This project relates to the development of an in vitro ELISA potency assay to replace the guinea pig death test portion of the official release test for the tetanus component in vaccines. Reports of an ELISA method in the literature, and the use of this method in the laboratory are dependent on a source of purified Tetanus Toxin. Preliminary data and proposals for an international collaborative study were discussed at a meeting in June 2000. There has been no further investigation of the correlation between animal and laboratory tests this year due to problems with the supply of this purified reagent.

Agency
National Institute of Health (NIH)
Institute
Center for Biologics and Evaluation - Product Quality Control (CBERPQC)
Type
Intramural Research (Z01)
Project #
1Z01BR003005-10
Application #
6436638
Study Section
(LST)
Project Start
Project End
Budget Start
Budget End
Support Year
10
Fiscal Year
2000
Total Cost
Indirect Cost