免疫比浊法检测糖化血红蛋白的性能评价

PERFORMANCE EVALUATION OF IMMUNOTURBIDIMETRY ASSAY IN DETERMINING GLYCOSYLATED HEMOGLOBIN ALC

目的探讨免疫比浊法在糖化血红蛋白A1c（HbAlc）检测中的应用价值。方法分析免疫比浊法检测HbAlc的精密度、线性以及干扰因素，同时与高效液相色谱测定法进行相关性比较，评价免疫比浊法测定HbAlc的可靠性。结果免疫比浊法检测HbAlc的批内CV为1．2％～2．0％，批间CV为1．8％～2．2％；黄疸、脂血及类风湿因子对本法无明显干扰；免疫比浊法（x）与高效液相色谱法（y）相关性良好，相关系数R。=0．98（P〈0．01），直线回归方程为Y=1．04x＋0．11。结论免疫比浊法检测HbAlc与HPLC法检测结果相关性良好，能满足临床需要，值得临床推广。

Objective To evaluate the reliability of immunoturbidimetric assay for the detection of glycosylated hemoglobin （ HbA1 c）. Methods The precision, linearity, interfere factor and the correlation of immunoturbi- dimetrie assay compared with high performance liquid chromatography （HPLC） were analyzed. Results The CV within - run of immunoturbidimetrie assay for HbAlc was 1.2% - 2.0% and The CV between - run was 1.8% 2. 2% ; There was no significant interference in lipemia, icterus and rheumatoid factor; There was a good correlation between the results of immunoturbidimetry assay and HPLC R2 = 0. 98, （p 〈 0.01 ） , （ the linear regression equation is ： y = 1.04x ＋ 0. 11 ）. Condusion HbA1 c level was effectively determined by immunoturbidimetry assay method and have a good correlation with HPLC, so it meet the clinical requirement and is suitable for clinical application.