The World Health Organization has added the first molecular diagnostic test for Bundibugyo virus (BDBV) to its Emergency Use Listing (EUL), marking a critical step in outbreak response capabilities. The test detects viral genetic material in blood samples, enabling rapid and accurate infection confirmation during the ongoing Ebola Bundibugyo outbreak in the Democratic Republic of the Congo and Uganda.
Key takeaways
- WHO approved the first BDBV diagnostic test on 2 July 2026, following the 17 May 2026 declaration of a public health emergency of international concern
- The test identifies viral genetic material in blood samples through molecular detection, enabling rapid case confirmation and outbreak response
- The EUL mechanism accelerates access to quality-assured diagnostics in low- and middle-income countries while maintaining international standards for safety and performance
- Less than two weeks after the emergency declaration, WHO launched a call for diagnostic manufacturers to submit applications
WHO Emergency Use Listing Timeline for Bundibugyo Virus Diagnostics
From emergency declaration to diagnostic approval, May–July 2026
Source: WHO News, 2 July 2026 | Georgian Medical Journal News
Why speed matters in Bundibugyo outbreaks
Diagnostic speed is essential during Ebola outbreaks because early case detection enables rapid isolation and prevents community transmission. According to WHO’s announcement, the EUL procedure assesses quality, safety, and performance of diagnostic tests based on available evidence while ensuring they meet minimum international standards and address the needs of low- and middle-income countries. Dr Yukiko Nakatani, WHO Assistant Director-General for Health Systems, Access and Data, stated that “timely access to quality-assured diagnostic tests can make a critical difference in containing transmission” during fast-moving outbreaks.
The Bundibugyo virus outbreak currently underway is the largest recorded outbreak of Ebola disease caused by BDBV, according to WHO. Cases have been confirmed in both the Democratic Republic of the Congo and Uganda, making rapid, reliable diagnostics a priority for outbreak containment across the region. Global health systems depend on pre-qualified diagnostics to make informed procurement decisions in emergency settings.
Timely access to quality-assured diagnostic tests can make a critical difference in containing transmission during a fast-moving outbreak.
— Dr Yukiko Nakatani, WHO Assistant Director-General for Health Systems, Access and Data (WHO News, 2 July 2026)
How the Emergency Use Listing accelerates access
The WHO EUL mechanism is designed to accelerate access to reliable diagnostic tools while maintaining standards. According to WHO, the EUL supports United Nations procurement agencies and governments in making informed decisions about procuring and using diagnostic products in public health emergency settings. The mechanism was specifically created to balance the need for speed with assurance of quality and safety.
The timeline for BDBV demonstrates this acceleration: WHO declared a public health emergency on 17 May 2026, and issued a call for diagnostic manufacturers to submit expressions of interest less than two weeks later. The first test received approval by 2 July 2026. This compressed timeline reflects the critical need to provide countries with trusted diagnostic tools rapidly so they can respond more effectively to the outbreak. Clinical updates on diagnostic capacity remain essential for healthcare systems in affected regions.
Implications for outbreak response in low-resource settings
The approval of a quality-assured BDBV diagnostic test directly supports disease surveillance and effective outbreak response in countries with limited laboratory infrastructure. According to WHO, the EUL procedure ensures that approved diagnostics meet minimum international standards while addressing the specific needs of low- and middle-income countries, where most Ebola cases occur. This approval enables national health authorities in DRC, Uganda, and neighbouring countries to implement rapid case detection protocols with confidence in diagnostic accuracy.
The test detects viral genetic material through molecular methods, allowing confirmation of infection in blood samples. This capability is essential for identifying cases quickly, initiating appropriate clinical care, and implementing isolation measures to prevent further transmission. The availability of a quality-assured diagnostic also strengthens the reliability of epidemiological data during the outbreak, supporting real-time monitoring and response decisions.
What this means
Frequently asked questions
What is Bundibugyo virus and why is this outbreak significant?
Bundibugyo virus (BDBV) is one of six known species of Ebola virus. According to WHO, the current outbreak in the Democratic Republic of the Congo and Uganda is the largest recorded outbreak caused by BDBV, making rapid diagnostic and clinical response capacity critical for containment.
How does WHO’s Emergency Use Listing work?
The EUL is WHO’s expedited procedure for assessing quality, safety, and performance of essential health products during public health emergencies. According to WHO, it ensures approved products meet minimum international standards while addressing the needs of low- and middle-income countries, enabling faster procurement and deployment.
Why is molecular diagnostic testing important for Ebola outbreaks?
Molecular tests detect viral genetic material in blood samples, enabling accurate and rapid confirmation of infection. Early case detection through reliable diagnostics is essential for isolation protocols, contact tracing, and preventing community transmission during outbreaks.
The approval of the first BDBV diagnostic test signals WHO’s commitment to supporting outbreak response in affected countries and demonstrates the capacity of the Emergency Use Listing mechanism to deliver quality-assured tools rapidly when public health emergencies demand swift action. As the outbreak continues, access to reliable diagnostics will remain central to containment efforts and clinical management across the region.
Source: WHO adds first diagnostic test for Ebola Bundibugyo virus to its Emergency Use Listing
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