Perng Cherng-Lih, Jian Ming-Jr, Chang Chih-Kai, Lin Jung-Chung, Yeh Kuo-Ming, Chen Chien-Wen, Chiu Sheng-Kang, Chung Hsing-Yi, Wang Yi-Hui, Liao Shu-Jung, Li Shih-Yi, Hsieh Shan-Shan, Tsai Shih-Hung, Chang Feng-Yee, Shang Hung-Sheng
Division of Clinical Pathology, Department of Pathology, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan, ROC.
Division of Infectious Diseases and Tropical Medicine, Department of Medicine, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan, ROC.
PeerJ. 2020 Jun 17;8:e9318. doi: 10.7717/peerj.9318. eCollection 2020.
Coronavirus disease 2019 has become a worldwide pandemic. By April 7, 2020, approximately 1,279,722 confirmed cases were reported worldwide including those in Asia, European Region, African Region and Region of the Americas. Rapid and accurate detection of Severe Acute Respiratory Syndrome Virus 2 (SARS-CoV-2) is critical for patient care and implementing public health measures to control the spread of infection. In this study, we developed and validated a rapid total nucleic acid extraction method based on real-time RT-PCR for reliable, high-throughput identification of SARS-CoV-2 using the BD MAX platform. For clinical validation, 300 throat swab and 100 sputum clinical samples were examined by both the BD MAX platform and in-house real-time RT-PCR methods, which showed 100% concordant results. This BD MAX protocol is fully automated and the turnaround time from sample to results is approximately 2.5 h for 24 samples compared to 4.8 h by in-house real-time RT-PCR. Our developed BD MAX RT-PCR assay can accurately identify SARS-CoV-2 infection and shorten the turnaround time to increase the effectiveness of control and prevention measures for this emerging infectious disease.
2019冠状病毒病已成为全球大流行疾病。截至2020年4月7日，全球报告的确诊病例约为1279722例，包括亚洲、欧洲区域、非洲区域和美洲区域的病例。快速准确地检测严重急性呼吸综合征冠状病毒2（SARS-CoV-2）对于患者护理和实施公共卫生措施以控制感染传播至关重要。在本研究中，我们开发并验证了一种基于实时逆转录聚合酶链反应（RT-PCR）的快速总核酸提取方法，用于使用BD MAX平台可靠、高通量地鉴定SARS-CoV-2。为进行临床验证，采用BD MAX平台和内部实时RT-PCR方法对300份咽拭子和100份痰液临床样本进行检测，结果显示两者完全一致。该BD MAX方案是全自动的，24个样本从样本到结果的周转时间约为2.5小时，而内部实时RT-PCR为4.8小时。我们开发的BD MAX RT-PCR检测方法能够准确鉴定SARS-CoV-2感染，并缩短周转时间，以提高对这种新发传染病的防控措施的有效性。
