Scientific Report of the European Food Safety Authority on the Evaluation of Seven New Rapid post mortem BSE Tests

The European Food Safety Authority (EFSA) and its Scientific Expert Working Group on Transmissible Spongiform Encephalopathy (TSE) Testing were asked by the European Commission (EC) to take over the mandate of the former Scientific Steering Committee (SSC) gor the scientific evaluation of rapid TSE/BSE (Bovine Spongiform Encephalopathy) tests. At present 5 rapid BSE test kits are approved by the EC for the post mortem testing of slaughtered cattle in accordance with the TSE Regulation (EC) No 999/2001. Following an EC call for expression of interest in the Official Journal of the European Union (No C15) on 22 January 2003, several parties indicated their interest in participating in the third European evaluation exercise for newly developed rapid post mortem and live animal TSE/BSE tests. This call for the expression of interest remained open until 4th April 2003. The laboratory evaluation of selected rapid post mortem BSE tests was divided in two phases: a phase I laboratory evaluation and a field trial. The laboratory evaluation was organised, carried out and analysed by the European Commission’s Institute of Reference Materials and Measurements (IRMM) and the results were assessed by EFSA’s Working Group on TSE Testing. Only those candidates that had successfully passed the phase I laboratory evaluation were allowed to enter into the field trial. This EFSA Scientific Report provides synopses and conclusions on the results from the phase I laboratory evaluation of 10 tests and from 7 finalized field trials. Based on an overall assessment on the application dossiers, the phase I laboratory evaluation, the field trials and the approval of the package inserts, the experts of EFSA´s Working Group on TSE Testing express their favourable opinion on 7 new tests and recommend these test for approval by the European Commission in the framework of regulation (EC) No 999/2001.