title: Accuracy and precision evaluation of seven self-monitoring blood glucose systems.
abstract: BACKGROUND
  Self-monitoring blood glucose (SMBG) systems play a critical role in management of diabetes. SMBG systems should at least meet the minimal requirement of the World Health Organization's ISO 15197:2003. For tight glycemic control, a tighter accuracy requirement is needed.
  
  
  METHODS
  Seven SMBG systems were evaluated for accuracy and precision: Bionime Rightest(™) GM550 (Bionime Corp., Dali City, Taiwan), Accu-Chek(®) Performa (Roche Diagnostics, Indianapolis, IN), OneTouch(®) Ultra(®)2 (LifeScan Inc., Milpitas, CA), MediSense(®) Optium(™) Xceed (Abbott Diabetes Care Inc., Alameda, CA), Medisafe (TERUMO Corp., Tokyo, Japan), Fora(®) TD4227 (Taidac Technology Corp., Wugu Township, Taiwan), and Ascensia Contour(®) (Bayer HealthCare LLC, Mishawaka, IN). The 107 participants (44 men and 63 women) were between 23 and 91 years old. The analytical results of seven SMBG systems were compared with those of plasma analyzed with the hexokinase method (Olympus AU640, Olympus America Inc., Center Valley, PA).
  
  
  RESULTS
  The imprecision of the seven blood glucose meters ranged from 1.1% to 4.7%. Three of the seven blood glucose meters (42.9%) fulfilled the minimum accuracy criteria of ISO 15197:2003. The mean absolute relative error value for each blood glucose meter was calculated and ranged from 6.5% to 12.0%.
  
  
  CONCLUSIONS
  More than 40% of evaluated SMBG systems meet the minimal accuracy criteria requirement of ISO 15197:2003. However, considering tighter criteria for accuracy of ±15%, only the Bionime Rightest GM550 meets this requirement. Because SMBG systems play a critical role in management of diabetes, manufacturers have to strive to improve accuracy and precision and to ensure the good quality of blood glucose meters and test strips.
authors.affiliation: Department of Clinical Laboratory, Tai-An Hospital, Taichung, Taiwan.
authors.forename: Chih-Yi
authors.initials: CY
authors.lastname: Kuo
authors.forename: Cheng-Teng
authors.initials: CT
authors.lastname: Hsu
authors.forename: Cheng-Shiao
authors.initials: CS
authors.lastname: Ho
authors.forename: Ting-En
authors.initials: TE
authors.lastname: Su
authors.forename: Ming-Hsun
authors.initials: MH
authors.lastname: Wu
authors.forename: Chau-Jong
authors.initials: CJ
authors.lastname: Wang
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation*; D048909:Diabetes Complications / Q000517:prevention & control; D003920:Diabetes Mellitus / Q000097:blood* / Q000188:drug therapy; D004867:Equipment Design; D005260:Female; D017408:Guidelines as Topic; D006801:Humans; D006943:Hyperglycemia / Q000175:diagnosis; D007003:Hypoglycemia / Q000175:diagnosis; D008297:Male; D008422:Materials Testing; D008875:Middle Aged; D011786:Quality Control; D011934:Reagent Strips; D015203:Reproducibility of Results; D014481:United States; D014486:United States Food and Drug Administration; D014944:World Health Organization; D055815:Young Adult
chemical_list: D011934:Reagent Strips