验孕试纸用于乙肝病毒耐药突变基因的便携式体外分子诊断

中国是乙型肝炎病毒（HBV）的高发国家，抗病毒药物耐药突变的早期诊断对于接受抗病毒治疗的乙肝患者至关重要。针对当前耐药突变基因检测方法成本高、技术和设备要求高、操作繁琐、耗时费力、误诊率高等问题，本项目拟将新型核酸检测探针——绒毛膜促性腺激素蛋白（hCG）-DNA缀合物和核酸分子线路结合，利用商品化验孕试纸来诊断HBV耐药突变基因的等温扩增产物，通过验孕试纸这种极具小型化和阵列化前景的检测方法来发展低成本、高效、简便的HBV耐药突变基因诊断新方法，为临床HBV的精准、普适化诊断平台的构建寻找理想的体外诊断新原理。通过研制相应检测试剂盒及装置并结合临床样本分析，搭建样品处理到信号输出一体化便携式体外诊断平台，满足HBV耐药突变基因低至单分子的灵敏、特异和便携的诊断需求，推动我国体外诊断技术的发展，加快分子工程深入精准医疗领域的步伐，为基础与应用研究的有效衔接提供新的契机和应用导向。

The early discovery for drug-resistant mutation is important for the patients suffering from HBV, especially for China where HBV prevails. The current detection method has the disadvantages of high cost, complicated manipulation, time consuming, high misdiagnosis rate, and it usually requires special technology as well as the equipment. This project aims at detecting products of isothermal amplification of drug-resistance gene mutation via commercially available pregnancy test strip, which is realized by combining nucleic acid molecule circuit and novel detection nucleic acid probe, human chorionic gonadotropin (hCG)-DNA complex. The final purpose is to develop a new way to diagnosing drug-resistance gene mutation with cost-effectiveness and high working efficiency. The project goes with the tide of miniaturizing and integrating in the detection device to construct clinical accurate and general diagnosis platform under novel mechanism. The great demand for single molecular diagnosis with good sensitivity, selectivity and portability will be met through building the in vitro diagnosis (IVD) that integrating both sample processing and signal output. This project is beneficial for the development of IVD technology in our country, pushing forward the precise medical treatment based on molecule engineering. It provides guiding significance and new chances for valid convergence between fundamental research and application.