The European Food Safety Authority (EFSA) has reviewed field performance data of the BOVIGAM(R)Interferon-gamma (IFN-gamma) test and recommended such tests for inclusion in the official list of stand-alone tests for bovine tuberculosis (TB). BOVIGAM is currently widely used as a supplementary test in addition to skin testing. The Prionics company believes the positive EFSA opinion will lead to the use of BOVIGAM as a stand-alone TB test in the European Union.
In its evaluation, the EFSA evaluated a large set of data generated using the BOVIGAM IFN-gamma test as part of the EU TB surveillance. Based on the data, the EFSA concluded that the PPD-based IFN-gamma test fulfilled the criteria of being equivalent or superior to skin tests and therefore can be considered for stand-alone testing for TB.
The EFSA also discussed a further boosted performance of the test using alternative antigens. Prionics currently offers its BOVIGAM IFN-gamma test both with PPD as well as the alternative antigens (Prionics(R) PC-EC and PC-HP).
BOVIGAM is currently used as a supplementary test to complement skin testing in the EU. Elevating the status of the IFN-gamma test to an official test in the EU legislation means that BOVIGAM can be used for stand-alone TB diagnosis, equivalent to the skin test.
The IFN-gamma test is the only new test recommended by the EFSA. None of the other proposed tests should be considered for inclusion in the official tests for the purpose of granting and retaining official TB-free herd status and for certification for intra-Union trade of bovine animals.
The EFSA stated that the application of the IFN-gamma test offers several practical advantages over the skin test. According to the EFSA, the test is robust and easy to standardize, and has a beneficial impact on workload, safety of personnel and animal welfare.