The EFSA Journal (2007) 508, 1-20 © European Food Safety Authority 2007 Protocol for the evaluation of new rapid BSE post mortem tests 1 Scientific Opinion of the Panel on Biological Hazards (Question No EFSA-Q-2007-053) Adopted on 7 June 2007 PANEL MEMBERS Olivier Andreoletti, Herbert Budka, Sava Buncic, Pierre Colin, John D Collins, Aline De Koeijer, John Griffin, Arie Havelaar, James Hope, Günter Klein, Hilde Kruse, Simone Magnino, Antonio Martínez López, James McLauchlin, Christophe Nguyen-The, Karsten Noeckler, Birgit Noerrung, Miguel Prieto Maradona, Terence Roberts, Ivar Vågsholm, Emmanuel Vanopdenbosch. SUMMARY Currently, 12 rapid BSE test kits are approved by the EC for the routine post mortem testing of slaughtered cattle over 30 months of age in accordance with the TSE Regulation (EC) No 999/2001. The EC is considering launching a new open call for expression of interest for rapid tests for use in the framework of TSE monitoring. Therefore, the EFSA was requested to update the current protocols for the laboratory evaluation and field trial, taking into account experience gained in past evaluation rounds. The experts of the BIOHAZ panel conclude that the revised evaluation protocol takes into account, experience gained in previous evaluation rounds, knowledge accumulated in recent years with the active surveillance program, constraints such as practicability and potential availability of biological material. This protocol ensures that newly approved tests will not be inferior to previously approved BSE post mortem screening tests. The criteria in this revised protocol introduce more comprehensive and higher standards than have previously been approved for validation of cattle post mortem BSE tests which will allow a more comprehensive evaluation of the test’s performance (analytical sensitivity). Since the last rapid test evaluation two new forms of TSE in cattle have been reported in different EU member states and USA (Atypical BSE H and L). Despite concerns about these two types of TSE, the protocol does not include evaluation of rapid test performances with regards to atypical BSE, because currently available biological material is lacking. 1 For citation purposes: Scientific Opinion of the Panel on Biological Hazards on a request from the European Commission on a protocol for the evaluation of new rapid BSE post mortem tests. The EFSA Journal (2007) 508, 1-20