摘要
目的了解便携式血糖仪检测的质量,规范便携式血糖仪管理。方法对56台血糖仪进行重复性试验测试,并与OLYMPUS AU640全自动生化分析仪进行比对试验,对其结果进行分析与质量管理探讨。结果 56台血糖仪中,有9台对部分样本的重复性测试不合格,1台强生血糖仪检测4号样本(6.40 mmol/L)最大相差为12.03%,3台伯乐血糖仪检测6号样本(14.59 mmol/L)最大相差大于10%,5台伯乐血糖仪检测7号样本(9.06 mmol/L)最大相差大于10%;但56台血糖仪准确度检测都合格。结论 56台便携式血糖仪检测质量总体上是可靠的,完善的管理制度是保证血糖仪检验质量的重要措施。
Objective To investigate the detection quality of portable blood glucose meter,and to normalize its management. Methods The replicate test and the contrast test were performed on 56 portable blood glucose meters and OLYMPUS AU640 biochemical analyzer,and the results were compared and analyzed. Results The repeatability of the experiment was unqualified on some samples detected by 9 portable blood glucose meters.In the result of the contrast test between 56 portable blood glucose meters and OLYMPUS AU640 biochemical analyzer,the blood glucose difference for the fourth sample（6.40 mmol/L） was 12.03% with 1 LifeScan meters;for the sixth sample（9.06 mmol/L） exceeded 10% with 3 Bio-Rad meters.The blood glucose difference for the seventh sample（9.06 mmol/L） exceeded 10% with Bio-Rad meters.But the accuracy of the test using the 56 portable blood glucose meters was qualified. Conclusions The detection quality of the 56 portable blood glucose meters is reliable in total.The perfect quality management is the important measure to ensure the detection quality of portable blood glucose meter.
出处
《实用预防医学》
CAS
2011年第11期2046-2048,共3页
Practical Preventive Medicine
基金
郴州市第一人民医院资助科研项目(N2010-025
N2010-024)
关键词
血糖仪
重复性试验
比对试验
质量管理
Portable blood glucose meter
Replicate test
Contrast test
Quality management
