Evaluation of a New Antibody-Based NT-proBNP Assay for Acute Dyspnea in the Emergency Department.

Allen, B. R., Guidi, J. L., Headden, G., Winden, N., Alahapperuma, D., Christenson, R. H., Peacock, F., Collins, S., Walters, E. L., & Januzzi, J. L. (2026). Evaluation of a New Antibody-Based NT-proBNP Assay for Acute Dyspnea in the Emergency Department.. Clinical Chemistry, 72(3), 398-407.

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.

Last updated on 04/01/2026
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