Diagnostic Immunology/HIV Proficiency Testing Program

Diagnostic Immunology

This category is for laboratories that perform or anticipate performing the following tests:

1. Serologic tests for autoantibodies, excluding tests for antibodies against blood cells which are performed under the categories of hematology, immunohematology, and histocompatibility; and excluding tests for antibodies against spermatozoa which is performed under the category of Andrology.
2. Serology tests for specific markers of infectious diseases or exposure to such disease, excluding tests for HIV, which are performed under the HIV category.
3. Tests for nonspecific indicators of infectious diseases or exposure to such diseases.
4. Immunoglobulin A, E, G, and M, serum complement C3, C4 levels, and Alpha-1-Antitrypsin.

The Diagnostic Immunology category encompasses two subcategories:

1. Diagnostic Services Serology - for laboratories that perform any diagnostic immunologic test described above on patient specimens for diagnostic or prognostic purposes.
2. Donor Services Serology - for donor banks and laboratories under contract to donor banks that perform any tests on donors of human organs, tissues, and/ or blood for transfer, transfusion, or transplantation.

Human Immunodeficiency Virus

This category is for laboratories performing serological or molecular tests for Human Immunodeficiency Virus (HIV) for diagnostic or prognostic purposes; for expedited maternal/ newborn testing; for screening potential candidates for donations of gametes, blood, or other body fluids; for testing for insurance applications; and/ or laboratories performing HIV tests as part of a clinical trails.

The HIV category encompasses three subcategories:

1. Screening Tests Only - for laboratories performing initial testing for HIV such as EIA antibody or p24 antigen, but NOT performing any confirmatory test such as Western blot or IFA.
2. General - for laboratories performing any testing included in the Screening Tests Only subcategory AND performing confirmatory testing, or laboratories performing only confirmatory testing.
3. Viral Identification - for laboratories performing molecular identification tests such as PCR, bDNA, or NASBA or performing genotyping, phenotyping, or cultivation of the virus.