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

JACC advances Pub Date : 2025-09-29 DOI:10.1016/j.jacadv.2025.102206

Maria Belkin MD , Desiree Wussler MD , Pedro Lopez-Ayala MD , Albina Nowak MD , Danielle M. Gualandro MD , Dilbar Sailova MD , Codruta Popescu MD , Ivo Strebel PhD , Marie Niggemann Ms , Julia Reinhardt PhD , Gabrielle Huré MS , Nikola Kozhuharov MD , Freya Jenkins MD , Emel Kaplan PhD , Fabiana Sgueglia Ms , Zaid Sabti MD , Laureve Chollet MD , Katharina Rentsch PhD , Joanna Gawinecka MD , Felix Mahfoud MD , Christian Mueller MD

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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.

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一种新型n端前b型利钠肽检测在急性心力衰竭早期诊断中的应用。

背景：新型nt -pro- b型利钠肽(NT-proBNP)-Access测定在急性心力衰竭（AHF）早期诊断中的作用尚不清楚。目的：本研究的目的是评估NT-proBNP-Access对急性呼吸困难患者的诊断准确性，并将其与已建立的NT-proBNP-Elecsys测定法进行比较。方法：在一项前瞻性多中心诊断研究中，纳入急诊科出现急性呼吸困难的患者，采用盲法测量NT-proBNP-Access，并与NT-proBNP-Elecsys浓度进行比较。主要终点是通过受试者工作特征曲线下面积（AUC）量化诊断准确性。次要终点是指南推荐的AHF临床决策值（排除：450/900/ 1800 pg/mL）的执行情况。结果：在1400例患者（53% AHF）中，NT-proBNP- access检测的NT-proBNP浓度明显高于NT-proBNP- elecsys检测（中位数为2087 pg/mL vs 1568 pg/mL [P < 0.001]）。NT-proBNP-Access法具有非常高的诊断准确率（AUC: 0.914; 95% CI: 0.898-0.93），略低于NT-proBNP-Elecsys法（AUC: 0.922; 95% CI: 0.908-0.937; P = 0.006）。使用指南推荐的临床决策值，NT-proBNP-Access检测比NT-proBNP-Elecsys （18.7% vs 26.3%）排除的患者更少，灵敏度相似（98.9% vs 98.5%）。相反，更多的患者被确诊（58.1% vs 52.1%），特异性较低（77.6% vs 84.8%; P < 0.001）。诊断一致性高（85.3%），严重不匹配（无AHF vs AHF）不常见（0.6%），但轻微不匹配（灰色地带vs排除规则，反之亦然）常见（14.1%）。结论：NT-proBNP-Access法对AHF具有很高的诊断准确性。NT-proBNP-Access与NT-proBNP-Elecsys的水平大约高出25%，导致7例患者中有1例使用指南推荐的诊断值存在轻微的诊断不一致。

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来源期刊

JACC advances Cardiology and Cardiovascular Medicine

CiteScore

1.90

自引率

0.00%

发文量