BACKGROUND: To assess the accuracy and precision of the Roche Performa and Medisense Optium Xceed (5 and 10 s reading) blood glucose meters. METHODS: Capillary blood samples were taken from 100 patients attending a diabetes centre and blood glucose measured on Roche Performa (n = 4) and Medisense Optium Xceed 5 s (n = 2) and 10 s reading (n = 2) meters. Venous plasma glucose from samples taken simultaneously was measured by the laboratory hexokinase method as reference standard. Imprecision was determined on the meters by replicate analysis (n = 20) of control solutions provided by the manufacturers and also patient venous whole-blood samples. Accuracy was assessed relative to the reference method by Bland-Altman plots, Passing and Bablok regression analysis, and both Clarke and consensus error grid analysis. Coefficients of variation (CVs) were calculated to determine imprecision. RESULTS: Bland-Altman and Passing-Bablok analysis confirmed significant systematic bias for all meters, with relative under-reading of higher glucose concentrations. Error grid analysis showed that <5% readings exceeded +/-20% (or +/-0.83 mmol/L for readings <4 mmol/L) deviation from the reference method (1%, 2% and 4% for the Roche, Optium 5 and 10 s meters, respectively). CVs were all <4% for the control solutions and <6% for patient samples. CONCLUSIONS: Both Roche Performa and Medisense Optium glucose meters (5 and 10 s readings) perform satisfactorily and are acceptable for operational use.
BACKGROUND: To assess the accuracy and precision of the Roche Performa and Medisense Optium Xceed (5 and 10 s reading) blood glucose meters. METHODS: Capillary blood samples were taken from 100 patients attending a diabetes centre and blood glucose measured on Roche Performa (n = 4) and Medisense Optium Xceed 5 s (n = 2) and 10 s reading (n = 2) meters. Venous plasma glucose from samples taken simultaneously was measured by the laboratory hexokinase method as reference standard. Imprecision was determined on the meters by replicate analysis (n = 20) of control solutions provided by the manufacturers and also patient venous whole-blood samples. Accuracy was assessed relative to the reference method by Bland-Altman plots, Passing and Bablok regression analysis, and both Clarke and consensus error grid analysis. Coefficients of variation (CVs) were calculated to determine imprecision. RESULTS: Bland-Altman and Passing-Bablok analysis confirmed significant systematic bias for all meters, with relative under-reading of higher glucose concentrations. Error grid analysis showed that <5% readings exceeded +/-20% (or +/-0.83 mmol/L for readings <4 mmol/L) deviation from the reference method (1%, 2% and 4% for the Roche, Optium 5 and 10 s meters, respectively). CVs were all <4% for the control solutions and <6% for patient samples. CONCLUSIONS: Both Roche Performa and Medisense Optium glucose meters (5 and 10 s readings) perform satisfactorily and are acceptable for operational use.
Authors: Sarah Lou Bailey; Helen Ayles; Nulda Beyers; Peter Godfrey-Faussett; Monde Muyoyeta; Elizabeth du Toit; John S Yudkin; Sian Floyd Journal: BMC Infect Dis Date: 2016-12-05 Impact factor: 3.090