title: Implementation of Good Clinical Laboratory Practice (GCLP) guidelines within the External Quality Assurance Program Oversight Laboratory (EQAPOL).
abstract: 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.
authors.affiliation: Department of Surgery, Duke University Medical Center, Durham, NC, USA.
authors.forename: Christopher A
authors.initials: CA
authors.lastname: Todd
authors.affiliation: Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA.
authors.forename: Ana M
authors.initials: AM
authors.lastname: Sanchez
authors.affiliation: Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA.
authors.forename: Ambrosia
authors.initials: A
authors.lastname: Garcia
authors.affiliation: Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA.
authors.forename: Thomas N
authors.initials: TN
authors.lastname: Denny
authors.affiliation: Department of Surgery, Duke University Medical Center, Durham, NC, USA; Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA; Department of Immunology, Duke University Medical Center, Durham, NC, USA. Electronic address: marcella.sarzottikelsoe@dm.duke.edu.
authors.forename: Marcella
authors.initials: M
authors.lastname: Sarzotti-Kelsoe
mesh_terms: D016915:AIDS Vaccines / Q000627:therapeutic use; D018070:Biological Specimen Banks / Q000592:standards; D015415:Biomarkers / Q000097:blood; D002568:Certification; D016207:Cytokines / Q000097:blood*; D058501:Enzyme-Linked Immunospot Assay / Q000592:standards*; D005434:Flow Cytometry / Q000592:standards*; D019983:Guideline Adherence / Q000592:standards; D015658:HIV Infections / Q000097:blood / Q000175:diagnosis* / Q000276:immunology / Q000628:therapy / Q000821:virology; D015497:HIV-1 / Q000235:genetics / Q000276:immunology; D006801:Humans; D059425:Interferon-gamma Release Tests / Q000592:standards*; D007753:Laboratories / Q000592:standards* / Q000706:statistics & numerical data; D059232:Laboratory Personnel / Q000592:standards; D059021:Laboratory Proficiency Testing / Q000592:standards*; D015166:Monitoring, Immunologic / Q000592:standards*; D015588:Observer Variation; D017410:Practice Guidelines as Topic / Q000592:standards; D011237:Predictive Value of Tests; D016730:Program Development; D015397:Program Evaluation; D011786:Quality Control; D019984:Quality Indicators, Health Care / Q000592:standards*; D015203:Reproducibility of Results; D013048:Specimen Handling / Q000592:standards; D057188:Workflow
chemical_list: D016915:AIDS Vaccines; D015415:Biomarkers; D016207:Cytokines
keywords: Biorepository; GCLP; Laboratory; Proficiency testing; Quality assurance; Quality management