硼酸亲和层析法检测糖化血红蛋白A1c的效果评估

Detection of GHbA1c by boronic acids affinity chromatography

目的评估硼酸亲和层析法检测GHbA1c的临床效果。方法利用高效液相色谱法(HPLC(B法))硼酸亲和层析法(A法)同步盲测118例全血GHbA1c水平,计算二者的相关系数、灵敏度、特异性和总符合率,同时对溶血、黄疸等可能的干扰因素进行评估。结果两种方法的灵敏度、特异性和总符合率分别为100%、92.3%和97.1%,相关系数r为0.980,表明两种方法的检测结果具有较高的一致性和等效性。结论硼酸亲和层析法检测GHbA1c结果准确,用血量少,检测时间短,可随机检测,单标本独立检测,适合急诊、基层医疗机构、了解糖尿病患者病情和治疗效果的个人监测,具有很高的临床实用前景。

Objectives To evaluate the clinical results of boronic acids affinity chromatography in detection of GHbAlc. Methods HbAle levels in 118 whole blood samples were detected by high performance liquid chromatography （HPLC, Method B）. Method A was applied to blind experiment simultaneously. The correlation coefficient,sensitivity,specificity and the total coincidence with clinical effect were analyzed. The possible interference factors, such as hemolysis and icterus etc., were also evaluated. Results The sensitivity, specificity and the total coincidence with clinical effect of these two methods were 100% ,92.3% and 97.1% ,respectively. The correlation coefficient was 0.980,suggesting that the results of these two methods had high consistency and equivalence. Conclusions The measurement of GHbAle by boronic acids affinity chromatography had some advantages,sueli as accuracy,less blood need,less measurement time,random testing and independent single sample testing. This method was appropriate to apply to emergency,primary health care institution, detection of the condition and treatment effect of diabetic patients. Boronie acids affinity chromatography had a good practical prospect for clinic.