The Immunology Virology Quality Assessment Center (IVQAC), led by Thomas Denny MSc, MPhil, 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 IVQAC has multiple focuses including directing the External Quality Assurance Program Oversight Laboratory (EQAPOL), the Immune Quality Assessment (IQA) program, the Non-Human Primate Core Virology Laboratory (NHPCVL) and the Virology Quality Assurance Program (VQA).
Additionally, the IVQAC has 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 IVQAC 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.
The IVQAC services and tests are available here. The IVQAC is a GCLP laboratory which is also accredited by CAP, CLIA and ISO-17043.
Since August 2007, the IVQAC lab has been the home of the CAVD-CCVIMC bio repository. The outcome from these efforts is to facilitate the ability to conduct cell-based assays that inform vaccine strategy and design. The CCVIMC central bio repository provides well-characterized cells to CCVIMC labs as well as to other CAVD collaborators and non-CAVD collaborators.
The IVQAC has 2 CAP accreditations. One is for the Flow-CD4/CD8, HIV-1 Viral Load and HIV-1 EIA (awarded in 2008) and one is for the PBMC Biorepository (awarded in 2014). More information about the CAP accreditation process.
The Commission on Laboratory Accreditation of the College of American Pathologists (CAP) Laboratory Accreditation Program inspects a spectrum of laboratory test disciplines to assure participating programs “meet or exceed regulatory requirements, incorporates best practices, and promotes continuous quality improvement; and to enhance the recognition of the role of the laboratory director.” As the leading organization with more than 18,000 board-certified pathologists, the CAP serves patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide.
The CAP's Laboratory Improvement Programs, initiated 65 years ago, currently have customers in more than 100 countries, accrediting 7,700 laboratories and providing proficiency testing to 20,000 laboratories worldwide and is current recognized by the federal government as being equal to or more stringent than the government’s own inspection program.
The International Organization for Standardization (ISO) is an independent, non-governmental organization that brings together experts to publish and develop voluntary consensus standards. These standards provide requirements and specifications that can be used to ensure consistent materials, products, or services. ISO has published 22436 International Standards.
The IVQAC was awarded ISO 17043 in August 2010; reaccredited on 11/09/2018 after an onsite audit in August of 2018.