First Rapid Diagnostic Test for Detecting Ebola Virus Allowed by FDA

Officials from the FDA have allowed marketing of a rapid diagnostic test (RDT) to help detect Ebola virus antigens in the bloodstream from certain living individuals and samples from recently deceased individuals suspected to have Ebola.

The OraQuick Ebola Rapid Antigen Test is the first ever test approved for marketing in the U.S. by the FDA for the Ebola Virus Disease (EVD). It is intended for use in patients suspected of and with signs and symptoms consistent with EVD, and not to be used for general Ebola infection screening. It may also be used on recently diseased individuals with epidemiological risk factors suspected to have died of EVD.

EVD is severe and often fatal, and can spread through direct contact with blood, body fluids, or objects contaminated with body fluids. It can also spread when in contact with bodies of those who have passed away from the virus.

After the massive Ebola epidemic in Africa in 2014, the Ministry of Health in the DRC, the World Health Organization, the U.S. government, and more have partnered to make extensive efforts to combat the disease and any future outbreaks. Some ways that these organizations have taken action towards combatting the disease include campaigns to promote good hygiene, large-scale vaccination campaigns, specialized Ebola treatment centers, and comprehensive efforts to trace and prevent the spread of EVD.

The OraQuick Ebola Test was granted Breakthrough Device designation by the FDA, meaning that the FDA feels this innovation will provide more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition.

Reference

FDA allows marketing of first rapid diagnostic test for detecting Ebola virus antigens [news release]. Silver Spring, MD; FDA Newsroom: October 10, 2019. https://www.fda.gov/news-events/press-announcements/fda-allows-marketing-first-rapid-diagnostic-test-detecting-ebola-virus-antigens. Accessed October 10, 2019.