Diabetes is epidemic worldwide and places an increasingly heavy cost burden on health care systems. Measurement of percent hemoglobin Alc (%HbA1c) is the most effective tool for assessing overall glycemic control of people with diabetes, especially when done while a patient is with their care provider. Current systems for decentralized testing of %HbA1c are expensive and/or the cost per test is relatively high, and the methodology is more complex than desirable. Scripps is developing an inexpensive, simple to use strip based """"""""glucometer"""""""" type system that will lower testing costs and make measurement of %HbA1c more widely available at the point of care. Scripps' proprietary separation technology effectively measures % glycated hemoglobin in a strip format measured on a simple reflectometer. The format of the test must be further refined in order to achieve the necessary assay precision of < 5% CV and to provide the necessary convenience features. In SBIR Phase I existing prototype meters will be used to systematically evaluate and optimize both lateral flow and flow through strip designs. Strips materials, flow rates, reflecting layers and assay methods will be evaluated. Convenience features and full-scale development will be addressed in an SBIR Phase II.
