The National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), has awarded Duke University Medical Center up to $52.8 million over the next seven years 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 project, External Quality Assurance Oversight Laboratory (EQAPOL), will be led by Thomas Denny, MSc, professor of medicine, chief operating officer of the Duke Human Vaccine Institute and affiliate of the Duke Global Health Institute.
“This is critical work, and I believe the contract is a tribute to the extraordinary depth and reach of our research and support teams in the Duke Human Vaccine Institute,” said Nancy Andrews, MD, PhD, dean of the Duke University School of Medicine.
Reliable and reproducible laboratory data are essential in evaluating treatments for HIV infection. Denny says there are several dozen laboratories globally that perform assays for HIV studies. “The absence of a single, centralized laboratory makes it imperative that strict quality assurance standards and protocols are in place. Patients, physicians and researchers all need to feel confident that a test on a blood sample performed in New York will yield the same results as the same test performed in London or South Africa as an example. Today, you might not find that.”
The Division of Acquired Immunodeficiency Syndrome (DAIDS) at NIAID has requested Duke concentrate its work on several programs under the contract, including evaluation of processing and storage of blood from participants enrolled in NIAID supported clinical trials; evaluation of tests that measure immune responses to new therapies; coordination of efforts for new assays and new assay validation procedures, and participation in establishing and characterizing unique clade-specific HIV viral panels.
“Virus panels are used to determine how well new laboratory tests perform, but some of the panels developed for this work are more than 15 years old,” says Denny. “As a result, current panels may not be truly reflective of which virus strains are circulating in the world today; they can change over time.”
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