Clin Chem. 2026 Jan 28:hvaf168. doi: 10.1093/clinchem/hvaf168. Online ahead of print.

ABSTRACT

BACKGROUND: Diagnosis and risk stratification of acute heart failure (HF) in the emergency department (ED) remains challenging. N-terminal pro-B type natriuretic peptide (NT-proBNP) measurement is useful in evaluating acute dyspnea. The objective of this study was to evaluate the diagnostic performance of a new Access NT-proBNP assay in a large cohort of ED patients presenting with suspected acute HF.

METHODS: This prospective study enrolled 2701 ED patients across 17 US sites (Nov 2019 to May 2022). Diagnoses were adjudicated by a blinded Clinical Events Committee. The diagnostic performance of the new NT-proBNP assay was evaluated by sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). Secondary analyses included association of NT-proBNP levels with HF severity and 90-day major adverse cardiovascular events (MACE).

RESULTS: Among 2384 patients, 45.5% had acute HF. The Access NT-proBNP assay demonstrated an area under the receiver operating characteristic curve (AUC) of 0.87 (P < 0.001). Sensitivity across age-based cutoffs was high: 96% (<300 ng/L), 90% (<450 ng/L under age 50), 85% (<900 ng/L ages 50 to 75), and 79% (<1800 ng/L over age 75). At a 300 ng/L threshold, NPV was 95% and PPV was 73%. Higher NT-proBNP levels correlated with greater HF severity and predicted shorter MACE-free survival. The Access assay showed similar performance (AUC 0.8536 vs 0.8562) as the Elecsys proBNP II assay.

CONCLUSIONS: The new Access NT-proBNP assay provides strong diagnostic and prognostic performance in ED patients with suspected acute HF, with results comparable to a reference NT-proBNP assay.

PMID:41603598 | DOI:10.1093/clinchem/hvaf168