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From: TSS ()
Subject: EFSA Scientific Report on the Evaluation of Rapid post mortem TSE Tests intended for Small Ruminants
Date: June 24, 2005 at 8:20 pm PST

EFSA Scientific Report on the Evaluation of Rapid post mortem TSE Tests intended for Small Ruminants

Last updated: 22 June 2005
Adopted on 17 May 2005 (Question N° EFSA-Q-2003-084)

Summary of the Report

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.

Until 2004 no evaluation of rapid TSE tests on material from small ruminants was conducted by the European Commission. In the absence of such data, 5 rapid post mortem TSE tests performing satisfactorily on bovine tissue were provisionally approved by the EC for the TSE monitoring of small ruminants 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 this third European evaluation exercise for newly developed rapid post mortem and live animal TSE/BSE tests.

EFSA was asked to take over the scientific aspects of this evaluation and to assess the outcome of the IRMM evaluation of rapid TSE post mortem tests, taking also into account an opinion of the French Food Safety Agency (AFSSA), and to give recommendations on the approval of the tests.

During January to June 2004, the European Commission’s Institute of Reference Materials and Measurements (IRMM) carried out an evaluation of the diagnostic and analytical sensitivities, of the diagnostic specificity and repeatability of six rapid post mortem tests on samples from natural scrapie cases. Additionally the ability of these tests and their analytical sensitivity for the detection of “atypical” scrapie strain (Nor 98) in sheep tissue were evaluated. During August 2004, further brain samples from three clinical cases of sheep orally challenged with BSE-affected cattle brain homogenate were screened using each of the six rapid tests. In March 2005, in response to concerns of the EFSA WG on TSE Testing following confirmation of a case of BSE in a French goat, the six rapid tests were re-evaluated against dilutions of brain homogenates from experimentally BSE infected sheep to provide analytical sensitivity for this material comparable to that previously obtained for scrapie.

The assessment comprised the assessment of the application dossiers, of the results obtained from the laboratory evaluation, organised, carried out and analysed by the IRMM, and of the package inserts. Based on an overall assessment on the application dossiers, the laboratory evaluation and the approval of the package inserts, the experts of EFSA´s Working Group on TSE Testing express their opinion on 6 rapid post mortem TSE tests for small ruminants.

Keywords: BSE, Bovine Spongiform Encephalopathy, TSE, Transmissible Spongiform Encephalopathy, post mortem, rapid BSE test, small ruminants, evaluation, Regulation (EC) No 999/2001, TSE monitoring.

Publication date: 22 June 2005



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