WHO Adds First Bundibugyo Ebola Molecular Test to Emergency Use Listing
Posted on 08 Jul 2026
Ebola disease caused by Bundibugyo virus is a severe, often life-threatening illness that spreads through contact with infected bodily fluids. Rapid confirmation of infection is critical for early care, surveillance, and effective outbreak response, especially during large-scale transmission events. The Democratic Republic of the Congo is now facing the largest recorded outbreak of this virus, with 1,406 laboratory-confirmed cases and 438 deaths as of July 2, 2026. In response, WHO has added the first molecular diagnostic test for Bundibugyo virus to its Emergency Use Listing.
The World Health Organization (WHO) listed the first molecular diagnostic test for Bundibugyo virus (BDBV) under its Emergency Use Listing (EUL) on July 2, 2026. The assay identifies viral genetic material in blood samples to help confirm infection rapidly and accurately. Under the EUL procedure, WHO assesses the quality, safety, and performance of essential health products, ensures they meet minimum international standards and address the needs of low- and middle-income countries, and supports United Nations procurement agencies and governments in making informed decisions on their use in public health emergencies.
WHO declared the Bundibugyo virus outbreak a public health emergency of international concern on May 17, 2026, and called for manufacturers of in vitro diagnostics (IVDs) to submit Expressions of Interest for Emergency Use Listing less than two weeks later. The listing comes as countries respond to the largest recorded BDBV outbreak, which continues to expand in the Democratic Republic of the Congo.
With support from WHO and the Africa Centres for Disease Control and Prevention (Africa CDC), testing capacity has expanded from a limited number of sites, primarily the Institut National de Recherche Biomédicale in Kinshasa and Goma, with an estimated capacity of 200–400 tests per day, to a network of 10 laboratories across affected provinces with reported capacity exceeding 2,000 tests per day. Rapid and reliable diagnosis remains essential to identify cases early, guide timely patient care, and help bring outbreaks under control.
WHO continues to work with manufacturers, partners, and countries to expand access to quality-assured health products, and additional BDBV IVD applications are under review through the EUL procedure. In parallel, WHO and Africa CDC—working with PATH, FIND and CHAI, and with support from Unitaid—are establishing a joint validation platform to rapidly evaluate the performance of laboratory-based molecular tests, near–point-of-care molecular tests, and antigen rapid diagnostic tests. The platform is intended to generate urgently needed clinical evidence on diagnostic performance in outbreak settings.
“Public health emergencies require not only speed, but also confidence that the health products being used meet standards for quality, safety and performance. During a fast-moving outbreak, timely access to quality-assured diagnostic tests can make a critical difference in containing transmission. Through this Emergency Use Listing, WHO is helping countries access trusted diagnostic tools more rapidly so that they can respond more effectively,” stated Dr Yukiko Nakatani, WHO Assistant Director-General for Health Systems, Access and Data.
