酶法测定糖化血红蛋白的临床应用研究.doc

酶法测定血液中HbA1c浓度的临床应用研究 陈同庆( （安徽省立新安医院 检验科，230022） 【摘要】 目的 探讨酶法测定血液中糖化血红蛋白（HbA1c）水平的临床应用价值。方法 首先利用定值高低值质控物的检测结果来评价酶法测定HbA1c的稳定性，然后利用酶法及高效液相色谱法（HPLC法）同时平行测定明确诊断的31例糖尿病患者及68例非糖尿病患者血液标本的HbA1c水平；对两种方法测得的HbA1c结果进行比较和分析。结果 酶法的批内变异系数为：0.93% (低值）、0.55%(高值）；批间变异系数（CV）为：1.43% (低值）、1.03%(高值）。本法与HPLC法相关性良好（r= 0.974,n=99，p0.001）， 31例糖尿病组（r= 0.967,n=31，p0.001），68例非糖尿病组（r= 0.954,n=68，p0.001）；本法HbA1c（%）的测定结果分别为:31例糖尿病组（6.66±1.55）%、68例非糖尿病组（5.20±0.81）%；酶法结果与HLPC法测定值有显著性差异（p0.001，n=99）；以HPLC法为参考，酶法结果的偏倚为-4.71%（n=99）。结论 该方法可用于全自动生化分析仪且具有简便、快速、重复性好、易于推广等优点，但要注意结果及参考范围与HPLC法有一定的差异。 【关键词】 高效液相色谱法； 糖化血红蛋白 The clinical application research of enzymatic assay for detecting of glycosylated hemoglobin (HbA1c) concentration CHEN Tong-qing.(Department of Clinical laboratory ,Xin-an Hospital , Anhui,Hefei 230022,China.) 【Abstract】 Objective To discuss the value of clinical application with enzymatic assay for glycosylated hemoglobin (HbA1c) concentration Methods The precision test of enzymatic assay was evaluated by the result of high or low quality control (QC) sample test. HbA1c concentration of patients with diabetes and non-diabetes had been detected in parallel with enzymatic assay and HPLC and the results between enzymatic assay and HPLC had been compared and analyzed . Results The within-run imprecision (CVs) about enzymatic assay for QC sample is 0.93% (low value ）、0.55%(high value）. The between-run CVs of QC sample is 1.43% (low value ）、1.03%(high value）.The correlation of enzymatic assay and HPLC was excellent （r= 0.974,n=99，p0.001）, diabetes（r= 0.967,n=31，p0.001）and non-diabetes （r= 0.954,n=68，p0.001）.The averages concentration of HbA1c in diabetes and non-diabetes were （6.66±1.55）% and（5.20±0.81）%.There is significant statistic difference between enzymatic assay and HPLC. Compared with HPLC, bias of enzymatic assay were -4.71%（n=99）. Conclusion Enzymatic assay method, being automatically analyzed with biochemical analyzer, provide a rapid ,accurate ,reproductive and easy