Diagnostic Immunology

Diagnostic immunology refers to the use of serological markers such as antibodies and antigens to establish evidence of infectious or autoimmune disease conditions. Laboratories and donor banks performing any test that meets the definitions described below must hold one or both of the diagnostic immunology categories.

  • a)Serologic tests for autoantibodies, excluding testing for antibodies against blood cells performed in hematology, immunohematology, histocompatibility; and excluding tests for antibodies against spermatozoa performed under the Andrology category.
  • b)Serologic tests for specific markers of infectious disease or exposure to such diseases (e.g.,antibody/antigen), excluding HIV;
  • c) Tests for nonspecific indicators of infectious disease or exposure to such diseases (e.g., immunoglobulin or complement levels).