The FDA approved its first rapid in vitro diagnostic for confirming Ebola virus infections.
The single-use OraQuick Ebola test developed by OraSure Technologies searches for virus antigens in samples to provide an early, probable readout that must later be confirmed with another test. It can be used on human blood—through either venipuncture or finger stick—as well as on oral fluids taken from people suspected to have died from the disease.
“Today’s marketing authorization provides another important tool in the effort to fight Ebola, which continues to be a priority of the U.S. Government, especially as we work with our partners, including the World Health Organization, to help address the current Ebola outbreak in the Democratic Republic of Congo,” said Acting Commissioner Ned Sharpless in an agency statement.
“The current outbreak in the DRC has already killed thousands and the outbreaks in West Africa that began in 2014 tragically killed more than 11,000,” Sharpless said. “Investigational vaccines and therapeutics have shown promising results, but one of the most important tools in stopping these outbreaks is quickly diagnosing patients and supporting safe and dignified burials.”
The rapid diagnostic test could help healthcare providers quickly isolate patients and begin potentially life-saving treatments, he added, while also reducing the risk of transmission during the handling of bodies or contaminated objects.
The 2014 West African Ebola epidemic was the largest outbreak in recorded history, while the ongoing outbreak in Congo is currently the second largest, the FDA said.
During the 2014 outbreak, the U.S. government authorized emergency use of unapproved in vitro diagnostics for Ebola, with the FDA and the Centers for Disease Control and Prevention (CDC) working with multiple test developers including OraSure to make tests available.
Now, the OraQuick Ebola test—with previously approved versions focused on HIV, hepatitis C and flu—has received a de novo approval under the FDA’s premarket review pathway. It previously received a breakthrough device designation.
The agency reviewed multiple clinical studies of blood samples and cadaver oral fluid from the 2014 West African outbreak and other sources and gave the green light alongside special controls.
The amount of Ebola virus present in a patient can vary greatly depending on the severity of their symptoms; the FDA said that clinical studies showed the OraQuick test should be used only on symptomatic individuals so viral levels are high enough to be detected by the diagnostic.
The test is intended for sick patients that meet the CDC’s epidemiological criteria, including a history of residence or travel to a region with active Ebola transmission. It is not meant for general Ebola infection screening, such as in an airport, the FDA said. Additionally, a negative test result does not rule out an infection, and a more sensitive test—such as a less rapid PCR test—is still required.