{
  "url": "https://openlegislation.uk/eu-regulation-2008-315/annex",
  "json_url": "https://openlegislation.uk/eu-regulation-2008-315/annex.json",
  "legislation": "eur/2008/315",
  "legislation_title": "Commission Regulation (EC) No 315/2008 of 4 April 2008 amending Annex X to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards the lists of rapid tests (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2008-315",
  "path": "annex",
  "kind": "annex",
  "number": null,
  "heading": null,
  "text": "In Annex X, Chapter C, to Regulation (EC) No 999/2001, point 4 is replaced by the following:\n‘4.\nRapid tests\nFor the purposes of carrying out the rapid tests in accordance with Articles 5(3) and 6(1), the following methods shall be used as rapid tests for the monitoring of BSE in bovine animals:\nimmuno-blotting test based on a Western blotting procedure for the detection of the Proteinase K-resistant fragment PrPRes (Prionics-Check Western test),\nchemiluminescent ELISA test involving an extraction procedure and an ELISA technique, using an enhanced chemiluminescent reagent (Enfer test & Enfer TSE Kit version 2.0, automated sample preparation),\nmicroplate-based immunoassay for the detection of PrPSc (Enfer TSE Version 3),\nsandwich immunoassay for PrPRes carried out following denaturation and concentration steps (Bio-Rad Te-SeE test),\nmicroplate-based immunoassay (ELISA) which detects Proteinase K-resistant PrPRes with monoclonal antibodies (Prionics-Check LIA test),\nconformation-dependent immunoassay, BSE antigen test kit (Beckman Coulter InPro CDI kit),\nchemiluminescent ELISA for qualitative determination of PrPSc (CediTect BSE test),\nimmunoassay using a chemical polymer for selective PrPSc capture and a monoclonal detection antibody directed against conserved regions of the PrP molecule (IDEXX HerdChek BSE Antigen Test Kit, EIA),\nlateral-flow immunoassay using two different monoclonal antibodies to detect Proteinase K-resistant PrP fractions (Prionics Check PrioSTRIP),\ntwo-sided immunoassay using two different monoclonal antibodies directed against two epitopes presented in a highly unfolded state of bovine PrPSc (Roboscreen Beta Prion BSE EIA Test Kit),\nsandwich ELISA for the detection of Proteinase K-resistant PrPSc (Roche Applied Science PrionScreen),\nantigen-capture ELISA using two different monoclonal antibodies to detect Proteinase K-resistant PrP fractions (Fujirebio FRELISA BSE post-mortem rapid BSE Test).\nFor the purposes of carrying out the rapid tests in accordance with Articles 5(3) and 6(1), the following methods shall be used as rapid tests for the monitoring of TSE in ovine and caprine animals:\nconformation-dependent immunoassay, BSE antigen test kit (Beckman Coulter InPro CDI kit),\nsandwich immunoassay for PrPRes carried out following denaturation and concentration steps (Bio-Rad Te-SeE test),\nsandwich immunoassay for PrPRes carried out following denaturation and concentration steps (Bio-Rad Te-SeE Sheep/Goat test),\nchemiluminescent ELISA test involving an extraction procedure and an ELISA technique, using an enhanced chemiluminescent reagent (Enfer TSE Kit version 2.0),\nmicroplate-based immunoassay for the detection of PrPSc (Enfer TSE Version 3),\nimmunoassay using a chemical polymer for selective PrPSc capture and a monoclonal detection antibody directed against conserved regions of the PrP molecule (IDEXX HerdChek BSE-Scrapie Antigen Test Kit, EIA),\nmicroplate-based chemiluminiscent immunoassay for the detection of PrPSc in ovine tissues (POURQUIER’S-LIA Scrapie),\nimmuno-blotting test based on a Western blotting procedure for the detection of the Proteinase K-resistant fragment PrPRes (Prionics-Check Western Small Ruminant test),\nmicroplate-based chemiluminescent immunoassay for the detection of Proteinase K-resistant PrPSc (Prionics Check LIA Small Ruminants).\nIn all tests, sample tissue on which the test must be applied must comply with the manufacturer’s instructions for use.\nProducers of rapid tests must have a quality assurance system in place that has been approved by the Community Reference Laboratory (CRL) and ensures that the test performance does not change. Producers must provide the CRL with the test protocols.\nChanges to rapid tests and to test protocols may only be made after prior notification to the CRL and provided that the CRL finds that the change does not alter the sensitivity, specificity or reliability of the rapid test. That finding shall be communicated to the Commission and to the national reference laboratories.’",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2008/315/annex",
    "retrieved_at": "2026-11-01T14:52:20.218105+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}