Performance of 10 Systems for Self-Monitoring of Blood Glucose by Trained Healthcare Professionals and in the Hands of the Users

[摘要] To the Editor:Accurate and reproducible blood glucose results are important for adequate therapeutic decision for people with diabetes. Few studies assessing the accuracy of systems for self-monitoring of blood glucose (SMBG)1 systems against the requirements from the International Organization for Standardization (ISO) standard 15197:2013 (1) have been published, and none of them has addressed analytical quality in the hands of the users. To our knowledge, no studies have evaluated SMBG systems against the requirements for accuracy in the new US Food and Drug Administration (FDA) draft guidance for SMBG systems for over-the-counter use (2). The aim of this study was to assess the accuracy of 10 SMBG systems under optimal conditions achieved by biomedical laboratory scientists (BLSs) and by people with diabetes against the minimum accuracy requirements specified in ISO 15197:2013, ISO 15197:2003, and FDA draft guidance.We used data from 10 SMBG system evaluations performed from 2005 to 2013 by the Scandinavian evaluation of laboratory equipment for primary healthcare (SKUP). The evaluations were carried out in line with common guidelines and standardized protocols according to international recommendations. All measurements on …

[学科分类] 过敏症与临床免疫学