Periodic Report Summary 1 - EQUATOX (Establishment of Quality Assurances for the Detection of Biological Toxins of Potential Bioterrorism Risk)
Project Context and Objectives:
Their characteristics place biological toxins at the interface of classical biological (B-) and chemical (C-) agents: for example, ricin and saxitoxin (STX) are prohibited substances under both of the Chemical Weapons Convention (CWC) and the Biological Weapons Convention (BWC), the latter one also includes bacterial toxins such as botulinum toxins and staphylococcal enterotoxins. The relative ease in preparing some of the mentioned toxins and the world-wide availability of the biological sources has also made them a potential agent of bioterrorism. The ricin-containing letters sent to President Obama and several other decision makers in the USA in April and May 2013 recalled that toxins can be easily produced by laypersons and that they can be intentionally released in a criminal act to harm individuals or groups of people.
While different technologies for toxin detection and analysis have been established, hardly any universally agreed “gold standards” are available. For three of the mentioned toxins, there is no certified reference material available and only single inter-laboratory exercises have been performed with a limited number of European participants. Expert laboratories currently use differently purified in-house reference materials, making any comparison of accuracy and sensitivity of different methods nearly impossible.
The focus of EQuATox is to set up a network of European laboratories working in the field of biological toxins, integrating selected leading experts from all over the world. A main effort is to define the status quo of detection capabilities on the four mentioned toxins, based on the sound results obtained from large proficiency tests (PT). Based on qualitative and quantitative results obtained in the PTs a thorough evaluation allows the determination of best practices as well as gaps in detection technology.
Project Results:
In the first 18 months the EQuATox consortium successfully established a network of expert laboratories which focus on the detection and identification of biological toxins. The network currently integrates expertise from 36 laboratories from 24 countries working in the security, verification, health and food sector. As a starting point, a list of EU laboratories with toxin detection capabilities was compiled. Based on questionnaires dedicated to different biological toxins the diverse spectrum of techniques and tools used by the expert laboratories was described. Based on this information, two large proficiency tests were organised: the first PT focussed on ricin, the second PT on STX. As challenging task both PTs asked for the detection of toxins from complex sample materials in order to evaluate sample preparations strategies. The results highlight technical capabilities from 17 expert laboratories in the case of ricin and 10 laboratories in the case of STX, respectively. The results of the ricin and STX PT provided highly relevant insights in the status quo of detection capabilities and offer a sound basis for further development. Depending on the analyte tested, shortcomings have been identified both in qualitative and quantitative detection as well as in sample preparation strategies. Based on the results obtained in the PTs, quality assurance in the field of toxins has to focus on establishing and making available suitable reference materials, ideally certified ones. As a first step in this direction and as a major result of the ricin PT, a consensus concentration could be determined on the ricin reference material prepared for the PT. The EQuATox meetings offered a valuable opportunity for in-depths networking: An exchange of know-how between all network partners has been initiated and will help to optimise analytical procedures.
Potential Impact:
In response to the high media coverage of the recent toxin incidents in the US it is important to know detection capabilities in EU-27 and to develop further detection, identification, preparedness and response planning in case of a potential toxin incident. By creating a network of experts working on biological toxins EQuATox substantially helps to minimise security and health threats posed by biological toxins by improving preparedness in case of an incident.
Based on the status quo of toxin detection described in EQuATox, good practices and critical gaps in detection technology will be identified as foundation to harmonise and standardise detection capabilities of biological toxins, a field that has been somewhat neglected in the past. This includes the future development of reference materials into certified reference materials as well as the development of strategies and validated methods for detection of biological toxins. Furthermore, recommended operating procedures will be developed as well as detection criteria for selected techniques that proved to be superior in the PTs (best practices).
The future perspective of EQuATox after 2014 has to aim at the consolidation of the network, the spreading of technical know-how including reagents and protocols. Training capacities will have to be offered for Member States which are not well-developed in the field. In order to develop a sustainable, reliable network working in the field of biological toxins, regular ring trials with an increasing level of difficulty on selected techniques will have to be organised. The efforts will be of mutual interest in the security and health sector and will help to increase preparedness in case of national or cross-border incidents.
