Assessment of System Accuracy, Intermediate Measurement Precision, and Measurement Repeatability of a Blood Glucose Monitoring System Based on ISO 15197.

BACKGROUND

Analytical quality of blood glucose monitoring systems (BGMS) is an important aspect for many diabetes patients. Sufficiently high analytical quality is required for adequate diabetes therapy.

METHODS

In this study, system accuracy and measurement precision of a BGMS were assessed based on ISO 15197:2013. For system accuracy, this standard requires a specific glucose distribution and at least 95% of results obtained with the BGMS in capillary blood to fall within ±15 mg/dl or ±15% (at glucose concentrations <100 mg/dl or ≥100 mg/dl, respectively) of corresponding comparison method results, and at least 99% of results to be found within clinically acceptable consensus error grid (CEG) zones A and B. Based on ISO 15197:2013, intermediate measurement precision, using control solution, and measurement repeatability, using venous blood samples, were analyzed by calculation of standard deviations (SDs) and coefficients of variation (CV) at glucose concentrations <100 mg/dl or ≥100 mg/dl, respectively, although ISO 15197:2013 does not specify acceptance criteria.

RESULTS

The BGMS fulfilled system accuracy requirements with ≥99% of results within ±15 mg/dl or ±15% of the comparison method results, and 100% of results in CEG zones A and B. Intermediate measurement precision analysis showed SD ≤2.2 mg/dl and CV ≤2.3%. Analysis of measurement repeatability showed SD ≤2.1 mg/dl and CV ≤2.4%.

CONCLUSION

System accuracy requirements of ISO 15197:2013 were fulfilled by the BGMS. As ISO 15197:2013 does not specify precision requirements, precision analysis results were compared with those reported for other BGMS in the literature and found to be similar.