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一种用于心力衰竭诊断的新型NT-前脑钠肽检测方法:一项前瞻性多中心临床试验。

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

作者信息

Guidi Jessica L, Allen Brandon R, Headden Gary, Winden Nicole, Alahapperuma Dileepa, Christenson Robert H, Peacock W Franklin, Januzzi James L

机构信息

Cardiology Division, Warren Alpert Medical School of Brown University, Providence, RI, United States.

Department of Emergency Medicine, College of Medicine, University of Florida, Gainesville, FL, United States.

出版信息

Clin Chim Acta. 2025 May 15;572:120249. doi: 10.1016/j.cca.2025.120249. Epub 2025 Mar 17.

DOI:10.1016/j.cca.2025.120249
PMID:40107595
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.

摘要

目的

N末端B型利钠肽原(NT-proBNP)被广泛用于急性心力衰竭(HF)的诊断。本研究评估了一种新型N末端B型利钠肽原(NT-proBNP)检测方法在评估急诊环境中呼吸困难患者时的诊断性能。

方法

这是一项针对因急性HF可能出现临床症状而就诊于急诊科的个体的多中心研究。使用贝克曼库尔特Access NT-proBNP检测方法采集血液进行NT-proBNP评估,并将结果与经判定的诊断结果进行比较。终点包括年龄独立切点<300 ng/L排除急性HF的阴性预测值和敏感性,以及年龄相关切点>450 ng/L、>900 ng/L和>1800 ng/L分别用于<50岁、50 - 75岁和>75岁人群诊断急性HF的阳性预测值。

结果

纳入490名研究参与者,其中41%经判定患有急性心力衰竭。该检测方法诊断急性HF的受试者工作特征曲线下面积(AUC)为0.87(P<0.001),与其他市售NT-proBNP检测方法的AUC相当。<300 ng/L的排除切点敏感性为96%,阴性预测值为95%。年龄相关切点的敏感性分别为84%、90%和87%,特异性分别为81%、70%和61%,阳性预测值分别为72%、62%和74%。

结论

这种新型NT-proBNP检测方法在诊断和排除未分化呼吸困难患者的急性HF方面表现出较高的临床性能,与临床实践中使用的经过验证的检测方法表现相似。

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