Ahene Ago B
XOMA (US) LLC, 2910 Seventh Street, Berkeley, CA 94710, USA.
Bioanalysis. 2011 Jun;3(11):1287-95. doi: 10.4155/bio.11.104.
Ligand-binding assays are used to determine concentration levels of biopharmaceuticals in biological matrices. The whole molecule does not serve as a basis for quantification, but subregions are captured and detected by specific binding critical reagents that have been produced for the sole purpose of bioanalysis. An assay can be designed to measure the free or the total analyte. Depending on the format of the assay, different observations and interpretations could be deemed. In the case studies presented in this article, the same serum samples were subjected to analysis in parallel by two different assay formats. In three out of the four cases presented, the results and the data interpretation were remarkably different. Therefore, it is essential for the bioanalyst to communicate to other stake-holders, such as toxicologists and pharmacokineticists, what the assay detects and measures for plausible data interpretation and implication.
配体结合分析用于测定生物基质中生物药物的浓度水平。整个分子不作为定量的基础，而是由专门为生物分析目的生产的特定结合关键试剂捕获和检测亚区域。一种分析方法可以设计用于测量游离或总分析物。根据分析方法的形式，可以有不同的观察结果和解释。在本文介绍的案例研究中，相同的血清样本通过两种不同的分析方法进行平行分析。在所呈现的四个案例中的三个案例中，结果和数据解释明显不同。因此，生物分析人员向其他利益相关者（如毒理学家和药代动力学家）传达该分析方法检测和测量的内容，以进行合理的数据解释和推断是至关重要的。
