Hsu Cheng-Teng, Wu Ming-Hsun, Kuo Chih-Yi, Zen Jyh-Myng
School of Medical Laboratory and Biotechnology, Chung Shan Medical University, Taichung, Taiwan.
Department of Laboratory Medicine, Min Sheng Hospital, Taoyuan, Taiwan.
Clin Chim Acta. 2014 Nov 1;437:62-5. doi: 10.1016/j.cca.2014.07.003. Epub 2014 Jul 9.
In response to the problem of erroneous readings due to miscoding when performing self-monitoring blood glucose (SMBG), this study introduces a user-friendly SMBG biosensor with an innovative auto-coding module on the meter and strip. Actual users characterized the performance of the SMBG systems.
A total of 105 patients were incorporated in the study and Clarke error grid analysis (EGA) was administered to evaluate the clinical accuracy of the results obtained by the patients versus the technicians. All patients used the questionnaires to comment on the use of the auto-coding sensor.
In the imprecision test, the total CV of the 5 BG levels was 2.1%. In the EGA plot, the results of the auto-coding sensor were 96.2%, both lots A and B, in zone A for the patients and 99.0% and 97.1% for the technician. The paired t-test demonstrated no statistically significant difference between the patient and technician measurements. Regression analysis also demonstrated that the measurements taken by the patients agreed with those obtained using the laboratory method.
The patients achieved satisfactory performance using the auto-coding SMBG sensor and derived similar results with both laboratory reference and operation by a technician.
为应对自我血糖监测（SMBG）过程中因编码错误导致读数错误的问题，本研究推出了一种用户友好型的SMBG生物传感器，其血糖仪和试纸条上带有创新的自动编码模块。实际用户对SMBG系统的性能进行了表征。
共有105名患者纳入本研究，并采用克拉克误差网格分析（EGA）来评估患者与技术人员所获结果的临床准确性。所有患者都使用问卷对自动编码传感器的使用情况进行评价。
在不精密度测试中，5个血糖水平的总变异系数为2.1%。在EGA图中，自动编码传感器的结果，A批次和B批次对于患者而言在A区的比例均为96.2%，对于技术人员而言分别为99.0%和97.1%。配对t检验表明患者和技术人员的测量结果之间无统计学显著差异。回归分析还表明，患者的测量结果与采用实验室方法获得的结果一致。
患者使用自动编码SMBG传感器取得了令人满意的性能，并且无论是与实验室参考结果还是技术人员操作的结果相比，都得出了相似的结果。
