Liu Zijie, Tong Yongqing, Wu Jun, Du Lutao, Wei Chaojun, Cui Wei, Cao Yongtong, Chen Ming, Cai Zhen, Chen Wei, Ding Haitao, Guan Ming, Guo Wei, Gao Chunfang, Hao Xiaoke, Hu Chengjin, Huang Shan, Jiang Yanfang, Li Jinming, Li Ping, Li Zhuo, Ming Liang, Pan Shiyang, Shen Zuojun, Su Jianrong, Sun Ziyong, Wang Hui, Wang Junjun, Xu Bin, Yu Nong, Zheng Lei, Zhang Yi, Zhang Xin, Zhang Ying, Duan Yong, Wang Chengbin
Yunnan Key Laboratory of Laboratory Medicine, Kunming, China.
Department of Laboratory Medicine, First Affiliated Hospital of Kunming Medical University, Kunming, China.
Ann Transl Med. 2020 Dec;8(24):1631. doi: 10.21037/atm-20-4060.
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.
2019年冠状病毒病（COVID-19）已成为大流行病，事实证明，对该感染进行及时诊断有利于患者治疗和疾病控制。核酸检测一直是检测严重急性呼吸综合征冠状病毒2（SARS-CoV-2）的主要实验室诊断方法。为确保实验室工作人员安全和核酸检测质量，中国医学检验学会根据国家建议和以往核酸检测文献制定了本共识。一个由34名具有SARS-CoV-2实时聚合酶链反应（PCR）检测经验的医院专业人员组成的工作组在在线讨论期间起草了指导声明。采用改良的德尔菲法在更广泛的具有SARS-CoV-2检测经验的医院专业人员群体中达成共识。针对四类内容制定了指导声明：（I）样本类型、优先级、采集、运输和接收；（II）核酸分离和扩增；（III）质量控制；（IV）生物安全管理和去污。改良的德尔菲投票过程共包括29项指导声明和最终协议。经过两轮投票达成了共识。基于证据和小组共识，制定了使用实时PCR检测SARS-CoV-2的建议。本手稿根据《研究与评价工具指南评估》（AGREE II）进行了评估，旨在帮助医学实验室工作人员检测SARS-CoV-2的核糖核酸（RNA）。
