Abstract
OBJECTIVE: To evaluate the analytical reliability and accuracy as well as the practicability of the Glucocard Memory 2 glucose meter, intended to the control of the diabetic patient. DESIGN: Descriptive, crossover study. To validate an analytical instrument according to guidelines of the Spanish Society of Clinical Biochemistry and Molecular Pathology. SETTING: Primary health care, urban setting. PARTICIPANTS: Ninety-three blood samples from diabetic patients were used. These samples were selected by a consecutive sampling of the tubes received in the laboratory for the diabetes follow-up protocol. MEASUREMENTS AND MAIN RESULTS: Repeatability of the system was studied analysing the within-run precision at four concentrations of glucose. We obtained coefficients of variation between 2.12% (at 410 mg/dl of glucose) and 4.17% (at 37.2 mg/dl). The linearity study allowed to check experimentally the linear response of the instrument between 27 and 485 mg/dl. The accuracy was evaluated comparing the Glucocard results with the routine procedure of our laboratory (Hitachi 747, GOD-PAP) and calculating the regression parameters with the Passing and Bablok method (y = 1.01 x -2.34) and the intraclass correlation (99%). To evaluate the clinical significance of possible deviations related with the reference laboratory method the "error Grid" analysis was used. This analysis showed that 100% of Glucocard Memory 2 results fell into the clinical accuracy zone. Practicability study showed that the instrument is very simple to use. CONCLUSIONS: Glucocard Memory 2 is a glucose meter intended to the measurement of glucose both on capillary and venous blood that, besides its extreme simplicity of use, shows very good analytical features.