Difference Analysis of System Accuracy Criteria between Self-Monitoring Blood Glucose Test System and Point-of-Care Blood Glucose Monitoring Systems.
10.3969/j.issn.1671-7104.2020.04.013
- Author:
Wei SONG
1
;
Jun WANG
1
;
Yong XU
1
Author Information
1. Beijing Institute of Medical Device Testing, Beijing, 101111.
- Publication Type:Journal Article
- Keywords:
accuracy;
self-monitoring blood glucose test system;
standards
- MeSH:
Blood Glucose;
Blood Glucose Self-Monitoring;
Point-of-Care Systems;
Reference Standards;
Reproducibility of Results;
United States;
United States Food and Drug Administration
- From:
Chinese Journal of Medical Instrumentation
2020;44(4):338-342
- CountryChina
- Language:Chinese
-
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.
