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.
Highlights
The External Quality Assurance Program Oversight Laboratory (EQAPOL) is a contract awarded by the National Institutes of Health/National Institute of Allergy and Infectious Diseases/Division of AIDS (NIH/NIAID/DAIDS) to support the development of external proficiency testing programs for flow cytometry, ELISpot, and Luminex bead-based assays
Implementation of Good Clinical Laboratory Practices (GCLP) into the EQAPOL Laboratory Teams began with an initial laboratory assessment, followed by GCLP training of laboratory staff, implementation of a Quality Management System (QMS), equipment qualification, standard operating procedures (SOPs) document control, and audits by the Central Quality Assurance Unit (CQAU)
Converting EQAPOL into a GCLP-compliant operation has a number of added benefits that include increased credibility for the program and improved accuracy, integrity, and traceability of generated data
Summary
The EQAPOL Program is comprised of a Central Management Team, Central Quality Assurance Unit (CQAU), Statistical Group, Data Management Group, Biorepository, Central Laboratory, A3R5 Neutralizing Antibody Assay Validation Program, and three EQAPOL Oversight Laboratories (EOLs) described in detail in this issue of Journal of Immunological Methods (see Ferrari et al for ELISpot; Staats et al for ICS by Flow Cytometry; Sempowski et al for cytokine-based Luminex). While external laboratories, participating in the EQAPOL proficiency testing programs, are not required to operate under GCLP, many of these laboratories are already GCLP-compliant and perform clinical trial related work It is for this reason that the program operates in GCLP compliance as it ensures the quality, integrity, and validity of the test data. This report describes the process by which GCLP compliance was established for the entire EQAPOL Program
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