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Proof-of-Concept Development of a Novel Fluorescent Immunoassay (FIA) for Rapid, Point-of-Care Detection of Growth Differentiation Factor-15 (GDF-15)

John G. Bruno, Ying Chen, Reem Mahrat

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Source: Crossref

Published: Jan 1, 2026

DOI: 10.2139/ssrn.7584725

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Source abstract

We describe the proof-of-concept development and preliminary analytical characterization of an extremely sensitive fluorescent immunochromatographic assay (FIA) test strip for GDF-15 in human serum. The FIA utilizes a sandwich combination of custom antibodies to yield a visible dynamic range of detection of 2 – 10,000 pg/mL for GDF-15 in serum by utilizing highly fluorescent Europium nanoparticle reporter tags with a very long Stoke’s shift (UV excitation and 620 nm peak emission). Visual detection was optimized at an excitation of 365 nm using an orange Wratten emission filter. The FIA is also very specific for GDF-15 with demonstrably low detection levels for five other proteins that could be found in normal or diseased serum. Because GDF-15 is a general stress and inflammatory disease biomarker, this work paves the way for a rapid and facile at-home or point-of-care test to help assess daily stress levels and inflammatory status. As a proof-of-concept, this study focuses on assay feasibility and preliminary analytical characterization; full quantitative and clinical validation remains to be established.

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Proof-of-Concept Development of a Novel Fluorescent Immunoassay (FIA) for Rapid, Point-of-Care Detection of Growth Differentiation Factor-15 (GDF-15) — Mathematical Frontier Network