Periodic Reporting for period 4 - EuroBioTox (European programme for the establishment of validated procedures for the detection and identification of biological toxins)
Periodo di rendicontazione: 2021-06-01 al 2023-05-31
The EuroBioTox project focused on biotoxins of potential bioterrorism risk integrating 63 expert institutions from 23 countries. Previous studies showed that there was 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 biotoxins, and that they even succeeded in the production of toxic material. Therefore, the European capabilities urgently needed to be strengthened to cope with a potential intentional release of biotoxins. The toxins in the scope of EuroBioTox comprised of selected large protein toxins (ricin, abrin, botulinum neurotoxins [BoNT], staphylococcal enterotoxins [SE]) as well as small molecule biotoxins (saxitoxin [STX]). The project was implemented by 13 core partners in collaboration with 50 outer network partners who had access to training, reagents, protocols, and proficiency tests.
EuroBioTox focused on the following main objectives:
1) The evaluation of available analytical tools, methods, reagents, and matrices for biotoxin detection using the expertise of the 13 core partners.
2) The establishment of a comprehensive mechanism to increase quality assurance in the field.
3) The improvement of validation and testing capabilities for biotoxin analysis across the EU including methods for detection and identification.
4) The evaluation of animal replacement methods for the detection of BoNT.
EuroBioTox focused on the following main objectives:
1) The evaluation of available analytical tools, methods, reagents, and matrices for biotoxin detection using the expertise of the 13 core partners.
2) The establishment of a comprehensive mechanism to increase quality assurance in the field.
3) The improvement of validation and testing capabilities for biotoxin analysis across the EU including methods for detection and identification.
4) The evaluation of animal replacement methods for the detection of BoNT.
Progress beyond the state of the art was achieved by the production and characterization of five certified reference materials for ricin, abrin, SEB, BoNT/A and BoNT/B produced in WP1. The five candidate CRMs were assigned with reference values and were released for sale. The CRMs shall be made available to authorised laboratories worldwide.
Under WP2, an EU repository for validation of toxin methods containing proprietary toxin-specific tools and reagents was established and made accessible to all network partners.
In WP3, 11 proficiency tests (PTs) on different biotoxins were organised, targeting either laboratory-based detection, identification and quantification of biotoxins or in-situ detection with up to 29 participating laboratories. The exercises highlighted technical capabilities of EuroBioTox network partners and demonstrated further room for technical advancement.
WP4 aimed at implementing quality procedures. A set of criteria was established to prioritise training applicants. A standardised guideline for PT organisation was produced, along with validation protocols for immuno- and MS-based methods. The results of the two rounds of PTs for all toxins were compared, highlighting capacity building in the programme.
In WP5, 19 training courses were successfully conducted and 41 institutions were trained on different biotoxin methods, including distance teaching courses, strongly supporting capability building within the EuroBioTox network.
Based on a comprehensive threat analysis, forensic scenarios were developed in WP6 and information on European organisations with the ability to train first responders was compiled. Procedural guidelines for first responders on toxin sampling, detection and decontamination were developed and demonstrated at a workshop for first responders. Additionally, a forensic peptide database was delivered.
Under WP7, a panel of BoNT types was produced and characterized as the basis for the evaluation of five in vitro and ex vivo BoNT detection methods which were compared to the current gold standard, mouse bioassay. The comprehensive evaluation of replacement methods was successfully implemented and provided highly relevant information on superior in vitro and ex vivo methods for botulism diagnostics.
WP8 aimed at the dissemination of information within the network and to relevant decision makers and scientists. To this end, a project website was established counting more than 49000 visitors so far; four annual newsletters were released. In total, 64 oral and 11 poster presentations, three scientific publications, several conferences and workshops were organized by the consortium. Finally, a position paper, two EuroBioTox brochures, two explanatory movies as well as different e-learning materials on detection methods for biotoxins were delivered. A special issue in a peer-reviewed journal highlighting the scientific achievements is planned for 2023/2024.
WP9 was dedicated to the general coordination of the project, including all administrative and financial issues. This task covered, among others, the organisation of several face-to-face meetings with all network partners and a series of virtual meetings.
In WP10 a number of documents highlighting relevant ethics issues were provided and information on ethics issues were continuously documented.
Under WP2, an EU repository for validation of toxin methods containing proprietary toxin-specific tools and reagents was established and made accessible to all network partners.
