Research Project
2142258
The objective of this Phase II project is to develop simple, specific and reliable immunoassays to measure non-enzymatically glycated albumin in human plasma. The circulating level of glycoalbumin is an index of the ambient blood glucose concentration over the preceding 3-4 weeks. The assays use EIA constructs and employ monoclonal antibodies that specifically recognize glycated albumin. Phase I established the feasibility of measuring glycoalbumin with a monoclonal antibody based microtiter ELISA, optimized the ELISA conditions for commercialization, and evaluated correlations between glycoalbumin levels and other parameters of glycemia and the retrospective period that is reflected by monoclonal antibody ELISA glycoalbumin measurement. Further modifications will yield tests that are easy to use and give rapid quantitative results, using two types of formats envisioned for use in the physician's office. In the first type, quantitation of results is achieved with a simple spectrophotometer, using a competitive assay construct with antibody immobilized onto high affinity binding test tubes. The second type of format uses a "strip" format to allow visual discrimination of color intensity to determine defined levels of glycated albumin. An integrated approach will be used to simplify the manner in which the assay is run, to make the assays both robust and practical for use in the physician's office, to further validate the modified assays, to select the final solid phase matrix and assay constructs from the combined optima of stability and shelf life of the reagents and the safety and simplicity for physician office use and to complete systems able to attract Phase III support.
