{"title":"3种NT-proBNP分析方法诊断心力衰竭的分析性能评价及比较。","authors":"Jooyoung Cho, Jong-Han Lee, Sang-Guk Lee","doi":"10.5858/arpa.2021-0587-OA","DOIUrl":null,"url":null,"abstract":"<p><strong>Context.—: </strong>The N-terminal prohormone of the brain natriuretic peptide (NT-proBNP) is a major diagnostic biomarker for heart failure.</p><p><strong>Objective.—: </strong>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).</p><p><strong>Design.—: </strong>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. 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引用次数: 1
摘要
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。
Evaluation of Analytical Performances and Comparison of 3 NT-proBNP Assays for Diagnosing Heart Failure.
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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