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

Abstract

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 [Correction added on 28 September 2024, after first online publication: The text in Section 3.3 and Figure 3 caption had been changed from "100.00% (2979 out of 2978)" to "100.00% (2978 out of 2978)".]