Accuracy and precision evaluation of seven self-monitoring blood glucose systems.

doi:10.1089/dia.2010.0223

中山醫學大學機構典藏 CSMUIR > 醫學院 > 生化微生物免疫研究所 > 期刊論文 > Item 310902500/10727

Please use this identifier to cite or link to this item: https://ir.csmu.edu.tw:8080/ir/handle/310902500/10727

Title:	Accuracy and precision evaluation of seven self-monitoring blood glucose systems.
Authors:	Kuo, Chih-Yi Hsu, Cheng-Teng Ho, Cheng-Shiao Su, Ting-En Wu, Ming-Hsun Wang, Chau-Jong
Contributors:	中山醫學大學
Date:	2011
Issue Date:	2015-05-04T10:43:42Z (UTC)
ISSN:	1520-9156
Abstract:	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. 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). 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%. 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. Accuracy and precision evaluation of seven self-monitoring blood glucose systems. - ResearchGate. Available from: http://www.researchgate.net/publication/50398069_Accuracy_and_precision_evaluation_of_seven_self-monitoring_blood_glucose_systems [accessed May 4, 2015].
URI:	https://ir.csmu.edu.tw:8080/ir/handle/310902500/10727 http://dx.doi.org/10.1089/dia.2010.0223
Relation:	Diabetes Technology & Therapeutics (Impact Factor: 2.29). 03/2011; 13(5):596-600.
Appears in Collections:	[生化微生物免疫研究所] 期刊論文

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