Opinion of the Scientific Panel on Animal Health and Welfare (AHAW) on a request from the Commission concerning Brucellosis Diagnostic Methods for Bovines, Sheep, and Goats
Bo Algers
Harry J. Blokhuis
Donald Maurice Broom
Patrizia Costa
Mariano Domingo
Matthias Greiner
Daniel Guémené
Jörg Hartung
Trevor Stewart Hastings
Per Have
Frank Koenen
David B. Morton
Christine Müller-Graf
Albert Osterhaus
Dirk Udo Pfeiffer
Mo Salman
Moez Sanaa
James Michael Sharp
Philippe Vannier
Martin Wierup
Marion Wooldridge
No abstract available
EFSA has been requested by the European Commission for an assessment of the available scientific data on brucellosis diagnostic tests, and to issue a scientific opinion on the suitability of current and new tests for the diagnosis of brucellosis in bovines, sheep, and goats.
At the Plenary Meeting of 25/26 May 2005, the AHAW Panel decided to entrust the collection and analysis of available data to a working group. A report on this task was given to the AHAW panel. The conclusions and recommendations were adopted at the Plenary Meeting on 11/12 December 2006.
The Scientific Report reviewed all the available scientific data on Brucellosis diagnostic tests for bovines, sheep, and goats using a meta-analysis approach.
Based on the data of a systematic literature review, meta-analytical estimates of the animal-level diagnostic sensitivity (Se) and specificity (Sp) for all new and standard tests, as well as the estimates of the difference for Se and Sp for all combination of tests, were obtained. Using an equivalence analysis approach, the null hypotheses that Se or Sp of a new brucellosis test are lower than the performance of standard tests were investigated. The Report elaborated on the importance of the negative predictive value and the Se with regard to safety in intra-Community trade and in addition explored the role of the Sp for the given purpose.
For bovines the key conclusions and recommendations of the AHAW panel were:
i) the following brucellosis diagnostic tests currently considered as standard tests in the EU legislation on intra-Community trade showed comparable Se and Sp and were found to be suitable for remaining as standard test: Rose Bengal Test (RBT), Complement Fixation Test (CFT), and Indirect Enzyme Linked Immunosorbent Assay (iELISA);
ii) the Fluorescence Polarization Assay test (FPA) showed Se and Sp comparable to that of standard tests and was found to be suitable for inclusion in the EU legislation on intra-Community trade of bovines as standard test for brucellosis diagnosis;
iii) the Radial Immunodiffusion Test with Native Hapten (RIDNH) showed lower Se and equal Sp comparable to that of standard tests and could be suitable for inclusion in the EU legislation on intra-Community trade as complementary test for brucellosis diagnosis;
iv) for the Competition Enzyme Linked Immunosorbent Assay (cELISA), it is recommended that this type of test should remain in the EU legislation on intra-Community trade, where it is currently included i.e. as a complementary test, pending the conduct of further studies;
v) the Serum Agglutination Test (SAT) showed lower Se and Sp compared to other standard tests and was not found to be suitable for remaining in the EU legislation on intra-Community trade.
For sheep and goats the key conclusions and recommendations of the AHAW panel were:
i) the two brucellosis diagnostic tests currently considered as standard tests in the EU legislation on intra-Community trade (RBT and CFT) showed comparable Se and Sp and were found suitable for remaining as standard tests;
ii) the modified Rose Bengal Test (MRBT), the iELISA, the cELISA, the FPA, and the Brucellin Skin Test (BST) are suitable for inclusion in the EU legislation on intra-Community trade because their Se was equal to that of standard tests. However, with the exception of the BST, these tests have Sp lower to the standard tests or their Sp is not sufficiently documented. Thus, when using Se and Sp as criteria for assessing the fitness for the purpose of intra-Community trade, the AHAW Panel concludes that these tests, except BST, are not suitable for inclusion in the EU legislation on intra-Community trade of sheep and goats unless new data demonstrate that these tests are at least as specific as the standard tests.
iii) the RIDNH is not suitable for inclusion in the EU legislation on intra-Community trade because its Se was lower compared to that of standard tests. It can be pointed out that this test has equal Sp compared to standard tests.
Brucellosis, Bovines, Sheep, Goats, Animal Health, Diagnostic tests, Meta-analysis, Intra-Community trade, Zoonosis.
