Scientific Report of the European Food Safety Authority on the Evaluation of two 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) for 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. On 16 November 2004, the EFSA Working Group on TSE Testing adopted its Scientific Report on the Evaluation of Seven New Rapid post mortem Tests. In April 2005, EFSA has received the reports of the European Commission’s Institute of Reference Materials and Measurements (IRMM) on the field trial of a further two post mortem BSE test. The assessment of selected rapid BSE post mortem tests comprises the evaluation of the application dossiers, the phase I laboratory evaluation, the field trials and the package inserts of recommended tests. The laboratory evaluation was organised, carried out and analysed by the IRMM and the results were assessed by the EFSA Working Group (WG) on TSE Testing. Only those candidates that had successfully passed the phase I laboratory evaluation were allowed to enter into the field trial (= phase II). Based on an overall assessment the experts of EFSA´s Working Group on TSE Testing express their opinion on the evaluated two rapid post mortem BSE tests. Based on the overall assessment covering the application dossier, a phase I laboratory evaluation, the field trial and the approval of the package insert, the experts of EFSA´s Working Group on TSE Testing concluded that the Fujirebio FRELISA post mortem rapid BSE Test met the predefined criteria. As the submitted Priontype post mortem rapid BSE Test could not succeed the field trial, the overall assessment on the Priontype post mortem test (LDL) is negative. Therefore, the experts of the EFSA WG on TSE Testing therefore recommend the Fujirebio FRELISA post mortem rapid BSE Test (Fujirebio Inc. Japan) for approval by the European Commission whereas the Priontype post mortem rapid BSE Test (Labor Diagnostik GmbH Leipzig, Germany) is not recommended for approval.