Validation of point-of-care device for rapid detection of urinary tract infection and antibiotic susceptibility

Background: Urinary tract infections (UTI) presents a high prevalence in the community setting. Rapid and accurate microbiological diagnosis is essential to ensure adequate and effective therapy. Aim: To evaluate a rapid antibiogram kit (KAR (R)) in point-of-care format for rapid detection of UTI and antibiotic susceptibility. Methods: The KAR (R) device has been designed and developed in collaboration with technical engineers and clinical microbiologists. Its evaluation has been carried out through a multicenter study in which three Spanish hospitals have participated. Thus, different in vivo tests have been implemented in order to determine device correlation with the reference microbiological techniques. Results: During the study period, a total of 400 urine samples from patients with suspected ITU were tested. The KAR (R) device provided fast results (mean positivity time of 7,8 +/- 1,5 hours) with 97% sensitivity, 89% specificity and 87% agreement for the detection of significant bacteriuria. The percentages of specificity for the antibiotics tested were: ciprofloxacin (97%), fosfomycin (94%),cotrimoxazole (84%), ampicillin (80%) and amoxicillin/clavulanic acid (55%). Conclusion: The KAR (R) device could be a useful tool for diagnosing UTI in outpatients, especially in areas of low socio-economic level.