antibiotic regimen. Currently, this kind of technology does not yet exist. Project Number: 1R01AI195924-01 | Fiscal Year: 2026 | NIH Institute/Center: National Institute of Allergy and Infectious Diseases (NIAID) | Principal Investigator: Sapna Deo (+1 co-PI) | Institution: UNIVERSITY OF MIAMI SCHOOL OF MEDICINE, CORAL GABLES, FL | Award Amount: $617,438 | Activity Code: R01 | Study Section: Enabling Bioanalytical and Imaging Technologies Study Section[EBIT] View on NIH RePORTER: https://reporter.nih.gov/project-details/1R01AI19592401