Emergency use authorization for Ebola virus detection by FDA-approved techniques

VernacularTitle:FDA紧急使用授权的埃博拉检测技术的评估比较
Author: Yajun GU ¹ ; Tiantian SHE ; Hongwei FU ; Wei QIN ; Yichao WANG ; Yunde LIU
Author Information

1. 300203,天津医科大学医学检验学院
Keywords: FDA; emergency use authorization; Ebola; nucleic acid; antigen
From: Chinese Journal of Experimental and Clinical Virology 2016;30(5):496-499
CountryChina
Language:Chinese
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 RTPCR 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.