Analytical Performance Evaluation of Infopia Element? Auto‐coding Blood Glucose Monitoring System for Self‐Monitoring of Blood Glucose

摘要

BackgroundElement? Auto-coding Blood Glucose Monitoring System (BGMS; Infopia Co., Ltd., Anyang-si, Korea) was developed for self-monitoring of blood glucose (SMBG). MethodsPrecision, linearity, and interference were tested. Eighty-four capillary blood samples measured by Element? BGMS were compared with central laboratory method (CLM) results in venous serum. Accuracy was evaluated using ISO 15197:2013 criteria. ResultsCoefficients of variation (CVs; mean) were 2.4% (44.2 mg/dl), 3.7% (100.6 mg/dl), and 2.1% (259.8 mg/dl). Linearity was shown at concentrations 39.25–456.25 mg/l ( y = 0.989 + 0.984 x , SE = 17.63). Up to 15 mg/dl of galactose, ascorbic acid, and acetaminophen, interference 10.4% was not observed. Element? BGMS glucose was higher than CLM levels by 3.2 mg/dl (at 200 mg/dl) to 8.2 mg/dl (at 100 mg/dl). The minimum specification for bias (3.3%) was met at 140 and 200 mg/l glucose. In the Clarke and consensus error grids, 100% of specimens were within zone A and B. For Element? BGMS values, 92.9% (78/84) to 94.0% (79/84) were within a 15 mg/dl ( 100 mg/dl) of the average CLM value. ConclusionElement? BGMS was considered an appropriate SMBG for home use; however, the positive bias at low-to-mid glucose levels requires further improvement.