Performance of Yueyou 301 blood glucose monitoring meter in a multicenter clinic study

Abstract

Objective This multicenter clinic study was conducted to evaluate the accuracy of Yueyou 301 blood glucose meter (Yuwell Medical Equipment & Supply Co.,Ltd.,Jiangsu,China) in comparison with YSI2300 Stat Plus glucose analyzer.Methods Capillary blood glucose and the forearm venous plasma glucose levels were measured with the Yueyou 301 glucose meter and YSI 2300 Stat Plus glucose analyzer.In accordance with the ISO 15197:2003 requirements and permits,Yuwell laboratory obtained the extremely low and high concentration samples,which were also assessed by the glucose meter and the glucose analyzer.Taking the venous plasma glucose as the reference value,the accuracy of the Yuwell glucose meter was evaluated flowing the DIN EN ISO (International Organization for Standardization) 15197:2003.The consistency of capillary blood glucose and venous plasma glucose was studied by Consensus Error Grid Analysis,the correlation of capillary blood glucose and venous plasma glucose was analyzed according to liner regression analysis.Reproducibility precision test was carried on in the Yuwell laboratory with the control solution of high and low concentration tested for 20 times in five glucose meters.Results There were 1 092 venous plasma glucose values paired with capillary blood glucose values,of which,comparing to venous plasma glucose,98.6％ met the minimum requirements defined by the ISO15197:2003 standard (95％ of all measurements within ± 0.83 mmol/L for the range ＜ 4.2 mmol/L and ± 20％ for the glucose range ≥ 4.2mmol/L).Paired glucose measurements from the Yueyou 301 glucose meter and laboratory glucose measurement demonstrated that 100％ of paired points in the overall subject population fell in zones A and B of the error grid analyze.The capillary blood glucose value was well correlated to venous plasma glucose value in the overall level(r=0.981 5).Regarding the reproducibility,the low concentrations (＜ 5.6 mmol/L) had SD ≤ 1.51 mg/dl (＜ 0.1mmol/L),which was well within the acceptability criteria of＜5 mg/dl (＜0.3 mmol/L) and the high concentrations ＞100 mg/dl(＞5.6 mmol/L)had a CV＜2％,which were well within the acceptability criteria of＜5％.Conclusion The accuracy and reproducibility of the Yueyou 301 blood glucose meter meet the performance criteria established by the ISO15197:2003. Key words: Yueyou 301 glucose meter; Self-monitoring of blood glucose; Reproducibility; Accuracy