Measurement of Galectin-3 with the ARCHITECT assay: Clinical validity and cost-effectiveness in patients with heart failure

Galectin-3 (Gal-3) testing is emerging as a valuable tool for the prognosis of heart failure (HF). Our objectives were to determine the clinical validity and cost-effectiveness of the recently developed ARCHITECT Gal-3 automated immunoassay.Gal-3 levels were measured in HF patients with reduced left ventricular ejection fraction with the ARCHITECT i2000SR Gal-3 assay as well as with the reference Gal-3 ELISA assay. The relationship between Gal-3 levels determined with the automated assay and HF severity as well as its predictive value for long-term cardiovascular death were evaluated. The impact of Gal-3 testing on the diagnostic related group (DRG) based reimbursement was also estimated.Gal-3 levels measured with the ARCHITECT assay were related to the severity of HF based on New York Heart Association functional classes (p0.001) and were also significantly and positively correlated to BNP concentrations (r=0.35, p0.001). Gal-3 values higher than 19.2 ng/mL were predictive of long-term cardiovascular death in patients with systolic HF and also provided incremental prognostic information to BNP testing. In addition, Gal-3 testing was estimated to save DRG in comparison to standard of care.Our results demonstrated the clinical validity of the ARCHITECT Gal-3 automated immunoassay for the risk stratification of HF patients. The automation of Gal-3 testing was also cost-effective and might help to preserve hospital budget.