HyTest Ltd., Turku, Finland.
School of Biology, Moscow State University, Moscow, Russia.
Adv Clin Chem. 2018;85:1-30. doi: 10.1016/bs.acc.2018.02.001. Epub 2018 Mar 3.
Brain natriuretic peptide (BNP) and the N-terminal fragment of the BNP precursor (NT-proBNP) are widely used as heart failure (HF) biomarkers. Since the discovery of BNP in 1988, much effort has been allocated to the precise detection of BNP and NT-proBNP levels for reliable HF diagnostics. As a result, measurements of these biomarkers are globally accepted and used in clinical practice for the diagnosis of acute and chronic HF, risk stratification, and monitoring response to therapy. Several immunoassays specific for BNP and NT-proBNP are currently commercially available. Recent comparative studies show that there are marked differences between different BNP and NT-proBNP assays and platforms, and the results of measurements are not comparable enough. The lack of equivalence between the assays complicates the interpretation of the results and renders the cut-off points for diagnostic decisions to be method dependent. Presently, there is no agreement on what kind of BNP or NT-proBNP standard should be used for calibration, and a certified reference material as well as reference measurement procedures are lacking. The aim of this chapter is to summarize the available data on the complex nature of BNP-related peptides, specificity for existing BNP and NT-proBNP immunoassays, and to discuss potential approaches for standardization of BNP and NT-proBNP measurements.
脑钠肽（BNP）和 BNP 前体的 N 端片段（NT-proBNP）被广泛用作心力衰竭（HF）的生物标志物。自 1988 年 BNP 被发现以来，人们投入了大量精力来精确检测 BNP 和 NT-proBNP 水平，以实现可靠的 HF 诊断。因此，这些生物标志物的测量在全球范围内得到认可，并在临床实践中用于急性和慢性 HF 的诊断、风险分层和治疗反应监测。目前有几种针对 BNP 和 NT-proBNP 的免疫测定法可用于商业用途。最近的比较研究表明，不同的 BNP 和 NT-proBNP 测定法和平台之间存在明显差异，测量结果的可比性不足。测定法之间缺乏等效性使得结果的解释变得复杂，并使得诊断决策的截止值取决于方法。目前，对于应该使用哪种 BNP 或 NT-proBNP 标准进行校准还没有达成共识，也缺乏经过认证的参考物质和参考测量程序。本章旨在总结有关 BNP 相关肽的复杂性质、现有 BNP 和 NT-proBNP 免疫测定法的特异性的现有数据，并讨论 BNP 和 NT-proBNP 测量标准化的潜在方法。
