New diagnostic tests are needed to make vaccination against bovine tuberculosis (bovine TB) viable, and the number of false positives from these tests must be below 15 out of every 10,000 cattle tested, researchers from Cambridge University announced on Thursday.

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Currently, vaccinated animals that test positive have to be treated as infected animals. Under European law, if an animal tests positive, it must be slaughtered. The remaining herd is put under movement restrictions and tested repeatedly using both the skin test and post-mortem examinations until it can be shown to be officially clear of infection.

The EU is looking into changing legislation to allow cattle vaccination and a recent report from its European Food Safety Authority (EFSA) emphasized the importance of demonstrating that BCG vaccine works, and that DIVA tests can be shown to perform in large-scale field trials.

More false positives from DIVA

However, a key factor overlooked in the EU report was that the currently viable DIVA tests have a lower specificity than tuberculin testing; this could lead to vaccinated herds being unable to escape restrictions once a single test-positive animal has been detected, as the more times the herd is tested, the more likely the test is to record a false positive.

In their study, the researchers from Cambridge and APHA used herd level models to show that the level of infection can be reduced in vaccinated herds even when DIVA sensitivity is lower than tuberculin skin testing. However, in order to see this benefit of vaccination over 99.85% of uninfected animals will need to test negative in the DIVA test. This improved accuracy will be necessary to avoid increasing the duration of breakdowns and the number of animals condemned.

Using data from previous tests on cattle, the researchers said this level of ‘specificity’ is achievable, though they said there will be challenges associated with improving accuracy.

The researchers said, “Currently, there is no gold standard test to diagnose TB in cattle. Cattle that test positive are slaughtered immediately and therefore have rarely developed any physical signs - in fact, only around a half of animals examined post-mortem show physical signs of infection even if they are, indeed, infected.”

Dr Andrew Conlan from the Department of Veterinary Medicine at the University of Cambridge explained "In order for vaccination to be viable, we will need a DIVA test that has extremely high specificity. If the specificity is not good enough, the test will find false positives, leading to restrictions being put in place and a significant financial burden for the farmer.

"But validating a test that has a very high specificity will in itself be an enormous challenge. We would potentially need to vaccinate, test and kill a large number of animals in order to be confident the test is accurate. This would be very expensive."

The need for a better DIVA test was acknowledged by the Government at the end of last year. In a written statement to the House of Commons noting data from the University of Cambridge and Animal Health and Veterinary Laboratories Agency, the Rt Hon Elizabeth Truss, Secretary of State for Environment, Food and Rural Affairs, said: "An independent report on the design of field trials of cattle vaccine and a test to detect infected cattle among vaccinated cattle (DIVA) shows that before cattle vaccination field trials can be contemplated, we need to develop a better DIVA test."