两种不同原理的方法测定糖化血红蛋白的结果比对评估  

Comparative evaluation of HbA1c results detected by two methods of different principles

作　　者：姜莹[1] 肖鸽飞[1] 赵军[1] 陈福光 黄琳[2] 

机构地区：[1]广东省珠海市妇幼保健院检验科/珠海市医学遗传研究所,519001 [2]广东省珠海市人民医院检验科,519001

出　　处：《检验医学与临床》2014年第1期23-24,27,共3页Laboratory Medicine and Clinic

摘　　要：目的以高效液相色谱法作为参考方法,对免疫透射比浊法测定糖化血红蛋白(HbA1c)水平的正确度进行评估。方法分别应用丽珠试剂股份有限公司生产的免疫透射比浊法试剂与美国BIO-RAD公司生产的高效液相色谱法试剂,对200例不同程度糖尿病患者与健康人的临床血液标本的HbA1c水平进行盲法平行测定,并对结果进行比较分析。结果本批标本测定结果中最高值为13.7%,最低值为4.5%,无须剔除的离群值。两种检测方法经统计学分析,计算出其相关性系数(r)=0.997 0,组内相关系数(ICC)=0.996 6,拟合的直线回归方程Y=0.999 8 X-0.017 8,r2=0.993 2。结论免疫透射比浊法测定HbA1c的结果与高效液相色谱法相比具有很好的相关性和一致性,且因前种方法无须特殊的仪器设备及其相对较低的试剂成本而更适合在广大基层医院推广应用。Objective To assess the accuracy of the immunoturbidimetry assay for detecting glycated hemoglo- bin Alc（HbAlc） with the high-performance liquid chromatography（HPLC） as the reference method. Methods 200 clinical blood samples collected from different degrees of diabetic patients and healthy people were performed the HbAlc blinded parallel detection by the Livzon HbAlc immunoturbidimetry reagent and the BIO-RAD HPLC rea- gent. Results The highest and the lowest values of HbAlc in the results of this batch of samples were 13.7% and 4.5% respectively, there was no outlier needing to be excluded. We calculated several parameters by statistical analy- sis,including the linearity correlation coefficient（r= 0. 997 0）, the intraclass correlation coefficient（ICC= 0. 996 6） and the fitting linear equation was（Y=0. 999 8X-0. 017 8,r2 =0. 993 2）. Conclusion The immunoturbidimetry as- say and HPLC have a good correlation and consistence for detecting HhAle, and the former assay method is more suitable for promotion and application in primary hospitals because of its relative low reagent cost and no need of spe- cial instrument.

关 键 词：糖化血红蛋白 高效液相色谱法 免疫透射比浊法 

分 类 号：R587.1[医药卫生—内分泌]