List of Websites:
www.equatox.eu; www.equatox.org; www.equatox.net; www.equatox.com
Their characteristics place biological toxins at the interface of classical biological (B-) and chemical (C-) agents: for example, ricin and saxitoxin (STX) are prohibited substances under both of the Chemical Weapons Convention (CWC) and the Biological Weapons Convention (BWC), the latter one also includes bacterial toxins such as botulinum toxins and staphylococcal enterotoxins. The relative ease in preparing some of the mentioned toxins and the world-wide availability of the biological sources has also made them a potential agent of bioterrorism. The ricin-containing letters sent to President Obama and several other decision makers in the USA in April and May 2013 recalled that toxins can be easily produced by laypersons and that they can be intentionally released in a criminal act to harm individuals or groups of people.
While different technologies for toxin detection and analysis have been established, hardly any universally agreed “gold standards” are available. For three of the mentioned toxins, there is no certified reference material available and only single inter-laboratory exercises have been performed with a limited number of European participants. Expert laboratories currently use differently purified in-house reference materials, making any comparison of accuracy and sensitivity of different methods nearly impossible.
The focus of EQuATox is to set up a network of European laboratories working in the field of biological toxins, integrating selected leading experts from all over the world. A main effort is to define the status quo of detection capabilities on the four mentioned toxins, based on the sound results obtained from large proficiency tests (PT). Based on qualitative and quantitative results obtained in the PTs a thorough evaluation allows the determination of best practices as well as gaps in detection technology.
Project Results:
In the first 18 months the EQuATox consortium successfully established a network of expert laboratories which focus on the detection and identification of biological toxins. The network currently integrates expertise from 36 laboratories from 24 countries working in the security, verification, health and food sector. As a starting point, a list of EU laboratories with toxin detection capabilities was compiled. Based on questionnaires dedicated to different biological toxins the diverse spectrum of techniques and tools used by the expert laboratories was described. Based on this information, two large proficiency tests were organised: the first PT focussed on ricin, the second PT on STX. As challenging task both PTs asked for the detection of toxins from complex sample materials in order to evaluate sample preparations strategies. The results highlight technical capabilities from 17 expert laboratories in the case of ricin and 10 laboratories in the case of STX, respectively. The results of the ricin and STX PT provided highly relevant insights in the status quo of detection capabilities and offer a sound basis for further development. Depending on the analyte tested, shortcomings have been identified both in qualitative and quantitative detection as well as in sample preparation strategies. Based on the results obtained in the PTs, quality assurance in the field of toxins has to focus on establishing and making available suitable reference materials, ideally certified ones. As a first step in this direction and as a major result of the ricin PT, a consensus concentration could be determined on the ricin reference material prepared for the PT. The EQuATox meetings offered a valuable opportunity for in-depths networking: An exchange of know-how between all network partners has been initiated and will help to optimise analytical procedures.
Potential Impact:
In response to the high media coverage of the recent toxin incidents in the US it is important to know detection capabilities in EU-27 and to develop further detection, identification, preparedness and response planning in case of a potential toxin incident. By creating a network of experts working on biological toxins EQuATox substantially helps to minimise security and health threats posed by biological toxins by improving preparedness in case of an incident.
Based on the status quo of toxin detection described in EQuATox, good practices and critical gaps in detection technology will be identified as foundation to harmonise and standardise detection capabilities of biological toxins, a field that has been somewhat neglected in the past. This includes the future development of reference materials into certified reference materials as well as the development of strategies and validated methods for detection of biological toxins. Furthermore, recommended operating procedures will be developed as well as detection criteria for selected techniques that proved to be superior in the PTs (best practices).
The future perspective of EQuATox after 2014 has to aim at the consolidation of the network, the spreading of technical know-how including reagents and protocols. Training capacities will have to be offered for Member States which are not well-developed in the field. In order to develop a sustainable, reliable network working in the field of biological toxins, regular ring trials with an increasing level of difficulty on selected techniques will have to be organised. The efforts will be of mutual interest in the security and health sector and will help to increase preparedness in case of national or cross-border incidents.
List of Websites:
www.equatox.eu; www.equatox.org; www.equatox.net; www.equatox.com
