Development of viable markers of alcohol consumption is essential for early diagnosis and treatment of alcoholics and can potentially reduce the health costs. Plasma carbohydrate-deficient transferrin is considered a viable marker for alcohol intake but lately, its validity has been questioned. The applicants have demonstrated the validity and feasibility of the use of sialic acid deficiency of plasma Apolipoprotein J(SDJ) as a biological marker for alcohol consumption in rats. The measurement of plasma SDJ seems to be specific, sensitive, simple, and cost-effective. In Phase II, they will extend studies on the validity of the use of plasma SDJ in human alcoholics, and design, optimize and validate a diagnostic kit that can be screened for its commercialization. Thus, the Specific Aims include: 1. Validity of plasma SDJ as a viable marker for alcohol consumption in human alcoholics, II. Stability of SDJ, III. Persistence of plasma SDJ in alcoholic subjects undergoing detoxification, IV. Design, development, optimization and validation of a commercially viable diagnostic kit, V. Comparison of SDJ and CDT methods, VI. Cost and Time Analysis of the diagnostic kit. VII. Association Analysis of SDJ to alcoholism in random human sampling. VIII. Production and Scale Up for Manufacturing, IX. Production Validation Runs.
