Fischer Saloumeh K, Joyce Alison, Spengler Mark, Yang Tong-Yuan, Zhuang Yao, Fjording Marianne Scheel, Mikulskis Alvydas
Department of BioAnalytical Sciences, Genentech, 1 DNA Way, South San Francisco, California, 94080-4990, USA,
AAPS J. 2015 Jan;17(1):93-101. doi: 10.1208/s12248-014-9682-8. Epub 2014 Oct 18.
Ligand binding assays (LBAs) have been the method of choice for protein analyte measurements for more than four decades. Over the years, LBA methods have improved in sensitivity and achieved larger dynamic ranges by using alternative detection systems and new technologies. As a consequence, the landscape and application of immunoassay platforms has changed dramatically. The introduction of bead-based methods, coupled with single molecule detection standardization and the ability to amplify assay signals, has improved the sensitivity of many immunoassays, in some cases by several logs of magnitude. Three promising immunoassay platforms are described in this article: Single Molecule Counting (SMC™) from Singulex Inc, Single Molecule Arrays (Simoa™) from Quanterix Corporation, and Immuno-PCR (Imperacer®) from Chimera Biotec GmbH. These platforms have the potential to significantly improve immunoassay sensitivity and thereby address the bioanalytical needs and challenges faced during biopharmaceutical drug development.
四十多年来，配体结合分析（LBA）一直是蛋白质分析物测量的首选方法。多年来，LBA方法在灵敏度方面有所改进，并通过使用替代检测系统和新技术实现了更大的动态范围。因此，免疫分析平台的格局和应用发生了巨大变化。基于微珠方法的引入，再加上单分子检测标准化以及放大检测信号的能力，提高了许多免疫分析的灵敏度，在某些情况下提高了几个数量级。本文介绍了三种有前景的免疫分析平台：Singulex公司的单分子计数（SMC™）、Quanterix公司的单分子阵列（Simoa™）以及Chimera Biotec GmbH公司的免疫PCR（Imperacer®）。这些平台有潜力显著提高免疫分析的灵敏度，从而满足生物制药药物开发过程中面临的生物分析需求和挑战。
