Kridsada Sirisabhabhorn

Microalbuminemia, characterized by a urinary albumin concentration between 20 and 200 mg/L, is a critical marker in assessing the risk of chronic kidney disease (CKD), diabetic nephropathy, and various other chronic conditions. Previously, we developed and validated the MyACR point-of-care (PoC) device, which facilitates the monitoring of CKD progression through real-time data transmission, thus enhancing patient management. This device utilizes a spectrophotometric dye-binding assay to measure albumin and creatinine concentrations in urine samples, providing an albumin-to-creatinine ratio (ACR) result. In the present study, we introduced a refined version of the PoC device, MyμAlbumin, designed to offer a simple, accurate, specific, sensitive, and rapid method for detecting microalbumin in urine as an early indicator of CKD and related diseases. The measurement is based on a specific immunoturbidimetric assay in a microcuvette, using a total solution volume of 125 µL (n = 5 for each validation test). The MyμAlbumin device demonstrated excellent performance, achieving high accuracy (%DMV ≤ 4.67) and precision (%CV < 5) and a strong correlation (R² > 0.995) with laboratory spectrophotometry (dye-binding assay) and reference hospital-based immunoturbidimetric assay. Its high sensitivity (LOQ = 5 mg/L) positions MyμAlbumin as a highly viable and cost-effective tool for clinical use. Additionally, the device supports real-time, seamless data transmission, making it ideal for integration into remote healthcare settings.

Chronic kidney disease (CKD) continues to pose a critical global health challenge, making ongoing monitoring vital for effective management and preventing its progression to end-stage renal disease. The urinary albumin-to-creatinine ratio (uACR) stands out as a reliable biomarker. MyACR was developed and validated as a novel point-of-care (POC) device for identifying and monitoring the progress of CKD. MyACR device operates using a colorimetric-based spectroscopy to quantify albumin and creatinine levels at 625 nm and 515 nm, respectively. Calculated uACR values were compared with results from the reference turbidimetry method using a dataset of 103 random urine samples from patients at high risk of advanced CKD. The device showed excellent performance in detecting severe nephropathy, with sensitivity, specificity, and accuracy of 100%, 100%, and 100%, respectively. The PPV (positive predictive value) was 100%, indicating perfect identification of patients with severe nephropathy (uACR > 300 mg/g creatinine). The NPV (negative predictive value) was 100%, suggesting a strong ability to rule out severe nephropathy, though a small risk of false negatives remained. Bland–Altman analysis confirmed a high level of agreement, with 96.11% (for all data) and 95.87% (for uACR > 300 mg/g creatinine) of MyACR measurements falling within the 95% confidence interval (−27 to +19). Correlation analysis revealed a significant alignment between MyACR and the reference method (r² 0.9720 to 0.9836). The ROC analysis suggested that combining uACR with the estimated glomerular filtration rate (eGFR) demonstrated strong predictive performance, yielding an area under the curve (AUC) of 0.933 (95% CI: 0.86–1.0). In conclusion, the MyACR device is a robust, affordable, and user-friendly tool for detecting nephropathy, showing performance comparable to the reference method. Its portability and cost-effectiveness make it particularly suitable for use in low-resource environments. Additionally, integrating uACR with eGFR enhances prognostic capabilities, offering a comprehensive approach to assessing kidney function and predicting CKD progression.