HAND-HELD DIAGNOSTIC FOR THE DETECTION OF AUTOANTIBODIES

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 DETERMINANATS FOR THE TWO CLASSES OF AUTOANATIBODIES 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 IN THE HOSPITAL AT THE PATIENT'S BEDSIDE OR IN A PHYSICIAN'S OFFICE. THE DATA FROM THE SUCCESSFUL COMPLETION OF THIS TASK 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 OTHER AUTOIMMUNE DISORDERS.