| Evaluation of the analytical performance of the coulometry-based optium omega blood glucose meter. | |
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MedLine Citation:
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PMID: 22226286 Owner: NLM Status: In-Data-Review |
Abstract/OtherAbstract:
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Background: The goal of diabetes treatment is maintaining near normoglycemia based on self-monitoring of blood glucose (SMBG). In this study, an evaluation of the analytical performance of the coulometry-based Optium Omega™ glucose meter designed for SMBG has been carried out. Methods: The assessment of precision and between-lot variability was based on glucose measurements in ethylene-diaminetetraacetic acid venous blood samples. Glucose concentrations measured in 289 fresh capillary blood samples using the Omega glucose meter and the Biosen C_line analyzer were compared. Results: Within-run imprecision coefficient of variation for the lower and higher glucose concentrations amounted to 5.09 and 2.1%, respectively. The relative lot-dependent differences found for the lower and higher glucose concentrations were equal to 6.8 and 2.6%, respectively. The glucose meter error calculated for various concentration ranges amounted from 2.22 to 4.48%. The glucose meter error met the accuracy criteria recommended by the International Organization for Standardization and the American Diabetes Association. The Passing-Bablok agreement test and error grid analysis with 96% of results in zone A indicated good concordance of results, including glucose concentrations below 100 mg/dl. Conclusions: The evaluated Optium Omega glucose meter fits the analytical requirements for its use in blood glucose monitoring in diabetes patients. |
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Authors:
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Bogdan Solnica; Beata Kusnierz-Cabala; Krystyna Slowinska-Solnica; Przemyslaw Witek; Agnieszka Cempa; Maciej T Malecki |
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Publication Detail:
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Type: Journal Article Date: 2011-11-01 |
Journal Detail:
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Title: Journal of diabetes science and technology Volume: 5 ISSN: 1932-2968 ISO Abbreviation: J Diabetes Sci Technol Publication Date: 2011 |
Date Detail:
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Created Date: 2012-01-09 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 101306166 Medline TA: J Diabetes Sci Technol Country: United States |
Other Details:
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Languages: eng Pagination: 1612-7 Citation Subset: IM |
Copyright Information:
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© 2011 Diabetes Technology Society. |
Affiliation:
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Department of Diagnostics, Jagiellonian University Medical College, Krakow, Poland. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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