The detection of autoantibodies in the liver diseases PBC, PSC and CAH may serve as a diagnostic in assessing the severity and/or progression of disease. In Phase I, we plan to develop enzyme-based immunoassays (EIAs) for the detection of autoantibodies associated with PBC. We plan to use the recombinantly engineered molecule "PDC-E2/BCOADH-E2", which contains the antigenic determinants for the two classes of autoantibodies associated with PBC as the detection antigen. Initially, we will generate a plate-based EIA offering both positive and negative controls for comparison. Upon successful completion of this task, we will, using the designer molecule, develop a hand-held diagnostic for detecting the autoantibodies associated with PBC. The hand-held EIA, will be a quick, simple system which could be performed at the patient's bedside in the hospital, or in a physician's office. The data would then serve as the technical base for the development of hand-held EIAs for the detection of autoantibodies associated with PSC/and CAH, as well as for other autoimmune disorders.Awardee's statement of the potential commercial applications of the research:Successful completion of the project would provide a new clinical diagnostic for autoimmune liver disease. The larger application will be the potential commercialization of a new hand-held antigen/antibody diagnostic.National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
