Brussels, 5 December 2000
BSE: Commission evaluating five new tests
In a continuation of its work on tests for BSE and other transmissable spongiform encephalopathies (TSEs), the European Commission is evaluating five new tests. The tests were identified following a world-wide call for expressions of interest which closed on 30 September. Commissioner David Byrne, responsible for Health and Consumer Protection, said "The introduction of testing for BSE in the EU has already had rapid beneficial results for the consumer. We now have improved knowledge of the incidence of BSE and as a result additional measures have been taken. Consumers and industry must be informed of the real situation throughout the EU and the widespread implementation of the testing programme is the best way to achieve this." Commissioner Philippe Busquin, responsible for Research, added: "I am glad to announce that more tests are being evaluated in the Commission's Research Centre since only reliable testing will lay the scientific foundation on which we can base serious and efficient political measures."
An earlier evaluation, carried out last year, identified three tests which performed excellently and which were subsequently approved for use in the EU. Their use has led to the detection of higher incidences of BSE in France and to the first BSE-cases in Germany and Spain. The use of tests becomes mandatory on 1 January for at risk animals and from 1 July for all cows aged over 30 months slaughtered in the EU.
The evaluation of the five new tests will be similar to that conducted last year by the Commission but will involve a smaller series of samples. Particular emphasis has been placed on the ability of tests to distinguish the various TSE diseases. A number of candidate tests offer this possibility though this aspect of the test development is at a very early stage. All of the identified tests are suitable for post mortem diagnosis only.
The following research and development teams produced the tests that have been accepted for evaluation:
1. ID-Lelystad, the Netherlands.
2. Imperial College of Science Technology and Medicine, United Kingdom
3. The Institute of Neurodegenerative Diseases / University of California, San Francisco (IND/UCSF) USA.
4. PerkinElmer Life Sciences. United Kingdom
5. Prionics AG, Switzerland. A western blot from this Company has already been approved. This application refers to an ELISA, a different test methodology.
An addition to the already approved CEA test (commercialised as the Biorad test), which may permit a distinction between BSE and scrapie, has also been retained for examination. All of the above tests are suitable for post mortem diagnosis only.
Field work and evaluation
The field work, which will be done in stages, has already commenced and will continue until late spring 2001. The evaluation of tests that might distinguish between BSE and scrapie will take longer and be more complex.
The evaluation is being carried out by the Health and Consumer Protection Directorate General with the Institute for Reference Materials and Measurements (IRMM) in Geel (Belgium). This laboratory, which is part of the European Commission's Joint Research Centre (JRC), has a world-wide reputation for the preparation of highly specialised reference samples for many fields of measurement.
Evaluation of technical standards in EU laboratories using rapid tests
The Commission is also preparing reference standards and will perform a ring trial of all laboratories in the EU using rapid tests. This is designed to evaluate the technical performance of the various laboratories that are carrying out surveillance tests in line with EU legislation. The Institute of Reference Materials and Measurement (IRMM) will carry out this trial in late spring when the testing programme is underway in all Member States.