Technical and clinical evaluation of a glucose meter employing amperometric biosensor technology

Technical and clinical evaluation of a glucose meter employing amperometric biosensor technology
Suleyman Demir, Gamze Can Yilmazturk, Diler Aslan

Diabetes Res Clin Pract 79 (2008), pp. 400–404

The objective of this study was to assess accuracy and precision of the Optimum H System for measuring glucose in fresh venous whole blood samples. Ninety-one whole blood specimens were analyzed duplicate on two optimum blood glucose meter and compared to YSI reference analyser and Beckman LX20 laboratory analyser. The study demonstrated that the Optimum H System gives clinically accurate, plasma equivalent glucose results for venous samples, compared to the YSI*1.12 reference method. All results were within the clinically acceptable A and B zones of the Parkes error grid, with 98.6% falling within zone A. The mean bias of the Optimum H System versus the YSI*1.12 reference was +5.39%, which is consistent with the strip claim that slightly higher results may be observed when using venous samples. The Optimum H System results showed good precision, with an overall mean CV of 3.0%. Plasma results from the Beckman laboratory analyser correlated well with the YSI*1.12 whole blood reference with a slightly higher mean bias of +3.92%. The study demonstrated the Optimum H System to give clinically accurate and precise results for glucose in fresh venous whole blood samples.