Scientific Opinion on Analytical sensitivity of approved TSE rapid tests – new data for assessment of two rapid tests
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.
Acknowledgment
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.
Contact
biohaz@efsa.europa.eu
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.
© European Food Safety Authority, 2010
Following a request from the European Commission, the Panel on Biological Hazards (BIOHAZ) was asked to deliver a scientific opinion on analytical sensitivity of approved TSE rapid tests – new data for assessment of two rapid tests.
On 18 December 2009 EFSA published a Scientific Opinion on analytical sensitivity of approved TSE rapid tests. With regard to approved rapid tests for the detection of BSE in cattle, the Opinion concluded that, during a comparative analytical sensitivity study performed by the Community Reference Laboratory (CRL) for TSEs, the two rapid tests, Prionics®-Check LIA and Prionics®-Check PrioSTRIP, gave unexplained and unresolved specificity problems which hampered the interpretation of their analytical sensitivity. On this basis, the BIOHAZ Panel recommended that the analytical sensitivity of those two tests with cattle BSE samples should be re-assessed by appropriate experiments, under the supervision of the CRL. Following this recommendation, a new study (“re-assessment study”) was submitted for evaluation by the European Commission to EFSA. This Opinion provides a scientific assessment of the re-assessment study and provides conclusions on the analytical sensitivity of the two above rapid tests with regard to cattle BSE.
The BIOHAZ Panel concludes 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. The study was not hampered by specificity problems and allowed the re-assessment of the analytical sensitivity of Prionics®-Check LIA and Prionics®-Check PrioSTRIP with cattle BSE samples. 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.
The BIOHAZ Panel further concludes 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.
BSE, analytical sensitivity, TSE rapid tests
