ArticleBiomolecules2025
CLSI Validation of Exchangeable Copper Determination in Serum by ICP-MS: A Focus on Alzheimer's Disease and Wilson Disease.
Article in Biomolecules, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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Who cites it
3 citing papers in PubMed.
- Zinc Therapy in Mild Cognitive Impairment: Cognitive Stabilization in Pharmacodynamically Responsive Patients in the ZINCAiD Trial.Biomolecules · 2025Trial
- The Exchangeable Copper-Zinc Ratio Links Sex Hormones, Tumor Burden, and Epithelial Remodeling in Colorectal Cancer.Biomolecules · 2026Article
- Ferroptosis and Cuproptosis in Cancer and Neurodegeneration: A Comprehensive Review of Modulation by Iron and Copper Chelators and Related Agents.Biomolecules · 2026Review
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundCopper dyshomeostasis has been implicated in a subset of Alzheimer's disease (AD) patients, characterized by elevated non-ceruloplasmin-bound copper (non-Cp Cu). However, traditional methods for estimating non-Cp Cu are indirect and analytically imprecise. This study introduces and validates a direct assay for exchangeable copper (ExcCu) by inductively coupled plasma-mass spectrometry (ICP-MS), compliant with Clinical and Laboratory Standards Institute (CLSI) guidelines.
methodsWe performed analytical validation of the ExcCu assay following CLSI protocols (EP5, EP6, EP7, EP9, EP15, and EP28). ExcCu and other copper-related biomarkers were quantified in serum samples from 154 healthy controls, 82 AD patients, and 10 patients with Wilson disease (WD). Diagnostic performance was evaluated via receiver operating characteristic (ROC) curve analysis, and inter-method agreement was assessed using Bland-Altman plots.
resultsThe ExcCu assay demonstrated excellent linearity, precision (CV < 6%), and inter-laboratory reproducibility. Among AD patients, ExcCu levels were significantly elevated compared to controls (
conclusionsThe validated ExcCu assay overcomes the limitations of the traditional non-Cp Cu calculation, offering a reliable biomarker for copper-related AD subtypes. Its high specificity supports its use in patient stratification, potentially contributing to personalized approaches in AD diagnosis and therapy.
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