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Abstract
Grant Number: 5R44DK058523-03 PI Name: NIKOLYUKIN, YURI PI Email: yuri@portascience.com PI Title: Project Title: A simple point-of-care glycated hemoglobin test Abstract: DESCRIPTION (provided by applicant): Development of a novel non-antibody based method for measuring the concentration of glycated hemoglobin in blood is proposed. Utilizing only a single measurement, the proposed method will provide a standardized percent HbA1c (glycated hemoglobin A1c) result using a handheld instrument. The method requires only a one-step application of a fingerstick whole blood sample and takes less than 10 minutes. Preliminary data obtained with whole blood samples containing normal (4.3 - 7.0 percent) and high (> 7 percent) HbA1c levels demonstrate the potential of the proposed method. All current point-of-care instruments for HbA1c require more than one step to operate. We believe our proposed method is eligible to receive a CLIA waiver status due to its one-step operation. HbA1c measurement can provide diabetic patients and their healthcare providers an overview of their success in meeting long-term goals for controlling their blood glucose level. PROPOSED COMMERCIAL APPLICATION: There are more than 10 million diabetics in the United States alone, and the number is expected to grow larger--to 25.3% of the population by year 2005. The American Diabetes Association has recommended monitoring of the hemoglobin A1c level at least four times a year. The potential market for a user-friendly monitoring device is very large. The proposed device is expected to provide a simple, and accurate alternative to the current techniques.
Thesaurus Terms:
biomedical equipment development, blood glucose, boronic acid, diagnosis design /evaluation, glycation, hematology, hemoglobin, method development, serology /serodiagnosis, spectrometry
diabetes mellitus, hemoglobin A
clinical research, high performance liquid chromatography, human subject
Institution: PORTASCIENCE, INC. 337 TOM BROWN RD MOORESTOWN, NJ 08057 Fiscal Year: 2003 Department: Project Start: 08-JUL-2002 Project End: 30-JUN-2004 ICD: NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES IRG: ZRG1