Quantification of Urine Albumin-Creatinine Ratio (uACR) by Point-of-Care Test and Its Comparison with Other Analytical Methods for Easy Detection
Nadda Muhamad
Department of Biomedicine and Health Informatics, Faculty of Pharmacy, Silpakorn University, Nakhon Pathom 73000, Thailand.
Napaporn Youngvises
Bangkok High Lab Co., Ltd., Bang Khen District, Bangkok 10220, Thailand.
Tullayakorn Plengsuriyakarn
Graduate Program in Bioclinical Sciences, Chulabhorn International College of Medicine, Thammasat University, Pathum Thani 12120, Thailand.
Wanchai Meesiri
Bangkok High Lab Co., Ltd., Bang Khen District, Bangkok 10220, Thailand.
Wanna Chaijaroenkul
Graduate Program in Bioclinical Sciences, Chulabhorn International College of Medicine, Thammasat University, Pathum Thani 12120, Thailand.
Kesara Na-Bangchang *
Graduate Program in Bioclinical Sciences, Chulabhorn International College of Medicine, Thammasat University, Pathum Thani 12120, Thailand.
*Author to whom correspondence should be addressed.
Abstract
Background: Chronic kidney disease (CKD) is a progressive condition affecting over 10% of the global population. Monitoring the urine albumin-to-creatinine ratio (uACR) is the gold standard for early detection and ongoing management of nephropathy. However, access to laboratory testing is limited in many community healthcare settings.
Objective: This study aimed to develop and evaluate the performance of MyACR, a simple, accurate, sensitive, and rapid point-of-care test (PoCT) device for measuring uACR, with the goal of facilitating CKD screening and monitoring in community settings.
Methods: MyACR uses spectrophotometric dye-binding (tetrabromophenol blue) and colourimetric Jaffe methods to quantify urinary albumin and creatinine, respectively. Urine samples were diluted 1:80 with distilled water and reacted with respective reagent mixtures. The creatinine reaction was incubated at 25°C for 30 minutes before analysis. Optical densities were measured at 625 nm (albumin) and 515 nm (creatinine). Calibration curves were established for albumin (0–60 mg/L) and creatinine (0–2 mg/dL), and analytical performance was evaluated in terms of linearity, accuracy, precision, and sensitivity. Clinical validation was conducted on urine samples from 20 CKD patients.
Results: Calibration curves demonstrated strong linearity, with correlation coefficients (R²) exceeding 0.997. The method demonstrated good intra- and inter-day accuracy (per cent deviation of mean value ≤ 5.42%) and precision (coefficient of variation ≤ 12.69%). The method was specific, without interference from blood components. The limits of quantification were 5 mg/L for albumin and 0.25 mg/dL for creatinine, based on spiked samples (n = 5). Comparison with hospital-based immunoassays showed a high correlation (R² > 0.98) and acceptable agreement (median %DMV = 3.48%, range: -17.05% to 21.64%).
Conclusion: MyACR demonstrated satisfactory analytical performance for the point-of-care measurement of uACR, offering a promising tool for early detection and monitoring of CKD in resource-limited settings. Further studies are warranted to assess its cost-effectiveness and clinical utility in large-scale, multisite community and home-based applications.
Keywords: Albumin, albumin-to-creatinine ratio, creatinine, microalbumin, point-of-care medical device