低浓度乙肝病毒光波导分析方法的临床应用研究

Hepatitis B virus(HBV) infection is a serious public problem in China. There are 94 million chronic HBV infectors. HBV infection may lead to hepatitis, liver cirrhosis or cancer. The detection of HBV surface antigen(HBsAg) is important for epidemiology, diagnosis and treatment. Currently, the methods for HBsAg detection including Colloidal Gold immunochromatography assay(GICA), Enzyme-Linked Immunosorbent Assay(ELISA), Chemiluminescence immunoassay(CLIA) and electrochemiluminescence immunoassay(ECLIA). The former two methods are mostly used for HBsAg qualitation with low sensitivity and specificity, though they are simple and cheap for practice. Contrarily, the latter two methods, with the representative products of Abbott Architect and Roche Elecsys II for HBsAg quantification, are expensive and of poor availability. So it is essential to invent a new method with good sensitivity and specificity for HBsAg quantification. In view of the shortcomings of these existing measuring methods, this project proposed a new sensing technique for measuring trace HBsAg based on optical waveguide resonance. The limit of detection for HBsAg of the proposed sensor will be below , which is about four times lower than the current detection technique. In addition to the high sensitivity, this approach is capable of fast on-line detection with stable performance and lower price. This new kind of sensor will has an important clinical value on the diagnosis and treatment of chronic HBV infection.

乙型肝炎病毒（HBV）感染是一个严重的公共卫生问题。我国现有慢性 HBV 感染者约 9300 万人。HBV感染可以引起肝炎、肝硬化和肝癌。因此，乙肝病毒表面抗原（HBsAg）的检测对于流行病学调查、HBV感染的诊断和治疗反应的监测均有重要意义。目前HBsAg的检测方法主要有胶体金免疫层析法、酶联免疫吸附试验、化学发光法和电化学发光法等。前两者敏感性和特异性不高，常作为定性检测；后两者可作定量检测，但价格昂贵，临床可及性和检测下限有限。因此探索一种新型HBsAg定量检测系统势在必行。本项目提出一种利用邻苯二胺特异性结合并显色的光波导共振技术，来研发一种分辨率可达100 IU/ml （现临床下限为500 IU/ml ）的病毒分析仪器。他将具有高灵敏度、纯液相、特异性好且可在线检测等诸多优点，并对慢性HBV感染的诊断和治疗有着极其重要的临床价值。

乙型肝炎病毒（HBV）感染是一个严重的公共卫生问题。HBV感染可以引起肝炎、肝硬化和肝癌。因此，乙肝病毒表面抗原（HBsAg）的检测对于流行病学调查、HBV感染的诊断和治疗反应的监测均有重要意义。本项目研究了对称金属包覆波导的传感特性，利用邻苯二胺特异性结合并显色的光波导共振技术，实现了分辨率可达20 IU/ml的乙肝病毒DNA高灵敏探测。主要取得了4篇相关发表论文，1篇正在审稿的论文。同时在基金委的支持下开展了有关布里渊拉曼随机激光器的研究，取得了2篇相关发表论文。