title: Quality control of antibodies for assay development.
abstract: Antibodies are used as powerful tools in basic research, for example, in biomarker identification, and in various forms for diagnostics, for example, identification of allergies or autoimmune diseases. Due to their robustness and ease of handling, immunoassays are favourite methods for investigation of various biological or medical questions. Nevertheless in many cases, additional analyses such as mass spectrometry are used to validate or confirm the results of immunoassays. To minimize the workload and to increase confidence in immunoassays, there are urgent needs for antibodies which are both highly specific and well validated. Unfortunately many commercially available antibodies are neither well characterized nor fully tested for cross-reactivities. Adequate quality control and validation of an antibody is time-consuming and can be frustrating. Such validation needs to be performed for every assay/application. However, where an antibody validation is successful, a highly specific and stable reagent will be on hand. This article describes the validation processes of antibodies, including some often neglected factors, as well as unspecific binding to other sample compounds in a multiparameter diagnostic assay. The validation consists of different immunological methods, with important assay controls, and is performed in relation to the development of a diagnostic test.
authors.affiliation: Fraunhofer Institute for Cell Therapy and Immunology - Bioanalytics und Bioprocesses, Am Mühlenberg 13, 14476 Potsdam, Germany; Humboldt University Berlin, Department of Biology, Invalidenstr. 110, 10115 Berlin, Germany.
authors.forename: Sarah
authors.initials: S
authors.lastname: Schumacher
authors.affiliation: Fraunhofer Institute for Cell Therapy and Immunology - Bioanalytics und Bioprocesses, Am Mühlenberg 13, 14476 Potsdam, Germany. Electronic address: harald.seitz@izi-bb.fraunhofer.de.
authors.forename: Harald
authors.initials: H
authors.lastname: Seitz
mesh_terms: D000906:Antibodies; D000918:Antibody Specificity; D015415:Biomarkers / Q000032:analysis; D001709:Biotechnology; D003429:Cross Reactions; D006801:Humans; D013287:Illicit Drugs / Q000032:analysis / Q000276:immunology; D007118:Immunoassay / Q000379:methods* / Q000592:standards; D011786:Quality Control; D019966:Substance-Related Disorders / Q000175:diagnosis
chemical_list: D000906:Antibodies; D015415:Biomarkers; D013287:Illicit Drugs