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A Novel N-Terminal Pro-B-Type Natriuretic Peptide Assay in the Early Diagnosis of Acute Heart Failure.

Year: 2025
Type: article
Abstract: Background The performance of the novel NT-pro-B-type natriuretic peptide (NT-proBNP)-Access assay in the early diagnosis of acute heart failure (AHF) is unknown.Objectives The objective of the study was to assess the diagnostic accuracy of NT-proBNP-Access in patients presenting with acute dyspnea and compare it to the established NT-proBNP-Elecsys assay.Methods In a prospective multicenter diagnostic study enrolling patients presenting with acute dyspnea to the emergency department, NT-proBNP-Access was measured in a blinded fashion and compared to NT-proBNP-Elecsys concentrations. The primary endpoint was diagnostic accuracy quantified by area under the receiver operating characteristics curve (AUC). Secondary endpoints were the performance of the guideline-recommended clinical decision values (rule-out: <300 pg/mL, rule-in: age-adjusted >450/900/1,800 pg/mL) for AHF.Results Among 1,400 patients (53% AHF), the NT-proBNP-Access assay yielded significantly higher NT-proBNP concentrations vs the NT-proBNP-Elecsys assay (median 2,087 pg/mL vs 1,568 pg/mL [P < 0.001]). The NT-proBNP-Access assay had very high diagnostic accuracy (AUC: 0.914; 95% CI: 0.898-0.93), which was slightly lower than the NT-proBNP-Elecsys assay (AUC: 0.922; 95% CI: 0.908-0.937; P = 0.006). Using guideline-recommended clinical decision values, the NT-proBNP-Access assay ruled out fewer patients compared to NT-proBNP-Elecsys (18.7% vs 26.3%) with similar sensitivity (98.9% vs 98.5%). Conversely, more patients were ruled in (58.1% vs 52.1%), with lower specificity (77.6% vs 84.8%; P < 0.001). Diagnostic concordance was high (85.3%), with major mismatch (no AHF vs AHF) uncommon (0.6%), but minor mismatch (gray zone vs rule in/rule out and vice versa) common (14.1%).Conclusions The NT-proBNP-Access assay had a very high diagnostic accuracy for AHF. Levels were approximately 25% higher with NT-proBNP-Access vs NT-proBNP-Elecsys, resulting in minor diagnostic discordance in 1 of 7 patients using guideline-recommended decision values.
DOI: 10.48620/91619
Authors: Belkin, Maria, Wussler, Desiree, Lopez-Ayala, Pedro, Nowak, Albina, Gualandro, Danielle M, Sailova, Dilbar, Popescu, Codruta, Strebel, Ivo, Niggemann, Marie, Reinhardt, Julia, Huré, Gabrielle, Kozhuharov, Nikola, Jenkins, Freya, Kaplan, Emel, Sgueglia, Fabiana, Sabti, Zaid, Chollet, Laureve, Rentsch, Katharina, Gawinecka, Joanna, Mahfoud, Felix, Christ, Michael, Hammerer-Lercher, Angelika, Breidthardt, Tobias, Mueller, Christian
Language: English
Field: Medicine
Open Access status: green
OpenAlex ID: W7084602134
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