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

Treatment of Urinary Tract Infections (UTI) is currently initiated empirically because conventional diagnosis takes 2-3 days from sample to results. Moreover, the pharmaceutical pipeline is almost dry. Therefore, the last decade has globally witnessed a huge explosion of antibiotic (AB) resistance in Gram Negative Bacteria (GNB), which has drastically reduced the available AB therapy choices for UTI. The WHO considers this one of the major public health threats. Rapid detection of bacterial species and their AB susceptibility provides the main option to curb this development and prolong the lifetime of currently available antibiotics.In ROUTINE, 3 SMEs and 2 Universities will develop a prototype benchtop instrument that will rapidly (< 30 min) detect bacteria and characterize key antibiotics resistance profiles of ESBL (extended spectrum beta lactamase) and carbapenemase producing GNB directly from the patient urine at the point of care in outpatients and hospitals at a low cost (~20 €/test) and with near 100% sensitivity and specificity.Key factors to success are:1.The consortium has an established collaboration through other projects2.The starting point, builds on previous knowhow and the reader, cartridge and bioassay technologies developed within previous collaborations.3.The “uncomplicated” raw urine sample material and the choice of technologies will ensure reaching the ground-breaking end goals in terms of assay time, cost, sensitivity, specificity and ease-of-use.4.The designs, materials and processes used are familiar to regulatory authorities, which enable approval by e.g. FDA.5.The 3 SMEs have experience in developing and bringing diagnostics products to the market.The project will lead to 1) a complete, tested, POC system, and 2) a tailor-made software algorithm for detection of AB resistant GNB, delivering a revolutionary tool in patient treatment, reducing morbidity and mortality, and curbing the spread of AB resistance.