BHF Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, College of Medical Veterinary and Life Sciences, University of Glasgow, UK.
Expert Rev Proteomics. 2011 Oct;8(5):615-29. doi: 10.1586/epr.11.46.
The technology platforms for proteome analysis have advanced considerably over the last few years. Driven by these advancements in technology, the number of studies on the analysis of the proteome/peptidome, with the aim of defining clinically relevant biomarkers, has substantially risen. Urine has become an increasingly relevant target for clinically oriented proteome analysis; the first clinical trials based on urinary proteomics have been initiated, and studies including several hundred patients have been published. In this article, we summarize the relevant technical aspects in biomarkers discovery and the course from biomarker discovery or 'potential' biomarkers to those that have been validated and are clinically important. We discuss experimental design based on the statistics calculated to produce a clinically important end point. We present several examples of proteomic studies that have defined urinary biomarkers for clinical applications, focusing on capillary electrophoresis coupled to mass spectrometry as a technology. Finally, current challenges and considerations for future studies will be discussed.
在过去的几年中，蛋白质组分析的技术平台有了显著的进步。受这些技术进步的推动，以定义临床相关生物标志物为目标的蛋白质组/肽组分析研究数量大幅增加。尿液已成为临床导向蛋白质组分析的一个越来越重要的目标；基于尿液蛋白质组学的首次临床试验已经启动，并且已经发表了包括数百名患者的研究。在本文中，我们总结了生物标志物发现的相关技术方面，以及从生物标志物发现或“潜在”生物标志物到已验证并具有临床重要性的生物标志物的过程。我们根据计算得出的统计学数据来讨论基于实验设计，以产生具有临床重要意义的终点。我们介绍了一些已定义尿液生物标志物用于临床应用的蛋白质组学研究的实例，重点介绍了毛细管电泳与质谱联用作为一种技术。最后，将讨论当前的挑战和对未来研究的考虑。
