English
Summary of key study findings: A novel NT-proBNP assay for heart failure diagnosis: A prospective, multicenter clinical trial1
The Beckman Coulter Access NT-proBNP assay is an industry-leading heart failure diagnostic that delivers proven analytical excellence through rigorous, independent validation. A recent prospective multicenter feasibility trial evaluated the diagnostic performance of our novel NT-proBNP assay in emergency department settings, demonstrating strong accuracy in identifying and excluding acute heart failure among dyspneic patients. The study employed established ICON-validated cut points across three age groups (<50, 50-75,="" and="">75 years) and validated an age-independent rule-out threshold, providing clinicians with reliable diagnostic confidence across diverse patient populations.Key Study Findings:
- Strong diagnostic accuracy with an area under ROC curve (AUROC) of 0.87 (95% CI: 0.85-0.91, P<0.001) for="" acute="" heart="" failure="">
- Comparable performance to established assays with no significant differences in diagnostic accuracy versus commercially validated NT-proBNP methods
- Outstanding rule-out performance using <300 ng/l="" cut="" point="" achieved="" 96%="" (95%="" ci:="" 92-98%)="" sensitivity="" and="" 95%="" (95%="" ci:="" 91-98%)="" negative="" predictive="">
- Robust performance across age groups and demographics with age-stratified cut points (>450, >900, >1800 ng/L), with 84-90% sensitivity for all patients and particularly strong performance in African American participants (85-100% sensitivity across age cohorts)
