Impaired clinical utility of sequential patient GEM blood gas measurements associated with calibration schedule

Cembrowski, George S.; Xu, Qian; Cembrowski, Adam R.; Mei, Junyi; Sadrzadeh, Hossein

doi:10.1016/j.clinbiochem.2017.03.014

Cited by 8 publications

(3 citation statements)

References 6 publications

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“…“Big data” retrospective studies such as ours are very important as they provide unique views of accuracy and imprecision that are virtually impossible to replicate with all of the current method evaluation approaches. These data, however, have validated our hypothesis about two periods of testing in the GEM 4000, an early morning optimal period and the other 18 hours when factitious trends may be encountered due to consecutive intrapatient samples being assayed on two GEMs rather than repeated on the same analyzer (repeat Reference 9 ).…”

Section: Discussionsupporting

confidence: 61%

“…validated our hypothesis about two periods of testing in the GEM 4000, an early morning optimal period and the other 18 hours when factitious trends may be encountered due to consecutive intrapatient samples being assayed on two GEMs rather than repeated on the same analyzer (repeat Reference 9 ).…”

Section: Declaration Of Conflicting Interestssupporting

confidence: 67%

“…It is the only GEM process control solution that is run every 24 hours and suspicions increase given the fact that it is generally run at 0200, concurrent with the beginning of the more accurate testing. Once this solution is run, the imprecision of the analyzers drops to highly acceptable levels and both GEMs produce concordant results for the next few hours; subsequently, the imprecision increases, 9 with the imprecision's effects amplified when multiple analyzers analyze serial intrapatient samples. 1,2 The North Star for glucose measurement improvement has been the ever-tightening consensus guidelines for glucose measurement accuracy.…”

Section: Introductionmentioning

confidence: 99%

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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

Cembrowski

Jung

Mei

et al. 2019

J Diabetes Sci Technol

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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.

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Section: Discussionsupporting

confidence: 61%

Section: Declaration Of Conflicting Interestssupporting

confidence: 67%