From MyACR to MyμAlbumin: Clinical Validation of a High-Precision, Real-Time Immunoturbidimetric PoC Device for Early Chronic Kidney Disease Detection.

BACKGROUND: Early detection of Chronic Kidney Disease (CKD) is essential for preventing disease progression, with microalbuminuria serving as a key marker for renal impairment. While conventional laboratory methods are accurate, they often come with high costs and long turnaround times. Our research group previously developed the point-of-care (PoC) MyACR device for determining urine albumin-to-creatinine ratios. Building on this, we introduced MyμAlbumin, a PoC, high-precision immunoturbidimetric device designed for rapid, real-time quantification of urinary albumin.

METHODS: The MyμAlbumin system uses a 340 nm UV LED and an integrated microcontroller to measure turbidity from specific antigen-antibody interactions. Clinical validation was performed on urine samples from 138 patients at risk for CKD, with device performance compared to a hospital-grade immunoturbidimetric reference method through Spearman's correlation and Bland-Altman analysis.

RESULTS: The MyμAlbumin device demonstrated exceptional diagnostic accuracy, with a sensitivity of 99.11% and a specificity of 98.23%. It maintained a strong linear correlation (R2 = 0.9925) across a concentration range of 0-1000 mg/L, with Bland-Altman analysis showing high agreement with the reference method (mean bias of 0.57 mg/L). Urinary albumin levels correlated significantly with elevated blood urea nitrogen (BUN) and serum creatinine. Clinical analysis indicated that microalbuminuria was more prevalent among older patients with diabetes, hypertension, and CKD.

CONCLUSIONS: The MyμAlbumin device significantly advances PoC testing, surpassing conventional tools in sensitivity and specificity. Its rapid, laboratory-grade results enhance clinical decision-making, making it a transformative tool for early CKD screening in primary care and resource-limited settings.