两种仪器与试剂测定糖化血红蛋白的对比研究及偏倚评估  

Comparative Study and Bias Assessment of Two Instruments and Reagents for Determination of Glycosylated Hemoglobin

作　　者：李宗祥 彭琳 罗继全 李凤叶 Li Zongxiang;Peng Lin;LuoJiquan;Li Fengye(Sinocare Inc,Changsha Hunan 410013,China;Hunan Testing Institute For Medical Devices,Changsha Hunan 410014,China)

机构地区：[1]三诺生物传感股份有限公司,湖南长沙410013 [2]湖南省医疗器械检验检测所,湖南长沙410014

出　　处：《医疗装备》2021年第17期7-9,共3页Medical Equipment

基　　金：湖南省糖尿病全病程管理科技创新体系落地的配套改革政策研究(2019ZL2030)。

摘　　要：目的评价三诺Icare 2000(酶法)与东曹HLC-723 G8(色谱法)两种方法测定糖化血红蛋白的结果是否存在偏差,同时进行偏倚评估分析。方法收集40份经乙二胺四乙酸二钾(EDTA-K2)抗凝的新鲜全血样本,以东曹HLC-723 G8作为对照系统,以三诺Icare 2000作为试验系统,参考EP9-A3,用患者样本进行方法学间的比对及偏倚评估,两种方法各测定1次,采用广义极端学生化偏差(ESD)方法判断离群值,绘制偏差图,选择最佳回归模型进行分析,并对回归参数进行假设检验,且考察医学决定水平处的偏倚,以1/2允许总误差作为可接受标准。结果ESD方法确认两种方法的相关性好,无离群值;根据浓度差值偏差图、百分比差值偏差图、浓度差值排序偏差图和百分比差值排序偏差图,选择普通线性回归(OLR)分析模型进行拟合,结果显示,两种方法的相关系数平方大于0.99,医学决定水平处的预期偏倚95%置信区间为[-0.068,0.076],未超出可接受偏倚的限值。结论三诺Icare 2000(酶法)与东曹HLC-723 G8(色谱法)两种方法测定糖化血红蛋白的结果具有可比性。Objective The deviation between Sinocare Icare 2000(enzymatic method)and TOSOH HLC-723 G8(chromatographic method)was evaluated and the bias was assessed.Methods 40 fresh whole blood samples treated by anticoagulant dipotassium ethylenediamine tetraacetic acid(EDTA-K2)were collected.TOSOH HLC-723 G8 was designated as the control group,while Sinocare Icare 2000 was designated as the experiment group,and then taken EP9-A3 as the references,both parameters referring to methodology and the bias were evaluated through detecting patients'samples.All samples were detected by the two methods for once,the outliers were judged by extreme studentized deviate(ESD)method,the deviation chart was drew and the best regression model was selected for analysis,and then the regression parameters were evaluated by hypothesis test.The bias at the level of medical decision was examined,and 1/2 of the total allowable error was taken as the acceptable standard.Results ESD method confirmed that the correlation between the two methods was good and there was no outlier.According to the concentration difference deviation diagram,percentage difference deviation diagram,concentration difference ranking deviation diagram and percentage difference ranking deviation diagram,the ordinary linear regression(OLR)analysis model was selected for fitting.The results showed that the square of correlation coefficient of the two methods was greater than 0.99,and the 95%confidence interval of medical decision level to expected bias was[-0.068,0.076],which was less than the acceptable standard.Conclusion The results of Sinocare Icare 2000(enzymatic method)and TOSOH HLC-723 G8(chromatographic method)are comparable.

关 键 词：糖化血红蛋白 EP9-A3 对比研究 偏倚分析 

分 类 号：R466.1[医药卫生—临床医学]