BHF Glasgow Cardiovascular Research Centre, University of Glasgow, G12 8TA Glasgow, United Kingdom.
Clin Biochem. 2013 Apr;46(6):432-43. doi: 10.1016/j.clinbiochem.2012.09.025. Epub 2012 Oct 4.
Mass spectrometry platforms have attracted a lot of interest in the last 2 decades as profiling tools for native peptides and proteins with clinical potential. However, limitations associated with reproducibility and analytical robustness, especially pronounced with the initial SELDI systems, hindered the application of such platforms in biomarker qualification and clinical implementation. The scope of this article is to give a short overview on data available on performance and on analytical robustness of the different platforms for peptide profiling. Using the CE-MS platform as a paradigm, data on analytical performance are described including reproducibility (short-term and intermediate repeatability), stability, interference, quantification capabilities (limits of detection), and inter-laboratory variability. We discuss these issues by using as an example our experience with the development of a 273-peptide marker for chronic kidney disease. Finally, we discuss pros and cons and means for improvement and emphasize the need to test in terms of comparative clinical performance and impact, different platforms that pass reasonably well analytical validation tests.
在过去的 20 年中，质谱平台作为具有临床潜力的天然肽和蛋白质的分析工具引起了广泛关注。然而，与重现性和分析稳健性相关的限制，尤其是最初的 SELDI 系统，阻碍了此类平台在生物标志物鉴定和临床应用中的应用。本文的目的是简要概述不同肽谱分析平台的性能和分析稳健性方面的现有数据。本文以 CE-MS 平台为例，介绍了分析性能的数据，包括重现性（短期和中期重复性）、稳定性、干扰、定量能力（检测限）和实验室间变异性。我们将使用我们在开发用于慢性肾病的 273 肽标志物方面的经验来讨论这些问题。最后，我们讨论了优缺点以及改进的方法，并强调需要根据比较临床性能和影响来测试不同的平台，这些平台需要通过合理的分析验证测试。
