• Open Access

Scientific Opinion on Analytical sensitivity of approved TSE rapid tests – new data for assessment of two rapid tests

Authors

  • EFSA Panel on Biological Hazards (BIOHAZ)


  • Panel members: Olivier Andreoletti, Herbert Budka, Sava Buncic, John D Collins, John Griffin, Tine Hald, Arie Hendrik Havelaar, James Hope, Günter Klein, James McLauchlin, Winy Messens, Christine Müller-Graf, Christophe Nguyen-The, Birgit Noerrung, Luisa Peixe, Miguel Prieto Maradona, Antonia Ricci, John Sofos, John Threlfall, Ivar Vågsholm, Emmanuel Vanopdenbosch. One member of the Panel did not participate in part of 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.
  • Correspondence: biohaz@efsa.europa.eu
  • Acknowledgement: The Panel wishes to thank the members of the Working Group on Analytical sensitivity of approved TSE rapid tests - II for the preparation of this opinion: Olivier Andreoletti, Jean-Noël Arsac, Anne Buschmann, John Griffin, Micha Nübling, Emmanuel Vanopdenbosch.
  • Adoption date: 22 April 2010
  • Published date: 29 April 2010
  • Question number: EFSA-Q-2010-00114
  • On request from: European Commission

Abstract

A former EFSA Scientific Opinion on analytical sensitivity of approved TSE rapid tests concluded that, during a comparative analytical sensitivity study performed by the Community Reference Laboratory (CRL) for TSEs, two rapid tests (Prionics®-Check LIA and Prionics®-Check PrioSTRIP) gave unexplained and unresolved specificity problems which hampered the interpretation of their analytical sensitivity. The Opinion therefore recommended that the tests should be re-assessed by appropriate experiments, under the supervision of the CRL. This Opinion provides a scientific assessment of a new study (“re-assessment study”) performed to re-assess the analytical sensitivity of the two above rapid tests with cattle BSE samples. It is concluded: (1) that the experimental design used in the new study is scientifically sound and can be considered equivalent to that applied during the first CRL study; and (2) that the two tests performed within a maximal 2 log10 inferiority range as compared to the most sensitive test system identified in the first CRL study, as set out in the current EFSA protocols for the evaluation of TSE rapid post mortem tests. It is further concluded that the precise causes of the initial reactives in negative control samples observed in the first CRL study with the two rapid tests remain unidentified, since the re-assessment study was not designed for investigating them.

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