Performance evaluation of 20 blood glucose meters for home use testing / 国际检验医学杂志

ABSTRACT

Objective To evaluate the precision and accuracy of blood glucose meter(BGM ) for community home use testing . Methods According to the In Vitro Diagnostic Test Systems‐Requirements for Blood Glucose Monitoring Systems for Self‐Testing in Managing Diabetes Mellitus in DIN EN ISO151972013 .Capillary blood and venous blood were tested by BGM and the laborato‐ry biochemical analyzer respectively .The measurement results of each BGM were compared with the results of the biochemical ana‐lyzer for conducting the bias analysis .Results In evaluated 20 BGM ,none of them met the requirements of ISO151972013(when blood glucose concentrations < 5 .5 mmol/L ,the bias in 95% of detection results is within the range of ± 0 .83 mmol/L ;when blood glucose concentrations ≥ 5 .5 mmol/L ,the bias in 95% of detection results is within the range of ± 15% .Only 11 imported BGM (55% ) met the state standard .Conclusion The bias of 20 BGM ranged - 28 .7% - 3 .8% ,with the average bias of - 12 .2% . These detection results will bring the large risk of therapy in the diabetic patients .The regular and standardized evaluation of BGM performance may ensure the quality of blood glucose self - monitoring .