便携式血糖仪与全自动生化仪的生化结果比较和实验分析

Comparison and experimental analysis of biochemical results between portable blood glucose meter and automatic biochemical analyzer

目的为了保证临床科室便携式血糖仪的规范使用,让临床科室人员更加便捷快速对患者进行血糖的即时检测(POCT),对全院28台三诺金智型血糖仪进行准确度和精密度的检验。方法选取高、中、低及两个随机共5个水平的肝素抗凝静脉血进行血糖检测,结果与检验科日立7180全自动生化仪的血糖项目进行生化比对,准确度通过偏倚和相对偏倚来判断,精密度通过均值、变异系数和标准差来判断。结果28台三诺金智血糖仪的结果与日立7180全自动生化仪的结果采用SPSS13.0软件进行统计分析。以7180生化仪为标准计算血糖的偏倚和相对偏倚,其准确度符合ISO15197:2003、GB/T19634-2005的标准,与生化仪的结果比较,当血糖仪的结果<4.2 mmoL/L时,偏倚≤±0.83mol/L,当血糖仪的结果≥4.2 mmoL/L时,相对偏倚≤±20.00%;同一水平检测10次,检测高低两个水平,计算其均值、标准差和变异系数,结果显示:当血糖浓度<5.5 mmoL/L时,标准差(SD)应<0.42 mmol/L;当血糖浓度≥5.5 mmol/L时,变异系数(CV)应<7.50%。结论28台血糖仪的准确度和精密度均符合我国的POCT血糖仪应用准则与国际标准,但与生化仪结果比对仍有一定差异,只能用于临床床旁的快速血糖筛查,不能作为确诊试验。

Objective In order to ensure the standard use of portable blood glucose meters in clinical departments,and make the clinical department staff more convenient and fast for Point of care testing(POCT),the accuracy and precision of 28 sannuojin intelligent blood glucose meters in the hospital were tested.Methods Five levels of heparin anticoagulant venous blood were selected for blood glucose detection.The results were compared with the blood glucose items of Hitachi 7180 automatic biochemical analyzer.The accuracy was judged by bias and relative bias,and the precision was judged by mean value,coefficient of variation and standard deviation.Results The results of 28 sannuojinzhi blood glucose meters and Hitachi 7180 automatic biochemical analyzer were analyzed by SPSS 13.0 software.The results of Hitachi 7180 automatic biochemical analyzer were used as the standard to calculate the bias and relative bias of blood glucose.The accuracy was in accordance with the standards of iso15197:2003 and GB/t19634-2005.Compared with the results of biochemical analyzer,when the results of blood glucose analyzer were less than 4.2 mmol/L,the bias was≤±0.83 mol/L,when the result of blood glucose meter is≥4.2 mmol/L,the relative bias is<±20.00%;when the same level is detected 10 times,the two levels of high and low are detected,and the mean value,standard deviation and coefficient of variation are calculated.The results show that when the concentration of blood glucose is less than 5.5 mmol/L,the standard deviation(SD)should be less than 0.42 mmol/L;when the concentration of blood glucose is less than 5.5 mmol/L When the concentration of blood glucose≥5.5 mmol/L,the coefficient of variation(CV)should be<7.50%.Conclusion The accuracy and precision of 28 blood glucose meters are in line with the application standards and international standards of POCT blood glucose meter in China.However,there are still some differences with the results of biochemical instrument.They can only be used for the rapid blood glucose screening by clinical bed,and can not be used as diagnosis test.