Profile
International Journal of Clinical & Medical Microbiology Volume 1 (2016), Article ID 1:IJCMM-107, 7 pages
https://doi.org/10.15344/2456-4028/2016/107
Research Article
A Pilot Clinical Trial on a New Point-of-care Test for the Diagnosis and Fast Management of Urinary Tract Infections in the Emergency Department

Alyexandra Arienzo1, Valentina Cellitti1, Valeria Ferrante1, Francesca Losito1, Ottavia Stalio1, Flavia Cristofano2, Rossella Marino2, Laura Magrini2, Iolanda Santino3, Alberto Mari4, Paolo Visca1, Salvatore Di Somma2 and Giovanni Antonini on behalf of GREAT Network1,5*

1Department of Science, Roma Tre University, 00146 Rome, Italy
2Emergency Medicine, Department of Medical-Surgery Sciences and Translational Medicine, Sapienza University of Rome, Sant’Andrea Hospital, 00189 Rome, Italy
3Department of Clinical and Molecular Medicine, Sapienza University of Rome and Microbiology Unit, Sant’Andrea Hospital, 00189 Rome, Italy
4MBS srl, 00131 Rome, Italy
5INBB Interuniversity Consortium of Structural and Systems Biology, 00136 Rome, Italy
Prof. Giovanni Antonini, Department of Science, Roma Tre University, Viale G. Marconi 446, 00146 Rome, Italy, Tel: +39-3290570913; E-mail: giovanni.antonini@uniroma3.it
06 May 2016; 30 June 2016; 02 July 2016
Arienzo A, Cellitti V, Ferrante V, Losito F, Stalio O, et al. (2016) A pilot clinical trial on a new point-of-care test for the diagnosis and fast management of urinary tract infections in the Emergency Department. Int J Clin Med Microbiol 1: 107. doi: https://doi.org/10.15344/2456-4028/2016/107
This work has been partially supported by Marjan Miklus Stiftung, Zur Förderung der Forschung, 16761 Hennigsdorf , Germany, by Waltraut Bergmann Stiftung, Zur Förderung von Wissenschaft und Forschung, 16556 Borgsdorf , Germany and by Sviluppo Lazio spa, 00198 Roma, Italy, [grant number FILAS- RS-2009-1026].

Abstract


Background: Urinary tract infections (UTIs) are among the most common bacterial infections occurring in both community and health care setting. Laboratory diagnosis of UTIs is attained by conventional urine culture which identifies and quantifies infecting bacteria, followed by antibiotic susceptibility testing. This approach is time consuming and requires a considerable workload. A user-friendly, automated test for rapid bacterial quantification has been developed by MBS (a spin-off of Roma Tre University, Rome, Italy) as a point-of-care test (POCT) for UTIs. The aim of this study was to perform a preliminary clinical trial of the new MBS POCT for diagnosis and management of UTIs.
Methods: A prospective diagnostic accuracy evaluation study was performed in collaboration with the Emergency Department of the Azienda Ospedaliera Sant’Andrea of Rome (Italy), on 122 patients with clinically suspected UTIs. Results of the MBS POCT were compared with those of the routine tests for urine culture and antibiotic susceptibility.
Results: The MBS POCT, used in the Emergency Department, provided a UTI diagnosis in < 5 hours with very high accuracy, sensitivity and specificity. However, antibiotic susceptibility evaluation provided some false resistant results, when exceedingly high concentrations of bacteria were present in urines.
Conclusion: The MBS POCT represents a valuable diagnostic tool for the detection of UTI, substantially saving time and assuring comparable quality of results, ultimately facilitating the successful management of infections. As for conventional antibiotic susceptibility tests, the bacterial inoculum is critical for significance of results.