Open AccessAnalytical Performance Evaluation of Infopia Element™ Auto‐coding Blood Glucose Monitoring System for Self‐Monitoring of Blood Glucose
Author(s) -
Park Haeil,
Lee SeongSu,
Son JangWon,
Kwon HeeSun,
Kim Sung Rae,
Chae Hyojin,
Kim Myungshin,
Kim Yonggoo,
Yoo Soonjib
Publication year - 2016
Publication title -
journal of clinical laboratory analysis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.536
H-Index - 50
eISSN - 1098-2825
pISSN - 0887-8013
DOI - 10.1002/jcla.21947
Subject(s) - ascorbic acid , chemistry , glucose meter , chromatography , medicine , zoology , endocrinology , biology , diabetes mellitus , food science
Background Element™ Auto‐coding Blood Glucose Monitoring System (BGMS; Infopia Co., Ltd., Anyang‐si, Korea) was developed for self‐monitoring of blood glucose (SMBG). Methods Precision, 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. Results Coefficients 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) or 15% (> 100 mg/dl) of the average CLM value. Conclusion Element™ BGMS was considered an appropriate SMBG for home use; however, the positive bias at low‐to‐mid glucose levels requires further improvement.