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

Abstract

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. © 2007 Elsevier Ireland Ltd. All rights reserved.