罗氏便携式血糖仪的性能评价

Performance evaluation of roche portable glucose instrument

目的比较便携式血糖仪和全自动生化仪测定患者血糖结果的一致性,评价该院血糖仪测定血糖的准确度,为临床提供可靠的诊断依据。方法使用覆盖血糖仪线性范围的5个不同水平的样本,分别用血糖仪和生化仪进行测定,计算出偏倚以及偏倚%,分别取高、中、低3个水平样本用其中1台血糖仪连续检测同一标本共20次,记录血糖仪检测结果并计算均值及变异系数(CV%)。结果罗氏血糖仪检测高中低水平样本结果重复性好,精密度高,CV值2.04%~3.86%,本院35台血糖仪与生化仪比对结果均为可接受,通过率为100%,而血糖仪和生化分析仪检测血糖的相关系数为0.999988,约接近于1。结论全自动生化仪与罗氏血糖仪检测血糖高度相关,都能得到有效的结果,就快速、便捷来讲,血糖仪具有很好的优势,值得临床上广泛应用。但血糖仪测定结果与实验室检查结果相比还是有一定差异,所以血糖仪不能用于诊断糖尿病只能作为一个过筛和监测血糖的仪器。

Objective Compare the consistency of blood glucose results of clinical patients measured by portable glucose meter and automatic biochemical instrument,evaluate the accuracy of blood glucose measured by glucose meter,and provide reliable diagnosis basis for clinical. Methods The comparison samples of 5 different concentrations covering the linear range of the glucose meter were measured with the glucose meter and biochemical analyzer respectively,and the bias and the percent of bias were calculated.Two high,medium and low concentration samples were used to detect the same specimen 20 times in a row.The results were recorded and the mean and coefficient of variation( CV %) were calculated. Results The results of Roche blood glucose test were good repeatability and high precision.The CV value 2.04%-3.86%.The results of 35 blood glucose meters and biochemical analyzer in the hospital were acceptable,the pass rate is 100%.The correlation coefficient between the results of rapid glucose meter and biochemical analysis was 1. Conclusion Both conventional biochemical instrument and rapid glucose meter can achieve obvious results in blood glucose test of patients.In terms of speed and convenience,rapid glucose meter has a good advantage and is worthy of wide clinical application.However,there are still differences with the results of laboratory tests,which cannot be used to diagnose diabetes but only as a screening and monitoring experiment.