TSE test evaluation & approval

Click on the links below for further information:

Test approval

All TSE rapid tests which can be used for monitoring BSE and scrapie in EU countries must be approved by the EU Commission. Approved tests are listed in annex X of Regulation 999/2001 (pdf) (Official Journal of the European Communities L Series vol 44 L147 p1-40).
Annex X is periodically updated

  • Regulation 315/2008 (pdf) (Official Journal of the European Communities L Series Vol 51 L94 p3-5)

Please check Europa for any further amendments.

For further information about test evaluation please contact DG Health and Consumer Protection of the European Commission.

The three BSE tests originally approved by the Commission in 1999 have been re-evaluated to provide reassurance that the tests were still operating as they had been when officially evaluated and that they are still fit for purpose. Here is the full Comparative Testing Report (138kb pdf)

Tests currently approved

The currently approved rapid TSE tests have been evaluated using positive and negative panels of reference samples in independent evaluation studies.

More information may be found in the following documents:

Test protocols

Test approval is linked to an approved protocol which is lodged with the CRL and provision of details about the manufacturers quality system. All changes to the protocol must be agreed with the CRL prior to introduction. If changes are approved, the CRL issues the new protocol to NRLs.

Here are the revised (July 2008) Guidelines (29kb pdf) for evaluation of changes to approved protocols for TSE rapid tests. To discuss any other issues not covered in the document please contact Dr K Webster.

Current versions of approved protocols are linked here. If more information is required about a particular test it should be sought from the relevant test manufacturer.

Test performance

Information for NRLs on test performance / problems will be restricted to NRLs and is still being drafted. This will be circulated when it is available.

The ultimate diagnostic performance of any test relies on appropriate material being sampled and presented to the test. Methods for sampling material, and the limitations presented by suboptimal samples may both affect overall diagnostic sensitivity.

For further information see:

EU wide batch testing

The CRL is implementing a batch testing procedure for BSE rapid test kits as described below.

Confirmatory tests

  • All positive rapid tests results MUST be confirmed using one of the confirmatory tests which is listed in the TSE chapter of the OIE manual.
  • The confirmatory test must be performed by a recognised National Reference Laboratory or the CRL.

The CRL is working with the OIE to assess the performance of some additional tests which may be used in the future by National Reference Laboratories as confirmatory tests. This will not constitute a validation of a test, merely a statement of relative performance and these will be listed by the OIE.

Discriminatory testing

All confirmed TSE positive cases in small ruminants must be further classified as 'BSE-like' or 'scrapie-like' as detailed in Regulation 36/2005 (see also the Discriminatory Testing handbook). The discriminatory methods currently in use were approved following a blinded ring trial (156kb pdf).