ArticleKidney international reports2026
Ultrasensitive Immunoassay Using a Novel Galactose-Deficient IgA1 Antibody and Its Clinical Application in the Diagnosis of IgAN.
Article in Kidney international reports, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Introduction: IgA nephropathy (IgAN) diagnosis remains dependent on invasive renal biopsy because currently available serologic biomarkers, including galactose-deficient IgA1 (Gd-IgA1), have limited diagnostic performance. This study aimed to develop and evaluate a high-sensitivity time-resolved fluorescence immunoassay (TRFIA) based on a novel anti-Gd-IgA1 monoclonal antibody (i.e., MH33) for Gd-IgA1 detection in IgAN. Methods: MH33 glycoepitope specificity was characterized using surface plasmon resonance (SPR). An MH33-based TRFIA was developed and evaluated for analytical and diagnostic performance in healthy controls (HCs), non-IgAN renal disease controls, and patients with IgAN, with comparison to a KM55-based assay. Results: SPR analysis showed that MH33 recognized a GalNAc-modified IgA1 hinge-region glycopeptide distinct from the KM55 epitope. The MH33-based TRFIA achieved a detection limit of 0.20 response units (RU)/ml, a quantification range of 0.20 to 600 RU/ml, and acceptable analytical performance (intra-/inter-assay coefficients of variation: 2.32%-5.49% and 3.97%-5.23%; recoveries: 89.80%-103.76%). Correlation with KM55 was moderate (IgAN, Conclusion: MH33-based TRFIA provides a sensitive approach for Gd-IgA1 detection and demonstrates favorable diagnostic performance for IgAN.
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