Evaluation of a Urinary Tract Infections Test for Qualitative Detection of Leukocytes, Blood, Nitrite, and Protein in Human Urine

The Urinary Tract Infections (UTI) Test, an in vitro diagnostic tool, is designed for the qualitative detection of Leukocytes, Blood, Nitrite and Protein in human urine, with potential for self-testing. This study comprehensively evaluates its performance, including positive coincidence rate, negative coincidence rate, total coincidence rate and consistency with a commercially available urinalysis reagent strip. A total of 206 clinical urine specimens were tested using the UTI Test (Hangzhou Alltest Biotech Co., Ltd) and the ACON urinalysis reagent strip as a reference. The results showed a high positive coincidence rate of 98.36%, a negative coincidence rate of 100%, a total coincidence rate of 99.51% and a Kappa value of 0.988, indicating excellent consistency. Additionally, the test demonstrated good usability, suitable for self-testing scenarios, with most users finding the instructions, procedure and result interpretation easy to understand. These findings suggest that the UTI Test is a reliable and practical in vitro diagnostic tool, with potential for self-testing, for the qualitative detection of relevant markers in urine, contributing to the timely diagnosis of UTIs.