Novel Electrochemiluminescence Immunoassay Developed for Precise Semaglutide Measurement in Human Serum

Semaglutide, a potent GLP-1 analog (a hormone-mimicking drug that helps regulate blood sugar and appetite), is a cornerstone treatment for type 2 diabetes and obesity. Accurate and sensitive quantification of semaglutide levels in human serum is critical for understanding its pharmacokinetics, optimizing dosing, and ensuring patient safety during treatment. Existing methods often face challenges with throughput, sensitivity, or specificity, creating a need for improved analytical tools. This study addresses the development of a highly sensitive and specific method for semaglutide detection.

The developed ECLIA demonstrated exceptional analytical performance for semaglutide quantification. It achieved a remarkable limit of detection (LOD) of 0.08 ng/mL and a limit of quantification (LOQ) of 0.25 ng/mL, indicating high sensitivity. The assay exhibited excellent linearity across a broad range from 0.25 ng/mL to 1000 ng/mL, effectively covering the therapeutic concentrations of semaglutide. Precision was outstanding, with intra-assay coefficient of variation (CV) consistently below 3.5% and inter-assay CV below 6.0%. Furthermore, recovery rates ranged from 97% to 103%, confirming accuracy. The ECLIA showed no significant cross-reactivity with other GLP-1 receptor agonists or common endogenous serum components, demonstrating high specificity crucial for clinical applications.