Goodman Michael, Bercker Sven, Breitenbeck Nancy, Canada-Vilalta Cristina, Canepa Daisy D, Clarke William A, Farnsworth Christopher W, Ganser Edward O, Geerts Nienke, Goldsmith Barbara, Headden Gary, Hoppensteadt Debra, Klapperich Birgit, Matika Ryan, Miles Gabrielle, Mukhopadhyay Sagori, Nichols James H, O'Dell Rebecca M, Rafique Zubaid, Schuetzenmeister Andre, Slingerland Robbert, Stankiewicz Ann F, Swanson Jonathan R, Tran Nam K, Wu Alan H B, Karon Brad S
Department of Surgery, University of Cincinnati, Cincinnati, OH, USA.
Department of Anesthesiology and Critical Care Medicine, University Hospital, Leipzig, Germany.
J Diabetes Sci Technol. 2025 May 31:19322968251325873. doi: 10.1177/19322968251325873.
Evaluation of the performance of Cobas 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.
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 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.
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 pO, 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.
BGMSA was effective for determining blood glucose in venous, arterial, neonatal arterial, neonatal heel stick, and capillary WB samples.
评估Cobas Pulse（德国曼海姆罗氏诊断有限公司）的性能，这是一种新型血糖（BG）监测系统（BGMS；此处称为BGMSA），旨在供即时检验操作人员在各种临床环境中使用患者样本进行即时检验。
收集非重症和重症监护环境下患者的动脉血、毛细血管血、静脉血或足跟全血（WB）样本，使用BGMSA、Nova StatStrip BGMS（美国马萨诸塞州沃尔瑟姆的Nova Biomedical公司；此处称为BGMSB）和己糖激酶比较仪（Cobas 6000分析仪系列；德国曼海姆罗氏诊断有限公司）进行分析。根据美国食品药品监督管理局的指导标准评估血糖测量准确性。
介绍了两项研究。第一项研究中，从美国14个地点和欧洲3个地点的1577名患者中收集了2678份样本（622份动脉血、706份毛细血管血、1203份静脉血、147份足跟血）。综合所有数据来看，动脉血和静脉血样本均符合所有准确性标准。在动脉血、静脉血和足跟血检测中，BGMSA的准确性优于BGMSB；在毛细血管WB与静脉比较样本检测中，BGMSA的结果与BGMSB相似。未发现来自氧分压、血细胞比容和钠的内源性干扰。在单独分析以及与极端血细胞比容联合分析用于显示广泛葡萄糖浓度范围内准确性的人工合成样本时，BGMSA也具有准确性。在第二项研究中，在美国一个地点采集的117份毛细血管指尖血样本同时用BGMSA和比较仪进行测量，所有准确性标准均得到满足。通过糖尿病技术协会误差网格未观察到临床显著的医疗风险。
BGMSA在测定静脉血、动脉血、新生儿动脉血、新生儿足跟血和毛细血管WB样本中的血糖方面有效。
