Romanenko O. Standardization and control system of laboratory diagnostic methods and specific prophylaxis preparations for rabies

The dissertation is devoted to the development of means and methods for standardization and control of diagnostic analysis and quality of veterinary immunobiological preparations for the prevention of rabies in animals. The optimal conditions for cultivation of the rabies virus test strain CVS-27 have been determined. A quantitative and qualitative composition of the protective media for its lyophilization and long-term preservation has been proposed. While developing the reference vaccine a technological process of obtaining the rabies virus culture suspension by infecting cell cultures ВНК-21/C13 "in suspension" with its following passaging was proposed, which allows obtaining virus-containing material with a high titer of infectious activity and shortening the incubation period by 24 hours. It was determined that ?-propiolactone in final concentration 0,04-0,05 % with the exposition of 12 hours at 2-8 °C temperature provides total inactivation of the rabies virus, strain CVS-11. A protective medium was experimentally selected which provides the maximal reduction of immunogenic activity loss during lyophilization when added to the inactivated virus-containing material. It was established that during the lyophilization process of the native material the specificity of the standard control sample for the diagnosis of rabies is not lost. The method of determining the infectious activity of the rabies virus vaccine strains was improved by titration in the cell culture ВНК-21/C13, which allowed decreasing the time of determining the virus-containing suspension titers from 14-21 days to 3 days. Performing the modified neutralization test decreases the time of immunogenic activity studies from 28 days to 3 days when compared to the classical method NIH. Keywords: rabies, diagnostics, vaccine prophylaxis, standardization, control, infectious activity, immunogenicity.