Scientific Opinion on the evaluation of new TSE rapid tests submitted in the framework of the Commission Call for expression of interest 2007/S204-247339
In order to be approved for use for TSE monitoring in the EU, new TSE rapid tests need to go through a specific evaluation procedure. The first three evaluation programmes were completed in 1999, 2002 and 2004. The present opinion reports the results of the fourth evaluation programme, which was launched by the European Commission in October 2007 and remained open for five consecutive years. The evaluation procedure applied was based on the requirements foreseen by the Commission Call and by the current EFSA protocols for the evaluation of TSE rapid tests in ruminants. By the end of the first application period (1 March 2008), six companies submitted six applications for TSE rapid tests: 1 post-mortem rapid test for the detection of BSE in cattle; 4 post-mortem rapid tests for the detection of TSE in small ruminants; and 1 post-mortem rapid test for the detection of both BSE in cattle and TSE in small ruminants. The only rapid test that went through the whole evaluation and fulfilled all requirements foreseen is the rapid test Prionics® - Check PrioSTRIP SR (visual reading protocol) for detection of TSE in small ruminants’ central nervous system. This rapid test is considered suitable for approval as rapid test for detection of TSE in small ruminants’ central nervous system.