根据 ISO 15197:2003 和 ISO 15197:2013 标准对四种血糖监测系统的准确性评估。
The accuracy evaluation of four blood glucose monitoring systems according to ISO 15197:2003 and ISO 15197:2013 criteria.
机构信息
School of Clinical Medicine, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.
Department of Endocrinology, Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.
出版信息
Prim Care Diabetes. 2019 Jun;13(3):252-258. doi: 10.1016/j.pcd.2018.12.010. Epub 2019 Feb 13.
Self-monitoring of blood glucose is recommended to monitor glycaemic levels for the prevention and treatment of diabetes mellitus.The accuracy of blood glucose monitoring systems (BGMS) directly affects the health of the patients. In this study, we evaluated the accuracy of four different blood glucose monitoring systems, including Gold-Accu Meter, Nova StatStrip Xpress Glucose Hospital Meter, Freestyle Optium Neo H and Accu-Chek Performa according to ISO15197:2003 and ISO15197:2013 criteria. We found that four brands of BGMS (eight BGMS) all met the minimum requirements for system accuracy performance of ISO 15197:2003 and the accuracy criteria of ISO 15197:2013. All results of BGMS lie within zones A and B of the Consensus Error Grid (CEG). In conclusion, all BGMS met the accuracy criteria of ISO 15197:2003 and the accuracy criteria of ISO 15197:2013.
自我血糖监测被推荐用于监测血糖水平，以预防和治疗糖尿病。血糖监测系统（BGMS）的准确性直接影响患者的健康。在这项研究中，我们根据 ISO15197：2003 和 ISO15197：2013 标准评估了包括 Gold-Accu Meter、Nova StatStrip Xpress Glucose Hospital Meter、Freestyle Optium Neo H 和 Accu-Chek Performa 在内的四种不同的血糖监测系统的准确性。我们发现，四种品牌的 BGMS（八种 BGMS）均符合 ISO 15197：2003 系统准确性性能的最低要求和 ISO 15197：2013 的准确性标准。所有 BGMS 的结果均落在共识误差网格（CEG）的 A 和 B 区。总之，所有 BGMS 均符合 ISO 15197：2003 的准确性标准和 ISO 15197：2013 的准确性标准。
Zotero 插件