Galectin-3 as a cardiac biomarker

Galactoside-derived lectin galectin-3 (Gal-3) is an effective and promising cardiac fibrosis marker that can be used in heart failure management. Nevertheless, its clinical use demands strict standardization of preanalytical, analytical, and reporting methods. This systematic review addresses the key elements of implementation of Gal-3 testing in laboratory medicine. The preanalytical considerations will be specimen collection protocols (serum or plasma), handling procedures, storage stability, and freeze-thaw effects, which are critical in ensuring that the results are reliable. Analytical performance is the overall assessment of traditional immunoassays [enzyme-linked immunosorbent assay (ELISA), chemiluminescent magnetic microparticle immunoassay (CMIA), electrochemiluminescence (ECL)], and newer biosensors (electrochemical, plasmonic), including performance parameters such as limit of detection, linearity, precision, and cross-reactivity. The problems of standardization revolve around calibrator traceability, interchangeability of reference materials, lot-to-lot variance, involvement in external quality assessment, and establishment of decision limits based on evidence. The incorporation of Gal-3 into the clinical workflow must consider biological confounders such as renal and systemic inflammation and age, which have no effect on circulating levels based on cardiac fibrosis. Gal-3 plays a role in heart failure phenotyping [heart failure with preserved ejection fraction (HFpEF) vs. heart failure with reduced ejection fraction (HFrEF)], risk stratification, natriuretic peptides, high-sensitivity troponin, and monitoring of antifibrotic therapies. The inter-institutional comparability of results is improved by standardized reporting algorithms compatible with laboratory information systems. This comprehensive framework establishes a foundation for standardized and clinically pertinent Gal-3 testing by integrating assay engineering, quality systems, and evidence-based interpretation within diagnostic laboratory practice.