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Consensus Laboratory Assay Protocols -- HIV Immunology

Consensus immunological assay methodologies have been developed by the AIDS Clinical Trials Group (ACTG) for implementation in its multi-site HIV/AIDS investigations.

• Assay protocols for spontaneous apoptosis, cytotoxic T lymphocyte activity, HIV neutralization, inducible cytokine measurements, lymphocyte proliferation, natural killer cell activity, cytokine mRNA detection, and plasma cytokine and soluble marker measurements can be accessed from the ACTG web site by clicking here.
  
• Guidelines for 2-color and 3-color flow cytometric immunophenotyping have been published and are available by clicking here.
  
• Comparison study information for labs wishing to switch from 2-color to 3-color flow cytometry measurements of CD3+CD4+ and CD3+CD8+ cells can be accessed from the ACTG web site by clicking here.

The Immunology Quality Assessment Program

To enhance the integrity and comparability of immunological laboratory evaluations performed on patients enrolled in multi-site HIV/AIDS investigations, the Immunology Quality Assessment Program (IQAP) was established to assist DAIDS-sponsored and collaborating investigators by:

• Assessing the ability of laboratories to reliably measure patient CD4 and CD8 and investigating the sources and extent of measurement variability
• Facilitating the adaptation, standardization and quality assessment of immunological assays for implementation in multi-site investigations
• Supporting the evaluation of novel cytometric methods and instruments as alternatives to current labor intensive, highly variable and costly technologies

Please contact Daniella Livnat (phone: 301-496-0636; email: dl28a@nih.gov ) for additional information regarding this program.

Other Immunology Performance Evaluation Programs

• The College of American Pathologists maintains a Flow Cytometry Survey. For more information please call 708-446-8800.
  
• The Centers for Disease Control and Prevention (CDC) offer a Performance Evaluation/Proficiency Testing Program for T-Lymphocyte Immunophenotyping.
  
• FAST Systems, Inc. administers a Proficiency Testing Program for Flow Cytometric Immunophenotyping. For more information please call 301-977-0536.

Sample Publications on Multi-site Immunophenotypic Evaluations

• R. Gelman, et al. 1993. Assessment of the effects of instrumentation, monoclonal antibody, and fluorochrome on flow cytometric immunophenotyping: A report based on 2 years of the NIAID DAIDS Flow Cytometry Quality Assessment Program. Clin. Imm. and Immunopath. 66:150-162.
  
• A. Landay, et al. 1995. Interlaboratory variability of CD8 subset measurements by flow cytometry and its applications to multicenter clinical trials. Clin. and Diag. Lab. Imm. 2:462-468.
  
• M.R.G. O’Gorman, et al. 1997. Inter- and intrainstitutional evaluation of automated volumetric capillary cytometry for the quantitation of CD4- and CD8-positive T lymphocytes in the peripheral blood of persons infected with Human Immunodeficiency Virus. Clin. and Diag. Lab. Imm. 4:173-179.
  
• K.R. Tamul. 1996. Evaluating laboratory performance for flow cytometric immunophenotyping. ADVANCE for Med. Lab. Prof. September 2.