The Immunology Quality Assessment Center (IQAC) is led by Thomas N. Denny, M.P.H.  The IQAC is a resource designed to help domestic and international immunologists evaluate and enhance the integrity and comparability of immunological laboratory determinations performed on patients enrolled in multi-site HIV/AIDS therapeutic, vaccine and prevention investigations. The IQAC is divided into three subunits including Flow Cytometry, Immune Function Assay development, and an international unit that focuses on developing new alternative approaches to measuring CD4 cell levels in resource limited areas. This unit also focuses on developing QC/QA programs for clinical trials and capacity building for developing laboratories or staff in resource limited areas. The IQAC also offers both the Clinical Flow Cytometry Shared Resource and the Non-human Primate Viral Load Testing Shared Resource to DHVI investigators and the Duke community.

 

In October 2007, the IQAC received funding from the National Institute of Allergy and Infectious Diseases (NIAID) to expand its efforts to standardize and improve the quality of CD4 testing across domestic and international laboratories funded by the NIAID, the Centers for Disease Control (CDC) and many other organizations. The IQAC is currently working with 82 labs in the U.S. and 78 labs across 28 other countries in Africa, Latin America, South America and the Caribbean.

 

In January 2008, the IQAC received funding from the National Institutes of Health to establish the Peripheral Blood Mononuclear Cell (PBMC) Quality Assurance Program. This program offers proficiency testing of PBMC cryopreservation at sites funded by the National Institute of Allergy and Infectious Disease (NIAID). As part of the PBMC QA program, the IQAC team develops sensitive functional and phenotypic assays to monitor the quality of frozen PBMC’s including cell recovery, cell viability, and biological function. The IQAC team provides Quality Control (QC) mechanisms to assess the ability of sites to process, freeze, store and ship viable PBMC’s for future use. As part of this initiative, the IQAC established the DHVI Data Management Center, which provides statistical analysis of QC results. The IQAC also maintains a PBMC cell bank harvested from donors participating in the ongoing CHAVI leukapheresis program.

 

In July 2008, the IQAC was awarded an accreditation by the Commission on Laboratory Accreditation of the College of American Pathologists (CAP). The IQAC is one of the more than 6,000 CAP-accredited laboratories nationwide. The CAP Laboratory Accreditation Program, begun in the early 1960s, is recognized by the federal government as being equal to or more stringent than the government's own inspection program. During the CAP accreditation process, inspectors examine the laboratory's records and quality control of procedures for the preceding two years. CAP inspectors also examine the entire staff's qualifications, the laboratory's equipment, facilities, safety program and record, as well as the overall management of the laboratory.

 

Finally, the IQAC just recently received funding from the Cancer Research Institute to serve as a central processing laboratory for the Cancer Vaccine Consortium's Immune Proficiency Panel Program.