Accuracy of STANDARD™ GlucoNavii GDH in blood glucose monitoring according to ISO 15197:2013 criteria
ABSTRACT
Background:
Measurement accuracy of blood glucose monitoring systems (SMBG) is a relevant aspect in diabetes management.
Objective:
the objective of our study was to assess system accuracy of the SMBG SD GlucoNavii™ Mentor (SD Biosensor Inc., Korea).
Methods:
Study procedures were based on ISO 15197:2013. Capillary blood samples from fingertips were measured with three reagent system lots of the SMBG. Samples were collected for comparison measurements on a hexokinase-based glucose analyzer (Cobas Integra®400 Plus, Roche Instrument Center, Switzerland), which is traceable according to requirements of ISO 17511.
Results:
A total of 114 samples from 110 subjects were taken, of whom 14 samples were excluded from analysis for different reasons. The three reagent system lots showed 98.5%, 97.0%, and 99.5% of individual measurement results, respectively, within ±15 mg/dl or ±15% of the corresponding comparison method results. All results (100%) fell into Consensus Error Grid zones A and B, indicating clinically acceptable results. The SMBG system exhibited small positive measurement bias, ranging from 1.7% to 3.6%.
Conclusions:
the SMBG SD GlucoNavii™ Mentor device fulfilled system accuracy criteria of ISO 15197, indicating measurement accuracy sufficient for diabetes therapy.
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