Accuracy of the Standard GlucoNavii Mentor in Blood Glucose Monitoring According to International Organization for Standardization 15197:2013 Criteria

Abstract

This study was performed to assess the system accuracy of the blood glucose monitoring system SD GlucoNavii Mentor (SD Biosensor Inc, Korea). The study procedures were based on International Organization for Standardization 15197:2013, in that capillary blood samples from 100 participants’ fingertips were measured with three reagent system lots of the self-monitoring blood glucose system. Samples were collected for comparison measurements on a hexokinase-based glucose analyzer (Cobas Integra400 Plus, Roche Instrument Center, Switzerland). Glucose concentrations were distributed as required by International Organization for Standardization 15197. For each of the 100 evaluable samples, duplicate measurements were taken from three different reagent lots, for a total of 600 measurements. Overall, 98.3% (590/600) of individual measurement results (185/186, 99.5% for glucose values <100 mg/dl and 405/414, 97.8% for glucose values ≥100 mg/dl) were within ±15 mg/dl or ±15% of the corresponding comparison method results. All results (100%) fell into the consensus error grid zones A and B, indicating only clinically acceptable results. In conclusion, the blood glucose monitoring system SD GlucoNavii Mentor device fulfilled the system accuracy criteria of the International Organization for Standardization 15197, indicating measurement accuracy sufficient for diabetes therapy.