In late December 2019, an outbreak of pneumonia with an unknown etiology in Wuhan, China was considered as the first Disease X following the announcement by WHO. Shortly thereafter, a novel coronavirus, 2019-nCoV, as denoted by WHO,3 was identified as the pathogen causing the coronavirus disease COVID-19.4,5 2019-nCoV with 79.5 and 96% sequence identity to SARS-CoV and a bat coronavirus, SL-CoV-RaTG13, respectively,6 was renamed SARS-CoV-2 by the Coronaviridae Study Group (CSG) of the International Committee on Taxonomy of Viruses (ICTV),7 while, in the interim, it was renamed HCoV-19, as a common virus name, by a group of virologists in China.8,9,10
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We are very grateful to Qian Wang at Core Facility of Microbiology and Parasitology (SHMC) of Fudan University and the staff of the Structural Biology Core Facility (Institute of Biophysics, Chinese Academy of Sciences) for their technical assistance, especially Mr Yi Han, Ms Ya Wang and Mr Deqiang Yao of the iHuman Institute at ShanghaiTech University. We thank Guangzhou SageneBiotech Co., LTD for the assistance in preparing the figures with high quality. We would also like to thank Ping Shan, Ruigang Su and Si Wu (Institute of Biophysics, Chinese Academy of Sciences) for their assistance in lab management and providing Ulp1 enzyme. We are also grateful to Prof. Jie Cui (Institute Pasteur of Shanghai, Chinese Academy of Sciences) for providing SARS-CoV-2 genome information. This work was supported by the National Megaprojects of China for Major Infectious Diseases (2018ZX10301403 to L.L.), the National Natural Science Foundation of China (81822045 to L.L.; 81630090 to S.J.; 81703571 to W.X.), the National Key Research and Development Program of China (2018YFA0901102 & 2019YFA0904101 to Y.Z.), as well as the China Postdoctoral Science Foundation (2018M640341 and 2019T120302 to S.X.)
In response to CDC's request, on October 8, 2019 FDA concurred with the modifications to the Healthcare Provider and Patient Fact Sheets for the CDC Ebola Virus NP Real-time RT-PCR Assay to reflect changes to the CDC testing algorithm and updated epidemiological information concerning Ebola virus disease (EBV).
In response to CDC's request, on October 8, 2019 FDA concurred with the modifications to the Healthcare Provider and Patient Fact Sheets for the CDC Ebola Virus VP40 Real-time RT-PCR Assay to reflect changes to the CDC testing algorithm and updated epidemiological information concerning Ebola virus disease (EBV).
In response to BioFire Defense LLC's request, on November 12, 2019 FDA concurred with modifications to the authorized Instructions for Use of the FilmArray Biothreat-E test to include new data on analytical exclusivity wet-testing and associated limitations. FDA also concurred with the modifications to the (1) Instructions for Use, including wording in the intended use, to improve the overall clarity and accuracy of the document, and (2) Healthcare Provider and Patient Fact Sheets, that were requested by FDA.
In response to Chembio Diagnostic Systems, Inc.'s request, on April 2, 2019 FDA concurred with the modifications to the authorized Instructions for Use labeling for the DPP Ebola Antigen System to update 1) the cross-reactivity performance for Plasmodium malariae and Streptococcus pneumoniae in whole blood, and 2) the endogenous interference data for Rheumatoid Factor, Glucose, unconjugated bilirubin, cholesterol and HAMA.
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Fusogens are specialized proteins that mediate fusion between membranes (Brukman et al., 2019; Hernández and Podbilewicz, 2017). They drive membrane fusion by bringing two membranes at a distance of
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