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). But annex X is periodically updated and a revision EU956/2010 has been published on 22 October 2010. See the chronological list of amendments.

Please check Europa for any further amendments.

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

Tests currently approved

The currently approved rapid TSE tests have been evaluated using positive and negative panels of reference samples in independent evaluation studies. They have all been subjected to an EC Analytical Sensitivity Study with subsequent EFSA Opinions published. The resulting approval status is to be updated in an EC999/2001 revision (due for publication by end of 2010). The currently approved tests are identified below from the valid protocols list.

More information may be found in the following documents:

Test protocols

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

Here are the revised (October 2010) Guidelines (51kb 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. This will be circulated as and when it becomes 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 EURL currently implements a batch testing procedure for BSE rapid test kits as described below. This only applies for BSE testing and not for scrapie.

Confirmatory tests

  • All positive rapid tests results MUST be confirmed using one of the confirmatory tests which is listed in the BSE and Scrapie chapters (2.4.6 & 2.7.13) of the OIE manual.
  • The confirmatory test must be performed by a recognised National Reference Laboratory or the CRL.

The EURL 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).

Prionics® - Check PrioSTRIP SR RAPID TEST field trial evaluation

The EFSA opinion for this study was published on 8 May 2012 and is available on the EFSA website.