Immunoassay development is a multidisciplinary activity involving a wide range of skills possessed by few laboratories. This presentation of tried and tested methods should enable scientists and researchers in the pharmaceutical and related industries to more rapidly and effectively develop immunoassays upon which their work is becoming heavily dependent.; Important methods are included for preparing Lapten-protein conjugates and raising the necessary antibodies, concentrating on polyclonal sera, as well as methods for the synthesis of radio and enzyme labelled tracers. Particular attention is paid to the requirements of the regulatory authorities such as the FDA (Food and Drug Administration) with respect to assay validation. Further chapters deal with assay development and optimization, curve fitting and quality control procedures.
Table of Contents
An introduction to immunoassay development; preparation, purification and characterization of conjugates; immunization procedures; production of radiotracers; production of non-isotopic tracers; assay development and optimization; assay validation; standardization and quality control of immunoassays.