Evaluation of Analytical Performances and Comparison of 3 NT-proBNP Assays for Diagnosing Heart Failure.

IF 3.7 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY Archives of pathology & laboratory medicine Pub Date : 2023-08-01 DOI:10.5858/arpa.2021-0587-OA

Jooyoung Cho, Jong-Han Lee, Sang-Guk Lee

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引用次数: 1

Abstract

Context.—: The N-terminal prohormone of the brain natriuretic peptide (NT-proBNP) is a major diagnostic biomarker for heart failure.

Objective.—: To compare the analytical and clinical performance of 3 NT-proBNP immunoassays: the Atellica IM NT-proBNP assay (Siemens Healthcare Diagnostics), the Alere NT-proBNP assay (Abbott Laboratories), and the Elecsys proBNP II assay (Roche Diagnostics).

Design.—: For the Atellica IM NT-proBNP assay, analytical performance, including precision, linearity, and carryover, was fully evaluated. Method comparisons among the 3 assays were performed using the Passing-Bablok regression and the κ agreement test. To evaluate the clinical performance of the assays, 160 patient samples were used from patients with (n = 81) or without (n = 79) heart failure.

Results.—: The analytical performance of the Atellica IM NT-proBNP assay was acceptable according to the manufacturer's claims. The Atellica IM NT-proBNP assay showed a positive bias compared with the Elecsys proBNP II assay. The Cohen κ values among the 3 assays were satisfactory (>0.80) and comparable. There were no significant differences in areas under the curve. However, for the diagnosis of heart failure, the Elecsys proBNP II showed a higher specificity and positive likelihood ratio than the other assays.

Conclusions.—: All 3 NT-proBNP assays showed acceptable concordance, and their clinical performance was comparable. However, the Elecsys proBNP II might be a more discriminating NT-proBNP assay to diagnose heart failure.

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3种NT-proBNP分析方法诊断心力衰竭的分析性能评价及比较。

上下文。脑利钠肽n端原激素(NT-proBNP)是心力衰竭的主要诊断生物标志物。-:比较3种NT-proBNP免疫测定的分析和临床性能:Atellica IM NT-proBNP测定(西门子医疗诊断)、Alere NT-proBNP测定(雅培实验室)和Elecsys proBNP II测定(罗氏诊断)。-:对于Atellica IM NT-proBNP分析，分析性能，包括精度，线性和结转，得到了充分的评估。方法比较采用passingbablok回归和κ一致性检验。为了评估试验的临床表现，160例患者的样本来自(n = 81)或(n = 79)心力衰竭患者。-:根据制造商的声明，Atellica IM NT-proBNP检测的分析性能是可接受的。与Elecsys proBNP II相比，Atellica IM NT-proBNP检测显示出正偏倚。3个试验的Cohen κ值均令人满意(>0.80)且具有可比性。曲线下面积无显著差异。然而，对于心力衰竭的诊断，Elecsys proBNP II比其他检测方法具有更高的特异性和阳性似然比。-:所有3种NT-proBNP检测均显示可接受的一致性，其临床表现具有可比性。然而，Elecsys proBNP II可能是一种更具鉴别性的NT-proBNP检测来诊断心力衰竭。

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来源期刊

Archives of pathology & laboratory medicine 医学-病理学

CiteScore

9.20

自引率

2.20%

发文量

369

审稿时长

3-8 weeks

期刊介绍： Welcome to the website of the Archives of Pathology & Laboratory Medicine (APLM). This monthly, peer-reviewed journal of the College of American Pathologists offers global reach and highest measured readership among pathology journals. Published since 1926, ARCHIVES was voted in 2009 the only pathology journal among the top 100 most influential journals of the past 100 years by the BioMedical and Life Sciences Division of the Special Libraries Association. Online access to the full-text and PDF files of APLM articles is free.