Evaluation of a Urinary Tract Infections Test for Qualitative Detection of Leukocytes, Blood, Nitrite, and Protein in Human Urine
Year: 2025
Type: article
Abstract: 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.
Source: MEDS Clinical Medicine
Authors: Lei Zhang, Feng Yang, Junzhe Zhu
Institutions: Zhejiang Gongshang University, Wenzhou Medical University
Language: English
Subfield: Epidemiology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
OpenAlex ID: W4412820620