Adelhelm Josefine B H, Jørgensen Charlotte S, Hansen Heidi B, Østertoft Stine B, Nybo Mads, Jørgensen Louise H
Department of Clinical Biochemistry, Odense University Hospital, Odense, Denmark.
Scand J Clin Lab Invest. 2025;85(4):275-280. doi: 10.1080/00365513.2025.2512382. Epub 2025 May 30.
The aim of this study was to validate the blood glucose point-of-care system, cobas pulse (Roche Diagnostics GmbH), which is the successor to the Accu-Chek Inform II system (Roche Diagnostics GmbH). Since the cobas pulse device is intended to replace an existing device from the same manufacturer, we found it highly relevant to perform an industry-independent validation regarding accuracy and comparability with existing glucose measurement systems. From 40 randomly selected, non-fasting adults capillary and venous blood was drawn simultaneously. Correlation and agreement was evaluated by comparing capillary blood glucose on cobas pulse to plasma glucose on cobas 8000 (Roche Diagnostics GmbH) and capillary blood glucose on ABL800 Flex (Radiometer, Denmark), respectively. The cobas pulse generally showed good agreement with both comparison methods, although the agreement between cobas pulse and ABL800 Flex was better (bias -0.01 mmol/L) than between cobas pulse and cobas 8000 (bias 0.61 mmol/L). Differences between measurements of low blood glucose levels (range 0.5 to 4.8 mmol/L) and higher blood glucose levels (range 9.7 to 15.3 mmol/L) when comparing cobas pulse to ABL800 Flex was also within allowable limits. Altogether, the validation study demonstrated a clinically satisfactory performance of the cobas pulse point-of-care device.
本研究的目的是验证即时检测血糖系统cobas pulse（罗氏诊断有限公司），它是Accu-Chek Inform II系统（罗氏诊断有限公司）的后续产品。由于cobas pulse设备旨在取代同一制造商的现有设备，我们发现对其准确性以及与现有血糖测量系统的可比性进行独立于行业的验证具有高度相关性。从40名随机选择的非空腹成年人中同时采集毛细血管血和静脉血。通过分别比较cobas pulse上的毛细血管血糖与cobas 8000（罗氏诊断有限公司）上的血浆血糖以及ABL800 Flex（丹麦雷度米特公司）上的毛细血管血糖，评估相关性和一致性。cobas pulse与两种比较方法总体上均显示出良好的一致性，不过cobas pulse与ABL800 Flex之间的一致性（偏差 -0.01 mmol/L）优于cobas pulse与cobas 8000之间的一致性（偏差0.61 mmol/L）。在比较cobas pulse与ABL800 Flex时，低血糖水平（范围0.5至4.8 mmol/L）和高血糖水平（范围9.7至15.3 mmol/L）测量值之间的差异也在允许范围内。总之，验证研究表明cobas pulse即时检测设备在临床上具有令人满意的性能。
