WHO clears first emergency diagnostic test for Bundibugyo Ebola

The World Health Organization (WHO) has added the world's first molecular diagnostic test for the Bundibugyo strain of Ebola virus to its Emergency Use Listing (EUL), marking a major milestone in the global response to the ongoing outbreak in the Democratic Republic of the Congo and neighbouring Uganda.The emergency listing is expected to accelerate access to reliable laboratory testing, enabling health workers to confirm infections more quickly and strengthen surveillance, isolation and treatment efforts in affected communities.The newly listed test, the Altona RealStar Filovirus Screen RT-PCR Kit 1.0, is the first diagnostic specifically authorized for emergency use against the Bundibugyo virus species, a rare but deadly form of Ebola for which there is currently no licensed vaccine or approved targeted treatment.WHO Director-General Dr. Tedros Adhanom Ghebreyesus welcomed the development, saying it represents an important step in strengthening outbreak control."Timely and accurate diagnosis is the cornerstone of every effective outbreak response. The addition of this first diagnostic test for Bundibugyo virus to WHO's Emergency Use Listing will help countries detect cases faster, interrupt transmission and save lives," said Dr. Tedros Adhanom Ghebreyesus.The Emergency Use Listing is a WHO risk-based procedure designed to assess and make available essential medical products during public health emergencies. It enables countries and international procurement agencies to rapidly access quality-assured diagnostics while full regulatory approvals are still underway.The announcement comes as the Bundibugyo Ebola outbreak continues to pose a serious public health threat in eastern Democratic Republic of the Congo, where transmission has been complicated by insecurity, difficult terrain and population movement across borders. Uganda has also reported cases linked to cross-border transmission.Unlike the more common Zaire strain of Ebola, the Bundibugyo virus has no licensed vaccine and no approved specific treatment, making early diagnosis and supportive care critical to improving survival and containing the outbreak.WHO says the availability of a validated molecular test will strengthen laboratory capacity, improve patient management and support faster public health action by allowing suspected cases to be confirmed more rapidly.The agency also called on manufacturers to continue developing additional diagnostic tools, including rapid point-of-care tests that can be deployed in remote settings with limited laboratory infrastructure.The emergency listing of the Bundibugyo Ebola diagnostic comes as global health partners continue efforts to evaluate potential treatments and accelerate research into vaccines for the virus, with clinical trials already underway in the Democratic Republic of the Congo.