John Gleisner, Julie Walker and Patricia Gill
ARKRAY USA Inc., USA
Posters-Accepted Abstracts: J Diabetes Metab
Background: Blood Glucose Monitoring Systems (BGMS) are a critical tool used in the management of Diabetes. The gold standard in measuring the accuracy of BGMS in the testing of Diabetes Mellitus is known as the ISO 15197:2013. The level of accuracy of the BGMS results in the ability to regulate an individualā??s blood glucose levels. According to the ISO 15197:2013, system accuracy performance criteria is defined as 95% of the BGMS results falling within Ā±15 mg/dL of the reference analyzer results with glucose concentrations less than 100 mg/dL. For samples with glucose concentrations ā?„100 mg/dL, 95% of the BGMS results need to be within 15% of the reference analyzer results. Furthermore 99% of all results are required to be in the A and B zones of the Consensus Error Grid. Purpose: The objective of this study is to demonstrate whether the GLUCOCARDĀ® Shine aligns with the ISO 15197:2013 BGMS accuracy performance requirements. Methods: Two lots of GLUCOCARDĀ® Shine blood glucose test strips were evaluated for performance and bias comparison (n=240 data points). The samples were collected from the fingertip of confirmed diabetics by trained personnel at the ARKAY Factory, Inc. in Minneapolis, MN. Reference values were obtained using the YSI Model 2300 Analyzer. The data was analyzed using the minimum system accuracy performance criteria published in the ISO 15197:2013. Results: The results showed that 100% of the <100 mg/dL samples (13/13) were within Ā±15 mg/dL thus meeting the 95% accuracy criteria. 99.1% of the ā?„ 100mg/dL samples (n=225/227) fell within the pre-determined 15% which met the 95% performance criteria. All data were within the A and B zones of the Consensus Error Grid. The overall bias was ā??2.7% demonstrating strong agreement between the GLUCOCARDĀ® Shine and YSI reference analyzer results, which is considered the gold standard glucose assay for BGMS studies. The correlation coefficient (r) = 0.98 demonstrates a strong linear relationship between the YSI reference method and the meter results.
John Gleisner completed his PhD in Biochemistry from the University of Minnesota and Postdoctoral studies from the University of Iowa. His first career following graduate school was at the Virginia Mason Research Center in Seattle, WA. He later moved into industry where he is currently the Science Director at ARKRAY Factory in USA. He has spent nearly 30 years working on blood glucose system development and support. He has authored over 25 publications and holds 11 US patents.
Email: walker@arkrayusa.com
