The ongoing Ebola (Bundibugyo virus) outbreak in the Democratic Republic of the Congo (DRC) and Uganda is a major regional and international public health concern. The World Health Organization (WHO) has officially declared this outbreak a Public Health Emergency of International Concern (PHEIC). To learn more about altona’s response to the outbreak, please read the Q&A below.
It will be regularly updated and adapted to the current situation.
Learn more about our current PCR kits for the detection of Ebola and Bundibugyo virus:
RealStar® Bundibugyo Virus RT-PCR Kit 1.0 (RUO)
The ongoing Ebola outbreak caused by Bundibugyo virus in the Democratic Republic of the Congo and Uganda is a serious regional and international public health concern. WHO has declared the event a Public Health Emergency of International Concern (PHEIC). In response, altona Diagnostics has adjusted production of its filovirus PCR kits and is ready to support laboratories worldwide.
altona Diagnostics offers three relevant assays. The RealStar® Bundibugyo Virus RT-PCR Kit 1.0 RUO is a reagent system, based on real-time PCR technology, for the qualitative detection of Bundibugyo ebolavirus (BDBV) specific RNA. The RealStar® Filovirus Screen RT-PCR Kit 1.0 is a ready-to-use assay for qualitative detection and differentiation of Ebola- and Marburgvirus-specific RNA, including Bundibugyo virus. For research applications, the RealStar® Filovirus Type RT-PCR Kit 2.0 enables qualitative detection and differentiation of filovirus RNA and distinguishes five Ebolavirus species, including Bundibugyo ebolavirus, and Marburgvirus.
The kit is CE-IVD marked and has been listed by WHO for procurement under its Ebola emergency assessment mechanism since November 2014. It is intended for professional laboratory use and supports outbreak testing where rapid molecular diagnostics are required.
Yes. The RealStar® Bundibugyo Virus RT-PCR Kit 1.0 RUO is available. It is a dedicated assay based on the Bundibugyo-specific amplification system contained in the RealStar® Filovirus Type RT-PCR Kit 2.0. The product provides 96 reactions focused on Bundibugyo virus RNA and has been launched initially as RUO.
Published evaluation data show that the RealStar® Filovirus Screen RT-PCR Kit detects all tested human-pathogenic filoviruses, including Bundibugyo virus.
Yes. Publicly available outbreak reporting indicates that the RealStar® Filovirus Screen RT-PCR Kit 1.0 was used at INRB in Kinshasa in May 2026 for samples linked to the current outbreak.
In addition, recent Africa CDC recommendations include the assay among molecular RT-PCR tests for Bundibugyo ebolavirus that are approved, validated, or in current use.
Beyond the outbreak region itself, Charité Berlin used the altona filovirus products to monitor a Bundibugyo virus patient and to test close family contacts.
The assays are particularly relevant for reference laboratories, research centers, and outbreak-response partners that need flexible, molecular test solutions for emerging and high-consequence infectious diseases. This is especially important in situations where the causative agent may differ from the most common or best-known variant.
altona’s message is preparedness. The company is able to respond quickly to emerging outbreak situations by providing broad filovirus detection capability, molecular expertise, and flexible supply support for laboratories working under urgent public health conditions.
The RealStar® Bundibugyo Virus RT-PCR Kit 1.0 RUO is a reagent system, based on real-time PCR technology, for the qualitative detection of Bundibugyo ebolavirus (BDBV) specific RNA.
For rapid and reliable diagnosis, altona Diagnostics offers the RealStar® Filovirus Screen RT-PCR Kit 1.0 (CE-IVD, 96 reactions). This ready-to-use in vitro diagnostic assay employs real-time PCR technology to qualitatively detect and distinguish RNA specific to Ebola and Marburg viruses, including Bundibugyo virus. The kit is compatible with a broad range of laboratory instruments, ensuring flexible integration into diverse testing environments.
For further scientific research on the Bundibugyo virus, we also offer the RealStar® Filovirus Type RT-PCR Kit 2.0 (RUO) which is for research use only. It is a reagent system, based on real-time PCR technology, for the qualitative detection and differentiation of filovirus specific RNA. The assay is designed to detect Ebola– and Marburgvirus and differentiate the five Ebolavirus species: Bundibugyo ebolavirus (BDBV), Reston ebolavirus (RESTV), Sudan ebolavirus (SUDV), Tai Forest ebolavirus (TAFV) and Zaire ebolavirus (EBOV).
We have launched the RealStar® Bundibugyo Virus RT-PCR Kit 1.0 RUO. It is a product based on the BDBV specific amplification system contained in the RealStar® Filovirus Type RT-PCR Kit 2.0. The existing RealStar® Filovirus Type RT-PCR Kit 2.0 contains multiple master reagents for the detection of different filovirus species. As a result, only a limited number of reactions are available for Bundibugyo virus-specific testing. In the current outbreak situation, however, the causative agent is already known and only the Bundibugyo-specific master reagent is needed. The new product is therefore designed to provide 96 reactions dedicated to Bundibugyo virus RNA, making it more suitable for targeted, higher-throughput testing.
The product has been initially launched as RUO, and users will have to validate the assay as LDT before use.
We are exploring regulatory options to register the product – however, with assays detecting ebolaviruses classified in the highest risk-group within the EU-IVDR, this will not be an easy task.
A published evaluation of RealStar® reverse transcription-PCR kits for filovirus detection showed that the RealStar® filovirus screen kit detects all human-pathogenic filoviruses tested, including Ebola virus, Sudan virus, Tai Forest virus, Bundibugyo virus, Reston virus, and Marburg virus, with good analytical sensitivity when used on appropriate real-time PCR platforms.
It was confirmed by an article that the RealStar® Filovirus Screen RT-PCR Kit 1.0 was used at Institut National de la Recherche Biomédicale (INRB) in Kinshasa (Democratic Republic of the Congo) in May 2026, and that it detected the currently circulating Bundibugyo virus variant in clinical samples. The article with the title “Initial genomes from May 2026 Bundibugyo Virus Disease Outbreak in the Democratic Republic of the Congo and Uganda” has been published by Placide Mbala. Mbala wrote: “On 14 May 2026, 13 samples (11 whole blood, 1 serum and 1 oro-pharyngeal swab) were tested at INRB, Kinshasa … using the Altona RealStar Filovirus Screen RT-PCR kit 1.0 (a pan Ebola- and Marburgvirus specific RNA detection kit). … Eight out of thirteen RNA samples were tested positive for Ebola virus by the used real-time PCR (Altona RealStar Filovirus Screen).”
The Charité University Hospital in Berlin is treating a US doctor who was active in the DRC and who was evacuated to the Charité high-containment ward. His wife and their four children are in quarantine at the Charité. For monitoring the viral load status of the patient, the Charité lab is using our filovirus specific products. The family (as of May 22) is declared negative for the Bundibugyo virus (also tested with our kits).
World Health Organization (WHO): Ebola disease
Africa CDC (Centres for Disease Control and Prevention), May 22, 2026: Molecular Diagnostic Tests (RT-PCR) for Ebola Virus Bundibugyo Strain
Press release Charité Berlin, May 22, 2026: Charité provides an update on the condition of the patient diagnosed with Ebola (in German)
Virological.org, May 2026: Initial genomes from May 2026 Bundibugyo Virus Disease Outbreak in the Democratic Republic of the Congo and Uganda
PMC – PubMed Central, 2016: Evaluation of RealStar Reverse Transcription–Polymerase Chain Reaction Kits for Filovirus Detection in the Laboratory and Field.
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