POINT-OF-CARE MEASUREMENT OF GLYCATED HEMOGLOBIN

The overall objective of this project is to complete development and validation of a rapid point-of-care test for the measurement of glycolated hemoglobin, which is the established objective index of ambient blood glucose concentration over an integrated period of time. We have adapted the principle of specific chemical complexation and of fluid flow to separate glycated form non-glycated species of hemoglobin in a dry test strip format. Preliminary work indicates that this construct functions with direct application of one microliter of whole blood, completes the assay in 4 minutes, and that the ratio of color intensities in the two binding zones of the strip is proportionate to the amount of glycated hemoglobin applied and correlates with results obtained with HPLC analysis of HbA1c. Phase I is designed to prove feasibility for further development of the test system, which requires a durable, hand-held electronic readout device. The specific aims of Phase I are to: a) design and construct a prototype electronic device that reads color intensity in the glycated and non-glycated binding zones of the strip, calculates the ratio of the first to the sum of the first and second, and provides an LCD number display of the percent HbA1c; b) optimize the membrane components of the assay strip with respect to capture, flow and dispersion properties; and c) establish that results with the test system show a proportionate relationship with the amount of glycated hemoglobin applied and a correlation with HbA1c value obtained with laboratory-based methodologies. In Phase II, the specifications of the device will be refined and finalized, the limits of the testing system will be defined, and the performance characteristics of the test system will be systematically examined. Phase II follow-on with a partner for commercialization is anticipated.