Clinical Validation of AllTest UTI Self-Testing Reagent Strips in Urine

Abstract

The Urinary Tract Infections (UTI) Test (Urine) consists of firm plastic strips designed for the qualitative detection of four analytes—Leukocytes (LEU), Nitrite (NIT), Protein (PRO), and Occult Blood (BLO)—in human urine. This study evaluated the performance of the AllTest Biotech UTI Reagent Strips (Cat. No. U031-04H) compared with a commercially available reference test. A total of 206 clinical urine specimens (61 UTI-positive and 145 UTI-negative) were tested. The evaluated assay showed 98.36% positive concordance, 100% negative concordance, and 99.51% total agreement. No significant interference was observed from common urinary substances such as ascorbic acid, glucose, bilirubin, and hemoglobin. These results demonstrate the test’s high reliability, accuracy, and suitability for self-testing, confirming its clinical applicability as a rapid and user-friendly screening tool for preliminary UTI detection.