A gamepad-like nucleic acid testing device for rapid detection of SARS-CoV-2 via visible nested recombinase polymerase amplification

Ce Liu, Baobao Lin, Guohua Yuan, Zhi Geng, Zhe Zhao, Jiacheng Wang, Jingyu Shao, Zhenqi Wang, Yang Xu, Xujuan Yang, Chang Liu, Yingmei Feng, Xin Fan, Jing Wang, Lili Ren, Yan Xiao, Conghui Wang, Guang Shen, Yi Yang, Chao Zhao, Yinqing Li, Peng Liu, Jingwei Bai
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Abstract

Nucleic acid tests are essential for the accurate diagnosis and control of infectious diseases. However, current assays are not easily scalable for a large population, due to the requirement of laboratory settings or special equipment. Here, we developed an integrated box for instant nucleic acid screening which fully integrates nucleic acid release, amplification, and results visualization for self-service standalone test. Importantly, the operation of the box runs on a novel gamepad-like interface, which allows deployment of the box in home settings and operation by users without any prior professional training. The performance of the box is empowered by an RNA extraction-free sample inactivation process and nested recombinase polymerase amplification chemistry and exhibits sensitivity comparable to reverse transcription-quantitative polymerase chain reaction with high specificity for severe acute respiratory syndrome coronavirus 2 RNA in a reaction time of 30 minutes directly from fresh swab sample to results. These innovations make the box a novel platform for a convenient, accurate, and deployable point-of-care testing scheme. Ce Liu, Baobao Lin and colleagues report a rapid and straightforward nucleic acid screening test requiring no professional training or formal medical setting. The device runs on a novel gamepad-like interface and fully integrates nucleic acid release, amplification, and visualization.

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通过可见巢式重组聚合酶扩增快速检测 SARS-CoV-2 的游戏手柄式核酸检测装置
核酸检测对准确诊断和控制传染病至关重要。然而,由于需要实验室环境或特殊设备,目前的检测方法不容易扩展到大量人群。在此,我们开发了一种用于核酸即时筛查的集成盒,它完全集成了核酸释放、扩增和结果可视化功能,可用于自助式独立检测。重要的是,该盒子的操作是在一个类似游戏手柄的新颖界面上进行的,用户无需经过任何专业培训即可在家庭环境中部署和操作该盒子。无需提取 RNA 的样本灭活过程和巢式重组聚合酶扩增化学反应增强了该检测盒的性能,其灵敏度可与反转录定量聚合酶链反应相媲美,对严重急性呼吸系统综合征冠状病毒 2 RNA 具有高度特异性,从新鲜拭子样本到检测结果的反应时间仅需 30 分钟。这些创新使该检测盒成为一个新颖的平台,可用于方便、准确和可部署的床旁检测方案。Ce Liu、Baobao Lin 及其同事报告了一种快速、简单的核酸筛查测试,无需专业培训或正规医疗环境。该设备在一个类似游戏手柄的新颖界面上运行,完全集成了核酸释放、扩增和可视化功能。
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