Validation of biological toxins measurements after an incident: Development of tools and procedures for quality control

The large variability among families of biological toxins complicates their measurement and unambiguous identification in human specimens, and environmental or food samples. Toxins are rapidly metabolised and degraded after incorporation, limiting the time window for successful identification and forensic analysis. Proposals should develop quality control tools, as well as the Standard Operating Procedures necessary for establishing a mechanism to systematically validate laboratory-based measurement techniques, including sample preparation strategies and analyses made in-situ issued by mobile and quickly deployable laboratories, which should be proposed for adoption at EU level.

Indicative budget: The Commission considers that proposals requesting a contribution from the EU of € 8million would allow for this topic to be addressed appropriately. Nonetheless this does not preclude submission and selection of proposals requesting other amounts.

Recent incidents in Europe and worldwide recalled that biological toxins can be produced by laypersons or acquired illegally and intentionally released in a criminal act to harm people. While different technologies are available for toxin detection and analysis, recent findings have shown that the comparability of analytical results from different laboratories is poor, which cast severe doubts about the validation of current methods and about the overall validity of analytical data. This means that in case of a bioterrorist act using compounds such as e.g. ricin (or others such as abrin), saxitoxin, botulinum, neurotoxins, enterotoxins, etc. there is no guarantee that decisions to react are made based on data meeting basic quality requirements. The lack of quality assurance/quality control tools (e.g. certified reference materials of ricin, botulinum, etc.) and standard operating procedures hampers the validation and the EU-wide comparability of biological toxin measurement data. There is therefore a need to develop an EU-wide approach for enhancing validating analytical capacities for biological toxin measurements in case of bioterrorism threats, similarly to what exists regarding chemical threats.

Short term:

• Development, production and certification of reference materials for biological toxin determinations as a basis for strengthened validation capacities;
• Establishment of a stepwise learning inter-laboratory programme enabling relevant laboratories to improve their analytical skills and development and testing of an European Proficiency Testing (EPT) scheme from sampling to detection;

Mid term:

• Improved capabilities for the validation and testing of existing and emerging techniques, including sample preparation strategies, mobile laboratories for in-situ analyses and technical approaches for forensic analysis, for the detection and identification of biological toxins; Replacement of old ""gold standards"" employing animal experiments with death as endpoint for detection of potent biological toxins, by modern, in vitro methods as requested by EU regulations;

Long term:

• Based on the outcome of the EPT scheme, development of Standard Operational Procedures for the validation of analytical techniques, including in-situ techniques for biological toxin determinations in human specimens, environmental and food samples