Five-Year Two-Center Retrospective Comparison of Central Laboratory Glucose to GEM 4000 and ABL 800 Blood Glucose: Demonstrating the (In)adequacy of Blood Gas Glucose

Abstract

Purpose: To evaluate the glucose assays of two blood gas analyzers (BGAs) in intensive care unit (ICU) patients by comparing ICU BGA glucoses to central laboratory (CL) glucoses of almost simultaneously drawn specimens. Methods: Data repositories provided five years of ICU BGA glucoses and contemporaneously drawn CL glucoses from a Calgary, Alberta ICU equipped with IL GEM 4000 and CL Roche Cobas 8000-C702, and an Edmonton, Alberta ICU equipped with Radiometer ABL 800 and CL Beckman-Coulter DxC. Blood glucose analyzer and CL glucose differences were evaluated if they were both drawn either within ±15 or ±5 minutes. Glucose differences were assessed graphically and quantitatively with simple run charts and the surveillance error grid (SEG) and quantitatively with the 2016 Food and Drug Administration guidance document, with ISO 15197 and SEG statistical summaries. As the GEM glucose exhibits diurnal variation, CL-arterial blood gas (ABG) differences were evaluated according to time of day. Results: Compared to the GEM glucoses measured between 0200 and 0800, the run charts of (GEM-CL) glucose demonstrate significant outliers between 0800 and 0200 which are identified as moderate to severe clinical outliers by SEG analysis ( P < .002 and P < .0005 for 5- and 15-minute intervals). Over the entire 24-hour period, the rates of moderate to severe glucose clinical outliers are 3.5/1000 (GEM) and 0.6/1000 glucoses (ABL), respectively, using the 15-minute interval ( P < .0001). Discussion: The GEM ABG glucose is associated with a higher frequency of moderate to severe glucose clinical outliers, especially between 0800 and 0200, increased CL testing and higher average patient glucoses.