The World Health Organization (WHO) has added the first molecular diagnostic test for Bundibugyo virus to its Emergency Use Listing, according to a July 3 announcement. The new test detects the genetic material of the virus in blood samples, allowing for rapid and accurate confirmation of infection.
The WHO Emergency Use Listing procedure evaluates essential health products for quality, safety, and performance based on available evidence. The process ensures that products meet minimum international standards and are suitable for use in low- and middle-income countries. WHO said this mechanism is intended to accelerate access to reliable diagnostics for early case detection, timely clinical care, disease surveillance, and effective outbreak response. The listing also helps United Nations procurement agencies and governments make informed decisions about product use during public health emergencies.
On May 17, WHO Director-General Dr. Tedros Adhanom Ghebreyesus declared a public health emergency of international concern due to an Ebola outbreak caused by Bundibugyo virus in the Democratic Republic of the Congo, with cases reported in Uganda. Less than two weeks later, WHO called on manufacturers of in vitro diagnostics (IVDs) for Bundibugyo virus to submit applications for Emergency Use Listing.
The addition comes as countries respond to what is described as the largest recorded outbreak of Ebola disease caused by BDBV. As of July 3, there were 1,406 laboratory-confirmed cases and 438 deaths reported in the Democratic Republic of the Congo alone. Laboratory testing capacity has expanded from two main sites—Institut National de Recherche Biomédicale locations in Kinshasa and Goma—to a network of ten laboratories across affected provinces with a combined capacity exceeding 2,000 tests per day.
WHO continues collaborating with manufacturers and partners such as Africa Centres for Disease Control and Prevention (Africa CDC), PATH, FIND, CHAI, and Unitaid to expand access to safe diagnostic tools. Additional applications for BDBV IVDs are under review through the EUL procedure. In parallel, efforts supported by Unitaid include establishing a joint validation platform with Africa CDC and other partners to evaluate various diagnostic products’ performance during outbreaks.
Bundibugyo virus disease is described as severe and often life-threatening; it can spread from animals or between people through contact with infected bodily fluids or contaminated surfaces.
