【摘要】 目的:应用美国临床和实验室标准协会(CLSI)方案对快速血糖仪作初步性能评价并与检验科生化仪测定结果作可比性研究。方法:以美国Nova StatStrip快速血糖仪为例,采用CLSI的指南文件EP9-A和EP10-A的评价方案,检测来自临床的血标本,所有数据均输入按EP9-A、EP10-A文件公式编制的程序,电脑自动绘制各相关图表并给出各种参数。结果:本次实验所有的数据均无离群点存在。血糖值为24.65、12.79、1.25 mmol/L的全血在快速血糖仪上检测总不精密度分别为3.24%、4.85%、4.23%。多元回归方程的回归参数斜率、截距、交叉污染、非线性、漂移性均无统计学意义。检验科日立7600生化分析仪和美国Nova StatStrip快速血糖仪两种检测方法之间的回归方程Y=0.9506X+0.1089,相关系数(r)为0.9941。在医学决定水平处两方法的预期偏差分别为1.05%、3.38%、3.95%。结论:美国Nova StatStrip快速血糖仪的初步性能评价符合要求,与检验科日立7600生化分析仪的检测结果预期偏差小,远远小于中国临床检验标准化委员会有关便携式血糖仪测定指南所要求的±15%,该仪器可为临床接受。CLSI方案评价全面,可衡量快速血糖仪的检测质量。更多还原

【Abstract】 Objective:To value the performance of blood glucose meter and study the comparability between the auto-analyzer and glucose meter.Methods:According to the EP9-A and EP10-A evaluation standard of clinical and laboratory standards institute(CLSI),the blood samples collected from patients were detected by Nova StatStrip glucose meter(US).The data were inputted into computer and disposed according to the formula of the EP9-A and EP10-A,then get the charts and parameters automatically.Results:No outliers were found in our data.The imprecision of the glucose meter are 3.24%,4.85%,4.23% separately,corresponding the 24.65,12.79,1.25 mmol/L glucose level.There are no statistic values in the regression parameters including slope,intercept,cross-contamination,nonlinearity and drift.The regression formula between Nova StatStrip glucose meter and Hitachi biochemical auto-analyzer 7600 is Y=0.9506X+0.1089,correlation coefficient(r) is 0.9941.Expected deviations of the two methods in clinical decision level is 1.05%,3.38%,3.95% respectively.Conclusion:The primary performance of Nova StatStrip glucose meter is up to the requirement.The expected deviation value of the glucose meter and Hitachi biochemical auto-analyzer 7600 is less than ±15% which is required by national clinical laboratory standardization committee for portable glucose meter.It indicates that Nova StatStrip glucose meter(US) is admitted by clinic,CLSI method is credible to value the glucose meter.更多还原