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Title:: Design ofpoint of care testing device for nucleic acid detection

文章编号:: 1672-6278 (2022)02-0200-08

作者:: 谢璐1; 吴义才1; 刘家宇1; 陈留晓1; 谈鸿伟1; 汪圣舟1; 韦依珊1; 邹任玲1; 2△; 李丹1; 胡秀枋1; 1.上海理工大学健康科学与工程学院，上海 200093;2.上海贝瑞电子科技有限公司，上海 201100

Author(s):: XIE Lu1; WU Yicai1; LIU Jiayu1; CHEN Liuxiao1; TAN Hongwei1; WANG Shengzhou1; WEI Yishan1; ZOU Renling1; 2; LI Dan1; HU Xiufang1; 1.School of Health Science and Engineering，University of Shanghai for Science and Technology,Shanghai 20093，China;2.Shanghai Berry Electronic Technology Limited Company,Shanghai 201100

关键词:: 即时检测装置; 基因快速检测; 体外诊断; 光电检测电路; 光路设计; 温度控制

Keywords:: Instant testing device; Rapid genetic testing; In vitro diagnosis; Photoelectric detection circuit; Optical structure design; Thermal control

分类号:: R318.6；TH773；TN911.74

DOI:: 10.19529/j.cnki.1672-6278.2022.02.15

文献标识码:: A

摘要:: 传统的核酸检测装置体积大、操作困难。为了使核酸检测技术更具有即时性，本研究基于环介导等温核酸扩增技术设计了一台便携式现场即时检测装置。该装置由核酸扩增模块与核酸检测模块两部分组成。核酸扩增模块为核酸样本的扩增提供恒温环境，核酸检测模块对其扩增产物进行荧光检测，最终得到阴性或阳性的判断。为验证装置性能，依照聚合酶链反应分析仪行业标准设计并进行实验。结果表明，荧光检测变异系数小于行业标准所要求的3%，线性实验相关系数为0.997，大于行业标准0.990；不同环境光强变化实验的t检验分布结果证明了在不同光照环境下，检测结果无显著性差异；温控的变化范围为±0.5℃内。该仪器能够实现核酸的现场即时检测，性能可靠、稳定且低成本，可以向基层医疗机构推广。

Abstract:: The traditional nucleic acid detection device is large in size and difficult to operate. In order to make nucleic acid detection technology more instantaneous, we designed a portable molecular point of care testing（POCT）device based on Loop-mediated isothermal amplification. The device was composed of a nucleic acid amplification module and a nucleic acid detection module. The nucleic acid amplification module provided a constant temperature environment for the amplification of nucleic acid samples, the nucleic acid detection module detected the fluorescence of the amplification products, finally provided a negative or positive judgment. Experiments were designed and conducted based on the industrial standard of polymerase chain reaction analyzer to verify the performance of the device. The experimental results showed that the variation coefficient of fluorescence detection was less than 3% which required by industry standard, and the linear experiment correlation coefficient was 0.997, which was greater than 0.990 that required by industry standard; the t test distribution results of different light conditions showed that there was no significant difference in the detection results under different illumination environments；the change range of temperature control was within ±0.5℃. The instrument can realize the real-time detection of nucleic acid, with reliability, stability and low cost, can be promoted to primary medical and health care organizations.

《生物医学工程研究》[ISSN:1006-6977/CN:61-1281/TN]

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