Production of the YSI 2300 STAT PLUS Glucose and l-Lactate Analyzer (YSI Incorporated, Yellow Springs, OH, United States) has been discontinued. This benchtop instrument is the most widely used device for determining the accuracy of products that measure blood glucose and interstitial fluid glucose. An alternate comparator instrument must now be identified by the diabetes diagnostics industry. The available products should be reviewed by parties interested in accurate, fast, low-cost comparator benchtop, or portable (nonstrip) methods using small sample volumes with good ease-of-use and human factors. Stakeholders include glucose monitor manufacturers, test labs, clinical chemists, diabetes clinicians, professional organizations, and regulators. This article presents features of eleven possible alternative instruments to be considered as comparator methods for measuring the accuracy of glucose monitors.
Keywords: FDA; YSI 2300; accuracy; comparator; glucose; reference.