[Evaluation of the Glucocard Memory 2 analyzer for measuring glucose concentration in capillary blood].

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.