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Enhanced detection of Cystatin C for predicting adverse outcomes in gestational diabetes mellitus using a point-of-care immunosensor

Ya Jin, Yong-Mei Chen, Xiao-Qin Li, Song-Jun Han, L. Mou, Nan Li

Bioelectrochemistry, 2025

150 participants · 12 citations

Abstract

Cystatin C (Cys-C) is emerging as a critical biomarker for assess gestational diabetes mellitus (GDM), a condition that significantly impacts maternal and fetal health. In this study, we developed a novel label-free electrochemical immunosensor designed for point-of-care applications, offering lower reagent consumption and rapid detection of Cys-C in pregnant women with GDM. Compared to traditional enzyme-linked immunosorbent assays (ELISA), the sensor demonstrates enhanced sensitivity, reduced reagent usage, and faster detection. In a cohort study involving 150 pregnant women with GDM and 150 healthy controls, serum Cys-C levels were analyzed using the developed sensor. Serum samples were collected and analyzed for Cys-C levels using our immunosensor. Serum Cys-C levels were significantly elevated in GDM patients compared to controls (P < 0.05), and higher levels were observed in GDM complicated by pregnancy-induced hypertension (PIH) and fetal growth restriction (FGR). Furthermore, elevated Cys-C levels were positively correlated with adverse pregnancy outcomes, including premature birth, fetal distress, and cesarean section (P < 0.05). This study underscores the potential of Cys-C as a reliable biomarker for GDM and highlights the advantages of our novel sensor for quick, accurate, and scalable GDM diagnosis and management.

How strong is the evidence?

Evidence Hub reads this as a case-control, done in people. Its evidence level is 4 of 5 (Low · observational). Observational designs can show an association but not prove cause. Reported size: 150 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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