title: Analytical Performance Evaluation of Infopia Element™ Auto-coding Blood Glucose Monitoring System for Self-Monitoring of Blood Glucose.
abstract: 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 + 0.984x, 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.
  
  
  CONCLUSIONS
  Element™ BGMS was considered an appropriate SMBG for home use; however, the positive bias at low-to-mid glucose levels requires further improvement.
authors.affiliation: Department of Laboratory Medicine, Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Bucheon-si Gyeonggi-do, Republic of Korea.|Catholic Laboratory Development and Evaluation Center, Clinical Research Coordinating Center, Catholic Medical Center, Seoul, Republic of Korea.
authors.forename: Hae-Il
authors.initials: HI
authors.lastname: Park
authors.affiliation: Division of Endocrinology and Metabolism, Department of Internal Medicine, Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Bucheon-si Gyeonggi-do, Republic of Korea.
authors.forename: Seong-Su
authors.initials: SS
authors.lastname: Lee
authors.affiliation: Division of Endocrinology and Metabolism, Department of Internal Medicine, Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Bucheon-si Gyeonggi-do, Republic of Korea.
authors.forename: Jang-Won
authors.initials: JW
authors.lastname: Son
authors.affiliation: Division of Endocrinology and Metabolism, Department of Internal Medicine, Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Bucheon-si Gyeonggi-do, Republic of Korea.
authors.forename: Hee-Sun
authors.initials: HS
authors.lastname: Kwon
authors.affiliation: Division of Endocrinology and Metabolism, Department of Internal Medicine, Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Bucheon-si Gyeonggi-do, Republic of Korea.
authors.forename: Sung Rae
authors.initials: SR
authors.lastname: Kim
authors.affiliation: Department of Laboratory Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.|Catholic Laboratory Development and Evaluation Center, Clinical Research Coordinating Center, Catholic Medical Center, Seoul, Republic of Korea.
authors.forename: Hyojin
authors.initials: H
authors.lastname: Chae
authors.affiliation: Department of Laboratory Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.|Catholic Laboratory Development and Evaluation Center, Clinical Research Coordinating Center, Catholic Medical Center, Seoul, Republic of Korea.
authors.forename: Myungshin
authors.initials: M
authors.lastname: Kim
authors.affiliation: Department of Laboratory Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.|Catholic Laboratory Development and Evaluation Center, Clinical Research Coordinating Center, Catholic Medical Center, Seoul, Republic of Korea.
authors.forename: Yonggoo
authors.initials: Y
authors.lastname: Kim
authors.affiliation: Division of Endocrinology and Metabolism, Department of Internal Medicine, Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Bucheon-si Gyeonggi-do, Republic of Korea. sjyoo@catholic.ac.kr.
authors.forename: Soonjib
authors.initials: S
authors.lastname: Yoo
mesh_terms: D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000032:analysis*; D015190:Blood Glucose Self-Monitoring / Q000379:methods*; D003920:Diabetes Mellitus / Q000097:blood* / Q000175:diagnosis; D005260:Female; D006801:Humans; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D012016:Reference Values; D015203:Reproducibility of Results; D012189:Retrospective Studies; D012680:Sensitivity and Specificity
chemical_list: D001786:Blood Glucose
keywords: accuracy; blood glucose monitoring system; evaluation; self-monitoring of blood glucose