[Evaluation of the quality of blood glucose meters using the HemoCue B glucose system]

Analytical evaluation three models of blood glucose meters (Glucometer IV (Bayer), Glucotrend (Roche Diagnostics) and One touch (Life Scan, Johnson & Johnson)) were compared within a central laboratory to an analyzer (Hitachi 747, Boehringer-Mannheim, Grenoble, France) and to a photometric device (HemoCue B-glucose). Each glucose meters met the criteria of within-run precision defined by the Association Française d'Etudes du Diabète et des Maladies Métaboliques (ALFEDIAM). Furthermore, HemoCue B-glucose met criteria defined by the French Society of Biological Chemistry (SFBC). In the study realized within laboratory, 28 to 66% of glucose tests realized with meters differed by more than 10% from plasma values and 43% of glucose assays realized with different meters differed by more than 10% from HemoCue B-glucose value. Within clinical departments, 46 glucose meters from 5 different models were evaluated. Answers to a questionnaire stored in HemoCue B-glucose underlined the weak development of glucose meters quality assurance. Within clinical departments, 65% of glucose values realized with meters differed by more than 10% from reference values. Development in clinical departments of glucose meters quality assurance programs can be monitored by HemoCue B-glucose, and must allowed improvement of glucose meter quality.