WHO adds first diagnostic test for Bundibugyo Ebola virus to its emergency list

Today the World Health Organization (WHO) has added the first molecular diagnostic test for Bundibugyo virus (BDBV) to its Emergency Use List (EUL). The test detects the virus by identifying its genetic material in blood samples, helping to quickly and accurately confirm infection.

WHO’s EUL process assesses the quality, safety and efficacy of essential health products based on available evidence, while ensuring that they meet minimum international standards and meet the needs of low- and middle-income countries.

With this mechanism, WHO wants to accelerate access to reliable diagnostic tools for early detection of cases, timely clinical care, disease surveillance and effective response to disease outbreaks. EUL also supports United Nations procurement agencies and governments in making informed decisions about the procurement and use of these products in public health emergencies.

“Public health emergencies require not only speed, but also confidence that the health products being used meet standards of quality, safety and efficacy,” said Dr Yukiko Nakatani, WHO Assistant Director-General for Health Systems, Access and Data. “During a rapid outbreak, timely access to quality diagnostic tests can make a critical difference in containing transmission. Through this emergency list, WHO is helping countries gain faster access to reliable diagnostic tools so they can respond more effectively.”

On 17 May 2026, WHO Director-General Dr. Tedros Adhanom Ghebreyesus declared a Public Health Emergency of International Concern over an outbreak of Ebola caused by the Bundibugyo virus in the Democratic Republic of the Congo, with cases in Uganda. Less than two weeks later, WHO launched a call for Bundibugyo virus IVD manufacturers to submit Expressions of interest for the emergency list.

The list comes at a critical time as countries respond to the largest recorded outbreak of Ebola caused by BDBV, which continues to spread. To date, 1,406 laboratory-confirmed cases and 438 deaths have been reported in the Democratic Republic of Congo alone.

With support from WHO and the African Centers for Disease Control and Prevention (Africa CDC), laboratory testing capacity has expanded from a limited number of locations—primarily the Institut National de Recherche Biomédicale in Kinshasa and Goma, with an estimated combined capacity of approximately 200-400 tests per day—to a wider network of 10 laboratories in the affected provinces, with a reported capacity of over 2,000 tests per day. Rapid and reliable diagnosis remains critical to early case identification, directing timely patient care, terminating and helping to bring outbreaks under control.

WHO continues to work closely with manufacturers, global partners and countries to expand availability and access to safe, effective and quality life-saving health products. Additional requests for BDBV IVDs submitted through the EUL procedure are currently under review.

In parallel, WHO and the African CDC, with partners including PATH, FIND and CHAI, and supported by Unitaid, are establishing a joint validation platform for the rapid performance assessment of a selection of diagnostic products, including laboratory molecular tests, point-of-care molecular tests and rapid antigen diagnostic tests. The platform will generate critically needed clinical evidence of the efficacy of these products in outbreak settings.

Bundibugyo virus disease is a severe, often life-threatening illness caused by BDBV, one of three types of Ebola virus known to cause large outbreaks in humans. The virus can spread from animals to humans and then from person to person through contact with a sick or deceased person and their infected body fluids or surfaces or objects contaminated with those fluids.

Information on active EUL applications for IVDs to detect BDBV nucleic acid can be found here WHO website.

ABOUT WHO

Committed to the well-being of all people and guided by science, the World Health Organization leads and supports global efforts to give everyone, everywhere, an equal opportunity to live a safe and healthy life.

We are the UN health agency that connects nations, partners and people on the front lines in more than 150 locations – leading the world’s response to health emergencies, preventing disease, addressing the root causes of health problems and expanding access to medicines and healthcare. Our mission is to support countries in promoting, providing and protecting health.

“Together for health. Let’s stand by science”, is the theme World Health Day 2026 marks a year-long campaign to highlight science as the foundation for protecting health and well-being around the world.