显色型亲和层析法检测糖化血红蛋白的建立及性能评估

发布时间：2018-01-24 00:16

本文关键词： 糖化血红蛋白亲和层析显色法床旁检测　出处：《中国糖尿病杂志》2016年10期 　论文类型：期刊论文

【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(P0.05)。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,P0.01),定量偏差无统计学意义(Z=-1.6,P0.05)。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。
[Abstract]:Objective to use chromogenic affinity chromatography. A rapid quantitative detection method for human whole blood HbA_1c was established. The principle of specific binding of soluble blue phenylboric acid derivatives to HbA_1c sugar chain was used. A kit for quantitative detection of chromogenic affinity chromatography was developed. The whole blood samples of 472 outpatients with diabetes were selected to detect the level of HbA1c, and the linearity, precision, specificity and stability were evaluated at the same time. Results the linear range of the kit was 3 ~ 18, the lower limit of measurement was 1.0, the CV was 10 in and between batches, and the bias was acceptable (P 0.05). Glycosylated albumin. The relative deviation between fructosamine and fructosamine was less than 卤10% within 8 months, and the relative deviation was less than 卤10% with Bio-Rad. HbA_1c kit was used to detect 472 clinical specimens in parallel. The correlation was good and the quantitative deviation was not statistically significant. Conclusion in this study, a rapid and quantitative method for the detection of HbA_1c color type affinity chromatography was established, and all the indexes were up to the requirements of clinical detection. It can be used for rapid bedside detection of whole blood HbA1c content.
【作者单位】：山东省内分泌与代谢病研究所;山东中医药大学附属医院普外科;山东大学齐鲁医院核医学科;
【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
【分类号】：R587.1
【正文快照】： HbA1c是血液红细胞内的血红蛋白(Hb)与血糖发生不可逆结合的产物,其合成速率与血液中的葡萄糖含量呈正比,可准确反映出红细胞120d生命周期内的平均血糖水平,基本不受检测时间、是否空腹、是否使用胰岛素等因素的影响[1-2]。临床上HbA1c水平通常可反映患者近8~12周的血糖控制情

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