916-P: Precision Evaluation of Clinical Laboratory Glucose Reference Systems

Background: In response to the discontinuation of the industry standard YSI 2300 STAT PLUS glucose analyser Lifescan, as a major manufacturer of blood glucose measurement systems, initiated a comparative evaluation of currently marketed point of care (POC) glucose measurement devices to identify a potential replacement comparator system within a clinical environment. Method: Four POC devices were selected for in-depth assessment. Glucose measurement precision is a key performance metric for a comparator device, with higher standard deviation and coefficient of variation values imparting greater measurement uncertainty to diabetes test systems. This laboratory assessment used venous whole blood samples collected in Lithium Heparin coated tubes and tested within 12 hours of blood draw. All potential sources of variation such as donor and operator were controlled to give a best-case indication of performance. Results: Precision data were generated for the YSI 2300 STAT PLUS and four POC devices. 20 replicates were obtained per device at each of four glucose concentrations (50, 100, 200 and 500 mg/dL). The Abbott i-STAT Alinity (using CG8+ cartridge) demonstrated consistently lower standard deviation and coefficient of variation values when compared to the YSI 2300 STAT PLUS and other tests systems. Conclusions: A comparison of four currently marketed POC devices indicated that only one demonstrates precision performance that is equivalent or better than the YSI 2300 STAT PLUS across a wide range of glucose concentrations and thus is a strong candidate as a replacement clinical comparator system.