The Enferplex Bovine TB Antibody test was approved by the World Organisation for Animal Health (OIE) in June 2019 (Registration Number 20190113). Test kits are manufactured at Enfer Scientific in Ireland, and we are happy to deal directly with all product and service inquiries. For UK specific inquiries, please contact our partners Surefarm.
The Enferplex Bovine TB antibody test is a qualitative enzyme immunoassay based on the sequential addition of bovine serum or milk to a multiple antigen coated plate, chemiluminescent substrate is used to generate the signal and the image is captured for analysis. The image is analysed and data reduced to determine sample status in the Enferplex Bovine TB Macro. The assay has been developed using The Enferplex Multiplex Platform. This allows multiple results from one sample and the Enferplex Bovine TB macro analyse data from 11 individual antigens in this test to determine a result. The Enferplex Bovine TB Macro has high specificity and high sensitivity settings. Samples that give positive reactions to 2 or more antigens are deemed to be ‘POSITIVE’, while samples that recognise 0 or 1 antigen are deemed to be ‘NEGATIVE’.
The OIE approval for the test deems it fit for the detection of antibody to Mycobacterium bovis in cattle serum samples, to be used as an ancillary test in conjunction with other methods for serological prevalence surveys, or diagnosis and management of M. bovis infection within herds, for the following purposes as detailed in the Resolution No 31 adopted in May 2019 by the World Assembly of the OIE Delegates:
- To confirm, but not negate, diagnosis of suspect or clinical cases, including confirmation of positive screening tests in individual animals and in herds with infection prevalence ranging from very low to high, based on detection of antibodies in bovine serum.
- To detect Mycobacterium bovis infected animals not positive by single intradermal comparative cervical tuberculin (SICCT) or interferon gamma release assay (IFNɣ) tests, based on detection of antibodies in bovine serum.
- To confirm, but not negate, infection in animals giving inconclusive reactions in the SICCT, based on detection of antibodies in bovine serum.
- As a screening test, to identify animals most likely to have visible lesions by scoring the number of M. bovis antigens recognised by seropositive animals with bovine tuberculosis.
Species and specimens: This test has been validated and approved for testing serum samples from cattle, as noted above. Regarding intended use 4 above, during the first 5 years of registration, additional data will be required to better qualify and categorise the relationship between the number of M. bovis antigens and the likelihood of visible lesions.
This test is also provisionally approved for testing milk samples from cattle as a supplemental test for use in individual animals, when used in conjunction with other methods for diagnosing and managing M. bovis infection.