糖化血红蛋白快速诊断试纸研究-东南大学学报医学版

糖化血红蛋白快速诊断试纸研究

单位：1. 东南大学生物科学与医学工程学院, 生物电子学国家重点实验室, 江苏省生物材料与器件重点实验室, 南京 210096;
2. 南京东纳生物科技有限公司, 南京 211100

分类号：R446.1

出版年·卷·期（页码）：2019·38·第一期（181-186）

摘要：

目的：设计并构建两种糖化血红蛋白快速诊断试纸，比较两种不同原理的快速诊断试纸检测糖化血红蛋白（HbA_1c）的性能。方法：设计并构建了一种侧向亲和层析试纸，根据检测线上HbA_1c的颜色实现半定量检测。构建了一种荧光免疫层析试纸（FICTS），利用荧光免疫定量分析仪实现HbA_1c定量检测。针对HbA_1c临床样本，对两种快速诊断试纸进行相关性能分析。结果：亲和层析试纸检测流程满足床旁诊断（POCT）的需求，但半定量的HbA_1c检测结果完全无法实现准确的HbA_1c检测。HbA_1c荧光免疫层析试纸保证了良好的准确度、线性度（R²>0.99）、变异系数（CV<10%）和区分度，和临床比对结果十分优异（R²>0.95），且HbA_1c检测结果不受高浓度糖类和表面活性剂的影响。结论：相比于亲和层析试纸，FICTS是一种较为优秀的HbA_1c快速诊断试纸，这种试纸操作简便，有良好的线性度、准确度，能良好区分HbA_1c阴阳性样本，并且与临床高效液相色谱法（HPLC）的检测结果一致。

Objective:To prepare and compare two rapid test strips for diagnosing HbA_1c based on different principles in terms of performance detection. Methods:Based on the method of boric acid affinity chromatography, a lateral flow test strip was constructed. According to the color of glycosylated hemoglobin on the test line, the semi-quantitative detection was carried out. Fluorescence immunochromatographic test strips (FICTS) were also prepared and the quantitative detection was carried out by immunofluorescence reader. Results:Each of strips met the POCT requirements. Accurate detection of HbA_1c could not be achieved by the affinity chromatography strips. The test strips could semi-quantitatively detect HbA_1c with excellent linearity (R²>0.99) and the assay accuracy was demonstrated by comparing with high performance liquid chromatography (HPLC) (R²>0.95). Conclusion:Compared with the affinity chromatography strips, the simple, rapid, effective and quantitative FICTS provided a novel method for detection of HbA_1c in clinic.

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