Evaluation of a Rapid ante mortem BSE Test  : Scientific Report of the Scientific Expert Working Group of the European Food Safety Authority on Transmissible Spongiform Encephalopathy (TSE)

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 12 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. Expressions of interest were invited from those who had tests in advanced stages of development or available for use for the diagnosis of BSE in live cattle. Applications were received from six companies presenting six different tests. In order to ensure that useful tests would be widely available, applicants were also requested to give assurances that they were prepared to make their tests available on a non discriminatory basis following the evaluation. A panel of external scientists assessed all applications based on the pre-defined criteria, covering e.g. the scientific basis of the test, available experimental evidence, practicality of the sampling and testing procedures and stage of development of the test. Following this assessment 1 test was selected for the evaluation exercise. This joint application was presented by two companies: Scil Diagnostics GmbH, Martinsried, Germany and DiaSpec GmbH, Freiburg, Germany for the “AquaSpec BSE” rapid ante mortem test. Evaluation was based on the EFSA Scientific Report on the Design of a Field Trial Protocol for the evaluation of BSE Tests for Live Cattle adopted on 1 July 2004. On 10 October 2006, EFSA has received the report of the European Commission’s Institute of Reference Materials and Measurements (IRMM) on the evaluation of DiaSpec’s rapid ante mortem BSE test (IRMM, 2006). Based on the overall assessment covering the application dossier and a phase I laboratory evaluation, the experts of EFSA´s Working Group on TSE Testing express their opinion on the evaluated ante mortem BSE test. As the submitted AquaSpec BSE rapid ante mortem BSE Test could not succeed the laboratory trial, the overall assessment is negative. Therefore, the experts of the EFSA WG on TSE Testing concluded that the AquaSpec BSE ante mortem rapid BSE Test did not meet the predefined criteria and therefore do not recommend the AquaSpec BSE rapid ante mortem test (Scil Diagnostics GmbH, Martinsried, Germany and DiaSpec GmbH, Freiburg, Germany) for approval by the European Commission.