Louie R F, Tang Z, Sutton D V, Lee J H, Kost G J
Department of Medical Pathology, University of California, Davis, USA.
Arch Pathol Lab Med. 2000 Feb;124(2):257-66. doi: 10.5858/2000-124-0257-POCGT.
To assess the clinical performance of glucose meter systems when used with critically ill patients.
Two glucose meter systems (SureStepPro and Precision G) and a modular adaptation (Immediate Response Mobile Analysis-SureStepPro) were assessed clinically using arterial samples from critically ill patients. A biosensor-based analyzer (YSI 2700) and a hospital chemistry analyzer (Synchron CX-7) were the primary and secondary reference instruments, respectively.
Two hundred forty-seven critical care patients at the University of California, Davis, Medical Center participated in this study.
Error tolerances of +/-15 mg/dL for glucose levels </=100 mg/dL and +/-15% for glucose levels >100 mg/dL were used to evaluate glucose meter performance; 95% of glucose meter measurements should fall within these tolerances.
Compared to the primary reference method, 98% to 100% of SureStepPro and 91% to 95% of Precision G measurements fell within the error tolerances. Paired differences of glucose measurements versus critical care variables (Po(2), pH, Pco(2), and hematocrit) were analyzed to determine the effects of these variables on meter measurements. Po(2) and Pco(2) decreased Precision G and SureStepPro measurements, respectively, but not enough to be clinically significant based on the error tolerance criteria. Hematocrit levels affected glucose measurements on both meter systems. Modular adaptation did not affect test strip performance.
Glucose meter measurements correlated best with primary reference instrument measurements. Overall, both glucose meter systems showed acceptable performance for point-of-care testing. However, the effects of some critical care variables, especially low and high hematocrit values, could cause overestimated or underestimated glucose measurements.
评估血糖仪系统用于重症患者时的临床性能。
使用来自重症患者的动脉样本，对两种血糖仪系统（SureStepPro和Precision G）以及一种模块化适配装置（即时响应移动分析 - SureStepPro）进行临床评估。基于生物传感器的分析仪（YSI 2700）和医院化学分析仪（Synchron CX - 7）分别作为主要和次要参考仪器。
加利福尼亚大学戴维斯分校医学中心的247名重症监护患者参与了本研究。
血糖水平≤100 mg/dL时误差容限为±15 mg/dL，血糖水平>100 mg/dL时误差容限为±15%，用于评估血糖仪性能；95%的血糖仪测量值应在这些容限范围内。
与主要参考方法相比，SureStepPro测量值的98%至100%以及Precision G测量值的91%至95%落在误差容限范围内。分析血糖测量值与重症监护变量（氧分压、pH值、二氧化碳分压和血细胞比容）的配对差异，以确定这些变量对血糖仪测量的影响。氧分压和二氧化碳分压分别降低了Precision G和SureStepPro的测量值，但根据误差容限标准，降低幅度不足以具有临床意义。血细胞比容水平影响两种血糖仪系统的血糖测量。模块化适配未影响试纸条性能。
血糖仪测量值与主要参考仪器测量值的相关性最佳。总体而言，两种血糖仪系统在床旁检测中均表现出可接受的性能。然而，一些重症监护变量的影响，尤其是血细胞比容值过高或过低，可能导致血糖测量值被高估或低估。
