干化学分析仪与全自动生化分析仪葡萄糖氧化酶法测定血糖的比对分析

The Comparative Analysis on Blood Glucose Determination between Dry Chemistry Analyzer and Automatic Biochemistry Analyzer with Glucose Oxidase Method

目的探讨干化学法与全自动生化分析仪葡萄糖氧化酶法测定葡萄糖结果的可比性。方法根据美国临床和实验室标准研究院(CLSI)方法对比评价EP 9-A文件的要求,用两种检测系统即干化学法(Y)与全自动生化分析仪(X)葡萄糖氧化酶法各重复2次测定40例新鲜葡萄样品,做结果比对。结果两种检测系统回发方案:Y=1.042X-0.295,相关系数r=0.978,两系统的相关性良好。3个医学决定水平浓度(X c)下两系统间的比对试验总体符合临床要求,但在低值时不符合。两系统测定结果具有统计学差异(P<0.05),干化学法检测结果偏低。结论在测定低值血糖时要利用回归方程进行截距和斜率校准,使系统误差达到临床可接受标准。在室内质控结果不稳定时必须进行校准。干化学法仅适合于血糖的随机监测参考,而不能作为临床诊断的依据。在血糖仪检测结果接近临界值时,应以静脉血清(血浆)在生化分析仪上的检测结果为诊断参考依据。

Objective To discuss the comparability of blood glucose results between dry chemistry analyzer and automatic biochemical analyzer with glucose oxidase method.Methods According to EP 9-A file for method comparative evaluation from the American Clinical and Laboratory Standards Institute（CLSI）,40 cases of fresh samples were used to detect blood glucose by chemistry method（Y） and automatic biochemical analyzer（X） with glucose oxidase method.Each detection system was repeated 2 times per sample,and then,all the results underwent comparison.Result The regression equation of two detection systems： Y=1.042X-0.295.Correlation coefficient r=0.978,which demonstrated a good correlation.The two systems were generally consistent with the clinical requirements of the trial at three medical decision levels（Xc）.However,it was incompatible with the conditions at low-value Xc.Blood glucose results of the two systems had statistically significant difference（P0.05）.Dry chemical method results were low.Conclusion When blood glucose results are at low-value,the regression equation for the intercept and the slope of the calibration are taken advantage of so that the system error is under clinically acceptable standards.When the internal quality control results are instable,dry chemical method results must be calibrated.Dry chemical method is only suitable for random blood glucose monitor for reference,but can not serve as a basis for clinical diagnosis.In the test results of blood glucose dry chemical method close to the threshold,it should be based on venous serum（plasma） in the biochemical analyzer on the test results for diagnostic reference.