Title: Emergency use authorization for Ebola virus detection by FDA-approved techniques
Abstract: Ebola virus (EBOV) is an aggressive pathogen that causes a highly hemorrhagic fever syndrome in humans and other mammalian species. Early detection and proper treatment is the best defense against EBOV because of high mortality rate (70%-90%). Currently, there are eleven FDA approved Ebola tests, kits, or assays for emergency use, which can be divided into two main categories: rRT-PCR and viral antigen methods. In BSL 4 lab, rRT-PCR is the most sensitive technique to detect nucleic acid of Ebola virus, including Ebola Zaire (EZ1) rRT-PCR (TaqMan) Assay, Ebola Virus NP and VP40 Real-time RT-PCR Assay, FilmArray NGDS BT-E and Biothreat-E test, RealStar Ebolavirus RT-PCR kit, LightMix Ebola Zaire rRT-PCR test, and Xpert Ebola Assay. Antigen-based technology (ReEBOV Antigen Rapid Test, and OraQuick Ebola Rapid Antigen Test) provides rapid Ebola antigen test without relying on special PCR equipment. How to develop, manufacture, and market point-of-care and field testing will be the next major challenge for EBOV on various samples.
Key words:
FDA; emergency use authorization; Ebola; nucleic acid; antigen
Publication Year: 2016
Publication Date: 2016-10-30
Language: en
Type: article
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