Evaluation of quantitative anti-F1 IgG and anti-V IgG ELISAs for use as an in vitro-based potency assay of plague vaccine in mice.

Quantitative anti-F1 and anti-V IgG enzyme-linked immunosorbent assays (ELISAs) were developed to measure the serological response of female Swiss Webster mice after vaccination with the recombinant fusion protein, rF1-V, which is being developed as a plague vaccine. Several fundamental parameters of the ELISA were evaluated: specificity, precision, accuracy, and stability. Experimental results suggested that a potency assay based upon the serological response of female Swiss Webster mice, as measured by quantitative anti-F1 IgG and anti-V IgG ELISAs, might be used to evaluate the rF1-V fusion protein vaccine.