Gruson D, Mancini M, Ahn S A, Rousseau M F
Pôle 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.
Department of Laboratory Medicine, Cliniques Universitaires St-Luc and Université Catholique de Louvain, Brussels, Belgium.
Clin Biochem. 2014 Aug;47(12):1006-9. doi: 10.1016/j.clinbiochem.2014.06.001. Epub 2014 Jun 10.
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 (p<0.001) and were also significantly and positively correlated to BNP concentrations (r=0.35, p<0.001). 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.
半乳糖凝集素-3(Gal-3)检测正成为心力衰竭(HF)预后评估的一项重要工具。我们的目的是确定最新研发的ARCHITECT Gal-3自动化免疫测定法的临床有效性和成本效益。
采用ARCHITECT i2000SR Gal-3测定法以及参考Gal-3 ELISA测定法,对左心室射血分数降低的HF患者进行Gal-3水平检测。评估通过自动化测定法测得的Gal-3水平与HF严重程度之间的关系及其对长期心血管死亡的预测价值。还估算了Gal-3检测对基于诊断相关分组(DRG)的报销的影响。
通过ARCHITECT测定法测得的Gal-3水平与基于纽约心脏协会心功能分级的HF严重程度相关(p<0.001),并且与BNP浓度也呈显著正相关(r=0.35,p<0.001)。Gal-3值高于19.2 ng/mL可预测收缩性HF患者的长期心血管死亡,并且能为BNP检测提供额外的预后信息。此外,与标准治疗相比,Gal-3检测估计可节省DRG费用。
我们的结果证明了ARCHITECT Gal-3自动化免疫测定法在HF患者风险分层中的临床有效性。Gal-3检测的自动化还具有成本效益,可能有助于节省医院预算。