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ROutine diagnostic tool for Urinary Tract INfections caused by Esbl and carbapenamase producing bacteria

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A new tool for urinary tract infections

European researchers have developed a new, fully functional point-of-care device for the rapid diagnosis of bacterial infections.

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Persistent infections and antibiotic resistance require early, more informed antimicrobial choices. The EU-funded ROUTINE (Routine diagnostic tool for urinary tract infections caused by ESBL and carbapenamase producing bacteria) project has developed a fully functional reader in an injection moulded chip. This contains all necessary reagents as well as diagnostic algorithms and a ROUTINE designed user interface. This point-of-care test combines sample preparation, DNA amplification and a read-out system for antibiotic resistance, all within 30 minutes. The ROUTINE system will enable the physician to determine the severity of infection and provide information on effective and ineffective antibiotic choices. Project partners identified the most common bacteria responsible for urinary tract infections (UTIs) and set up polymerase chain reaction (PCR) assays for detecting resistance genes. Method optimisation used Escherichia coli and Klebsiella pneumoniae carbapenemase as model organisms. The device includes a chip for PCR amplification of bacteria-specific genes and a microarray reader for detecting the fluorescent signal. Assay design and end-point analysis tools are also under development. Project teams additionally envisage a remotely accessible data management system (validation manager software) for the design and implementation of bacterial diagnostic assays. Dissemination of ROUTINE activities and tools has already attracted considerable interest in international conferences, trade shows and conventions. There are two peer-reviewed publications of ROUTINE work and more anticipated on completion of preclinical and clinical trials. Extended work after the project includes optimising reader/chip settings using bacteria-spiked samples for UTI patient tests. On commercialisation, the device promises to improve patient management by offering evidence-based antibiotic treatment. In turn, this should minimise spreading of bacterial infections, reduce drug-associated mortality and prevent the emergence of antibiotic-resistant bacteria. A more targeted and effective treatment of UTI will undoubtedly reduce health care costs.

Keywords

Urinary tract infections, point-of-care device, diagnosis, antibiotic resistance, ROUTINE, antibiotic choice

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