Accuracy evaluation of Roche Accu-Chek Performa blood glucose meters at low glucose concentrations:A nine-year retrospective study  

作　　者：Zhipeng Zhao Runqing Li Xiuying Zhao Lina Zhang Tengjiao Wang Song Yang Ning Han Dong Zhu 

机构地区：[1]Laboratory Medicine Department of Beijing Tsinghua Changgung Hospital,School of Clinical Medicine,Tsinghua University,Beijing,China [2]Operations Management Department of Beijing Tsinghua Changgung Hospital,School of Clinical Medicine,Tsinghua University,Beijing,China

出　　处：《iLABMED》2024年第3期141-148,共8页智能检验医学（英文）

基　　金：The Incubation Program Project of Beijing Municipal Administration of Hospitals of China,Grant/Award Number:PG2018013;Education Reform Project of Tsinghua University,Grant/Award Number:ZY01_02;Beijing High-level Public Health Technical Personnel Project,Grant/Award Number:2023‐03‐03。

摘　　要：Objective:To evaluate the accuracy of Roche Accu-Chek Performa glucose meters at a low glucose concentration of<5.55 mmol/L(100 mg/dL)over a 9-year period.Methods:The accuracy of the Roche Accu-Chek Performa glucose meters at low glucose concentrations was evaluated using annual comparison data for 9 consecutive years from 2015 to 2023,according to the acceptability criteria specified in International Organization for Standardization(ISO)15197:2013.Blood samples with low glucose concentrations of<5.55 mmol/L were prepared by incubation and glycolysis.The glucose concentration was detected using Roche Accu-Chek Performa glucose meters and a biochemical analyzer in the central laboratory.Results:A total of 2978 pairs of comparison results from 211 glucose meters at a low glucose concentration of<5.55 mmol/L were retrospectively analyzed from 2015 to 2023.The clinical use duration spanned from 1 to 9 years and 40.76%(86 out of 211 glucose meters)had been used for more than 2 years.The correlation coefficient r between glucose meter measurements and laboratory reference values was 0.98(p<0.001).The mean according to Roche Accu-Chek Performa glucose meters was 0.05 mmol/L(0.9 mg/dL)higher than that of the biochemical analyzer(Z=-13.82,p<0.0001).The results showed that 100.00%(211 out of 211)of the Roche Accu-Chek Performa glucose meters met the acceptability criteria specified in ISO 15197:2013.At a low glucose concentration of<5.55 mmol/L,99.90%(2975 out of 2978)of the comparative data pairs in the error distribution fell within the range of±0.83 mmol/L(15 mg/dL).Parkes consensus error grid analysis showed that 100.00%(2978 out of 2978)of comparative data pairs fell within region A.Conclusions:This study demonstrated that Roche Accu-Chek Performa glucose meters successfully met the accuracy standards of ISO 15197:2013 for measuring blood glucose within the hypoglycemic range.Greater attention should be given to the performance of blood glucose monitoring systems in the low glycemic range,especially for patients with

关 键 词：blood glucose monitoring system comparative study DIABETES low glucose concentration POINT-OF-CARE 

分 类 号：R446[医药卫生—诊断学]