Quality assessment of visual test strips for home blood glucose monitoring

Abstract

AbstractA quality control filter‐paper method was applied to the assessment of two glucose enzyme reagent strips — Type A and Type B — in the home environment. Forty insulin‐dependent diabetics, experienced in home blood glucose monitoring, took part in a randomised, cross‐over trial. Marked variation was observed in the accuracy of readings with both strips over a wide range of glucose concentrations. Overall, Type B was found to read consistently higher than the reference filter‐paper method, whereas Type A read consistently higher for reference glucose concentrations < 10 mmol/l, but lower for concentrations ≥10 mmol/l. In particular, both strips were equally poor at detecting filter‐paper concentrations in the hypoglycaemic range. Although both strips have been modified since the study was initiated, the principle of quality control is equally applicable to all other currently used and visually read strips. Recommendations are provided for the quality assessment of all reagent strips employed by patients for home blood glucose monitoring.