Biological technique used as alternative method in the vaccine potency assays: in-house sandwich ELISA for Rabbit haemorrhagic disease virus

摘要

A biological technique wich is extensivelly used in the antigen detection and measurement is enzime linked immunosorbent assay (ELISA). In veterinary medicine, this technique is ussualy used in surveillance or control programs to establish antigenic prevalence and as a diagnostic tool for antigenic type detection (e.g., RHDV typing). In vaccinology, potency assessment (PA) of the vaccine batches is based more frequently on antibody detection using appropriate methods and less in using antigenic methods. The aim of paper is to assess the reliability of an in-house RHDV-Ag sandwich ELISA (sELISA) for PA. Batches of RHDV vaccine containing VSHI-CN-6 strain were tested with sELISA. Using the same batches, the potency tests were carried out according with European Pharmacopoeia 9.0. Healthy rabbits were vaccinated and the immune response was evaluated. The sELISA positive values (OD>300) were at the dilutions >1/64. The HI values of rabbit sera immunised with the same vaccine batches ranged between 1/128 and 1/2048. The sELISA could be a reliable alternative for the evaluation of the potency test for the RHDV vaccine batches. The sELISA is faster (1-2 days) than HI (>42 days) and is carried in respect with the regulation concerning the use of animals for medical purposes.