The long term objective of this project is to develop a simple, specific, and rapid immunodiagnostic test to measure the amount of non-enzymatically glycated albumin in human plasma. The test will be an ELISA construct that employs a monoclonal antibody that specifically recognizes glycated albumin, an index of the ambient blood glucose concentrations over the preceding 2-3 weeks. Clinical investigations during the past decade have established that periodic assessment of the prevailing blood glucose level is essential to establishing and maintaining control of diabetes, and that control of diabetes is important in arresting the development of complications of diabetes and preventing intrauterine and perinatal mortality in infants of diabetic mothers. The mainstay of monitoring diabetic control is measurement of blood glucose concentration and of the extent to which certain circulating proteins have become nonenzymatically glycated. The major proteins for which it has been found useful to measure the amount of nonenzymatic glycation are hemoglobin and albumin. Glycohemoglobin is measured every 2-3 months for an objective evaluation of the ambient glucose control during that preceding period, whereas glycoalbumin can be measured at shorter intervals to detect and document improvement or deterioration in control of more recent temporal relevance. However, there has been no reliable and specific method to quantitate glycoalbumin. This project will realize the opportunity to develop such a method, using a unique and highly specific monoclonal antibody, created in our laboratory, that recognizes glycated epitopes residing in albumin but not in other plasma proteins and that does not react with unglycated albumin.
