Rai Alex J
Memorial Sloan Kettering Cancer Center, Department of Clinical Laboratories, 1275 York Avenue, Box 88, New York, NY 10021, USA.
Expert Rev Mol Diagn. 2007 Sep;7(5):545-53. doi: 10.1586/14737159.7.5.545.
The field of biomarker discovery has exhibited a great surge of interest in recent years. Biomarkers can be used for many purposes including diagnosis, prognosis and selecting appropriate patient therapy, and can provide information on disease mechanism or progression. Translation of such markers to clinical testing encompasses phases for their discovery and characterization, assay development, and finally, implementation using automated platforms employed in clinical laboratories. With a focus on protein-based biomarkers and clinical immunoassays, the three phases are discussed in greater detail. The currently used technologies in the clinical laboratory are described, including attributes of existing immunoassay types, and some recent advances in methods development for multiplexed immunoassays. Finally, regulatory considerations that need to be addressed before a biomarker assay is commercialized are discussed briefly.
近年来，生物标志物发现领域展现出了极大的研究热潮。生物标志物可用于多种目的，包括诊断、预后评估以及选择合适的患者治疗方案，还能提供有关疾病机制或进展的信息。将此类标志物转化为临床检测包括发现和表征阶段、检测方法开发阶段，以及最终使用临床实验室的自动化平台进行实施阶段。本文聚焦于基于蛋白质的生物标志物和临床免疫测定，对这三个阶段进行了更详细的讨论。文中描述了临床实验室目前使用的技术，包括现有免疫测定类型的特点，以及多重免疫测定方法开发的一些最新进展。最后，简要讨论了生物标志物检测商业化之前需要考虑的监管问题。
