The Joint Action (JA) aims to link and consolidate the objectives of two existing networks dealing with highly infectious bacteria and viruses that emerged from the EU funded project EQADeBa, coordinated by the Robert Koch-Institut (RKI), Germany (EAHC no 2007 204) and the ENP4-Lab project, coordinated by L.Spallanzani National Institute for Infectious Diseases (INMI), Italy (EAHC no 2006 208). The primary objective of the current application is to stabilise both network activities that link 33 partners from 21 European countries highly specialised and advanced laboratories. This will ensure the universal exchange of best diagnostic strategies able to support a European response strategy to outbreaks of highly pathogenic infectious agents plus generating a biodiverse repository of reference materials. The JA will provide a supportive European infrastructure and strategy for external quality assurance exercises (EQAE, bacterial antibiotic susceptibility testing, training, and biosafety and biosecurity review of current practices).
The project is directed at ensuring and improving citizens´ health security and bridging Security and Health by improving the laboratory diagnostic capabilities of appointed European laboratories to detect high consequence pathogens in situations arising from natural outbreaks and deliberate or accidental release. These outbreaks would not respect national borders. A closely aligned European specialised laboratory network will ensure the universal ability to respond with rapid diagnostics of highly pathogenic bacteria or viruses in support of clinical and public health outbreak management. Moreover, the network has the ability to enhance the support of other agencies (veterinary, forensic) dealing with suspected or confirmed bioterrorist incidents. Participants of the JA will evaluate and develop rapid diagnostic tools that will provide the necessary infrastructure to support the effectiveness of mobile “field” diagnostics. This would also contribute to enhance the global health security capacity and address the requirements of the International Health Regulations (2005).
The project will be open for other laboratories not yet considered as Associated partners. There will be the opportunity to join the project as Collaborating partner as it was offered to the Hungarian P4 laboratory funded under the PHARE twining programme. There are more initiatives at the European level dealing with the management of biological threats like EURINHA project funded by DG RTD/ENTR or ENIVD supported by ECDC. QUANDHIP will provide a unique quality assurance schemes for high risk bacteria and the majority of European P4 laboratories will assess and improve the diagnostics for risk group 4 viruses. In a unique matter a bacterial and viral network of high threat agents will be linked together. Furthermore, biosafety and biosecurity issues from the laboratory perspective will be evaluated and recommendations drawn.
SO1 External Quality Assurance Exercises - Different EQAEs are planned for bacteria and viruses. Reference material will be quality assured in terms of agent characterisation, homogeneity, storage stability and suitability for different analytical approaches. Various formulations of reference material like dried samples will be checked for applicability. Protocols of EQAEs will be analysed and best practices identified.
SO2 Setting up of a repository for reference materials - The existing repository for bacteria is to be extended with additional strains provided by partners. Where possible, the bacterial and viral isolates will be characterized by all applicable means of phenotypic, molecular and immunological characterization. Viral reference material will be stored at recognised national laboratories and exchanged between appointed laboratories in inactivated form according to European Biosafety and Biosecurity Guidelines.
SO3 Training on best diagnostic practices and biosafety/biosecurity - Partners of the JA with a proven track record in the delivery of effective training and exchange programmes covering best microbiological, biosafety and biosecurity practices will be identified and listed. The training will consider actual biological events and possibilities to share laboratory capacities and capabilities.
SO4 Further improvement and application of checklists for evaluation of Biosafety and Biosecurity laboratory management - A common checklist for laboratory infrastructure, containment, and operational biosafety and biosecurity for European BSL3 and BSL4 will be evaluated and further improved by all partners.
SO5 Support to laboratory outbreak response coordination - Recommendations on laboratory management of biological events will be developed by a Working Group addressing issues like providing laboratory support for risk assessment in case of cross-border highly infectious pathogens. A final workshop will be used to present and discuss the project achievements to invited first responders and representatives from EU institutions and initiatives supported by the EU like DG Home, Europol, DG RTD ENTR, ECDC, beyond DEVCO and DG Sanco.
Once the objectives are reached, an improvement of the laboratory capabilities to detect and identify high threat pathogens and of the technical skills as well as more harmonised approaches on biosafety and biosecurity will be expected. The repository of reference material set up in the previous EQADeBa project will be extended and scientifically characterised reference material will be made available for quality assurance exercises and validation of methods and instruments. The reference material collected and characterised in the framework of the previous ENP4 project will be further extended and characterised. Data from three rounds of EQAEs, separately carried out for representative high-threat inactivated and native bacteria and viruses will be acquired. Recommendations for a "Gold Standard" in the diagnostics of high threat pathogens will be further developed and optimized.
The project will further strengthen the network among relevant laboratories appointed for the detection of high threat infectious pathogens throughout Europe. This network will contribute to the long-term monitoring of bacterial and viral zoonoses occurring naturally in Europe or being imported from other parts of the world. The Joint Action will contribute to training and to the improvement of biosafety and biosecurity skills for the handling of high threat pathogens through the dissemination of best practices. Information will be collected on the capabilities and the degree of European preparedness to detect highly infectious pathogens. Stakeholders will have the opportunity to evaluate their national needs for further support of individual reference laboratories appointed for recognition of high threat pathogens, including recognised bioterrorism agents.
In the framework of the project, a Working Group will be set up aiming to produce recommendations and guidelines from the laboratory perspective to manage biological events.