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Bacterial resistance to antimicrobials is considered a major issue worldwide. This condition may account for treatment failure of urinary tract infections, which are among the most common infections both in community and healthcare settings. Therapy against uropathogens is generally administered empirically, possibly leading to unsuccessful therapy, recurrence and development of antibiotic resistance. The reduction in analytical time to obtain antimicrobial susceptibility test (AST) results could play a key role in reducing the cost of healthcare, providing information about antibiotic efficacy and thus preventing from either exploiting new and expensive antibiotics unnecessarily or using obsolete and ineffective ones. A more rational choice among treatment options would hence lead to more effective treatment and faster resolution. In this paper we evaluated the performance of a new Point Of Care Test (POCT) for the rapid prediction of antimicrobial susceptibility in urine samples performed without the need of a laboratory or specialized technicians. 349 patients were enrolled in two open-label, monocentric, non-interventional clinical trials in partnership with an Emergency Medicine ward and the Day Hospital of two large healthcare facilities in Rome. Antibiogram was carried out on 97 patients. Results from analysis of urine samples with the POCT were compared with those from routine AST performed on culture-positive samples, displaying high accuracy (>90%) for all tested antimicrobial drugs and yielding reliable results in less than 12 hours from urine collection thus reducing analytical and management costs.

Urinary tract infections (UTIs) are among the most common infections in all age groups. Fast and accurate diagnosis is essential to ensure a timely and effective therapy. Alongside with reference culture-based methods, several point-of-care tests (POCTs) for early detection of UTIs have been developed, but they have not been significantly implemented in current clinical practice. The Micro Biological Survey (MBS) POCT is a simple test developed by MBS Diagnostics Ltd. (London, UK) for the detection and management of UTIs. The present study has been undertaken to investigate the potentials and limits of the MBS POCT. A total of 349 patients were enrolled in two open-label, monocentric, non-interventional clinical trials in collaboration with an Emergency Medicine department and the outpatient clinic of two hospitals in Rome. Results of urine analysis using the MBS POCT were compared with those of the routine culture-based tests for UTI diagnosis performed by the hospital laboratory. The MBS POCT provided fast results revealing high bacterial count UTIs (≥ 105 CFU/ml) with 97% accuracy, 92% sensitivity, 100% specificity, 99% PPV, and 96% NPV within a 5-h analytical time threshold. Electronic supplementary material The online version of this article (10.1007/s10096-019-03728-3) contains supplementary material, which is available to authorized users.

In clinically suspected urinary tract infections (UTIs), empirical antibiotic treatment is usually started long before the laboratory results of urine culture and antibiogram are available. Although molecular diagnostic approaches are being applied to the diagnosis of many infections, UTIs are generally diagnosed by traditional culture methods. Patient care could greatly benefi from the development of a rapid, accurate, inexpensive test that could be done at patient’s bedside, allowing the practitioner to plan targeted, more effctive therapy. Such a test would potentially reduce incorrect or unnecessary use of antibacterial drugs and reduce the emergence of bacterial resistance. In response to this pressing and unmet clinical need, several methods have been developed in the last few years. Among these, the new point-of-care test (POCT) for detecting UTIs named Micro Biological Survey (MBS) UTI CHECK holds promise, as it allows semi-quantitative determination of bacterial load in urine leading to a fast detection of UTIs and to evaluation of bacterial antibiotic susceptibility. This new technology operates through a colorimetric survey performed in low-cost, ready-to-use, disposable vials, in which 1 ml of urine is inoculated without any preliminary treatment and requiring neither specialized personnel nor a specialized equipment.