Gestational diabetes mellitus (GDM) affects between 2-14% of pregnant women in the United States every year. The glycated version of serum albumin, the most abundant protein in blood, owing to its half-life of ~21 days can effectively be used as an intermediate biomarker for monitoring GDM. Normal level of glycation of albumin is between 10-16% whereas in patients with diabetes it is much higher, between 16-40%. Thus, a point-of-care (POC) monitoring system to detect glycated albumin (GA) as a % of total serum albumin has been developed here. Specifically, a paper fluidic test to measure glycated and unglycated serum albumin has been developed that uses an aptamer-based assay with gold nanoparticles to produce colorimetric measurements. The assays were constructed using a sandwich aptamer format and colorimetric intensity was measured by scanning the capture layer of the paper fluidic device using a standard flatbed scanner followed by RGB analysis. The assays are able to determine the concentration of glycated and serum albumin in their physiologically relevant ranges of 50-300μM and 500-750μM. The paper fluidic system enabled the placement of gold nanoparticle probes in the device thereby automating the system and minimizing user intervention. Using aptamers as recognition elements and colorimetric transduction with gold nanoparticles, the system was shown, to possess the required sensitivity, selectivity, and dynamic range for physiologic monitoring.
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