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European programme for the establishment of validated procedures for the detection and identification of biological toxins

Periodic Reporting for period 2 - EuroBioTox (European programme for the establishment of validated procedures for the detection and identification of biological toxins)

Reporting period: 2018-06-01 to 2019-11-30

The EuroBioTox project focuses on biological toxins of potential bioterrorism risk integrating 61 expert institutions from 23 countries. Previous studies showed that there is a lack of robustness in European preparedness for biotoxin incidents. In this context recent incidents in France and Germany highlighted that extremists take an interest in the production of biological toxins, and that they even succeed in the production of toxic material. Therefore, the European capabilities urgently need to be strengthened to cope with a potential intentional release of biological toxins. The toxins in the scope of EuroBioTox comprise selected large protein toxins (ricin, abrin, botulinum neurotoxins [BoNT], staphylococcal enterotoxins [SE]) as well as small molecule biotoxins (saxitoxin [STX]). The project is implemented by 13 core partners in collaboration with 48 outer network partners who have access to training, reagents, protocols, and proficiency testing.
EuroBioTox focuses on four main objectives:
1) Evaluate currently available analytical tools, methods, reagents, and matrices using the expertise of the 13 core partners.
2) Improve validation and testing capabilities for biological toxin analysis across the EU.
3) Enable laboratories across the EU to further improve their analytical skills in detecting toxins.
4) Enable the replacement of animal experiments for the detection of BoNT.
In order to make reference materials available to authorised laboratories, the objective of WP1 is the development of certified calibrants for different biological toxins. Until month 30, four candidate reference materials (SEB, BoNT/A, ricin, abrin) were produced and production of a fifth material (BoNT/B) has started. Molecular characterisation of the materials continued including homogeneity and stability testing and revealed high quality results.

In WP2 proprietary tools and reagents for the detection of toxins were produced and will be made available in a EuroBioTox repository accessible for all network partners. In a comprehensive validation study, selected detection methods based on reagents from the repository were evaluated in detail.

Within WP3, eleven proficiency tests (PTs) on different biological toxins will be organised. Until the end of the second reporting period, four PTs on detection and quantification of STX, SEB and ricin/abrin were successfully conducted with 17 to 22 participating laboratories, and the planning for two further PTs was initiated.

WP4 is dedicated to the implementation of quality procedures throughout the project. A cross-sectional collection of quality criteria was delivered and a web-based questionnaire for an online survey was set up for pre-assessment of trainees which will be helpful for the follow up of the training courses.

WP5 is focused on the planning, organisation and evaluation of 19 training courses on ricin, abrin, STX, BoNT and SE toxins. Until now, 10 training courses on different methods, toxins and levels were successfully conducted, supporting capability development within the EuroBioTox network.

Based on a comprehensive threat analysis a new guideline for first responders was developed in WP6 providing procedural guidance for sampling, detection and decontamination in case of an incident involving biological toxins. Information on European organisations with the ability to train first responders was compiled. Additionally, the development of a forensic peptide database was initiated.

Under WP7, a comprehensive evaluation study targeting five different in vitro methods for BoNT detection against the mouse bioassay has been initiated. To this end, a panel of BoNT sero- and subtypes was produced and the toxin concentration was determined by mouse bioassay as reference.

The aim of WP8 is to disseminate information within the network and to provide information to relevant decision makers and scientists. To this end, a project website was established counting more than 10000 visitors so far, and annual newsletters were released. 36 oral and 6 poster presentations, one scientific publication and a EuroBioTox brochure were delivered.

WP9 is dedicated to the general coordination and management of the project, including all administrative and financial issues. This task covered, among others, the organisation of a kick-off meeting in June 2017 and two beneficiaries’ meetings in May 2018 and May 2019.

In WP10 a number of documents highlighting relevant ethics issues were provided and information on export/import of items is continuously documented.
EuroBioTox successfully consolidated an expert network working on biological toxins by linking professionals from the disaster management sector, first responders and industrial partners with expert laboratories in the security, health and food sectors. Progress beyond state of the art will be achieved by production of certified reference materials for different biological toxins. Four high quality candidate reference materials were already produced and currently undergo comprehensive molecular characterisation. Since there is no other reference material available worldwide for those toxins, the reagents will be highly useful for expert laboratories and practitioners, having a great potential for further exploitation. The creation of a European repository with proprietary toxin-specific tools is a prerequisite for a harmonisation of detection methods and will help to spread excellence among network partners. The EuroBioTox training programme helps to broaden the expertise across European Union in the analysis of biological toxins relevant to investigations of alleged use. The implemented training courses were beyond state of the art in that they were tailored to the maximum benefit of the attendees. In that respect, the courses foster multidisciplinary discussions integrating expertise from different fields. The proficiency tests organised by EuroBioTox offer an opportunity for participants to self-evaluate their technical capabilities. This is important, since there is almost no other option for regular self-assessment for the detection of the toxins in scope of EuroBioTox. With respect to the specific needs of first responders, new conceptual guidelines on sampling, detection and decontamination were established focusing on biological toxins. These guidelines will be presented at a first responder workshop in 2020, and relevant information will be challenged in a proficiency test focussing on in situ detection. With respect to animal replacement methods, a comprehensive evaluation study for five different in vitro methods for BoNT detection against the mouse bioassay has been initiated. Provided it will be successful, the study will directly support implementation requirements specified in Directive 2010/62/EU on the protection of animals.
Overall, EuroBioTox aims at implementing a comprehensive mechanism of training, method sharing, improvement of quality assurance measures and proficiency testing. It is expected that the spreading of good analytical practices will improve preparedness and response planning at national and international level. Along this line, EuroBioTox will contribute to minimise potential health and security threats in the EU and will increase resilience of civil society by sound capacity building and technical improvement.
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