WHO Approves First Diagnostic Test for Ebola Bundibugyo Virus in Emergency Use Listing
The World Health Organization (WHO) has included the first molecular diagnostic test for the Bundibugyo virus (BDBV) in its Emergency Use Listing (EUL). This test can identify the virus by detecting its genetic material in blood samples, providing rapid and precise confirmation of infection.
The EUL process evaluates the quality, safety, and performance of crucial health products, ensuring they meet international standards and cater to the needs of low- and middle-income countries. WHO aims to expedite the availability of reliable diagnostic tools for early case detection, timely clinical care, disease monitoring, and effective response to outbreaks.
Dr. Yukiko Nakatani, WHO Assistant Director-General for Health Systems, Access and Data, emphasized, “Public health emergencies require not only speed but also assurance that health products used are of high quality, safe, and perform well. During a fast-moving outbreak, quick access to quality-assured diagnostic tests can be pivotal in controlling transmission. This Emergency Use Listing allows countries to access trusted diagnostic tools swiftly, enhancing their response capabilities.”
On May 17, 2026, WHO Director-General Dr. Tedros Adhanom Ghebreyesus declared an international public health emergency due to an Ebola outbreak caused by the Bundibugyo virus in the Democratic Republic of the Congo, which has also affected Uganda. Following this, WHO invited manufacturers to submit applications for Emergency Use Listing for in-vitro diagnostics (IVDs) for the Bundibugyo virus.
This listing arrives as countries tackle the largest recorded outbreak of Ebola caused by BDBV, with 1,406 confirmed cases and 438 deaths reported in the Democratic Republic of the Congo alone. With support from WHO and the Africa Centres for Disease Control and Prevention (Africa CDC), laboratory testing capability has expanded from a few locations, like the Institut National de Recherche Biomédicale in Kinshasa and Goma, to a more extensive network of 10 laboratories across affected areas, boosting testing capacity to over 2,000 tests daily.
WHO continues collaborating with manufacturers, global partners, and countries to enhance access to safe, effective, and high-quality health products. Additional applications for BDBV IVDs are under consideration through the EUL procedure.
In collaboration with Africa CDC, PATH, FIND, CHAI, and with support from Unitaid, WHO is developing a joint validation platform to rapidly assess the performance of selected diagnostic products, including laboratory-based molecular tests, near-point-of-care molecular tests, and antigen rapid diagnostic tests. This platform will provide essential clinical data on these products in outbreak situations.
Bundibugyo virus disease is a severe, potentially life-threatening illness caused by BDBV, one of three Ebola virus species known to cause significant outbreaks in humans. The virus can transmit from animals to humans and subsequently from person to person through contact with infected individuals or their bodily fluids or contaminated surfaces.
For more information on active EUL applications for BDBV nucleic acid detection, please visit the WHO websites.
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