Call for data on Bovine Tuberculosis testing

Échéance: 26 avril 2012
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Background

The Commission requested the  European Food Safety Authority (EFSA)  to issue a scientific opinion on the suitability of the IFN test or other, possibly newer, tests for inclusion amongst the official tests for the purpose of granting and retaining an officially tuberculosis-free herd status as laid down in Annex A to Directive 64/432/EEC and certification for intra Union trade in bovine animals as required in Article 6(2)(a) of that Directive furthermore.

http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=EFSA-Q-2011-01254

Objective

To address this question it must be assessed if the performance of the alternative tests, are equivalent or better when compared to the current standard test used in the European Union (EU). 

Characteristics of diagnostic accuracy will be considered. Diagnostic sensitivity (DSe)  is defined as the probability of a positive test result in an infected animal, and  diagnostic specificity (DSp) as the probability of a negative test result in an animal that is not infected.

Call for Data

EFSA kindly asks governments, companies, universities, research institutions, other stakeholders and any individuals to submit any available data concerning diagnostic test accuracy (sensitivity and specificity).  EFSA will evaluate the received data if data is in compliance with the following inclusion and exclusion criteria:

Inclusion criteria:

  1. The diagnostic test  under evaluation (TUE) is one of the tests included in the table 1.
  2. The diagnostic test performance (diagnostic Se and/or  Sp) was measured on bovines
  3. Each study animal had been individually examined using  a official intradermal tuberculin test, either Single intradermal test (SIT) or Single intradermal comparative cervical test (SICCT) as the comparator test (CT) or with a reference standard (RT) for confirmation of infection by  culture, microscopic examination or identification of macroscopic lesions.

For a study to be included  animals must have been tested by at least 2 of the tests considered

Test under evaluation

Comparator test

Reference standard

X

X

 

 

X

X

X

X

X

X

 

X

  1. Additional data concerning testing of the same animals with other tests for confirmation of infection although valuable, is not essential.

Exclusion criteria:

  1. Any study where animals are experimentally infected with bTB.

Table 1: Diagnostic tests to be evaluated (TEU)

Test Name

Abbreviation

Long description

IFN-γ Bovine-Avian

IFN-γ-BA

Gamma - interferon test with bovine PPD and avian PPD diagnostic antigens

IFN-γ Bovine

IFN-γ -B

Gamma - interferon test with bovine diagnostic antigen

IFN-γ CFP10 ESAT6

IFN-γ -CE

Gamma - interferon test with CFP10 and ESAT6 diagnostic antigens

IFN-γ MPB70

IFN-γ -MPB

Gamma - interferon test with MPB70 diagnostic antigen

IFN-γ BACE

IFN-γ -BACE

Gamma - interferon test with bovine PPD and avian PPD diagnostic antigens and CFP10 and ESAT6 diagnostic antigens

IFN-γ OTHER

IFN-γ -OTHER

Gamma - interferon test with OTHER diagnostic antigens – PLEASE SPECIFY

ELISA Bovine-Avian

Elisa-BA

Enzyme-linked immunosorbant assay with bovine PPD and avian PPD diagnostic antigens

ELISA Bovine

Elisa-B

Enzyme-linked immunosorbant assay with bovine diagnostic antigen

ELISA MPB70

Elisa-MPB

Enzyme-linked immunosorbant assay with MPB70 diagnostic antigen

Latex Bead Agglutination assay

Latex

Latex bead agglutination assay (LBAA)

Multiplex immunoassay

Multiplex

Multiplex chemiluminescent immunoassay developed by Enfer Scientific

Serological Rapid

Rapid

Rapid immunochromatographic assay (rapid test)

 

Confidentiality and unpublished data

Specific issues relating to confidentiality of the data provided will be discussed between the owners and EFSA.

Closing date for the data submissions is 26 April 2012.

The data  should be transmitted to EFSA in electronic format using the MS Excel® table Tbtest.xls (0.1 Mb) .

Use worksheet RawData to enter experimental data for individual animals included in a study, one row per animal.

Use worksheet TestSummaries to report the total number of animals testing positive and negative in test comparison studies, complete only the area in blue.

A data dictionary for each column can be found in the first worksheet  and the controlled terminologies and definitions are provided in Terms.

Data submissions should be sent to this e-mail address: ahaw@efsa.europa.eu

For inquires regarding the reporting format please contact us at: ahaw@efsa.europa.eu

Publié: 26 mars 2012