External Quality Assurance Program Oversight Laboratory (EQAPOL)

Duke University, Durham NC

Investigators

Abstract

The National Institute of Allergy and Infectious Diseases (NIAID) supports a comprehensive research portfolio to advance biological knowledge of HIV/AIDS, its related co-infections and co-morbidities, and provides capability to support similar efforts related to emerging infectious diseases. A variety of immunological laboratory tests are included in NIAID-sponsored or supported clinical trials designed to evaluation of candidate vaccine platforms, immunogens, adjuvants, and monoclonal antibodies. Reliable, regulatory-compliant laboratory data are essential to the clinical evaluation of those products. Data from multiple laboratories performing assays in support of clinical trials testing single or multiple vaccine candidates or monoclonal antibodies must be accurate and reproducible. NIAID employs a variety of contract resources including the External Quality Assurance Program Oversight Laboratory (EQAPOL) to monitor and enhance the ability of laboratories to accurately and reliably perform trial-specified clinical laboratory testing to support vaccine immunogen and monoclonal antibody advancement and approval by U.S. and non-U.S. regulatory entities. This contract will provide external quality assurance/internal quality control (EQA/IQC) and operational activities in support of HIV vaccine efforts.