Abstract

Three glucose mono-analyzers Super G1, Super G2+ and Biosen 5030 were evaluated. The within run imprecision for the Super G1 analyzer was 0.4% to 5.6%, for the Super G 2+ from 3.7% to 7.9% and for the Biosen 5030 from 1.04% to 2.97%. Between run imprecision was in the range of 4.6% to 8.6% for the Super G1 and Super G2+ analyzers and ranged from 1.68% to 2.78% for the Biosen 5030 analyzer, respectively. Analytical bias was 0.0% to 4.6% for the Super G1 and Super G2+ analyzers and 0.64% to 8.43% for the Biosen 5030, respectively. The bias of 8.43% was observed at near normal glucose concentrations. All glucose analyzers studied showed a perfect linearity of response versus blood glucose concentrations in the range from 1.4 to 16 mmol/l. The calculated differences between glucose concentrations obtained by the Super G1 and Super G2+ analyzers amounted to 0.015, 0.06 and 0.21 mmol/l at glucose concentrations of 2.5, 5 and 10 mmol/l, respectively, and differences between the Super G2+ and Biosen 5030 amounted to 0.27, 0.07 and 0.33 mmol/l, respectively. The Bland Altmann difference analysis yielded mean difference values amounting to –0.024 mmol/l; 0.036 mml/l and 0.049 mmol/l for the Super G1, G21+ and Biosen 5030, respectively. The carried evaluation has shown that the analytical performance of all three electrochemical glucose analyzers studied approximates the reference laboratory method. Besides of some outlying results this type of glucose meters can be reliably used as laboratory back-up analyzers and as glucose analyzers employed in various satellite locations.

DOI: Clin. Lab. 2003;49:233-238