【摘要】目的 探讨使用亲和色谱法在Afinion AS100分析仪上测定糖化血红蛋白(HbA1c)的实验效果。方法 采集46例糖尿病患者和20例健康体检者EDTA抗凝静脉血及手指血标本，使用Afinion AS100分析仪和Bio-Rad D-10糖化血红蛋白分析仪测定HbA1c,对该法批内、批间变异及线性范围、回收试验、干扰试验等进行研究，探讨该方法测定HbA1c结果的参考区间和诊断效能。结果 本法批内与批间平均变异系数分别为1.0%和1.8%，HbA1c在4.0%～15.0%浓度范围内呈线性关系;常见干扰物对本法无明显影响;本法与离子交换高压液相色谱法(HPLC)测定结果呈高度相关，y = 1.02x-0.06，r = 0.999，P<0.01。手指血与静脉血样本测定结果相关性：y = 0.994x-0.11，r =0.992，P<0.01。健康人血液HbA1c水平的参考区间为4.2%～6.0%;以HbAlc 6.1%为切点，筛查糖尿病的灵敏度为80.2%，特异性为87.6%。结论 本实验方法测定HbA1c准确性、精密度高，干扰因素少，简单实用，适合在临床推广。

　　【关键词】硼酸盐亲和色谱法;糖化血红蛋白;离子交换高压液相色谱法

　　Evaluation the Afinion boronate affinity chromatography method in glycosylated hemoglobin A1c measurements Tong Hua-cheng, Yuan-quan , zhang-mei, Ma Min-min et a1.Department of Laboraory，Nanjing Tongren Hospital，Nanjing 211101，China

　　【Abstract】 0bjective To evaluate boronate affinity chromatography method for the glycated hemoglobin A1c measurements by Afinion AS100 analyzer. Methods 46 whole blood specimens and finger blood samples from diabetes patients and 20 healthy people were detected for HbA1c by Afinion AS 100 analyzer. The intra-and inter-coefficient of variation and the linear range of the method were studied，and compared these with those by Bio-Rad D-10 glycosylated hemoglobin analyzer.The reference range of HbA1c among healthy people was established and the diagnosis ability was studied by ROC curve. Results The within-run and between-run coefficients of variation(CV) were 1.0%and 1.8%for the assay.HbA1c was within 4.0%～15.O% range of good linearity.Bilirubin concentration in blood specimen up to 342 μmol/L and glucose 27.8 mmo1/L,triglyceride 9.12 mmo1/L,salicylic acid 2.84 mmo1/L, carbamylated Hb 3g/L，Acetylated Hb 5 g/L were observed no significant interference to Afinion HbA1c results. Compared with the results by D-10 analyzer，the regression equation was y = 1.031x-0.06,r =0.996,P<0.01; and that of finger to venous blood samples was y = 0.994x-0.11,r =0.992，P<0.01. The reference range of HbA1c was 4.2%- 6.0% among healthy people; When the cut off point of HbA1c related to diabetes diagnosis was 6.1%,the value of sensitivity was 80.2%and specificity was 87.6%.Conclusions The method on HBA1c determining has high accuracy and precision.It is simple and suitable for routine clinical use.

　　【Key words】 Boronate affinity chromatography;Glycated hemoglobin A1c; Ion exchange high-pressure liquid chromatography