Classical swine fever (CSF) marker vaccine: Trial III. Evaluation of discriminatory ELISAs

Abstract

The objective of the marker vaccine trial was to test the two available CSF marker vaccines in scenarios which are likely to occur in the field and to evaluate the reliability of the discriminatory tests. The evaluation of the discriminatory tests was of special importance because there is no requirement for formal data concerning their performance by the European Medicinal Products Evaluation Agency (EMEA) in London. EMEA is responsible for the licensing procedure of the marker vaccines within the EU. Sixteen National Swine Fever Laboratories (NSFL) participated in testing the discriminatory ELISAs. They were tested for sensitivity, specificity, reproducibility and practicability. Reference sera (CSFV and BVDV antibody positive) and field sera were used as well as sera from the weaner and sow experiments produced during the marker vaccine trial. Both discriminatory ELISAs were less sensitive than conventional CSF antibody ELISAs, although there was considerable variation between them. One discriminatory ELISA was less specific than the other, but more sensitive, and vice versa. Neither discriminatory ELISA consistently detected the marker-vaccinated, CSF-challenged weaner pigs correctly as ‘CSF positive’, although CSF-challenged pregnant sows were identified correctly. The limitations of the discriminatory ELISAs used in the trial was the major factor that would prevent the use of these two marker vaccines under emergency field conditions.