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中国医疗器械杂志 2020, Vol. 44 Issue (4) :338-342    DOI: 10.3969/j.issn.1671-7104.2020.04.013
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家用、医用血糖监测系统准确度评价标准的差异性分析
宋伟,王军,续勇
北京市医疗器械检验所,北京市,101111
Difference Analysis of System Accuracy Criteria between Self-Monitoring Blood Glucose Test System and Point-of-Care Blood Glucose Monitoring Systems
SONG Wei, WANG Jun, XU Yong
Beijing Institute of Medical Device Testing, Beijing, 101111

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摘要 根据使用人群及使用地点的不同,血糖监测系统可分为家用和医用两种,美国食品药品监督管理局认为 两者操作人员不同、使用环境不同、预期用途不同,适用人群不同,其评价指标和标准应不尽相同。目 前国际上评价血糖监测系统的标准文件有国际标准化组织发布的ISO 15197:2013标准、美国食品药品监 督管理局(FDA)发布的两个关于血糖监测系统指南以及美国临床和实验室标准化协会(CLSI)发布的 POCT12-A3指南,其中ISO 15197:2013标准和FDA指南Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use适用于自测用血糖监测系统,而CLSI指南和FDA指南Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use适用于医用血糖监测系统,通过分析四个标准文件对血 糖监测系统准确度评价过程,发现医用血糖监测系统准确度评价更严格,提出家用血糖监测系统和医用血 糖监测系统应分开监管。
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关键词自测用血糖监测系统   标准   准确度     
Abstract: According to users and places, blood glucose monitoring systems(BGMSs) can be divided into self-monitoring blood glucose test systems(SMBGs) and Point-of-Care Blood Glucose monitoring systems(POC-BGMSs). The Food and Drug Administration(FDA) believes that standards for SMBGs and POC-BGMSs should be different because of different operators, different use environments, different intendance uses and different applicable populations. Now the international standards for evaluating BGMSs include ISO 15197:2013 issued by International Organization for Standardization(ISO), two guidelines on blood glucose monitoring systems issued by FDA, and POCT12-A3 guidelines issued by the American Association for Clinical and Laboratory Standardization(CLSI), ISO standard and FDA guideline-OTC are applicable in SMBGs, CLSI guideline and FDA guideline-POCTI2-A3 are suitable for POC-BGMSs. By analyzing the accuracy evaluation processes of BGMSs based on four standard documents, it is found that the accuracy evaluation of medical BGMSs is more stringent. It is proposed that SMBGs and POC-BGMSs should be supervised separately.
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Received 2019-09-30;
Corresponding Authors: 王军     Email: wangjun1@bimt.org.cn
About author: 宋伟,E-mail: songwei@bimt.org.cn
引用本文:   
宋伟,王军,续勇.家用、医用血糖监测系统准确度评价标准的差异性分析[J]  中国医疗器械杂志, 2020,V44(4): 338-342
SONG Wei, WANG Jun, XU Yong.Difference Analysis of System Accuracy Criteria between Self-Monitoring Blood Glucose Test System and Point-of-Care Blood Glucose Monitoring Systems[J]  Chinese Journal of Medical Instrumentation, 2020,V44(4): 338-342
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