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用于 COVID-19 大流行期间现场分子诊断的高度自动化移动实验室。

A Highly Automated Mobile Laboratory for On-site Molecular Diagnostics in the COVID-19 Pandemic.

机构信息

Department of Biomedical Engineering, School of Medicine, Tsinghua University, Beijing, China.

National Engineering Research Center for Beijing Biochip Technology, Beijing, China.

出版信息

Clin Chem. 2021 Mar 31;67(4):672-683. doi: 10.1093/clinchem/hvab027.

Abstract

BACKGROUND

Infectious disease outbreaks such as the COVID-19 (coronavirus disease 2019) pandemic call for rapid response and complete screening of the suspected community population to identify potential carriers of pathogens. Central laboratories rely on time-consuming sample collection methods that are rarely available in resource-limited settings.

METHODS

We present a highly automated and fully integrated mobile laboratory for fast deployment in response to infectious disease outbreaks. The mobile laboratory was equipped with a 6-axis robot arm for automated oropharyngeal swab specimen collection; virus in the collected specimen was inactivated rapidly using an infrared heating module. Nucleic acid extraction and nested isothermal amplification were performed by a "sample in, answer out" laboratory-on-a-chip system, and the result was automatically reported by the onboard information platform. Each module was evaluated using pseudovirus or clinical samples.

RESULTS

The mobile laboratory was stand-alone and self-sustaining and capable of on-site specimen collection, inactivation, analysis, and reporting. The automated sampling robot arm achieved sampling efficiency comparable to manual collection. The collected samples were inactivated in as short as 12 min with efficiency comparable to a water bath without damage to nucleic acid integrity. The limit of detection of the integrated microfluidic nucleic acid analyzer reached 150 copies/mL within 45 min. Clinical evaluation of the onboard microfluidic nucleic acid analyzer demonstrated good consistency with reverse transcription quantitative PCR with a κ coefficient of 0.979.

CONCLUSIONS

The mobile laboratory provides a promising solution for fast deployment of medical diagnostic resources at critical junctions of infectious disease outbreaks and facilitates local containment of SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) transmission.

摘要

背景

传染病疫情(如 2019 年冠状病毒病(COVID-19)大流行)需要快速应对并对疑似社区人群进行全面筛查,以发现潜在的病原体携带者。中心实验室依赖于耗时的样本采集方法,而这些方法在资源有限的环境中很少可用。

方法

我们展示了一种高度自动化且完全集成的移动实验室,可快速部署以应对传染病疫情。该移动实验室配备了 6 轴机械臂,用于自动化或经口咽拭子标本采集;采集的标本中使用红外加热模块迅速使病毒失活。核酸提取和嵌套等温扩增由“样品进,答案出”的芯片实验室系统完成,结果由车载信息平台自动报告。使用假病毒或临床样本对每个模块进行了评估。

结果

移动实验室独立自足,能够进行现场标本采集、灭活、分析和报告。自动化采样机械臂实现了与手动采集相当的采样效率。采集的样本在 12 分钟内即可迅速失活,效率与水浴相当,且核酸完整性无损。集成微流控核酸分析仪的检测限在 45 分钟内达到 150 拷贝/ml。车载微流控核酸分析仪的临床评估与逆转录定量 PCR 具有良好的一致性,κ 系数为 0.979。

结论

移动实验室为在传染病疫情的关键时刻快速部署医疗诊断资源提供了一种有前途的解决方案,并有助于控制 SARS-CoV-2(严重急性呼吸综合征冠状病毒 2)的传播。

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