显色型亲和层析法检测糖化血红蛋白的建立及性能评估  

Establishment and evaluation of chromogenic affinity chromatography for glycosylated hemoglobin quantitative testing

作　　者：李新华[1] 赵珂[1] 魏芳[2] 丁文宇[1] 张勇[1] 黄亚丽[3] 

机构地区：[1]山东省内分泌与代谢病研究所,济南250000 [2]山东中医药大学附属医院普外科 [3]山东大学齐鲁医院核医学科

出　　处：《中国糖尿病杂志》2016年第10期892-896,共5页Chinese Journal of Diabetes

基　　金：山东省重点研发计划(2015GSF118131);山东省医学科学院医药卫生科技创新工程

摘　　要：目的利用显色型亲和层析技术,建立一种适用于即时检验的人全血HbA_1c快速定量检测方法。方法采用水溶性蓝色苯硼酸衍生物与HbA_1c糖链特异性结合原理,研制显色型亲和层析定量检测试剂盒。选取472例门诊糖尿病患者的全血标本,检测HbA1c水平,同时进行线性、精密度、特异性、稳定性等评价,并与国外试剂进行对比。结果该试剂盒线性范围为3%~18%,测量下限为1.0%。批内和批间CV均〈10%,偏倚可接受（P〉0.05）。葡萄糖、糖化白蛋白、果糖胺等常见干扰物对HbA1c定量无明显影响。试剂保存8个月内相对偏差控制在±10%以内。与Bio-Rad HbA_1c试剂盒平行检测472例临床标本,相关性良好（Y=0.180＋1.006 X,P〈0.01）,定量偏差无统计学意义（Z=-1.6,P〉0.05）。结论本研究建立了HbA_1c显色型亲和层析快速定量检测方法,各项指标均达到临床检测的要求,可用于全血HbA1c含量的床旁快速检测。Objective To establish a rapid quantitative detection method for point-of-care testing of HbA_1c by chromogenic affinity chromatography. Methods The rapid quantitative HbA_1c detection reagent using chromogenic affinity chromatography was developed by the principle that water-soluble phenylboronic acid derivatives can specifically combine with Cis-diol of HbA_1c.A total of 472 T2 DM outpatients（248male and 224female）were selected from Oct.2014 to May 2015 in Shandong lnstitute of Endocrine Metabolic Diseasese.The whole blood was collected for the detecting of HbA_1c.Imported reagents were used to evaluate the linearity,accuracy,specificity and the stability. Results The detection range of this reagent for HbA_1c was 3% ~18%.The coefficient of variation（CV）values of repeated 20 tests for low,median and high concentration control samples respectively were all less than15% and the bias was acceptable（P〈0.05）.The glucose,glycated albumin and fructosamine had no significant interference for HbA_1c quantitative detection.The relative deviation could be controlled within±10%in eight months storage period.This reagent was well correlated with Bio-Rad HbA_1c（HPLC）kit（Y Bio-Rad Y =0.180＋1.006 X,P〈0.01）with no significant deviation（Z=-1.6,P〈0.05）.Conclusion This study indicates that chromogenic affinity chromatography for rapid quantitative detect HbA_1c is valuable for the clinical application.

关 键 词：糖化血红蛋白 亲和层析 显色法 床旁检测 

分 类 号：R587.1[医药卫生—内分泌]