Laboratory guidance and resources for Ebola disease outbreak in DRC

This section compiles evidence-based laboratory guidance and resources to support EU/EEA countries’ laboratory preparedness and response to the 2026 Ebola disease outbreak in DRC, caused by Bundibugyo virus (BDBV).

Laboratory confirmation of orthoebolavirus infections, including BDBV infections, should be performed using nucleic acid tests (NAT). The recommended sample types are whole blood or plasma for patients, and oral swab for deceased individuals. 

All work involving the propagation or isolation of orthoebolaviruses, including BDBV, must be conducted in biosafety-level (BSL) 4 laboratories. However, this type of work is not essential for the primary diagnosis of orthoebolavirus infections, and is therefore outside the scope of this guidance, which only concerns the handling of clinical samples. 

In terms of biosafety, laboratory handling of clinical samples from suspected or confirmed cases must follow a risk-based approach, with each laboratory conducting its own risk assessment based on the type of materials and procedures. High-risk activities, including the handling of samples that have not been inactivated, require appropriate containment measures. Good microbiological practices must be followed, and validated inactivation methods should be applied. 

In terms of biosecurity, laboratories should ensure that appropriate biosecurity measures are in place to protect any relevant collected or produced materials from misuse, loss, or unauthorised access. 

The EU reference laboratory for public health on Emerging, rodent-borne and zoonotic viral pathogens (EURL-PH-ERZV) supports expert laboratories in EU/EEA countries by providing diagnostic support, up-to-date diagnostic protocols and technical advice on biosafety and laboratory procedures. 

ECDC’s webpage on Ebola disease and ECDC’s Ebola disease factsheet provide evidence-based information on virus transmission, symptoms, incubation period, and prevention. 

The World Health Organization (WHO) provides an Ebola and Marburg Virus Outbreak Toolbox, which is a structured set of technical resources designed to support outbreak detection, investigation, and response as well as an interim guidance for diagnostic testing for Ebola and Marburg virus diseases. Some of these resources are referenced under the specific sections below. 

The recommended sample type for testing BDBV is whole blood or plasma for patients, and oral swab for deceased individuals. Sampling from living or deceased patients suspected of orthoebolavirus infection should only be performed by trained personnel using appropriate personal protective equipment

Laboratories are encouraged to verify that the tests used can detect BDBV and are not limited to Ebola virus (Zaire) or other orthoebolaviruses only. NATs developed in-house should be verified against representative sequences from the current outbreak (e.g. see Ebola Bundibugyo - Browse | Pathoplexus). 

If the NAT used does not distinguish between different orthoebolaviruses, positive findings should be confirmed by sequencing and/or by further testing using assays specific for BDBV. 

Further useful information on safe sample collection and handling is available in the following documents: 

Handling of samples from suspected, probable or confirmed cases should be conducted with appropriate biosafety measures according to a risk-based approach. Each laboratory should perform their own risk assessment based on the clinical specimens to be handled in combination with the procedures to be performed. National guidelines on laboratory biosafety should be followed. Inactivation and handling of specimens from suspected patients require at least a BSL 3 laboratory facility, or ─ after proper risk assessment ─ BSL 2 laboratory facility using a Class III biosafety cabinet. Validated virus inactivation methods must be used before downstream testing of samples that may contain orthoebolaviruses. Good microbiological practice and procedure (GMPP) must be applied, including general behaviours and aseptic techniques, in line with WHO laboratory biosafety manual and national provisions.  

Biosecurity requirements need to be fulfilled by appropriate risk management and laboratory safety procedures, having secure facilities, controlled access, competent personnel, and full specimen traceability, ensuring that biological materials are protected from misuse, loss, or unauthorised access. 

Links to WHO guidelines: 

WHO’s guidance on regulations for the transport of infectious substances emphasises that all infectious samples must be classified correctly and transported in compliance with international regulations to prevent exposure during handling and transport. Patient specimens suspected of containing viable orthoebolaviruses, including BDBV, must be treated as Category A (UN2814) infectious substances. Proper labelling, documentation, and trained personnel are required to handle and ship the materials and clear coordination with the receiving laboratory must be established in advance. The overall aim is to ensure safe, traceable, and secure transport while minimising risks to transport workers, laboratory staff, and the public. 

Links to WHO guidelines:  

The EURL-PH-ERZV supports Member States’ laboratories during the current Ebola disease outbreak by providing uptodate diagnostic protocols, recommendations on appropriate assays for testing suspected cases, and technical advice on biosafety, biosecurity, and laboratory procedures. It also facilitates coordination and information exchange across the EU laboratory network to support the response. 

Key activities include: 

  • Diagnostic support, including primary and confirmatory testing of BDBV; 
  • Provision of guidance and protocols for molecular detection of BDBV and other orthoebolaviruses; 
  • Access to protocols and reagents for in-house assays used within the EURL consortium laboratories; 
  • Provide information on available commercial and in-house diagnostic tests;  
  • Advice on biosafety and biorisk management for handling suspected BDBV samples. 

For further information, please contact the EURL-PH-ERZV at: EURL-PH-ERZVatfolkhalsomyndigheten [dot] se (EURL-PH-ERZV[at]folkhalsomyndigheten[dot]se)