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Full validation of an ELISA for quantification of antibodies against Haemophilus influenzaetype b capsular polysaccharide


Journal of Applied Biotechnology & Bioengineering
Maylin Pérez-Bernal,1 Carlos Hernández,1 Magali Delgado,1 Zurina Cinza,2 Mabel Izquierdo,3 Ileana Rosales,3 Nelvis Figueroa,2 Pablo Díaz,2 Enrique Pérez1

Abstract

Since 1981, ELISA methods have been used for the quantification of antibodies against Haemophilus influenzaetype b (Hib), but their complete validation has been never reported.This work described the full validation of an ELISA for the quantification of antibodies against Hib capsular polysaccharide, following eleven parametersrecommended by European Medicines Agency and FDA guidelines. The method satisfied the acceptance criteria for the required parameters. The use of percent of inhibition and parallelism fulfillment as acceptance criteria for specificity was discussed. This ELISA will be a reliable device for the evaluationof Hib-vaccination efficacious.

Keywords

accuracy, anti-PRP antibodies, calibration curve, precision

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