Santockyte Rasa, Zeng Jianing, Zheng Naiyu
Bioanalytical Sciences, Bristol-Myers Squibb Company, Princeton, NJ 08543, USA.
Bioanalysis. 2019 Apr;11(8):785-795. doi: 10.4155/bio-2018-0277. Epub 2019 Apr 17.
In recent years, hybrid ligand-binding assays (LBAs)/LC-MS assays have been increasingly used for quantitation of protein biomarkers in biological matrices. However, unlike in LBAs where the importance of critical reagent screening and characterization is well understood and widely reported, benefits of well-characterized hybrid LC-MS assay reagents are frequently underestimated. Two groups of analyte-specific reagents, binding reagents and assay calibrators, are considered the critical reagents for biomarker assays. In this article, we summarize the similarities and differences of critical reagents used in LBAs and hybrid LC-MS assays, overview the benefits and approaches of critical reagent screening, characterization, antibody conjugation and discuss bioanalytical considerations in hybrid LC-MS assay development for robust measurements of protein biomarkers in biological matrices.
近年来，混合配体结合分析（LBA）/液相色谱-质谱联用（LC-MS）分析越来越多地用于生物基质中蛋白质生物标志物的定量分析。然而，与LBA不同，在LBA中关键试剂筛选和表征的重要性已得到充分理解并广泛报道，而性能良好的混合LC-MS分析试剂的优势却常常被低估。两组分析物特异性试剂，即结合试剂和分析校准物，被认为是生物标志物分析的关键试剂。在本文中，我们总结了LBA和混合LC-MS分析中使用的关键试剂的异同，概述了关键试剂筛选、表征、抗体偶联的优势和方法，并讨论了在混合LC-MS分析开发中进行生物分析考量以实现生物基质中蛋白质生物标志物的可靠测量。
