Analytical validation of the new plasma calibrated Accu-Chek Test Strips (Roche Diagnostics).

BACKGROUND: The Accu-Chek Inform glucose monitor is a point-of-care system for testing blood glucose. New test strips, calibrated to deliver glucose plasma-like values, were launched on the market in May 2005. The aim of our study was to perform analytical validation of these new strips. METHODS: We compared the new plasma strips with whole blood strips; results for the plasma strips with plasma values obtained using a clinical analyzer and with whole blood values given by the glucose electrode of a blood gas analyzer; and the influence of the type of blood (capillary or venous) on the results obtained by the glucose monitor with the plasma calibrated strips. RESULTS: Plasma strips give on average 7% higher results than the previous whole blood strips. However, the results given by the plasma strips on capillary whole blood, even if well correlated, are not completely comparable with those given by an analyzer for venous plasma. Nevertheless, these plasma strips and the glucose electrode of a blood gas analyzer give comparable results. CONCLUSIONS: Accu-Chek Inform plasma strips are a good method for monitoring of blood glucose values in patients with diabetes.