ELISA test for batch potency testing of tetanus vaccines for human use

Topic: Quality control of vaccines

Test Method Number:
TM1999-04 (EU)
Short Name of TM:
ELISA TET
Year received:
1999
Responsible Organisation:
General Comments:

Method Description

The ELISA TET measures antibody levels against tetanus in the serum of guinea pigs immunised with tetanus vaccine for human use. It is carried out for vaccine batch release to demonstrate the tested batch complies with the requirements set in the marketing authorisation for the given vaccine.

Track Approval Status

  •  
    Submission
  •  
    Validation
  •  
    Peer-review
  •  
    Recommendation
  •  
    Regulatory acceptance/Standards
Step
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