IVDT_In Vitro Diagnostics Technology

IVD Technology, Spring 2013

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ASSAY DEVELOPMENT Rabbit Monoclonal Antibody: a New Diagnostics Technology Compared with mouse and other rodent antibodies, RabMAbs achieve improved sensitivity and specifcity and enhanced epitope recognition. BY WEIMIN ZHU T he mouse monoclonal antibody has been a dominant tool in research and diagnostic and therapeutic areas. However, a new technology for generating rabbit monoclonal antibodies ofers an improved alternative for the scientifc community and novel opportunities for diagnostics and therapeutics. Te advantages of this new technology are manifold: higher afnity, improved specifcity, and recognition of antigens and epitopes that are nonimmunogenic to rodents. While the immunoassay is the most popular analytical technique applied in clinical and nonclinical diagnoses, there is still a gap between the antibody developer and IVD manufacturer. Tis is caused, to a certain extent, by a lack of high-quality antibodies in immunoassays and by increased demand for better or novel antibodies along with the emergence of genomics, proteomics, and epitomics. Antibody performance related to sensitivity, specifcity, linear dynamic range, matrix efect, and immunoassay standardization sets the primary determinant for the quality of IVD medical devices. Tis article discusses some characteristics of the rabbit immune system that result in better antibody generation, reviews rabbit monoclonal antibody technology, and considers its applications and potential in diagnostic areas. 22 IVD TEC HNOL O G Y | SP RIN G 2013 magenta cyan yellow black Figure 1. Structure of Rabbit IgG. A Better Immune System Although rabbits are well-known for mounting a strong immune response against foreign antigens and rabbit polyclonal antibodies are the oldest and most widely used research tools in immunology, why rabbits generally produce better antibodies to many antigens than rodents is still not fully understood. Recent research advancements in rabbit immunology have shed some light on this question: after primary and subsequent immunizations, naïve B cells are stimulated to diferentiate into antibody-secreting plasma or memory cells. T-cell epitopes presented by MHC class I and class II molecules are typically peptides, whereas nonclasi v d t e c hnol ogy. com ES236581_IV1305_022.pgs 04.24.2013 19:42 UBM

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