著者
Kiyoko Okamaoto Kazuya Shirato NagaNaganori Nao Shinji Saito Tsutomu Kageyama Hideki Hasegawa Tadaki Suzuki Shutoku Matsuyama Makoto Takeda
出版者
National Institute of Infectious Diseases, Japanese Journal of Infectious Diseases Editorial Committee
雑誌
Japanese Journal of Infectious Diseases (ISSN:13446304)
巻号頁・発行日
pp.JJID.2020.108, (Released:2020-04-30)
参考文献数
11
被引用文献数
13 33

The COVID-19 outbreak caused by SARS-CoV-2 in Wuhan (China) in December 2019 is currently spreading rapidly and globally. We recently reported a laboratory diagnostic protocol for SARS-CoV-2 based on real-time RT-PCR assays using two primer sets, N and N2. On 30–31 January 2020, the protocol and reagents for these assays were distributed to local public health institutes and quarantine depots in Japan, and nationwide, SARS-CoV-2 diagnostic testing was started. For further validation, the assays were compared with the commercially available kits using SARS CoV-2 viral RNA and the clinical specimens obtained from COVID19-suspected individuals. The LightMix Modular SARS and Wuhan CoV E-gene (LN S&W-E) assay was highly sensitive for SARS-CoV-2, as was the N2 set, and both assays had perfectly consistent results with the clinical specimens. While the LM S&W-E set targets the highly conserved region of the E gene in SARS-CoV and SARS-CoV-2, the N2 set was designed to target the unique region in the SARS-CoV-2 N gene. Thus, the N2 set has high specificity and sensitivity for SARS-CoV-2 detection. These indicate that the protocol using the N and N2 sets is comparable to commercially available kits and is reliable for the laboratory diagnosis of COVID-19.