Validated PoC immunoturbidimetric device enables rapid urinary albumin testing for early CKD screening
The study reports clinical validation of the MyμAlbumin, a point-of-care immunoturbidimetric device for rapid urinary albumin quantification. Investigators tested 138 patients at risk for chronic kidney disease and found the device achieved 99.11% sensitivity and 98.23% specificity against a hospital-grade reference method, with a linear correlation of R2=0.9925 and a mean bias of 0.57 mg/L. The findings demonstrate that the platform delivers laboratory-grade accuracy in a decentralized format. This validation supports the integration of rapid, cost-effective albumin testing into primary care and resource-limited settings to improve early chronic kidney disease screening.
The original study
From MyACR to MyμAlbumin: Clinical Validation of a High-Precision, Real-Time Immunoturbidimetric PoC Device for Early Chronic Kidney Disease Detection.
- Authors
- Plengsuriyakarn T, Chaijaroenkul W, Youngvises N, Sirisabhabhorn K, Bubpha W, Na-Bangchang K
- Journal
- Journal of clinical laboratory analysis
- Type
- Journal Article
- PMID
- 42517684
Original abstract
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.