Immunology Virology Quality Assessment Center (IVQAC)
Director: Thomas Denny, MSc, MPhil
The Immunology Virology Quality Assessment Center (IVQAC) 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, and the Non-Human Primate Core Virology Laboratory (NHPCVL).
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 is a GCLP laboratory which is also accredited by CAP, CLIA and ISO-17043.
External Quality Assurance Oversight Program Laboratory (EQAPOL)
In September 2010, the DHVI became the home of the NIAID DIADS External Quality Assurance Oversight Program Laboratory (EQAPOL) under the leadership of Thomas Denny, MSc, MPhil.
The goal of the EQAPOL program is to support the development, implementation and oversight of external quality assurance programs that monitor laboratories involved in HIV/AIDS research and vaccine trials around the world. The EQAPOL program currently administers four External Quality Assurance (EQA) programs with over 91 participating sites worldwide to assess proficiency in the following assays: interferon-gamma (IFN-y), Enzyme-linked Immunosorbent Spot (ELISpot) assay, Intracellular Cytokine Staining by Flow Cytometry, Luminex bead-based assay, and HIV incidence assay testing.
In addition to External Quality Assurance programs, the EQAPOL program has established and continues to add to an HIV Viral Diversity Panel that represents the current genetic and geographic diversity of HIV. The goal of the EQAPOL Viral Diversity program is to establish a panel of fully characterized viruses from acute/early and chronic HIV infections. The panel of viruses can be used for various applications, including:
- Impact of genetic diversity on assay performance
- Developing/validating new assays
- Assisting regulators to evaluate test kits
- Monitoring HIV drug resistance
- Informing vaccine development
For more information about the EQAPOL Viral Diversity Program and available panels, visit here.
In support of these programs, IVQAC maintains GCLP practices and is a College of American Pathologists-accredited biorepository, which contains well-characterized cryopreserved peripheral blood mononuclear cells (PBMCs) for use in External Quality Assurance testing and viral culture.
Numbers of Interest:
- Four External Quality Assessment (EQA) Programs
- 91 EQA Sites across 19 countries
- 61 Sites Signed up to Receive Viral Diversity Samples
- 10,061 Viral Samples Shared (9/2018) with 1,191 samples shared this year
*The IFN-y ELISpot, Flow Cytometry and Luminex External Quality Assurance programs are International Organization for Standardization and International Electrotechnical Commission (ISO) 17043 accredited by the American Association for Laboratory Accreditation as a Proficiency Testing provider (A2LA Cert. 3614.01). See ISO section for more details
Immunology Quality Assessment (IQA)
Thomas Denny, MSc, MPhil, has led the National Institute of Allergy and Infectious Disease (NIAID) Division of AIDS (DAIDS) Immunology Quality Assessment (IQA) program since 1999. The IQA 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.
As part of the IQA program, three Proficiency Testing efforts are administered:
1. Peripheral Blood Monoclonal Cell (PBMC) cryopreservation
2. CD4 and CD8 Immunophenotyping via flow cytometry
3. Leukapheresis Real-time external quality assurance Program
In addition, the IQA program assists the NIAID-sponsored clinical trial networks and collaborating study groups in a variety of capacities, including training sites for processing and freezing PBMCs from a leukapheresis. The IQA program currently assists the following NIAID-sponsored and collaborating study groups: AIDS Clinical Trials Group, Division of Microbiology and Infectious Diseases, National Institute for Research in Tuberculosis, the International Maternal Pediatric Adolescent AIDS Clinical Trials, the HIV Vaccine Trials Network, the HIV Prevention Trials Network, and the Microbicide Trials Network.
The IQA was recently requested to provide support to the NIAID Vaccine Research Center Zika Vaccine Clinical Trials.
Through the IQA proficiency testing programs, over 200 sites worldwide are served helping to ensure quality and consistency in data generated from these sites. The PBMC cryopreservation program currently includes 86 domestic and international sites. The domestic Immunophenotyping PT program currently services 60 laboratories across the United States, Canada and Puerto Rico.
The IQA also reviews the performance and offers remediation to the international DAIDS laboratories participating in the United Kingdom National External Quality Assessment Service Immune Monitoring program. Currently, there are 63 laboratories from 18 countries participating in this international review and monitoring program for CD4 enumeration.
*The IQA domestic Immunophenotyping CD4 program is an International Organization for Standardization and International Electrotechnical Commission (ISO) 17043 accredited by the American Association for Laboratory Accreditation as a Proficiency Testing provider (A2LA Cert. 3614.01). See ISO section for more details.
Non-Human Primate Core Virology Laboratory (NHPCVL)
The IVQAC was awarded funding from National Institute of Allergy and Infectious Disease (NIAID), as part of the National Institutes of Health (NIH), to establish the NHPCVL in December 2017. The Non-Human Primate Core Virology Laboratory (NHPCVL) supports the development and performance of simian immunodeficiency virus (SIV) or simian human immunodeficiency virus (SHIV) viral load assays that are performed in support of HIV vaccine development efforts by HIV/AIDS research laboratories around the world.
With this contract, the IVQAC team will work to improve and develop assays that are used to detect and characterize viral RNA from samples obtained from non-human primates that are part of HIV/AIDS preclinical research studies. For example, detection of viral RNA will be performed in specimens that include plasma, mucosal tissues or secretions, and lymphoid tissues from non-human primates that have been infected with SIV or SHIV.
The Collaboration for AIDS Vaccine Discovery (CAVD)
Comprehensive T-Cell Vaccine Monitoring Consortium (CCVIMC) Bio repository
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.
College of American Pathologist _ CAP Accreditation
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). For more information about the CAP accreditation process, visit here.
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.
ISO Accreditation 17043 for PT
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.
*The IFN-y ELISpot, Flow Cytometry and Luminex External Quality Assurance programs are International Organization for Standardization and International Electrotechnical Commission (ISO) 17043 accredited by the American Association for Laboratory Accreditation as a Proficiency Testing provider (A2LA Cert. 3614.01).
*The IQA domestic Immunophenotyping CD4 program is an International Organization for Standardization and International Electrotechnical Commission (ISO) 17043 accredited by the American Association for Laboratory Accreditation as a Proficiency Testing provider (A2LA Cert. 3614.01).