Conventional Test Method:

Lethal/paralytic challenge test in the batch potency testing of tetanus toxoid vaccines for human use (Methods A and B in PhEur 2.7.8)

Alternative Test Method:

Name & Description:

ELISA procedure for Batch Potency Testing of Tetanus Vaccines

The ELISA procedure estimates in vitro the quantity of tetanus antibodies in serum of immunised guinea pigs. Serial dilutions of the test serum and a standard serum are incubated on tetanus toxoid-coated microtiter plates.  Peroxidase-conjugated goat-guinea pig IgG is added and amount of tetanus antibody bound to toxoid visualized by adding substrate. Antibody titre is estimated by comparing the dose-response curves of the test and standard serum.

Validation Status:

EU: Endorsed as valid by ECVAM (2000)

Regulatory Status:

EU: Accepted into PhEur (Method C, 2.7.8) (2003)

Effect or Potential Effect on Animal Use:

Reduction
(single-dilution test instead of multi-dilution)

Refinement
(Does not rely on death as an endpoint)

References:
Information Last Reviewed:
May 2012