Laboratory Medicine and Pathology, University of Alberta, Edmonton, AB, Canada.
CC Quality Control Consulting, Laboratory Concision, Edmonton, AB, Canada.
J Diabetes Sci Technol. 2020 May;14(3):535-545. doi: 10.1177/1932296819883260. Epub 2019 Nov 5.
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.
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.
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 ( < .002 and < .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 ( < .0001).
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.
通过比较同时采集的 ICU 血气分析仪(BGA)血糖与中心实验室(CL)血糖,评估 2 种 BGA 在 ICU 患者中的血糖检测结果。
数据存储库提供了艾伯塔省卡尔加里市配备 IL GEM 4000 和 CL Roche Cobas 8000-C702 的 ICU 以及艾伯塔省埃德蒙顿市配备 Radiometer ABL 800 和 CL Beckman-Coulter DxC 的 ICU 5 年来的 ICU BGA 血糖和同时采集的 CL 血糖数据。如果在 ±15 或 ±5 分钟内同时采集了血糖分析仪和 CL 血糖值,则评估血糖差值。使用简单运行图和监测误差网格(SEG)以及 2016 年食品和药物管理局指导文件(ISO 15197 和 SEG 统计摘要)对血糖差值进行图形和定量评估。由于 GEM 血糖存在昼夜变化,因此根据一天中的时间评估 CL-动脉血气(ABG)差值。
与 GEM 血糖在 0200 至 0800 之间的测量值相比,(GEM-CL)血糖的运行图显示,0800 至 0200 之间存在显著的离群值,SEG 分析将其识别为中度至重度临床离群值(<0.002 和<0.0005,间隔为 5 分钟和 15 分钟)。在整个 24 小时期间,使用 15 分钟间隔,中度至重度血糖临床离群值的发生率分别为每 1000 次检测 3.5 次(GEM)和 0.6 次(ABL)(<0.0001)。
GEM ABG 血糖与中度至重度血糖临床离群值的频率较高相关,尤其是在 0800 至 0200 之间,这会增加 CL 检测次数和患者平均血糖水平。