糖化血红蛋白快速诊断试纸研究

Study on rapid test strips for diagnosing glycoslated hemoglobin

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(R^2>0.99)、变异系数(CV<10%)和区分度,和临床比对结果十分优异(R^2>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 HbA1c 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 HbA1c could not be achieved by the affinity chromatography strips. The test strips could semi-quantitatively detect HbA1c 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 HbA1c in clinic.