FDA clears OraSure’s OraQuick Ebola Test for marketing

11 October 2019 (Last Updated October 11th, 2019 10:31)

Diagnostic products developer OraSure Technologies has received marketing authorisation from the US Food and Drug Administration (FDA) for its rapid diagnostic test (RDT) to identify Ebola virus antigen.

FDA clears OraSure’s OraQuick Ebola Test for marketing
Scanning electron micrograph of Ebola virus Makona (in red) from the West African epidemic. Credit: National Institute of Allergy and Infectious Diseases, NIH.

Diagnostic products developer OraSure Technologies has received marketing authorisation from the US Food and Drug Administration (FDA) for its rapid diagnostic test (RDT) to identify Ebola virus antigen.

The OraQuick Ebola Rapid Antigen Test determines a rapid, presumptive diagnosis that must be approved.

It can be used to analyse blood from living individuals, as well as oral fluid from some recently deceased individuals suspected of having died from the Ebola Virus Disease, for informed decisions to prevent disease transmission via cadavers.

FDA acting commissioner Ned Sharpless said: “The ability to use this test to promptly make a presumptive Ebola diagnosis could help providers to more quickly isolate patients and begin treatments that can be potentially life-saving.

“Additionally, this device could be used to support safe and dignified burials while helping to reduce the risk of transmission during those burials.”

FDA approval comes after a review of results from various clinical studies conducted using blood samples and cadaveric oral fluid from the 2014 outbreak in West African and different analytical studies.

Based on the data, the regulator concluded that general and special controls were required to ensure the safety and effectiveness of the OraQuick test.

According to the FDA, studies showed that the test could be used only in symptomatic individuals, where the amount of virus is high enough for detection.

It cannot be used for general Ebola infection screening, or to test people at risk of exposure without observable signs of infection.

Ebola spreads via direct contact with blood or body fluids, as well as objects contaminated with body fluids. It can also spread from the bodies of people who have died from the virus.

The ongoing outbreak of the virus in the Democratic Republic of the Congo (DRC) is considered the second-largest in Africa.

During an outbreak in 2014, the FDA collaborated with Centers for Disease Control and Prevention (CDC) and diagnostics developers to provide access to tests, including the OraQuick test, through the Emergency Use Authorization (EUA) pathway.

In November last year, FDA granted EUA to Chembio Diagnostics’ DPP Ebola Antigen System.