This Phase II project will complete development and validation of a rapid test for measurement of glycated hemoglobin that is suitable for use in the point-of-care setting. The test system consists of disposable dry strips that are inserted into a hand-held electronic device that reads the color intensity in each of two conjoined zones in the strip that respectively capture glycated and non-glycated hemoglobin in an applied sample, calculates the ratio of color in the first zone to the sum of color intensities in the two zones, and provides the percent glycated hemoglobin in a liquid crystal display. The Phase I goals were to design and construct a prototype electronic device, optimize components of the test strips with respect to capture, flow and dispersion properties, and demonstrate that results with the test system show correlation with HbA1c values obtained with laboratory-based methodologies. These Phase I milestones have been accomplished.
The specific aims of Phase II are to: a) refine and finalize programming, processing and other specifications of the device (reader); b) define limits of the testing system with respect to sample collection, timing and stability; e) systematically examine performance characteristics of the test system including linearity interference and specificity, accuracy and precision; d) evaluate comparability of results between capillary versus venous sampling; e) standardize the test system with value-assigned samples from the NGSP; f) demonstrate substantial equivalence of the test system to an approved laboratory method; g) present results to prospective commercialization partners; and h) collate and analyze data for submission of an application to the FDA for approval for marketing.
