【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。更多还原

【Abstract】 Objective To assess the accuracy of the immunoturbidimetry assay for detecting glycated hemoglo- bin A1c(HbA1c)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 HbA1cblinded parallel detection by the Livzon HbA1cimmunoturbidimetry reagent and the BIO-RAD HPLC rea- gent.Results The highest and the lowest values of HbA1cin 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 8 X-0.017 8,r2=0.993 2).Conclusion The immunoturbidimetry as- say and HPLC have a good correlation and consistence for detecting HbA1c,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.更多还原