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

作　　者：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 

机构地区：[1]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 [2]Beijing Runbio Biotechnology Development Co.,Ltd,Beijing 100106,China [3]Beijing Beta Technology Co.,Ltd,Beijing 101318,China [4]Jiangsu Qitian Gene Biotechnology Co.,Ltd,Wuxi 214135,Jiangsu,China

出　　处：《Biomedical and Environmental Sciences》2024年第6期639-646,共8页生物医学与环境科学（英文版）

基　　金：supported by National Key R&D Program of China[2021YFC2301103 and 2022YFE0202600];Shenzhen Science and Technology Program[JSGG20220606142605011].

摘　　要：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±1.9μL(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 7.10×10^(6) copies/mL,while a commercial kit yielded 2.98×10^(6) 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).

关 键 词：An integrated disposable device SARS-Cov-2 Nucleic acid detection 

分 类 号：TH77[机械工程—仪器科学与技术]