Dade Behring Marburg GmbH, Technology Assessment & External Cooperations, Marburg, Germany.
Proteomics Clin Appl. 2007 Sep;1(9):1016-35. doi: 10.1002/prca.200700223. Epub 2007 Aug 10.
Reliable study results are necessary for the assessment of discoveries, including those from proteomics. Reliable study results are also crucial to increase the likelihood of making a successful choice of biomarker candidates for verification and subsequent validation studies, a current bottleneck for the transition to in vitro diagnostic (IVD). In this respect, a major need for improvement in proteomics appears to be accuracy of measurements, including both trueness and precision of measurement. Standardization and total quality management systems (TQMS) help to provide accurate measurements and reliable results. Reference materials are an essential part of standardization and TQMS in IVD and are crucial to provide metrological correct measurements and for the overall quality assurance process. In this article we give an overview on how reference materials are defined, prepared and what role they play in standardization and TQMS to support the generation of reliable results. We discuss how proteomics can support the establishment of reference materials and biomarker tests for IVD applications, how current reference materials used in IVD may be beneficially applied in proteomics, and we provide considerations on the establishment of reference materials specific for proteomics. For clarity, we solely focus on reference materials related to serum and plasma.
可靠的研究结果对于评估发现是必要的，包括蛋白质组学的发现。可靠的研究结果对于增加成功选择生物标志物候选物进行验证和随后的验证研究的可能性也至关重要，这是向体外诊断（IVD）过渡的当前瓶颈。在这方面，蛋白质组学似乎需要改进的一个主要方面是测量的准确性，包括测量的准确性和精密度。标准化和全面质量管理体系（TQMS）有助于提供准确的测量和可靠的结果。参考物质是体外诊断中标准化和 TQMS 的重要组成部分，对于提供计量正确的测量以及整个质量保证过程至关重要。在本文中，我们概述了参考物质的定义、制备方式，以及它们在标准化和 TQMS 中如何发挥作用，以支持可靠结果的产生。我们讨论了蛋白质组学如何支持为 IVD 应用建立参考物质和生物标志物检测，当前用于 IVD 的参考物质如何有益于蛋白质组学的应用，以及我们对建立特定于蛋白质组学的参考物质的考虑。为了清晰起见，我们仅专注于与血清和血浆相关的参考物质。
