Department of Clinical Laboratory, Tai-An Hospital, Taichung, Taiwan.
Diabetes Technol Ther. 2011 May;13(5):596-600. doi: 10.1089/dia.2010.0223. Epub 2011 Mar 15.
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.
自我监测血糖 (SMBG) 系统在糖尿病管理中起着至关重要的作用。SMBG 系统至少应符合世界卫生组织 ISO 15197:2003 的最低要求。为了实现严格的血糖控制，需要更严格的准确性要求。
评估了七种 SMBG 系统的准确性和精密度：Bionime Rightest(™) GM550（Bionime 公司，台湾大理市）、Accu-Chek(®) Performa（罗氏诊断公司，印第安纳波利斯，IN）、OneTouch(®) Ultra(®)2（LifeScan 公司，米尔皮塔斯，CA）、MediSense(®) Optium(™) Xceed（雅培糖尿病护理公司，阿拉米达，CA）、Medisafe（TERUMO 公司，东京，日本）、Fora(®) TD4227（台达科技公司，台湾武古乡）和 Ascensia Contour(®)（拜耳健康护理有限责任公司，米沙沃卡，IN）。107 名参与者（44 名男性和 63 名女性）年龄在 23 至 91 岁之间。七种 SMBG 系统的分析结果与使用己糖激酶法（奥林巴斯 AU640，奥林巴斯美国公司，中心谷，PA）分析的血浆结果进行了比较。
七种血糖仪的不精密度范围为 1.1%至 4.7%。七种血糖仪中有三种（42.9%）符合 ISO 15197:2003 的最低准确性标准。计算了每种血糖仪的平均绝对相对误差值，范围为 6.5%至 12.0%。
超过 40%的评估 SMBG 系统符合 ISO 15197:2003 的最低准确性标准要求。然而，考虑到更严格的 ±15%准确性标准，只有 Bionime Rightest GM550 符合这一要求。由于 SMBG 系统在糖尿病管理中起着至关重要的作用，制造商必须努力提高准确性和精密度，并确保血糖仪和测试条的质量良好。
