title: Emerging technologies to increase ligand binding assay sensitivity.
abstract: 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.
authors.affiliation: Department of BioAnalytical Sciences, Genentech, 1 DNA Way, South San Francisco, California, 94080-4990, USA, fischer.sally@gene.com.
authors.forename: Saloumeh K
authors.initials: SK
authors.lastname: Fischer
authors.forename: Alison
authors.initials: A
authors.lastname: Joyce
authors.forename: Mark
authors.initials: M
authors.lastname: Spengler
authors.forename: Tong-Yuan
authors.initials: TY
authors.lastname: Yang
authors.forename: Yao
authors.initials: Y
authors.lastname: Zhuang
authors.forename: Marianne Scheel
authors.initials: MS
authors.lastname: Fjording
authors.forename: Alvydas
authors.initials: A
authors.lastname: Mikulskis
mesh_terms: D015195:Drug Design; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D008024:Ligands; D011506:Proteins / Q000032:analysis*; D012680:Sensitivity and Specificity
chemical_list: D008024:Ligands; D011506:Proteins