On-line version ISSN 1025-0298
OCHOA, Rolando et al. Validation of qualitative immunoassays used to evaluate the immunogenicity of vaccines. Vaccimonitor [online]. 2000, vol.9, n.1, pp. 17-20. ISSN 1025-0298.
The importance of general principles and outline of procedures for the validation of qualitative immunoassays used to evaluate the immune response elicited by vaccines were analyzed. The main parameters used are discussed. Guidelines for the evaluation of the sensitivity, specificity, positive and negative predictive values, discrimination value and gray zone were carefully studied. Our experience is presented.
Keywords : Validation; vaccines; immunoassays.