Conventional Test Method:

Lethal/Intradermal Challenge Test in the Batch Potency Testing of Diphtheria Vaccine (Methods A and B in PhEur 2.7.6)

Alternative Test Method:

Name & Description:

ELISA Procedure for Potency testing of Diphtheria Vaccines

Dilutions of test and reference sera are made on ELISA plates coated with diphtheria toxoid. A positive and negative guinea-pig control are included on each plate to monitor the assay performance. Peroxidase-conjugated rabbit or goat anti-guinea pig IgG is added, followed by peroxidase substrate. Optical density is measured and the relative antibody titre is calculated.

Validation Status:

No information

Regulatory Status:

EU: Accepted into PhEur

Effect or Potential Effect on Animal Use:

Reduction

Refinement

References:

• Council of Europe (CE) (2008) 2.7.6 Assay of Diphtheria vaccine (adsorbed). In: European Pharmacopoeia, 6^th ed. Strasbourg, France: CE.

Information Last Reviewed:

May 2012