TSE testing

In the EU all slaughtered bovine cattle above 30 months and all fallen stock above 24 months have to be tested for bovine spongiform encephalopathy (BSE), the mad cow disease. More than 10 million BSE tests are carried out annually, as specifically laid down by Regulation (EC) No 999/2001. The regulation stipulates also the testing of about half a million sheep and goats per year for transmissible spongiform encephalopathy (TSE).

IRMM evaluates rapid tests, produces reference materials and investigates methods for detection of the transmissible spongiform encephalopathies (TSE). IRMM organises proficiency testing programmes for quality assurance of the measuring laboratories involved in BSE testing.

Evaluation of rapid tests

Rapid TSE tests are essential for increasing the efficiency of TSE detection in slaughtered animals, and for the epidemiological and eradication programme. Since 1999 IRMM has evaluated a number of post mortem BSE tests and 12 of them have been approved by the European Commission for monitoring as defined by Regulation (EC) No 999/2001.

The BSE tests approved in 2002 received also a provisional approval for TSE testing. To assess the performance of approved BSE tests or their modified versions and new specific scrapie tests, IRMM has carried out in 2004 an evaluation of six rapid tests, providing the test developers with more than 15000 sheep samples. Reports on the results will serve as a scientific basis for an approval of several assays for TSE testing.

Reports from IRMM:

Report on the Prionics®-Check PrioSTRIP SR PRIONICS AG[1699Kb] (2010)

Report on the BetaPrion® SCRAPIE EIA-Test aj ROBOSCREEN[933Kb] (2010)

Report on the pre-evaluation assessment (Stage 1) of the AJ Roboscreen BetaPrion Scrapie EIA rapid post-mortem test [2Mb] (Nov 2009)

Report on the pre-evaluation assessment (Stage 1) of the Prionics®-Check PrioSTRIP SR rapid post-mortem[5Mb]  (September 2009)

The evaluation of DiaSpec's rapid ante mortem BSE test[1113Kb] (November 2006)

Report on the IDEXX HerdCheck® BSE rapid post-mortem test in the EU scrapie test evaluation 2005[1568Kb] (July 2005)

Report on Beckman Coulter's 'InPro CDI™' rapid post-mortem BSE test (version 2) in the EU scrapie test evaluation 2005[1462Kb] (July 2005)

Report on evaluation of rapid tests for the diagnosis of TSE in sheep[1369Kb] (June 2005)

Report on phase I laboratory evaluation[1399Kb] (November 2004)

Report on field trial[2Mb] (November 2004) 
 

Reference materials and proficiency testing programmes

As the regulation on BSE tests and their large scale use require a thorough quality assurance scheme to guarantee proper control, IRMM has also developed reference materials for the quality control of approved rapid BSE tests. The different formats for quality control materials consist of stable homogenates and are available for test developers and national reference laboratories for BSE.

IRMM was the first to organise proficiency testing with national reference laboratories for BSE in the European Union and in all Candidate Countries to the EU in the years 2001 to 2003. The results obtained in these exercises help to develop test specific reference materials to control both laboratory and test performance in a standardised manner.

European Food Safety Authority (EFSA)