首页|Development of an Integrated Disposable Device for SARS-CoV-2 Nucleic Acid Extraction and Detection

Development of an Integrated Disposable Device for SARS-CoV-2 Nucleic Acid Extraction and Detection

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Objective To develop a highly sensitive and rapid nucleic acid detection method for the severe acute respiratory syndrome coronavirus 2(SARS-CoV-2). Methods We designed,developed,and manufactured an integrated disposable device for SARS-CoV-2 nucleic acid extraction and detection.The precision of the liquid transfer and temperature control was tested.A comparison between our device and a commercial kit for SARS-Cov-2 nucleic acid extraction was performed using real-time fluorescence reverse transcription polymerase chain reaction(RT-PCR).The entire process,from SARS-CoV-2 nucleic acid extraction to amplification,was evaluated. Results The precision of the syringe transfer volume was 19.2±1.9 μL(set value was 20),32.2±1.6(set value was 30),and 57.2±3.5(set value was 60).Temperature control in the amplification tube was measured at 60.0±0.0 ℃(set value was 60)and 95.1±0.2 ℃(set value was 95)respectively.SARS-Cov-2 nucleic acid extraction yield through the device was 7.10×106 copies/mL,while a commercial kit yielded 2.98×106 copies/mL.The mean time to complete the entire assay,from SARS-CoV-2 nucleic acid extraction to amplification detection,was 36 min and 45 s.The detection limit for SARS-CoV-2 nucleic acid was 250 copies/mL. Conclusion The integrated disposable devices may be used for SARS-CoV-2 Point-of-Care test(POCT).

An integrated disposable deviceSARS-Cov-2Nucleic acid detection

Jing Ma、Yanzhe Hao、Meiling Hou、Xiaoshan Zhang、Jingduan Liu、Haodi Meng、Jiangbo Chang、Xuejun Ma、Jihua Liu、Qingjie Ying、Xianhua Wang、Hongxia Li、Yuxi Cao、Xiaoguang Zhang

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National Key Laboratory of Intelligent Tracking and Forecasting for Infectious Diseases,National Institute for Viral Disease Control and Prevention,Chinese Center for Disease Control and Prevention,Beijing 102206,China

Beijing Runbio Biotechnology Development Co.,Ltd,Beijing 100106,China

Beijing Beta Technology Co.,Ltd,Beijing 101318,China

Jiangsu Qitian Gene Biotechnology Co.,Ltd,Wuxi 214135,Jiangsu,China

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National Key R&D Program of ChinaNational Key R&D Program of ChinaShenzhen Science and Technology Program

2021YFC23011032022YFE0202600JSGG20220606142605011

2024

生物医学与环境科学(英文版)
中国疾病预防控制中心

生物医学与环境科学(英文版)

CSTPCD
影响因子:0.76
ISSN:0895-3988
年,卷(期):2024.37(6)
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