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基于高效微流控的气溶胶 SARS-CoV-2 现场采样/监测平台。

Efficient Microfluidic-Based Air Sampling/Monitoring Platform for Detection of Aerosol SARS-CoV-2 On-site.

机构信息

Department of Chemistry and Institutes of Biomedical Sciences, Fudan University, Shanghai 200433, P. R. China.

Shanghai Suxin Biotechnology Co. Ltd, and IgeneTec Diagnostic Products Co. Ltd., Shanghai 201318, P. R. China.

出版信息

Anal Chem. 2021 Mar 9;93(9):4270-4276. doi: 10.1021/acs.analchem.0c05154. Epub 2021 Feb 26.

Abstract

Airborne pathogens have been considered as highly infectious and transmittable between humans. With the pandemic outbreak of the coronavirus disease 2019 (COVID-19), an on-site diagnostic system-integrated airborne pathogen-monitoring machine is recommended by experts for preventing and controlling the early stage β-coronavirus severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spread. In this work, a small-volume rotating microfluidic fluorescence chip-integrated aerosol SARS-CoV-2 sampling system was constructed to satisfy the demand for rapid on-site sample collection and detection of SARS-CoV-2. The rotating microfluidic fluorescence system with small volume has very high sensitivity in the detection of SARS-CoV-2 (detection limit of 10 copies/μL with the shortest Ct value of 15 min), which is comparable to reverse transcription polymerase chain reaction (RT-PCR). The precision variation coefficients within/between batches are very low [coefficient of variation (CV) % ≤ 5.0%]. Our work has passed the comprehensive inspection of the microfluidic chip performance by the Shanghai Medical Device Testing Institute [National Medical Inspection (Design) no. 4408] and successfully tested 115 clinical samples. The integrated system exhibits 100% specificity, high sensitivity (10 copies/μL), and good precision (CV % ≤ 5.0%) in the rapid detection of SARS-CoV-2, thus realizing rapid monitoring and diagnostics of SARS-CoV-2 nucleic acid on-site.

摘要

空气传播病原体被认为具有高度传染性,能够在人与人之间传播。随着 2019 年冠状病毒病(COVID-19)大流行的爆发,专家建议使用现场诊断系统集成的空气传播病原体监测机,以预防和控制早期β冠状病毒严重急性呼吸综合征冠状病毒 2(SARS-CoV-2)的传播。在这项工作中,构建了一个小体积旋转微流控荧光芯片集成的气溶胶 SARS-CoV-2 采样系统,以满足快速现场采集和检测 SARS-CoV-2 的需求。该小体积旋转微流控荧光系统在 SARS-CoV-2 的检测中具有非常高的灵敏度(最短 Ct 值为 15 分钟时检测限为 10 拷贝/μL),与逆转录聚合酶链反应(RT-PCR)相当。批内/批间的精密度变化系数非常低[变异系数(CV)%≤5.0%]。我们的工作已经通过上海医疗器械检验所[国家医疗器械检验(设计)编号 4408]对微流控芯片性能的全面检查,并成功测试了 115 个临床样本。该集成系统在快速检测 SARS-CoV-2 时表现出 100%的特异性、高灵敏度(10 拷贝/μL)和良好的精密度(CV%≤5.0%),从而实现了 SARS-CoV-2 核酸的现场快速监测和诊断。

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