A novel NT-proBNP assay for heart failure diagnosis: A prospective, multicenter clinical trial.

Abstract

Objectives: NT-proBNP is widely measured for the diagnosis of acute heart failure (HF). This study assessed the diagnostic performance of a novel N-terminal pro-B type natriuretic peptide (NT-proBNP) assay in evaluating the dyspneic patient in the acute care setting.

Methods: This was a multicenter study of individuals presenting to the emergency department exhibiting clinical symptoms potentially due to acute HF. Blood was drawn for NT-proBNP assessment using the Beckman Coulter Access NT-proBNP assay with results compared to adjudicated diagnoses. Endpoints included negative predictive value and sensitivity of an age-independent cut point of < 300 ng/L to exclude acute HF, and the positive predictive value of the age-dependent cut points of >450, >900, and >1800 ng/L for ages < 50 years, 50-75 years, and >75 years, respectively, for the diagnosis of acute HF.

Results: 490 study participants were included, of which 41 % were adjudicated as having acute heart failure. The assay had an area under the receiver-operator characteristic curve (AUC) for the diagnosis of acute HF of 0.87 (P < 0.001), comparable AUC to other commercially available NT-proBNP assays. A rule-out cut point of <300 ng/L had 96 % sensitivity and negative predictive value of 95 %. Age-dependent cut points had sensitivity of 84 %, 90 %, and 87 %, specificity of 81 %, 70 % and 61 %, and positive predictive value of 72 %, 62 %, and 74 %, respectively.

Conclusions: This novel NT-proBNP assay demonstrated high clinical performance in the diagnosis and exclusion of acute HF in the undifferentiated dyspneic patient and performed similarly well to validated assays used in clinical practice.