In WP3, 11 proficiency tests (PTs) on different biotoxins were organised, targeting either laboratory-based detection, identification and quantification of biotoxins or in-situ detection with up to 29 participating laboratories. The exercises highlighted technical capabilities of EuroBioTox network partners and demonstrated further room for technical advancement.
WP4 aimed at implementing quality procedures. A set of criteria was established to prioritise training applicants. A standardised guideline for PT organisation was produced, along with validation protocols for immuno- and MS-based methods. The results of the two rounds of PTs for all toxins were compared, highlighting capacity building in the programme.
In WP5, 19 training courses were successfully conducted and 41 institutions were trained on different biotoxin methods, including distance teaching courses, strongly supporting capability building within the EuroBioTox network.
Based on a comprehensive threat analysis, forensic scenarios were developed in WP6 and information on European organisations with the ability to train first responders was compiled. Procedural guidelines for first responders on toxin sampling, detection and decontamination were developed and demonstrated at a workshop for first responders. Additionally, a forensic peptide database was delivered.
Under WP7, a panel of BoNT types was produced and characterized as the basis for the evaluation of five in vitro and ex vivo BoNT detection methods which were compared to the current gold standard, mouse bioassay. The comprehensive evaluation of replacement methods was successfully implemented and provided highly relevant information on superior in vitro and ex vivo methods for botulism diagnostics.
WP8 aimed at the dissemination of information within the network and to relevant decision makers and scientists. To this end, a project website was established counting more than 49000 visitors so far; four annual newsletters were released. In total, 64 oral and 11 poster presentations, three scientific publications, several conferences and workshops were organized by the consortium. Finally, a position paper, two EuroBioTox brochures, two explanatory movies as well as different e-learning materials on detection methods for biotoxins were delivered. A special issue in a peer-reviewed journal highlighting the scientific achievements is planned for 2023/2024.
WP9 was dedicated to the general coordination of the project, including all administrative and financial issues. This task covered, among others, the organisation of several face-to-face meetings with all network partners and a series of virtual meetings.
In WP10 a number of documents highlighting relevant ethics issues were provided and information on ethics issues were continuously documented.
EuroBioTox successfully consolidated an expert network working on biotoxins 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 the state of the art was already achieved by the production of five certified reference materials (CRMs). Since there are no other CRMs available worldwide for those toxins, the reagents will be highly useful for expert laboratories and practitioners, having a great potential for further exploitation beyond the lifetime of EuroBioTox. The creation of a European repository with proprietary toxin-specific tools was a prerequisite for the harmonisation of detection methods and helped to spread excellence among network partners. The EuroBioTox training programme broadened technical expertise within the EU in the analysis of biotoxins relevant to investigations of alleged use. The implemented training courses for 156 trainees from 18 countries were beyond the state of the art in that they were tailored to the maximum benefit of the attendees. In that respect, the courses fostered multidisciplinary discussions integrating expertise from different fields. The 11 proficiency tests organised by EuroBioTox offered an opportunity for participants to self-evaluate their technical capabilities. This is important, since there are almost no other options for regular self-assessment for the detection of the biotoxins in the scope of EuroBioTox. With respect to the specific needs of first responders, conceptual guidelines on sampling, detection and decontamination of biotoxins were established and presented at a first responder workshop and a forensic database was released. With respect to animal replacement methods, a comprehensive evaluation study for five in vitro and ex vivo methods for BoNT detection against the mouse bioassay was implemented. The successful outcome highlighted superior animal replacement methods for botulism diagnostics and will help to reduce animal experiments in this field, directly supporting the Directive 2010/63/EU on the protection of animals.
Overall, EuroBioTox aimed at implementing a comprehensive mechanism of training, method and key reagent sharing, improvement of quality assurance measures and proficiency testing. The dissemination of good analytical practices helped to improve preparedness and response planning at national and international levels. Along this line, EuroBioTox has contributed to minimising potential health and security threats in the EU and increased resilience of civil society by sound capacity building and technical improvement.
Overall, EuroBioTox aimed at implementing a comprehensive mechanism of training, method and key reagent sharing, improvement of quality assurance measures and proficiency testing. The dissemination of good analytical practices helped to improve preparedness and response planning at national and international levels. Along this line, EuroBioTox has contributed to minimising potential health and security threats in the EU and increased resilience of civil society by sound capacity building and technical improvement.