SYNTHETIC CONTROLS FOR IMMUNOHISTOCHEMICAL ASSAYS

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DESCRIPTION: (Adapted from the applicant's abstract) The long-term objective of this new Phase I application is to develop tissue surrogate controls for clinical immunohistochemical assays. These surrogate controls are to be standardized and thus replace the tissue controls that are currently, for the most part, lab unique. This homegrown approach is labor intensive and does not address the question of reagent failure or procedure error on a per sample basis. There is a consensus that standardized controls for clinical immunohistochemical analysis are needed and would be readily adopted if available. Since tissue specific controls present significant preparation problems and would be prohibitedly expensive the investigator and associates propose to develop surrogate controls which will be developed using phage display technology. This Phase I application will develop tissue antigen surrogates for three commonly used monoclonal antibodies. The utility of these surrogates will be tested in defined clinical scenarios after the technical methods to insure surrogate antigen presentation as part of the immunohistochemical procedure have been proven. PROPOSED COMMERCIAL APPLICATION: NOT AVAILABLE