Clinical Validation of a Mobile-Based ACR (Urine Albumin-to-Creatinine Ratio) Test Kit: Comparative Analysis with Benchtop Devices

Background: Albuminuria, a marker for diabetes complications and kidney disease, is typically tested in hospitals, limiting patient monitoring. The mobile-based ACR (urine albumin-to-creatinine ratio) test, QSCheck-UISACR, was developed for easy detection of albuminuria. This study aimed to validate its clinical efficacy compared to a conventional benchtop device (Cybow R-50S) for early kidney disease diagnosis. Methods: Conducted in three hospitals with 303 kidney disease patients, urine samples were tested using both the mobile ACR kit and the benchtop device. Parameters measured included microalbumin, creatinine, and their ratio (albumin-to-creatinine ratio). Exact Agreement and Within One Block Agreement were calculated to compare methods.Results: Data collected from three university hospitals were aggregated and analyzed, showing that the microalbumin Exact Agreement was 73.3%, with a Within One Block Agreement of 96.0%. For creatinine, the Exact Agreement was 75.6%, and the Within One Block Agreement was 95.7%. Based on these two test results, the albumin-to-creatinine ratio analysis demonstrated an Exact Agreement of 78.5% and a Within One Block Agreement of 98.0%. These findings highlight the robust performance of the tests across the evaluated biomarkers.Conclusions: The mobile-based ACR test kit demonstrated high accuracy and comparability to the benchtop device, suggesting its potential as a reliable tool for early kidney disease screening in primary care settings, enhancing patient accessibility and reducing healthcare costs.