Apple Fred S, Panteghini Mauro, Ravkilde Jan, Mair Johannes, Wu Alan H B, Tate Jillian, Pagani Franca, Christenson Robert H, Jaffe Allan S
Department of Laboratory Medicine and Pathology, Hennepin County Medical Center, Minneapolis, MN 55415, USA.
Clin Chem. 2005 Mar;51(3):486-93. doi: 10.1373/clinchem.2004.044594.
The objective of this report is to improve the quality of immunochemical measurements of B-type natriuretic peptide (BNP) and its N-terminal propeptide (NT-proBNP). The recommendations proposed are intended for use by manufacturers of commercial assays, by clinical laboratories using those assays, by clinical trial groups and research investigators, and by regulatory agencies, such as the United States Food and Drug Administration.
A group of cardiac biomarker experts reviewed and abstracted the scientific literature to provide recommendations pertaining to the quality specifications for BNP/NT-proBNP assays.
The evidence-based recommendations encourage manufacturers to endorse and consistently follow the proposed recommendations; encourage that all package inserts for BNP/NT-proBNP immunoassays include uniform information on assay design, preanalytical performance characteristics, analytical performance characteristics, and clinical performance; and encourage regulatory agencies to adopt a minimal and uniform set of criteria for manufacturers to provide when seeking clearance for new and/or improved assays.
These recommendations address the use of BNP and NT-proBNP as cardiac biomarkers and not their physiologic and/or pathophysiologic relevance.
本报告的目的是提高B型利钠肽（BNP）及其N末端前体肽（NT-proBNP）免疫化学检测的质量。所提出的建议供商业检测试剂盒制造商、使用这些检测方法的临床实验室、临床试验组和研究人员以及监管机构（如美国食品药品监督管理局）使用。
一组心脏生物标志物专家对科学文献进行了审查和摘要，以提供有关BNP/NT-proBNP检测质量规范的建议。
基于证据的建议鼓励制造商认可并始终遵循所提出的建议；鼓励所有BNP/NT-proBNP免疫检测试剂盒的包装说明书包含有关检测设计、分析前性能特征、分析性能特征和临床性能的统一信息；并鼓励监管机构采用一套最低限度的统一标准，供制造商在寻求新的和/或改进的检测方法批准时提供。
这些建议涉及BNP和NT-proBNP作为心脏生物标志物的使用，而非它们的生理和/或病理生理相关性。
