Chinese Expert Consensus on the Nucleic Acid Detection of SARS-CoV-2

Zijie Liu; Yongqing Tong; Jun Wu; Lutao Du; Chaojun Wei; Wei Cui; Yongtong Cao; Ming Chen; Zhen Cai; Wei Chen; Haitao Ding; Ming Guan; Wei Guo; Chunfang Gao; Xiaoke Hao; Chengjin Hu; Shan Huang; Yanfang Jiang; Jinming Li; Ping Li; Zhuo Li; Liang Ming; Shiyang Pan; Zuojun Shen; Jianrong Su; Ziyong Sun; Hui Wang; Junjun Wang; Bin Xu; Nong Yu; Lei Zheng; Yi Zhang; Xin Zhang; Ying Zhang; Yong Duan; Chengbin Wang

doi:10.21037/atm-20-4060

Chinese Expert Consensus on the Nucleic Acid Detection of SARS-CoV-2

Ann Transl Med. 2020 Dec;8(24):1631. doi: 10.21037/atm-20-4060.

Authors

Zijie Liu^{1

2}, Yongqing Tong³, Jun Wu⁴, Lutao Du⁵, Chaojun Wei⁶, Wei Cui⁷, Yongtong Cao⁸, Ming Chen⁹, Zhen Cai¹⁰, Wei Chen¹¹, Haitao Ding¹², Ming Guan¹³, Wei Guo¹⁴, Chunfang Gao¹⁵, Xiaoke Hao¹⁶, Chengjin Hu¹⁷, Shan Huang¹⁸, Yanfang Jiang¹⁹, Jinming Li²⁰, Ping Li²¹, Zhuo Li²², Liang Ming²³, Shiyang Pan²⁴, Zuojun Shen²⁵, Jianrong Su²⁶, Ziyong Sun²⁷, Hui Wang²⁸, Junjun Wang²⁹, Bin Xu³⁰, Nong Yu³¹, Lei Zheng¹⁰, Yi Zhang³², Xin Zhang³³, Ying Zhang³⁴, Yong Duan^{1

2}, Chengbin Wang³⁴

Affiliations

¹ Yunnan Key Laboratory of Laboratory Medicine, Kunming, China.
² Department of Laboratory Medicine, First Affiliated Hospital of Kunming Medical University, Kunming, China.
³ Laboratory Medicine Center, Renmin Hospital of Wuhan University, Wuhan, China.
⁴ Department of Clinical Laboratory, Shanghai General Hospital Jiading Branch, Shanghai, China.
⁵ Laboratory Medicine Center of The Second Hospital of Shandong University, Jinan, China.
⁶ The Institute of Clinical Research and Translational Medicine, Gansu Provincial Hospital, Lanzhou, China.
⁷ Department of Laboratory Medicine, Cancer Hospital Chinese Academy of Medical Sciences, Beijing, China.
⁸ Laboratory Department of China-Japan Friendship Hospital, Beijing, China.
⁹ Laboratory Department of Southwest Hospital, Chongqing, China.
¹⁰ Department of Laboratory Medicine, Nanfang Hospital of Southern Medical University, Guangzhou, China.
¹¹ Department of Laboratory Medicine, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.
¹² Department of Laboratory Medicine, People's Hospital of Inner Mongolia Autonomous Region, Hohhot, China.
¹³ Department of Laboratory Medicine, Huashan Hospital, Fudan University, Shanghai, China.
¹⁴ Department of Laboratory Medicine, Zhongshan Hospital, Fudan University, Shanghai, China.
¹⁵ Department of Laboratory Medicine, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China.
¹⁶ Department of Laboratory Medicine, Xijing Hospital, Air Force Military Medical University, Xi'an, China.
¹⁷ Department of Laboratory Diagnosis, 960th Hospital of Chinese PLA, Jinan, China.
¹⁸ Guizhou Province Center for Clinical Laboratory, Guiyang, China.
¹⁹ Gene Diagnostic Center of the First Hospital of Jilin University, Changchun, China.
²⁰ National Center for Clinical Laboratories, Beijing, China.
²¹ Medical Laboratory and Pathology Center, the First Affiliated Hospital of Hunan University of Traditional Chinese Medicine, Changsha, China.
²² Department of Laboratory Medicine, the First Affiliated Hospital of Xi'an Medical College, Xian, China.
²³ Department of Laboratory Medicine, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
²⁴ Department of Laboratory Medicine, the First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
²⁵ Scientific Research Department of the First Affiliated Hospital of University of Science and Technology of China, Hefei, China.
²⁶ Department of Laboratory Medicine, Beijing Friendship Hospital, Capital Medical University, Beijing, China.
²⁷ Department of Laboratory Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
²⁸ Department of Laboratory Medicine, Peking University People's Hospital, Beijing, China.
²⁹ Department of Laboratory Medicine, Eastern Theater General Hospital; Nanjing, China.
³⁰ Provincial Clinical Inspection Center of Jiangsu Cancer Hospital, Nanjing, China.
³¹ Laboratory of Suzhou Branch of Xinhua Hospital Affiliated to Shanghai Jiaotong University, Suzhou, China.
³² Department of Laboratory Medicine, Qilu Hospital of Shandong University, Jinan, China.
³³ Department of Laboratory Medicine of Xinjiang Production and Construction Corps Hospital, Urumqi, China.
³⁴ Department of Clinical Laboratory Medicine, the First Medical Center, Chinese PLA General Hospital, Beijing, China.

Abstract

The coronavirus disease 2019 (COVID-19) has already become a pandemic wherein the infection's timely diagnosis has proven beneficial to patient treatment and disease control. Nucleic acid detection has been the primary laboratory diagnostic method for the detection of SARS-CoV-2. To ensure laboratory staff safety and quality nucleic acid testing, the Chinese Society of Laboratory Medicine formulated this consensus, based on the Chinese National Recommendations and previous literature for nucleic acid detection. A working group comprises 34 hospital professionals experience with real-time polymerase chain reactions (PCR) testing for SARS-CoV-2 drafted guidance statements during online discussions. A modified Delphi methodology was used in forming a consensus among a wider group of hospital professionals with SARS-CoV-2 detection experience. Guidance statements were developed for four categories: (I) specimen type, priority, collecting, transportation and receiving; (II) nucleic acid isolation and amplification; (III) quality control; (IV) biosafety management and decontamination. The modified Delphi voting process included a total of 29 guidance statements and final agreement. Consensus was reached after two rounds of voting. Recommendations were established for the detection of SARS-CoV-2 using real time PCR testing based on evidence and group consensus. The manuscript was evaluated against The Appraisal of Guidelines for Research & Evaluation Instrument (AGREE II) and was developed to aid medical laboratory staff in the detection of the ribonucleic acid (RNA) of SARS-CoV-2.

Keywords: SARS-CoV-2; coronavirus disease 2019 (COVID-19); nucleic acid; polymerase chain reaction (PCR).

Publication types

Review