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

TSE, BSE, Classical scrapie, Atypical scrapie, rapid test
First published in the EFSA Journal
8 May 2012
Adopted
19 April 2012
Type
Scientific Opinion

Abstract

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.

Panel members at the time of adoption

Olivier Andreoletti, Herbert Budka, Sava Buncic, John D Collins, John Griffin, Tine Hald, Arie Havelaar, Günter Klein, Kostas Koutsoumanis, James McLauchlin, Christine Müller-Graf, Christophe Nguyen-The, Birgit Noerrung, Luisa Peixe, Miguel Prieto Maradona, Antonia Ricci, John Sofos, John Threlfall, Ivar Vågsholm, Emmanuel Vanopdenbosch.
Panel on Biological Hazards
Contact
biohaz [at] efsa.europa.eu
doi
10.2903/j.efsa.2012.2660
EFSA Journal 2012;10(5):2660
On request from
European Commission
Competing interests
One member of the Panel did not participate in the discussion on the subject referred to above because of potential conflicts of interest identified in accordance with the EFSA policy on declarations of interests.