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Galectin-3 testing: validity of a novel automated assay in heart failure patients with reduced ejection fraction
D Gruson1, M Mancini2, S A Ahn3
1Pôle de Recherche en Endocrinologie, Diabète et Nutrition, Institut de Recherche Expérimentale et Clinique, Cliniques Universitaires St.-Luc and Université Catholique de Louvain, Brussels, Belgium; Department of Laboratory Medicine, Cliniques Universitaires St.-Luc and Université Catholique de Louvain, Brussels, Belgium.
Insights
A new automated assay for galectin-3 (Gal-3) shows excellent agreement with the reference method. This assay is clinically valid for heart failure patients, predicting cardiovascular death and improving risk stratification.
Area of Science:
- Biochemistry
- Cardiology
- Medical Diagnostics
Background:
- Galectin-3 (Gal-3) is a biomarker for cardiac fibrosis and remodeling, aiding in heart failure (HF) risk stratification.
- Assessing Gal-3 levels is crucial for managing patients with HF with reduced ejection fraction.
Purpose of the Study:
- To evaluate the analytical and clinical validity of a novel automated galectin-3 assay.
- To assess the assay's performance in patients with HF and reduced ejection fraction.
Main Methods:
- Comparison of the VIDAS® Gal-3 automated assay with the ELISA reference method.
- Analysis of Gal-3 levels in relation to NYHA functional classes and long-term cardiovascular outcomes.
- Evaluation of Gal-3's added value in multimarker strategies.
Main Results:
- Excellent agreement (r=0.90) between the automated assay and ELISA.
- Significant correlation between Gal-3 levels and NYHA functional classes (II, III, IV).
- Gal-3 levels predicted long-term cardiovascular death and enhanced natriuretic peptide testing.
Conclusions:
- The VIDAS® Gal-3 automated assay demonstrates strong analytical validity.
- The assay is clinically valid for use in heart failure patients.
- Automated Gal-3 testing offers valuable prognostic information and improves risk stratification in HF.
Abstract:
Circulating levels of galectin-3 (Gal-3), a marker of cardiac fibrosis and remodeling, contribute to the risk stratification of patients with heart failure (HF). The aim of our study was to determine the analytical validity and clinical validity of a novel automated Gal-3 assay in HF patients with reduced ejection fraction. We showed an excellent agreement between the VIDAS® Gal-3 automated assay and the ELISA reference method (r=0.90, p<0.001) and a mean difference of -1.3 ng/mL was observed on the Bland and Altman plot. Gal-3 levels measured with the VIDAS® assay were significantly related to NYHA functional classes (p<0.001) and mean Gal-3 levels were 13.8 ng/mL in NYHA II patients, 17.7 ng/mL in NYHA III and 19.6 ng/mL in NYHA IV. Furthermore, our results showed that Gal-3 levels measured with the VIDAS® assay were not only predictive of long-term cardiovascular death in patients with systolic HF but have also provided added value to natriuretic peptide testing in multimarker strategies. Therefore, our data are also supporting the clinical validity of the Gal-3 automated assay.
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