title: Performance of the Enferplex TB assay with cattle in Great Britain and assessment of its suitability as a test to distinguish infected and vaccinated animals.
abstract: Rapid, simple, and accurate antemortem tests for tuberculosis (TB) in cattle need to be developed in order to augment the existing screening methods. In particular, as cattle vaccines are developed, such tests would allow the continuation of test-and-slaughter policies alongside vaccination. Therefore, the development of an assay that distinguishes infected from vaccinated animals (a DIVA test) is an urgent research requirement. In this study, we assessed the performance of a novel multiplex serological test with sera collected from 96 skin-tested animals with bovine tuberculosis, 93 TB-free animals, and 39 cattle vaccinated with Mycobacterium bovis BCG. Our results indicate that the test has a relative sensitivity range of 77.0% to 86.5% at corresponding specificity levels of 100.0% to 77.6%. Comparison with the Bovigam gamma interferon antemortem test revealed that this serology test was significantly more sensitive at specificities above 97.9%, while the Bovigam test was, on average, about 10% more sensitive when the test specificity was set below 97%. Importantly, this serological multiplex assay does not react with sera from BCG-vaccinated calves and is therefore suitable as a DIVA test alongside BCG-based vaccine strategies.
authors.affiliation: Enfer Scientific, Unit T, M7 Business Park, Newhall, Naas, Kildare, Ireland.
authors.forename: Clare
authors.initials: C
authors.lastname: Whelan
authors.forename: Adam O
authors.initials: AO
authors.lastname: Whelan
authors.forename: Eduard
authors.initials: E
authors.lastname: Shuralev
authors.forename: Hang Fai
authors.initials: HF
authors.lastname: Kwok
authors.forename: Glyn
authors.initials: G
authors.lastname: Hewinson
authors.forename: John
authors.initials: J
authors.lastname: Clarke
authors.forename: H Martin
authors.initials: HM
authors.lastname: Vordermeier
mesh_terms: D000818:Animals; D002417:Cattle; D019411:Clinical Laboratory Techniques / Q000379:methods*; D003937:Diagnosis, Differential; D007118:Immunoassay / Q000379:methods; D009163:Mycobacterium bovis / Q000276:immunology*; D012680:Sensitivity and Specificity; D044967:Serum / Q000276:immunology; D032581:Tuberculosis Vaccines / Q000276:immunology*; D014380:Tuberculosis, Bovine / Q000175:diagnosis* / Q000276:immunology*; D006113:United Kingdom
chemical_list: D032581:Tuberculosis Vaccines