On 5 May 2026, the World Health Organization (WHO) was alerted of a high-mortality outbreak of an unknown illness in Ituri Province, Democratic Republic of the Congo, where several people—including health workers—had died. By 14 May, laboratory testing conducted by the Institut National de Recherche Biomédicale (INRB) in Kinshasa confirmed that the illness was Bundibugyo virus disease (BVD), a type of Ebola. Recognizing the seriousness of the situation and its spread across borders into Uganda, the WHO Director-General declared the outbreak a Public Health Emergency of International Concern (PHEIC) on 16 May 2026 (note) . BVD is a severe and often fatal disease caused by the Bundibugyo virus (BDBV) that can pass from animals to humans and then spread between people through direct contact with bodily fluids or contaminated surfaces.
Instructions and requirements for EUL submissions of IVDs for Bundibugyo virus (BDBV) nucleic acid detection are being prepared and an invitation to manufacturers for Expression of Interest will be launched soon.
Manufacturers of IVDs Bundibugyo virus (BDBV) nucleic acid detection are encouraged to complete the product questionnaire and submit it along with a copy of the product IFU (in English) to diagnostics@who.int. Based on the questionnaire, manufacturers may be contacted by WHO to arrange a pre-submission call to discuss next steps.