一种新型抗干扰高效液相色谱法血红蛋白分析系统

Anti-interference hemoglobin analysis system by high performance liquid chromatography

高效液相色谱法(HPLC)是目前主流的检测血红蛋白技术,糖化血红蛋白(HbA1c)是诊断糖尿病的金指标,但HPLC检测时HbA1c易受到地中海贫血因子血红蛋白F(HbF)/血红蛋白A2(HbA2)和血红蛋白变异体的干扰而影响检测结果的准确性。本研究基于高效液相色谱法提出一种新型抗干扰血红蛋白分析系统,本系统通过改进高压三梯度洗脱法,优化高压层析柱中微球粒径和筛板孔径,并优化双柱塞往复式串联高压泵的结构,既能检测HbA1c又可检测地中海贫血因子HbF/HbA2和血红蛋白变异体,抗干扰性好,性能稳定,有望实现产业化。本系统与日本东曹G8、美国伯乐Ⅶ和D10糖化血红蛋白分析系统等世界一线品牌产品进行HbA1c和地中海贫血因子HbF/HbA2检测性能对比,结果表明,本系统与世界一流系统的线性相关性好,检测性能优异,是国内首次实现快速、精准筛查糖化血红蛋白和地中海贫血因子HbF/HbA2的高效液相色谱法血红蛋白分析系统。

High performance liquid chromatography(HPLC) is currently the mainstream technology for detecting hemoglobin. Glycated hemoglobin(HbA1c) is a gold indicator for diagnosing diabetes, however, the accuracy of HbA1c test is affected by thalassemia factor hemoglobin F(HbF)/hemoglobin A2(HbA2) and variant hemoglobin during HPLC analysis. In this study, a new anti-interference hemoglobin analysis system of HPLC is proposed. In this system, the high-pressure three-gradient elution method was improved, and the particle size and sieve plate aperture in the highpressure chromatography column and the structure of the double-plunger reciprocating series high-pressure pump were optimized. The system could diagnose both HbA1c and thalassemia factor HbF/HbA2 and variant hemoglobin, and the performance of the system was anti-interference and stable. It is expected to achieve industrialization. In this study, the HbA1c and thalassemia factor HbF/HbA2 detection performance was compared between this system and the world’s first-line brand products such as Tosoh G8, Bio-Rad Ⅶ and D10 glycosylated hemoglobin analysis system. The results showed that the linear correlation between this system and the world-class system was good. The system is the first domestic hemoglobin analysis system by HPLC for screening of HbA1c and thalassemia factor HbF/HbA2 rapidly and accurately.