便携式核酸微全分析仪的设计与研发  

Design and development of a portably micro and entire analytical instrument for nucleic acid

作　　者：马俊杰 朱信 李晓宁 任宇航 吴丹 赵爽 胡笛 徐建栋 MA Jun-jie;ZHU Xin;LI Xiao-ning(Beijing Bohui Innovation Biotechnology Ltd., Beijing 102206, China.)

机构地区：[1]北京博晖创新生物技术股份有限公司,北京102206 [2]微流控分子检测技术北京市工程实验室,北京102206

出　　处：《中国医学装备》2019年第7期25-29,共5页China Medical Equipment

基　　金：国家自然科学基金(21606239)“基于氧分压-诱导因子浓度可控微流控芯片的干细胞生长和分化调控机制研究”;国家十二五重大科学仪器设备开发专项(2012YQ090197)“微膜泵驱动核酸微全分析仪”

摘　　要：目的:自主研制一款便携式核酸微全分析仪及配套微流控芯片,以满足快速现场分子检测的需要。方法:针对检测现场应用环境,采用低功耗电子元器件进行控制系统设计、轻质材料进行机械结构设计,进行小型化及低功耗开发;开发微型荧光检测模块、配套的荧光检测微流控芯片,研制一套新型的便携式核酸微全分析仪。结果:整套系统可以进行4通道荧光检测;微流控芯片一次性使用,一次处理4个样品;采用多重PCR-反向斑点杂交法快速定性检测人Y染色体3个AZF区的6个STS位点;检测禽流感病毒灵敏度为12.7 copies/μl,新城疫病毒灵敏度为63.3 copies/μl。结论:便携式核酸微全分析仪及配套微流控芯片仅用1台该仪器即可在90 min内实现从样本前处理、核酸提取、聚合酶链式反应(PCR)扩增到实时荧光定量PCR(RT-PCR)检测的全过程。实现人乳头瘤病毒(HPV)、Y染色体缺失(YMD)、禽流感及新城疫病毒等疾病检测。便携式核酸微全分析仪能够满足进出口检验检疫,偏远地区快速疾病筛查等特殊环境下的快速现场分子诊断需要。Objective: To self-design, develop, fabricate and test a portably micro and entire analytical instrument and its matching microfluidic chip so as to meet the needs of rapid detection for nucleic acid molecular in field. Methods: Aimed at the application environment of detection field, the electron components with low power consumption were adopted to design control system, and the lightweight materials were adopted to design mechanical structure and to implement developments with miniaturization and low power consumption. Through develop micro fluorescence detection module and its matching microfluitic chip for fluorescence detection to research and develop a new portably micro and entire analytical instrument for nucleic acid. Results: The whole system can perform 4 independent tests with fluorescence detection for quantification. The microfluidic chip was disposable, and it can dispose 4 samples at one time. The multiple PCR-reverse dot blot hybridization was adopted to implement fast qualitative detection for 6 STS loci of 3 AZF zones of human Y chromosome. And the sensitivity of detecting avian influenza virus was 12.7 copies/μl, and that of Newcastle disease virus was 63.3 copies/μl. Conclusion: The portable micro and entire analytical instrument for nucleic acid and its matching microfuidic chip can realize the entire process of detections from pretreatment, nucleic acid extraction and PCR to real-time fluorescence quantification PCR (RT-PCR). And it can implement series of detections for human papilloma virus, Y chromosome deficiency, avian influenza and Newcastle disease virus and others. This portable micro and entire analytical instrument can meet the needs of inspection and quarantine in import and export, and the needs of rapid on-site molecular diagnosis of rapid disease screening in remote areas and other special circumstances.

关 键 词：便携式核酸检测系统 微流控芯片 现场核酸分子检测 

分 类 号：R318.6[医药卫生—生物医学工程]