Harrison B, Markes R, Bradley P, Ismail I A
Bayer Corporation, Diagnostics Division, Elkhart, IN 46514, USA.
Clin Biochem. 1996 Dec;29(6):521-7. doi: 10.1016/s0009-9120(96)00092-6.
The objective of the study was to measure the performance of the Glucometer Elite, a technique-independent device for self-monitoring of capillary blood glucose. Several potential sources of error were incorporated into the study, including variability between lots, the age of a lot, variability between subjects, and variability between strips.
The Glucometer Elite was tested using capillary samples from 86 individuals. Duplicate readings with each of 8 sensor lots were done for each participant. Glucometer Elite readings were compared to YSI capillary plasma equivalent values, and the data was evaluated using a variety of both technical and clinical analysis methods.
All evaluation methods showed excellent agreement between the Glucometer Elite and the YSI plasma equivalent values.
The Glucometer Elite system provides accurate and clinically valuable information to the diabetic home tester.
本研究的目的是评估血糖仪精英版的性能，这是一种用于自我监测毛细血管血糖的技术独立设备。研究纳入了几个潜在的误差来源，包括批次间的变异性、批次的使用期限、受试者间的变异性以及试纸间的变异性。
使用来自86名个体的毛细血管样本对血糖仪精英版进行测试。为每位参与者对8个传感器批次中的每一批进行重复读数。将血糖仪精英版的读数与YSI毛细血管血浆等效值进行比较，并使用各种技术和临床分析方法对数据进行评估。
所有评估方法均显示血糖仪精英版与YSI血浆等效值之间具有极好的一致性。
血糖仪精英版系统为糖尿病家庭检测者提供了准确且具有临床价值的信息。
