Multicenter Evaluation of a New Strip-Based Blood Glucose System for Point-of-Care Testing in Critical and Non-Critical Care Settings

被引：0

作者：

Goodman, Michael ^{[1
]}

Bercker, Sven ^{[2
]}

Breitenbeck, Nancy ^{[3
]}

Canada-Vilalta, Cristina ^{[4
]}

Canepa, Daisy D. ^{[5
]}

Clarke, William A. ^{[6
]}

Farnsworth, Christopher W. ^{[7
]}

Ganser, Edward O. ^{[8
]}

Geerts, Nienke ^{[9
]}

Goldsmith, Barbara ^{[10
]}

Headden, Gary ^{[11
]}

Hoppensteadt, Debra ^{[12
]}

Klapperich, Birgit ^{[5
]}

Matika, Ryan ^{[13
]}

Miles, Gabrielle ^{[14
]}

Mukhopadhyay, Sagori ^{[15
]}

Nichols, James H. ^{[16
]}

O'Dell, Rebecca M. ^{[4
]}

Rafique, Zubaid ^{[17
]}

Schuetzenmeister, Andre ^{[18
]}

Slingerland, Robbert ^{[19
]}

Stankiewicz, Ann F. ^{[4
]}

Swanson, Jonathan R. ^{[20
]}

Tran, Nam K. ^{[21
]}

Wu, Alan H. B. ^{[22
]}

Karon, Brad S. ^{[23
]}

机构：

[1] Univ Cincinnati, Dept Surg, 231 Albert Sabin Way,ML 0558, Cincinnati, OH 45267 USA

[2] Univ Hosp, Dept Anesthesiol & Crit Care Med, Leipzig, Germany

[3] NB Res Inc, Indianapolis, IN USA

[4] Roche Mol Syst Inc, Indianapolis, IN USA

[5] Roche Diagnost Int AG, Rotkreuz, Switzerland

[6] Johns Hopkins Univ, Sch Med, Dept Pathol, Baltimore, MD USA

[7] Washington Univ Sch Med, Dept Pathol, Immunol, St Louis, St. Louis, MO USA

[8] Roche Diabet Care Inc, Indianapolis, IN USA

[9] Catharina Hosp, Clin Lab, Eindhoven, North Brabant, Netherlands

[10] Thomas Jefferson Univ, Dept Pathol & Genom Med, Philadelphia, PA USA

[11] Med Univ South Carolina, Emergency Med, Charleston, SC USA

[12] Loyola Univ Chicago, Mol Pharmacol & Neurosci, Chicago, IL USA

[13] Univ Arizona Hlth Network, Dept Anesthesiol, Tucson, AZ USA

[14] Roche Diagnost Operat Inc, Indianapolis, IN USA

[15] Childrens Hosp Philadelphia, Dept Pediat, Philadelphia, PA USA

[16] Vanderbilt Univ, Med Ctr, Dept Pathol Microbiol & Immunol, Nashville, TN USA

[17] Ben Taub Gen Hosp, Baylor Coll Med, Dept Emergency Med, Houston, TX USA

[18] Roche Diagnost GmbH, Biostat & Data Sci, Penzberg, Germany

[19] Isala Klin, Zwolle, Netherlands

[20] Univ Virginia, Childrens Hosp, Dept Pediat, Charlottesville, VA USA

[21] Univ Calif Davis Hlth, Dept Pathol & Lab Med, Sacramento, CA USA

[22] Univ Calif San Francisco, San Francisco, CA USA

[23] Mayo Clin, Dept Lab Med & Pathol, Div Clin Core Lab Serv, Rochester, MN USA

来源：

JOURNAL OF DIABETES SCIENCE AND TECHNOLOGY | 2025年

关键词：

accuracy; blood glucose monitoring systems; critical care; point-of-care; HYPERGLYCEMIA; HYPOGLYCEMIA; TOLERANCE;

D O I：

10.1177/19322968251325873

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Background: Evaluation of the performance of Cobas (R) Pulse (Roche Diagnostics GmbH, Mannheim, Germany), a new blood glucose (BG) monitoring system (BGMS; referred to here as BGMSA) intended for point-of-care testing using samples from patients in diverse clinical settings by intended point-of-care test operators.Methods: Arterial, capillary, venous, or heel stick whole blood (WB) samples from patients in non-critical and critical care settings were collected and analyzed using BGMSA and the Nova StatStrip (R) BGMS (Nova Biomedical, Waltham, MA; referred to here as BGMSB), and a hexokinase comparator (Cobas 6000 Analyzer Series; Roche Diagnostics GmbH). The blood glucose measurement accuracy was assessed by the Food and Drug Administration guidance criteria.Results: Two studies are presented. In the first, 2678 samples (622 arterial, 706 capillary, 1203 venous, 147 heel stick) were collected from 1577 patients in 14 US and three European sites. All accuracy criteria were met for arterial and venous samples considering all data combined. BGMSA showed better accuracy than BGMSB for arterial, venous, and heel stick, and similar results to BGMSB for capillary WB vs venous comparator. No endogenous interference from pO2, hematocrit, and sodium was identified. BGMSA was also accurate when analyzing contrived samples used to show accuracy over a wide range of glucose concentrations, alone and when combined with extreme hematocrit. In the second study, 117 capillary fingerstick samples collected at one US site were measured on both BGMSA and the comparator, and all accuracy criteria were met. No clinically significant medical risks were observed via Diabetes Technology Society Error Grids.Conclusions: BGMSA was effective for determining blood glucose in venous, arterial, neonatal arterial, neonatal heel stick, and capillary WB samples.

引用

页数：10

共 33 条

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