Development of glycated albumin sensor based on lateral flow assay strip for diagnosis and monitoring of diabetes mellitus

Abstract

Diabetes mellitus is one of the most common chronic diseases worldwide. Generally, the levels of fasting or postprandial blood glucose and other biomarkers, such as glycated hemoglobin, and glycated albumin are used to diagnose or monitor diabetes progression. Various studies on the quantification of glycated hemoglobin and glycated albumin as major medium/long-term biomarkers for diabetes excluding glucose have been conducted in diverse approaches. However, research for understanding the exact clinical significance and appropriate purpose for it is still insufficient. In particular, in the case of glycated albumin, the ratio of glycated albumin to the total albumin is a clinically important indicator rather than the concentration of glycated albumin itself. However, there are still few platforms that can accurately quantify this except for enzyme-based assays. In the present study, the purpose and significance of the study were properly examined by prioritizing the accurate research goals and perspectives for the development of a glycated albumin sensor platform for diagnosing and monitoring diabetes. Based on this discussion, a simultaneously detection platform was developed to determine the glucose levels and glycation ratios of human serum albumin using a lateral flow assay. Through the specific enzymatic reactions and immunoassays, a spiked glucose solution, total human serum albumin, and glycated albumin were measured simultaneously. To test the performance of the developed sensor, clinical serum samples from healthy subjects and patients with diabetes were analyzed. The glucose level and glycation ratios of the clinical samples were determined with reasonable correlation. The R-squared values of glucose level and glycation ratio measurements were 0.932 and 0.930, respectively. The average detection recoveries of the sensor were 85.80% for glucose and 98.32% for the glycation ratio. The glucose level and glycation ratio in our results were crosschecked with reference diagnostic values of diabetes. Based on the outcomes of the present study, it could possibly propose that this novel platform can be utilized for the simultaneous detection of glucose and glycation ratios to diagnose and monitor diabetes mellitus.