WHO Approves First Diagnostic Test for Bundibugyo Ebola Virus in Emergency Use List
The World Health Organization (WHO) has announced the inclusion of the first molecular diagnostic test for the Bundibugyo virus (BDBV) in its Emergency Use Listing (EUL). This diagnostic tool identifies the virus by detecting its genetic material in blood samples, enabling rapid and accurate infection confirmation.
Ensuring Quality and Accessibility
WHO’s EUL procedure evaluates the quality, safety, and performance of essential health products based on current evidence, ensuring they meet international standards. This listing particularly addresses the needs of low- and middle-income countries, facilitating quicker access to reliable diagnostic tools for early case detection, timely clinical care, disease surveillance, and effective outbreak management.
Dr. Yukiko Nakatani, WHO Assistant Director-General for Health Systems, Access and Data, emphasized the importance of having reliable health products during public health emergencies, stating, “Public health emergencies require not only speed but also confidence that the health products being used meet standards for quality, safety, and performance.”
Context of the Outbreak
On May 17, 2026, WHO Director-General Dr. Tedros Adhanom Ghebreyesus declared a public health emergency of international concern due to the outbreak of Ebola caused by Bundibugyo virus in the Democratic Republic of the Congo, with cases also identified in Uganda. As of now, 1,406 laboratory-confirmed cases and 438 deaths have been reported in the Democratic Republic of the Congo.
In response, WHO called on manufacturers to submit Expressions of Interest for the EUL of in vitro diagnostics (IVDs) for BDBV. With support from WHO and the Africa Centres for Disease Control and Prevention (Africa CDC), laboratory testing capacity has expanded significantly, from a few sites to a broader network capable of conducting over 2,000 tests per day.
Future Developments
WHO continues to collaborate with manufacturers, global partners, and countries to widen access to safe and effective health products. Additional applications for BDBV IVDs are under review. Concurrently, WHO and Africa CDC, alongside partners such as PATH, FIND, and CHAI, with Unitaid’s support, are developing a validation platform to assess the performance of various diagnostic products, including laboratory-based and rapid antigen tests.
About Bundibugyo Virus Disease
Bundibugyo virus disease is a severe, often life-threatening condition caused by the BDBV, one of three Ebola virus species known for causing significant human outbreaks. The virus can spread from animals to humans and subsequently from person to person through direct contact with infected individuals or contaminated surfaces and items.
For further information on active EUL applications for BDBV nucleic acid detection, please refer to the WHO’s official webpages.
Consult a healthcare professional if you have concerns about Ebola or related symptoms.
