ESTABLISHMENT OF A STANDARD OPERATING PROCUDURE FOR TESTING DIPHTHERIA POTENCY USING COMBINED ASSAYS OF IMMUNIZATION IN MOUSE AND TITRATION ON VERO CELL LINE

Abstract

For many years, the government immunization program's use of the diphtheria vaccine helped eradicate the disease among Vietnamese youngsters. To guarantee the efficacy of each batch of product utilized on the market, vaccination effectiveness must be established. There is currently just one standard sample of diphtheria computed per unit of guinea pig, but the high usage of guinea pigs makes the implementation process challenging. The National Institute for Accreditation of Vaccines and Medical Biologicals' Department of Microbiology has conducted research and devised a protocol to assess the efficacy of diphtheria on white mice of the ICR mouse line. The study used an immunological approach to examine the efficiency of diphtheria in mice, followed by a titration on Vero cells. Five separate tests were used to confirm the assay. The tests were run concurrently using the Diphtheria International Standard (NIBSC) using the test sample to be determined and known potency units of 213 IU/tube. The trials' findings are used to assess vaccine quality and provide a test strategy for diphtheria vaccine quality control.