New Rapid Ebola Antigen Test Detects Infection at Point of Care

Rapid diagnosis is critical, including confirmation in recently deceased individuals, but response efforts are complicated by the Bundibugyo virus, which has no approved vaccine or targeted treatment. A newly authorized rapid antigen test now supports time-critical detection at or near the point of care, delivering results in 30 minutes.

OraSure Technologies' OraQuick Ebola 2.0 Rapid Antigen Test has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for use with whole blood from living patients and cadaveric oral fluid from individuals suspected of having Ebola disease at the time of death. The second‑generation assay detects all four Ebola viruses known to cause human disease: Bundibugyo, Zaire, Sudan, and Taï Forest. The authorization encompasses use in symptomatic individuals with known risk factors and in the deceased to guide safe handling and burial.

The test is a single‑use, qualitative immunoassay that detects antigens from viruses within the Orthoebolavirus genus, though it does not differentiate between specific Ebola viruses. Results are read directly on the device at 30 minutes without instruments, batteries, smartphones, or laboratory analysis. The format is designed to support rapid triage and infection control in resource‑constrained or decentralized settings.

OraQuick Ebola 2.0 follows the company’s first‑generation OraQuick Ebola Rapid Antigen Test, which received De Novo marketing authorization in 2019 as the first and only rapid antigen test with full authorization for Ebola virus detection. The new version incorporates increased sensitivity, a new assay chemistry, and a more automated manufacturing process. 

The ongoing Ebola outbreak, concentrated in the Democratic Republic of the Congo and spreading into neighboring Uganda, has caused hundreds of deaths and led the World Health Organization to declare a global public health emergency. In response, the company is increasing production of the OraQuick Ebola 2.0 Rapid Antigen Test to address potential demand and broaden access to a reliable, proven diagnostic tool.

“We are proud to advance a second-generation Ebola test at a time when the world is confronting a serious and evolving outbreak in Central Africa. This outbreak is particularly challenging due to the Bundibugyo virus, which has no approved vaccine or targeted treatment, reinforcing the critical need for rapid, accurate diagnostics that can detect this virus and support timely containment efforts,” said Carrie Eglinton Manner, President and CEO of OraSure.