The aim of this assay is to assess the ability of a test system to mount an antibody response (IgM and/or IgG) to immunization with e.g. KLH (Keyhole limpet hemocyanin) in the presence or absence of co-administered test or reference item. Antigens – such as KLH - are referred to as T-dependent when B lymphocytes require the support of T-cells to elicit an optimal antigen-specific antibody response. TDAR is a primary first line functional assessment of immune system used to monitor the effects of drugs on the immune system.
Rat or mouse.
Five groups with a predefined number of animals per sex and group are used:
Route and scheme of administration should be the same as in the toxicity study.
All groups are pre-immunized with KLH via tail vein.
KLH-specific IgG and IgM antibody will be detected in serum samples by ELISA and the possible effect of test item treatment upon the immunoresponse to KLH immunization will be evaluated.