Abstract

CEDRE, Bárbara et al. Validation of Colorimetric Vibriocidal Assay to Determine Serum Antibodies against Vaccine Candidate Strains of Vibrio Cholerae. Vaccimonitor [online]. 2003, vol.12, n.1, pp.23-30. ISSN 1025-028X.

Finlay Institute possesses a group of attenuated strain candidates for an oral vaccine against cholera. Immunogenicity has been evaluated in volunteers by ELISA antibody determination and mainly by vibriocidal assay. Vibriocidal assay measures the functionality of antibodies elicited by a vaccine strain, that is why it is considered the most efficient tool for determining immunity levels against cholera in vaccines, for which reason, the validation of this test is very important. Precision, specificity and robustness were evaluated in this paper. The results were within the acceptance criteria for this technique (>50% coincidence). It was demonstrated that the differences between positive and negative samples were due precisely to Vibrio cholerae growth and that small changes may be introduced in the test without producing variations in sample titer or false results. According to these results, this test is considered appropriate to evaluate the immune response elicited by vaccine candidates against cholera.

Keywords : Vibriocidal; validation; precision; specificity; robustness.

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