Evaluation of repeated immunoassays (mouse intracerebral potency tests) of the second International Standard of Pertussis Vaccine.
During one year 27 potency assays of second International Standard of Pertussis Vaccine were performed, when the Indian Standard of pertussis vaccine was being standardized. In all the 27 assays, the 50% immunizing dose (ImD50) was calculated both by Wilson-Worcester method and by probit analysis. The ImD50 of the International Standard varied from 0.022 I.U. to 0.076 I.U. (Mean 0.041 I.U.) when it was calculated by Wilson-Worcester method and from 0.0226 I.U. to 0.0704 I.U. (Mean 0.0402 I.U.) when it was calculated by probit analysis. There were no statistically significant differences between ImD50 values calculated by Wilson-Worcester method and by probit analysis. The challenge dose of Bordetella pertussis in terms of LD50 units had no effect on the ImD50 values. The average slope (b) of the assays was 1.92 when calculated by probit analysis and the average homogeneity factor (alpha) in these assays calculated by Wilson-Worcester method was 1.73.
Gupta
R K
RK
Biological Standardization and Quality Control Division, Central Research Institute, Kasauli, India.
Sharma
S B
SB
Ahuja
S
S
Saxena
S N
SN
D000818:Animals; D005069:Evaluation Studies as Topic; D007118:Immunoassay; D051379:Mice; D008815:Mice, Inbred Strains; D010567:Pertussis Vaccine / Q000276:immunology / Q000592:standards*; D012015:Reference Standards
D010567:Pertussis Vaccine