Chaijaroenkul Wanna, Youngvises Napaporn, Thiengsusuk Artitaya, Plengsuriyakarn Tullayakorn, Suwanboriboon Jakkrapong, Sirisabhabhorn Kridsada, Meesiri Wanchai, Na-Bangchang Kesara
Graduate Program in Bioclinical Sciences, Chulabhorn International College of Medicine, Thammasat University, Pathum Thani 12120, Thailand.
Drug Discovery and Development Center, Office of Advanced Science and Technology, Thammasat University, Pathum Thani 12120, Thailand.
Biosensors (Basel). 2025 Jun 17;15(6):391. doi: 10.3390/bios15060391.
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 (R > 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.
微量白蛋白尿症的特征是尿白蛋白浓度在20至200mg/L之间，是评估慢性肾脏病（CKD）、糖尿病肾病和各种其他慢性病风险的关键指标。此前，我们开发并验证了MyACR即时检测（PoC）设备，该设备通过实时数据传输促进对CKD进展的监测，从而加强患者管理。该设备利用分光光度染料结合法测量尿样中的白蛋白和肌酐浓度，得出白蛋白与肌酐比值（ACR）结果。在本研究中，我们推出了PoC设备的改进版本MyμAlbumin，旨在提供一种简单、准确、特异、灵敏且快速的方法来检测尿中的微量白蛋白，作为CKD及相关疾病的早期指标。测量基于微量比色皿中的特定免疫比浊法，总溶液体积为125µL（每次验证测试n = 5）。MyμAlbumin设备表现出色，具有高准确度（%DMV≤4.67）和精密度（%CV<5），并且与实验室分光光度法（染料结合法）和参考医院免疫比浊法具有强相关性（R>0.995）。其高灵敏度（LOQ = 5mg/L）使MyμAlbumin成为临床使用中高度可行且具有成本效益的工具。此外，该设备支持实时、无缝的数据传输，非常适合集成到远程医疗环境中。
