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Jan Detmers, Mark Spengler, Michael Adler Chimera Biotec GmbH, Germany |
Abstract
While conventional ligand-binding assay formats like ELISA or ECL provide sufficient sensitivity in biological matrices to support many bio-analytical projects, a number of ligand-binding assay requires ultra-sensitivity. Immuno-PCR (IPCR) combines the high specificity of the antibody-antigen interaction with the exponential signal amplification by PCR as the most sensitive detection method in molecular biology, to an ultra-sensitive ligand-binding assay format. Due to exponential signal generation, assay sensitivity and broad detection range are the main advantages of IPCR over conventional ligand-binding assays. Here, we present a range of case studies, making use of Imperacer®, an IPCR based immunoassay system, in combination with tailored sample dilution procedures to enhance assay robustness and precision by minimizing interfering effects from the sample matrix, endogenous counterparts of the analyte or the biotherapeutic drug candidate in immunogenicity assessment. This approach has successfully been demonstrated in fields like PK/PD, Biomarkers, Replacement Therapy, Monitoring of Mucosal Vaccination, Virus Load Detection and Anti-Drug Antibody Testing.
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