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Ebola virus is a generic term used to refer to several viruses belonging to the virus, which belongs to the fibrous virusEVD, which is usually transmitted through blood and fluid, is a potent infectious disease that can cause Ebola haemorrhagic feverEVD mortality is high, mainly due to stroke, myocardial infarction, low blood volume shock or multiple organ failureEVD has caused several major outbreaks in Africa, the first in West Africa, where more than 11,000 people died, and the second in West Africa, where thousands of people have diedIn addition to ebola virus vaccines and therapies designed to prevent and treat Ebola virus, the most important tool to prevent the spread of the epidemic is the ability to quickly diagnose patients with test ingresss, which in turn isolates patients with EVD and timely burial of bodies that have died as a result of EVDoraQuick Ebola virus rapid antigen testing kit for blood samples from potential patients with already EVD symptoms, as well as oral fluids from bodies suspected of dying from EVDBecause the antigen levels in EVD patients in the incubation and early infection stages are not high enough, the kit cannot be used for screening testingPreviously, the kit had been awarded a breakthrough device by the FDA and had been granted emergency authorization by the FDA in 2014 (Emergency Authorization, EUA)Picture Source: OraSure Technologies
The OraQuick Ebola Virus Rapid Antigen Testing Kit uses an approval process called "de novo premarket review pathway." This approval process is used to approve innovative low-risk or moderate-risk medical devices or tests that are not available in the marketDr Ned Sharpless, acting director of theFDA, said: "The approval of this listing provides another important tool in the fight against the Ebola virusThe fight against the Ebola virus remains a priority for the U.Sgovernment, and we work with partners, including the World Health Organization, to help resolve the ongoing Ebola outbreak in the Republic of CongoReferences:s1 sFOD Retrieved Oct 10, 2019, from https://