1. Pathogens: Production of reference materials and testing samples for development and performance control of methods for the detection of pathogens in food. Contribution to method development and optimisation and provision of optimised tools for quality control. The activity offers the opportunity for training of scientists. Networking with expert laboratories and CRLs with the relevant experience is already carried out and will be further executed;
2. TSE: Evaluation of TSE tests, possibly for in vivo analysis, tissues other than CNS and able to distinguish TSEs. Contribution to the development of appropriate evaluation protocols. Contribution to quality assurance via proficiency testing and if feasible reference materials in collaboration with the CRL and the network of NRLs connected to it. The EU and Candidate Countries benefit from the improved quality assurance and the activity is offering training possibilities for scientists in a field were major advances can be expected. Anticipated milestones and schedule 1. Layout of a protocol to evaluate tests which distinguish different TSE in sheep. (12.2003) 2. Evaluation of rapid tests for their ability to detect scrapie in sheep. (06.2003);
3. Completion of a limited feasibility study on the suitability of trangenic mice brains for the evaluation of rapid post mortem tests (detection limit assessment) applying several rapid BSE tests. (12.2003);
4. Publication of a call for the expression of interest for new rapid BSE tests. (03.2003);
5. Evaluation schemes for new generation BSE tests designed and approved by SANCO and SSC. (06.2003);
6. Reports of field trial analysis drafted and new rapid BSE tests approved in the EU based on outcome. (06.2003);
7. Completion of certification of 4 new molecular reference materials related to food borne pathogens. (12.2003)
1.1 Completion of 2 CRMs based on genomic DNA of bacterial pathogens;
1.2 Development and certification of genomic DNA reference materials of additional 2 or more bacterial or viral pathogens. Priorities to be defined in cooperation with respective CRL and SANCO;
1.3 Production of standardised nucleic acids for the 'BioResource Centre' in the frame of the shared cost action 'Food PCR 2'. As the first Food PCR SCA the project will include partners form the Candidate Countries. 1.4 Evaluation of needs of CRLs and technical feasibility of reference material production with regard to reference materials required for adequate control of pathogens in food;
2.1 Completion of the protocol for the evaluation of tests which detect scrapie in sheep. In cooperation with DG SANCO and the Scientific Steering Committee;
2.2 Production of samples for the evaluation of rapid tests for the diagnosis of scrapie in sheep. Negatives: 8000 brainstem, 8000 spleen and 4000 mesenteric lymph node samples. Positives: 2000 brainstem, 2000 spleen and 1000 mesenteric lymph node samples. Coding, distribution and storage of the samples;
2.3 Supervision and analysis of an evaluation of up to 8 different tests to detect scrapie in sheep;
2.4 Application of brains of trangenic bovine prions expressing mice to rapid post mortem BSE tests. Start of feasibility studies to evaluate their applicability;
2.5 Analysis of results obtained in the field trial phase II evaluation of new rapid tests (up to two out of possibly 4 companies started already in 2002). 20400 results per participant;
2.6 Contribution to the development of a protocol for the evaluation of tests which distinguish forms of TSE in sheep. In cooperation with SANCO and SSC;
2.7 Contribution to the publication for an expression of interest for new rapid BSE tests (post mortem and for live animals). In cooperation with SANCO. Layout of new evaluation concepts for new matrices like blood/blood fractions or urine;
2.8 Start of acquisition of suitable raw materials and processing. Tissue type and specifications, i.e. collection and processing depend on tests submitted after publication of EoI mentioned under point 11;
2.9 Support to expert panels on TSE of DG SANCO and RTD. 2.10 Support to CRL with regard to the organisation and execution of proficiency testing rounds in the EU Member States and candidate countries.
Summary of the Action:
This action concerns the development or performance evaluation of methods for the detection of pathogens including TSE. The focus will be on DNA based methods for the detection of pathogens (bacteria, viruses) aiming at the understanding of the critical parameters having influence on their performance and improvement in reliability, sensitivity and applicability for quantification. For the development and validation of methods, in particular in comparison with implemented methods and for quality control, well- characterised reference materials are needed which may contain viable pathogens or may be based on isolated DNA. Ways of producing well characterised reference materials being fit for purpose will be investigated. Because of the large interest in having rapid TSE tests available for higher efficiency of TSE detection in slaughtered animals, for better epidemiological overview and eradication programmes for TSE the BSE test evaluation programme will be continued. The applicability of rapid tests to other types of tissue such as lymphoid tissue and spleen and for other species like sheep will be investigated. New tests, possibly not only performed post mortem but also in vivo or being able to distinguish TSEs, may be submitted for evaluation after the expected publication of another call for expression of interest. The implementation of rapid TSE tests will be further supported by the provision of suitable samples and evaluation / validation and development of reference materials for quality control. For this purpose TSE positive and negative samples need to be obtained from reliable sources.
Aspects related to the standardisation and quality control of TSE related tests will be clarified in collaboration with the CRL. The CRL and Candidate Countries to the EU will be supported in proficiency testing schemes. Rationale Following the BSE crisis and to avoid other crisis, the JRC must support DG SANCO and certified reference laboratories in relation to the implementation of EU legislation on TSE, the control of pathogens and prevention of disease outbreaks. It is also necessary to evaluate new methods incl. TSE tests, perform quality assurance of rapid TSE tests and performance testing in collaboration with the CRL. Where applicable, the JRC will develop and provide certified reference materials for calibration, method validation, proficiency testing etc.