POINT OF CARE DIAGNOSTICS FOR URINARY TRACT INFECTION

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DESCRIPTION (provided by applicant): Urinary tract infection (UTI) is an extremely common condition that occurs in both males and females of all ages and in children. UTI is the most common urological disease in the United States and the second most common bacterial infection of any organ system. Urinary tract infection (UTI) is defined by the presence of a growth of more than 105 colony forming units (CFU) of bacteria per mL of urine for asymptomatic individual and much lower for symptomatic individuals (~103 CFU/mL). The "gold standard" for UTI diagnosis is microbiological urine culture. However, a major drawback of urine culture systems is the time lag of approximately 2 days between specimen collection and pathogen identification. Currently available rapid diagnostic tests exhibit poor sensitivities and/r specificities for UTI. A rapid, sensitive, easy to use POC based molecular approach for accurate and reliable detection and identification of clinically significant concentrations of bacterial pathogens in clinical urine specimens would be of considerable benefit. The overall goal of this SBIR project is to develop a cost effective, sensitive, easy to use device for diagnosing Urinary Tract Infection (UTI) at the Point Of Care (POC). The application of our proposed technology will be directed towards the development of a sensor array specifically for the microorganisms most commonly associated with UTI including E. coli, and coagulase negative Staphylococcus. During PHASE II we will expand the menu to include for the detection of other organisms including Klebsiella pneumoniae, Proteus mirabilis, Enterococcus sp., Pseudomonas aeruginosa. PUBLIC HEALTH RELEVANCE: Urinary tract infection (UTI) is an extremely common condition that occurs in both males and females of all ages and in children. Currently available rapid diagnostic tests exhibit poor sensitivities and/or specificities for UTI. A rapid, sensitive, easy o use POC based molecular approach for accurate and reliable detection and identification of clinically significant concentrations of bacterial pathogens in clinical urine specimens would be of considerable benefit.