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深入了解 FDA-EUA 批准的新冠病毒诊断技术。

A Closer Look into FDA-EUA Approved Diagnostic Techniques of Covid-19.

机构信息

Center for Biomedical Engineering, School of Engineering, Brown University, Providence 02912, Rhode Island, United States.

Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong SAR 999077, China.

出版信息

ACS Infect Dis. 2021 Oct 8;7(10):2787-2800. doi: 10.1021/acsinfecdis.1c00268. Epub 2021 Sep 27.

Abstract

The 2019 coronavirus disease (COVID-19), caused by the severe acute respiratory syndrome coronavirus 2 virus, caused a worldwide pandemic in 2020 and is the most urgent health issue worldwide. In this review, we highlight the details of Food and Drug Administration-Emergency Use Authorizations approved diagnostics kits, focusing on the similarities and differences. It is essential to understand the currently available options and the advantages and disadvantages each provides to select the appropriate products that maximize the testing efficiency. We believe this work will provide a holistic evaluation of the current COVID-19 diagnostic resources, including variations across the countries, and guide developing novel diagnostic techniques to improve and optimize the current testing options.

摘要

2019 冠状病毒病(COVID-19)由严重急性呼吸系统综合征冠状病毒 2 型病毒引起,于 2020 年在全球引发大流行,是目前全球最为紧迫的卫生问题。在这篇综述中,我们重点介绍了获得美国食品和药物管理局(FDA)紧急使用授权的诊断试剂盒的详细信息,重点关注它们之间的异同。了解当前可用的检测方案及其各自的优缺点,选择最合适的产品,以最大限度地提高检测效率,这一点至关重要。我们相信,这项工作将对当前的 COVID-19 诊断资源进行全面评估,包括各国之间的差异,并为改进和优化当前检测方案提供新的诊断技术指导。

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