The World Health Organization (WHO) has added the first molecular diagnostic test for Bundibugyo virus (BDBV) to its Emergency Use Listing (EUL), a significant step in managing the ongoing Ebola disease outbreak in the Democratic Republic of the Congo. By validating this test for quality, safety, and performance, the WHO aims to accelerate the deployment of reliable diagnostic tools, enabling faster case detection and more effective clinical response in affected regions, according to an official statement from the organization.
This development arrives as health authorities grapple with the largest recorded outbreak of Ebola disease caused by BDBV. As of the most recent reports, the Democratic Republic of the Congo has documented 1,406 laboratory-confirmed cases and 438 deaths, according to data monitored by the World Health Organization. The EUL process is designed to assist United Nations procurement agencies and national governments in identifying health products that meet international standards during public health emergencies.
Addressing the Diagnostic Gap in Outbreak Zones
Rapid and accurate diagnosis is a cornerstone of outbreak containment. Before this listing, diagnostic capabilities were largely concentrated in a few specialized facilities, such as the Institut National de Recherche Biomédicale in Kinshasa and Goma. These facilities previously maintained a combined testing capacity of approximately 200 to 400 tests per day. Through collaborative efforts between the WHO and the Africa Centres for Disease Control and Prevention (Africa CDC), this infrastructure has been scaled up to a network of 10 laboratories, increasing capacity to over 2,000 tests per day.
Dr. Yukiko Nakatani, WHO Assistant Director-General for Health Systems, Access and Data, emphasized the necessity of these measures in high-stakes environments. “Public health emergencies require not only speed, but also confidence that the health products being used meet standards for quality, safety and performance,” Dr. Nakatani stated. “During a fast-moving outbreak, timely access to quality-assured diagnostic tests can make a critical difference in containing transmission.”
The Evolution of the Emergency Response
The urgency of this regulatory action is tied to the timeline of the current outbreak. On 17 May 2026, WHO Director-General Dr. Tedros Adhanom Ghebreyesus declared a public health emergency of international concern over the outbreak of Ebola disease caused by Bundibugyo virus in the Democratic Republic of the Congo, with cases in Uganda. Less than two weeks later, the WHO launched a call for manufacturers of IVDs for Bundibugyo virus to submit Expressions of Interest for Emergency Use Listing.
The Bundibugyo virus is one of three Ebola virus species known to trigger large-scale human outbreaks. It is primarily transmitted through direct contact with a person sick or deceased and their infected bodily fluids or surfaces or items contaminated by these fluids. Because the disease is often life-threatening, the ability to confirm a diagnosis in a clinical setting is essential for triaging patients and implementing infection prevention and control protocols.
Future Validation and Expanded Access
The work to improve diagnostic readiness is ongoing. In addition to the current EUL listing, the WHO and Africa CDC are partnering with organizations such as PATH, FIND, and CHAI—with financial support from Unitaid—to establish a joint validation platform. This initiative is tasked with evaluating a broader range of products, including laboratory-based molecular tests, near-point-of-care molecular tests, and antigen rapid diagnostic tests.
This validation platform is intended to produce the clinical evidence necessary to support the broader, evidence-based use of diagnostic tools in field settings. As of the latest update, the WHO continues to review additional applications for BDBV nucleic acid detection tests through the EUL procedure. The organization maintains webpages for tracking active applications and official guidance for health authorities.
The next phase of the response will focus on the integration of these newly listed diagnostics into the existing laboratory networks across the affected provinces. Health officials continue to monitor the transmission patterns of the virus as they work to strengthen surveillance and clinical care. Readers interested in the latest technical guidance and progress reports are encouraged to visit the official WHO health emergency dashboards for real-time updates.