免疫比浊法和高效液相色谱法测定糖化血红蛋白的价值比较

TO COMPARE THE VALUE OF IMMUNOTURBIDIMETRIC ASSAY AND HIGH PERFORMANCE LIQUID CHROMATOGRAPHY(HPLC) TO DETERMINE GLYCATED HEMOGLOBIN(HBA1C)

目的比较评估免疫比浊法和高效液相色谱法(HPLC)测定糖化血红蛋白(HbA1C)的价值及监测HbA1C在糖尿病诊疗中的临床意义。方法以奥林巴斯AU-400全自动生化分析仪及Drew Scientif-ic公司的DS-5糖化血红蛋白分析仪同时检测100例糖尿病病人及100例健康体检者的HbA1C,比较两种方法的相关性,并分别做精密度评价、线性关系及对比实验,同时整理病人临床资料,分析HbA1C监测与糖尿病并发症之间的关系。结果①两种检测方法的结果呈显著相关性(r=0.999 4),线性回归方程为Y=0.989 8X+0.06;预期相对偏差在低值(4.0%)时为2.51%;在中值(6.5%)为3.01%;在高值(16.0%)时为3.30%。②免疫比浊法的批内变异系数CV为3.9%,批间CV为4.6%,HPLC的批内变异系数CV为3.2%,批间CV为4.1%,均具有良好的重复性。③HbA1C水平与糖尿病患者发生并发症发生率密切相关,随着HbA1C水平的升高,糖尿病并发症的发生率也越高(p<0.01)。结论高效液相色谱法测定HbA1C结果准确、精密度高,可作为临床参考标准;免疫比浊法简单易行,且与HPLC具有良好相关性,适合基层医院推广。糖化血红蛋白水平与糖尿病并发症的发生密切相关,能为糖尿病的临床诊治提供可靠依据。

Objective To compare the value of immunoturbidimetric assay and high performance liquid chro- matography （HPLC） to determine glycated hemoglobin （HbA1 C ） and its application in diabetes care. Methods Immunoturbidimetric assay and HPLC of HbA1C from diabetes （N = 100） and normal adults （N = 100） were per- formed on Olympus AU -400 automatic biochemical analyzer and DS -5 respectively which would be compared via SPSS software. Meanwhile, clinical data was analyzed. Results （~）There was a strong correlation between immuno- turbidimetric assay and HPLC on detecting HbA1C （Y = 0 . 9898 X ＋ 0. 06, r = 0.9994）, and the predicted bi- as was 2.51% at 4.0% , 3.01% at 6.5% and 3.30% at 16.0% respectively. （~）The within - run coefficient of var- iation （CV） was 3.9% and the between - run CV was 4.6%, comparable to that of HPLC 3.2% and 4.1% with good repeatability. （~）Increasing HbA1C level resulted in higher diabetic complication mobility. There was a fight cor- relation between HbA1C level and diabetic complication mobility. Conclusion HPLC with high - qualified and re- peatable detection for HbA1C could be clinical standardized method. Immunoturbidimetric assay would be a relative accurate, simple alternative detection for promotion in primary hospitals. There is a tight correlation between HbA1C level and diabetic complication mobility. Glycated hemoglobin （HbA1C） detection could be an acountable indication for both diabetes diak, nosis and treatment.