Related Experiment Video
Updated: Feb 18, 2026

High Throughput Sequential ELISA for Validation of Biomarkers of Acute Graft-Versus-Host Disease
Published on: October 31, 2012
Establishing the upper reference limit of Galectin-3 in healthy blood donors
Luisa Agnello1, Chiara Bellia1, Bruna Lo Sasso1
1Section of Clinical Biochemistry and Clinical Molecular Medicine, Department of Biopathology and Medical Biotechnologies, University of Palermo, Italy.
Insights
This study established the upper reference limit for Galectin-3 (Gal-3) in healthy adults. Age significantly impacts Gal-3 levels, suggesting age-specific diagnostic cut-offs are necessary for accurate heart failure risk assessment.
Area of Science:
- Biochemistry
- Clinical Chemistry
- Cardiovascular Research
Background:
- Galectin-3 (Gal-3) is a prognostic biomarker for heart failure (HF).
- Establishing reference intervals for Gal-3 is crucial for clinical practice and research interpretation.
- No prior studies defined Gal-3 reference intervals in healthy populations.
Purpose of the Study:
- To determine the upper reference limit (URL) of plasma Gal-3 in a healthy population.
- To identify biological variables influencing Gal-3 concentration in healthy individuals.
Main Methods:
- Recruited 706 healthy blood donors after excluding individuals with underlying diseases.
- Calculated the URL for Gal-3 using the non-parametric percentile method.
- Analyzed Gal-3 concentrations stratified by age and sex.
Main Results:
- The 97.5th percentile URL for plasma Gal-3 was 26.1 ng/mL.
- Gal-3 levels were significantly higher in subjects older than 45 years compared to younger subjects.
- No significant sex-related differences in plasma Gal-3 concentration were observed.
Conclusions:
- An upper reference limit for Gal-3 was established in a healthy cohort.
- Age is a key determinant of plasma Gal-3 levels.
- Age-specific diagnostic cut-offs for Gal-3 are recommended for clinical use.
Introduction:
Galectin-3 (Gal-3) is an independent predictor of poor outcomes and mortality in patients with heart failure (HF). Thus, it has been proposed as a reliable prognostic biomarker for HF. The definition of reference intervals is mandatory for interpreting the findings of experimental studies and encouraging the routine use of biomarkers in clinical practice. To date, no study assessed the reference intervals of Gal-3 and identified the biological variables that affect its concentration in a well-defined healthy population. The aim of this study was to determine the upper reference limit (URL) of Gal-3 in a highly reliable population of healthy subjects.
Materials And Methods:
We recruited 714 blood donors. After measuring surrogate biomarkers to identify underlying diseases, 8 subjects were excluded. A final population of 706 individuals (385 men (54.5%); median age 39 (18-65) years) was included. The URL was calculated using the non-parametric percentile approach.
Results:
The 97.5th percentile URL of plasma Gal-3 in our study population (90% CI) was 26.1 (23.3-31.5) ng/mL. After stratifying subjects according to age, the URL of Gal-3 was found to be considerably higher in older (> 45 years) than in younger subjects (31.5 (26.2-51.4) vs 21.8 (21-26.1) ng/mL, respectively). No sex-related differences were found in Gal-3 plasma concentration.
Conclusions:
We established the URL of Gal-3 in a highly selected healthy population. Our findings indicate that age is an important determinant of Gal-3 plasma concentration, so that multiple diagnostic cut-offs should be preferably used according to the different age classes.

