EXAMPLES THE MOST COMMONLY USED TESTS FOR THE EVALUATION OF IMMUNE RESPONSES

Note:  Functional assays are generally more important than tests for soluble mediators or phenotyping.

Ref: http://www.fda.gov/cdrh/ost/ostggp/immunotox.html#T1

 

IMMUNE RESPONSES

FUNCTIONAL ASSAYS*

SOLUBLE MEDIATORS

PHENOTYPING

OTHER

HISTOPATHOLOGY

Not  Applicable or Not Needed

 

Not  Applicable or Not Needed

 

Cell surface markers

Morphology

HUMORAL RESPONSE

o        Immunoassays (e.g. ELISA) for antibody response to antigen plus adjuvant*

o        Plaque-forming cells

o        Lymphocyte  proliferation

o        Antibody-dependent cell-mediated cytotoxicity

o        Passive cutaneous anaphylaxis

o        Direct anaphylaxis

o        Complement (including C3a and C5a anaphylatoxins)*

o         Immune complexes

Cell surface markers

 

CELLULAR RESPONSES

 

 

 

 

T-CELLS

o Guinea pig maximization test*

o Mouse local lymph node assay*

o Mouse ear swelling test

o Lymphocyte proliferation

o Mixed lymphocyte reaction

Cytokine patterns indicative of T cell subsets (e.g. Th1 and Th2)

Cell surface markers (helper and cytotoxic T-cells)

 

NATURAL KILLER CELLS

Tumor cytotoxicity

NA

Cell surface markers

 

MACROPHAGES

Phagocytosis* Antigen Presentation

Cytokines (IL-1, TNF-alpha, IL-6, TGF-beta)

MHC markers

 

GRANULOCYTES

(Basophils, Eosinophils and/or Neutrophils)

Degranulation  Phagocytosis

Chemokines, Bioactive amines, Inflammatory cytokines, Enzymes

NA

Cytochemistry

HOST RESISTANCE

Resistance to bacteria, viruses and tumors

NA

NA

 

SIGNS OF ILLNESS

NA

NA

NA

Allergy, Skin rash, Urticaria, Edema, Lymphadenopathy