Implementation of Good Clinical Laboratory Practice (GCLP) guidelines within the External Quality Assurance Program Oversight Laboratory (EQAPOL).
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The EQAPOL contract was awarded to Duke University to develop and manage global proficiency testing programs for flow cytometry-, ELISpot-, and Luminex bead-based assays (cytokine analytes), as well as create a genetically diverse panel of HIV-1 viral cultures to be made available to National Institutes of Health (NIH) researchers. As a part of this contract, EQAPOL was required to operate under Good Clinical Laboratory Practices (GCLP) that are traditionally used for laboratories conducting endpoint assays for human clinical trials. EQAPOL adapted these guidelines to the management of proficiency testing programs while simultaneously incorporating aspects of ISO/IEC 17043 which are specifically designed for external proficiency management. Over the first two years of the contract, the EQAPOL Oversight Laboratories received training, developed standard operating procedures and quality management practices, implemented strict quality control procedures for equipment, reagents, and documentation, and received audits from the EQAPOL Central Quality Assurance Unit. GCLP programs, such as EQAPOL, strengthen a laboratory's ability to perform critical assays and provide quality assessments of future potential vaccines.
Biological Specimen Banks
Enzyme-Linked Immunospot Assay
Interferon-gamma Release Tests
Laboratory Proficiency Testing
Practice Guidelines as Topic
Predictive Value of Tests
Quality Indicators, Health Care
Reproducibility of Results
Published Version (Please cite this version)10.1016/j.jim.2013.09.012
Publication InfoDenny, Thomas Norton; Garcia, Ambrosia; Sanchez, Ana M; Sarzotti-Kelsoe, Marcella; & Todd, Christopher A (2014). Implementation of Good Clinical Laboratory Practice (GCLP) guidelines within the External Quality Assurance Program Oversight Laboratory (EQAPOL). J Immunol Methods, 409. pp. 91-98. 10.1016/j.jim.2013.09.012. Retrieved from http://hdl.handle.net/10161/14720.
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Professor in Medicine
Thomas N. Denny, MSc, M.Phil, is the Chief Operating Officer of the Duke Human Vaccine Institute (DHVI) and the Center for HIV/AIDS Vaccine Immunology (CHAVI), and a Professor of Medicine in the Department of Medicine at Duke University Medical Center. He is also an Affiliate Member of the Duke Global Health Institute. He has recently been appointed to the Duke University Fuqua School of Business Health Sector Advisory Council. Previously, he was an Associate Professor of Pathology, Laboratory M
Research Professor of Immunology
Ongoing Applied Activities •I direct a Global Quality Assurance Program, which I developed and pioneered here at Duke University, to oversee compliance with Good Clinical Laboratory Practice Guidelines in three HIV vaccine trial networks (CHAVI, CAVD, Duke HVTN, EQAPOL, Duke VTEU) involving domestic and international laboratory sites. •I also direct a Global Proficiency Testing Program for laboratories testing for neutralizing antibody function in individuals infected
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Chan, C; Denny, Thomas Norton; Enzor, Jennifer; Frelinger, J; McKinnon, K; Richards, AJ; Staats, Janet; ... (8 authors) (J Immunol Methods, 2014-07)The accurate identification of rare antigen-specific cytokine positive cells from peripheral blood mononuclear cells (PBMC) after antigenic stimulation in an intracellular staining (ICS) flow cytometry assay is challenging, ...
The Immunology Quality Assessment Proficiency Testing Program for CD3⁺4⁺ and CD3⁺8⁺ lymphocyte subsets: a ten year review via longitudinal mixed effects modeling. Bainbridge, John; Denny, Thomas Norton; Garcia, Ambrosia; Louzao, Raul; Perza, N; Rountree, Wes; Wilkening, CL; ... (8 authors) (J Immunol Methods, 2014-07)Since 1999, the National Institute of Allergy and Infectious Diseases Division of AIDS (NIAID DAIDS) has funded the Immunology Quality Assessment (IQA) Program with the goal of assessing proficiency in basic lymphocyte subset ...
Toward development of a comprehensive external quality assurance program for polyfunctional intracellular cytokine staining assays. Chan, C; Chan, RC-F; Denny, Thomas Norton; Enzor, Jennifer; Gaur, A; Jaimes, M; Rountree, Wes; ... (10 authors) (J Immunol Methods, 2014-07)The External Quality Assurance Program Oversight Laboratory (EQAPOL) Flow Cytometry Program assesses the proficiency of NIH/NIAID/DAIDS-supported and potentially other interested research laboratories in performing Intracellular ...