Evaluation of BSE/TSE tests

Following an European Commission (EC) call for expressions 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 and its Scientific Expert Working Group on Transmissible Spongiform Encephalopathy (TSE) Testing were asked by the EC to take over the mandate of the former Scientific Steering Committee on new rapid TSE/BSE (Bovine Spongiform Encephalopathy) tests and to assess the outcome of the laboratory evaluation of rapid TSE post mortem tests conducted by the EC’s Institute for Reference Material and Measurements. The documents in this section provide information on protocols for the evaluation of post mortem and ante mortem tests, the selection process of submitted tests, laboratory results, conclusions and recommendations to the EC for approval of tests.

GBR assessments

GBR is a qualitative indicator of the likelihood of the presence of one or more cattle being infected with Bovine Spongiforme Encephalopathy(BSE), pre-clinically as well as clinically, at a given point in time, in a country. Where the presence of BSE is confirmed, the GBR gives an indication of the level of infection. Four levels are defined and refer to the presence of one or more cattle clinically or pre-clinically infected with the BSE agent in a geographical region or country.

The levels range from one to four:

Level 1: Highly unlikely
Level 2: Unlikely but not excluded
Level 3: Likely but not confirmed or confirmed at a lower level
Level 4: Confirmed at a higher level

The GBR methodology is defined by and amended by

• An overview of those countries that have already been assessed
• An overview of former GBR assessments and general Risk Assessments on BSE/TSE issues as carried out by the former Scientific Steering Committee (SSC)2