A-402 Rapid, point-of-care, pathogen ID and ast for uncomplicated urinary tract infections

Background Uncomplicated urinary tract infection (uUTI) is one of the most common infections requiring medical intervention and antibiotic use. Routine treatment of uUTI at the point of care is often based on symptoms and/or urinalysis; however, it is known that clinical presentation and dipstick testing alone do not adequately identify a true infection. At best, culture-based identification is not reported until 18 hours after a specimen arrives at a lab, with susceptibility results following at 36-48 hours. GeneCapture is developing a rapid, sample-to-answer system to provide pathogen identification, semi-quantification, and antibiotic susceptibility results directly from clean-catch urine samples. CAPTURE ID will report the presence of clinically relevant concentrations (=100,000 CFU/mL) of pathogens directly from a urine sample within one hour. CAPTURE AST will then determine effective antibiotics within 2 additional hours, allowing same-day accurate treatment of uUTI. Methods CAPTURE ID uses automated, on-cartridge systems to filter concentrate and disrupt bacteria, fragment their RNA, and pass that RNA over an array of GeneCapture’s proprietary species-specific probes. A fluorescent detector then shows which captors have found their targets. CAPTURE AST is currently a lab-based assay with prototypes in development. Filter concentrated samples are grown in the presence and absence of antibiotics at their CLSI-mandated susceptible breakpoint concentrations for the targeted organism. Changes in growth in the presence and absence of antibiotic are then interpreted to determine susceptibility. The uUTI System identifies five common UTI organisms, and CAPTURE AST tests the three most common of these against 5 antibiotics. Results CAPTURE ID produced a sensitivity/specificity of 95%/100% in a small study of uUTI clinical samples. The ID cartridge has been finalized, and sample-to-answer testing of a larger spiked study is underway. Early results are similar to the above and will be reported in full at the meeting. CAPTURE AST has produced a data set this year of 332 antibiotic/uropathogen pairs with 92% agreement to standard culture methods. This data set is being expanded, and prototype cartridges and assays are being developed. These results are all generated in two hours or less of assay time and represent a strong preliminary data set. Conclusion GeneCapture’s CAPTURE UTI system will enable faster and more accurate treatment of uUTI patients, which in turn will reduce incorrect or unnecessary antibiotic use, minimize return office visits, and aid in the prevention of antimicrobial resistance.