The use of the Toxin Binding Inhibition (ToBI) test for the estimation of the potency of the diphtheria component of vaccines.
The Toxin Binding Inhibition (ToBI) test, previously developed for the estimation of diphtheria and tetanus antitoxin in human sera, was adapted for the estimation of the potency of diphtheria components in vaccines. Data are presented to show that antitoxin titres of individual sera of mice obtained by the ToBI test are in good agreement with those obtained in the Vero cell test. In addition, diphtheria potency and 95% confidence interval of twelve batches of vaccine in different compositions were estimated by the ToBI test and the results were compared with those obtained in Vero cells. A significant correlation could be demonstrated. It is concluded from this study that the ToBI test is a valuable model in the potency assay of diphtheria toxoids, based on antitoxin induction in mice.
Hendriksen
C F
CF
Laboratory for the Control of Bacterial Vaccines, National Institute of Public Health and Environmental Protection, Bilthoven, The Netherlands.
van den Gun
J W
JW
Kreeftenberg
J G
JG
D000818:Animals; D004167:Diphtheria Toxin / Q000276:immunology; D004168:Diphtheria Toxoid / Q000276:immunology*; D005260:Female; D008297:Male; D051379:Mice; D015203:Reproducibility of Results; D014709:Vero Cells
D004167:Diphtheria Toxin; D004168:Diphtheria Toxoid