SBIR-STTR Award

Proposed is the development of a miniaturized, minimally invasive test tab device for estimating the concentration of blood glucose and other diabetes-related parameters (analytes). The device doses and transports a blood sample of a volume in the nanoliter range to an integrated detection or signal site. The detection site contains dried chemical reagents capable of reacting with analyte, as well as a composition capable of absorbing a defined volume of blood plasma while inhibiting cellular component of blood from penetrating the composition. The cellular component is wholly removed from the detection site by proprietary chemical and physical mechanisms, thereby obviating the need for a separate cell filtering material, and unmasking the reacted test field for visual or instrumented analysis. PROPOSED COMMERCIAL APPLICATION: The proposed technology would, for the first time, provide measurement on a single analytical system of the most important diabetes parameters. This system is designed to be operationally rugged and simple so that it can be used by both diabetics and professionals at the POC. This should enhance patient/physician interaction, foster education and compliance, and improve outcomes

The applicant organization proposes to develop an ultra-miniaturized, minimally invasive diabetes monitoring system for estimating concentrations of diabetes-related parameters (analytes) in whole blood. The system is comprised of analyte specific test tabs and a hand-held meter. The test tabs dose and transport a blood sample in the nanoliter range (approximately 300nL) to an integrated polymeric detection site. The detection site embodies dried chemical reagents capable of reacting with analyte, as well as a polymeric composition capable of absorbing a defined volume of blood plasma while preventing cellular component of blood from penetrating the composition. Cells are wholly removed from the detection site by proprietary chemical and physical mechanisms, thereby obviating the need for a separate cell filtering material and unmasking the detection site for visual or instrumented analysis. Test procedure is streamlined and performance time drastically reduced by consolidating all testing steps into one single disposable device. Primary target markets are point-of-care and self-testing environments.

Thesaurus Terms:
biomedical equipment development, blood chemistry, blood glucose, diabetes mellitus, enzyme analyzer, miniature biomedical equipment, patient monitoring device beta hydroxybutyrate, cholesterol, diabetic angiopathy, glycation, hemoglobin A, insulin, polymer, triglyceride bioengineering /biomedical engineering, clinical research, human tissue