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

Author:

Xing Wanli123,Wang Jiadao4,Zhao Chao5,Wang Han1,Bai Liang3,Pan Liangbin23,Li Hang2,Wang Huili1,Zhang Zhi2,Lu Ying1,Chen Xiang3,Shan Sisi6,Wang Dong2,Pan Yifei2,Weng Ding4,Zhou Xinying3,Huang Rudan2,He Jianxing7,Jin Ronghua8,Li Weimin9,Shang Hong10,Zhong Nanshan11,Cheng Jing12

Affiliation:

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

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

3. CapitalBio Technology, Beijing, China

4. State Key Laboratory of Tribology, Tsinghua University, Beijing, China

5. Department of Industrial Design, Academy of Arts & Design, Tsinghua University, Beijing, China

6. Center for Global Health and Infectious Diseases, Comprehensive AIDS Research Center, Beijing, Advanced Innovation Center for Structural Biology, School of Medicine, Tsinghua University, Beijing, China

7. State Key Laboratory of Respiratory Disease and National Clinical Research Center for Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China

8. Beijing Ditan Hospital, Capital Medical University, Beijing, China

9. Department of Respiratory and Critical Care Medicine, West China Hospital, Sichuan University, Chengdu, China

10. National Clinical Research Center for Laboratory Medicine, The First Affiliated Hospital of China Medical University, No 155, Nanjing North Street, Heping District, Shenyang, Liaoning Province, China

11. State Key Laboratory of Respiratory Disease/National Clinical Research Center for Respiratory Disease/National Center for Respiratory Medicine/Guangzhou Institute of Respiratory Health/The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China

Abstract

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.

Funder

Guangzhou Institute of Respiratory Health Open Project

Consulting Research Project of the Chinese Academy of Engineering

Emergency Project of the Ministry of Science and Technology of China

Publisher

Oxford University Press (OUP)

Subject

Biochemistry, medical,Clinical Biochemistry

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