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Updated: Mar 8, 2026
In Vitro ELISA Test to Evaluate Rabies Vaccine Potency
Published on: May 11, 2020
Replacement of in vivo human rabies vaccine potency testing by in vitro glycoprotein quantification using ELISA -
Sylvie Morgeaux1, Bertrand Poirier2, C Ian Ragan3
1Agence Nationale de Sécurité du Médicament et des Produits de Santé, Laboratory Controls Division, Batch Release and Marketing Surveillance of Biological Products Department, 312 Avenue Jean Jaurès, F-69007 Lyon, France.
Abstract:
Three different ELISAs quantifying rabies glycoprotein were evaluated as in vitro alternatives to the National Institutes of Health (NIH) in vivo potency test for batch release of human rabies vaccines. The evaluation was carried out as an international collaborative study supported by the European Partnership for Alternatives to Animal Testing (EPAA). This pre-validation study, the results of which are presented in this paper, compared three different ELISA designs, assessing their within- and between-laboratory precision. One of the ELISA designs was proposed to the European Directorate for the Quality of Medicines & HealthCare (EDQM) and accepted for an international collaborative study under the umbrella of the Biological Standardisation Programme.
