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Implementation of Good Clinical Laboratory Practice (GCLP) guidelines within the External Quality Assurance Program Oversight Laboratory (EQAPOL).

Publication ,  Journal Article
Todd, CA; Sanchez, AM; Garcia, A; Denny, TN; Sarzotti-Kelsoe, M
Published in: J Immunol Methods
July 2014

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.

Duke Scholars

Published In

J Immunol Methods

DOI

EISSN

1872-7905

Publication Date

July 2014

Volume

409

Start / End Page

91 / 98

Location

Netherlands

Related Subject Headings

  • Workflow
  • Specimen Handling
  • Reproducibility of Results
  • Quality Indicators, Health Care
  • Quality Control
  • Program Evaluation
  • Program Development
  • Predictive Value of Tests
  • Practice Guidelines as Topic
  • Observer Variation
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Todd, C. A., Sanchez, A. M., Garcia, A., Denny, T. N., & Sarzotti-Kelsoe, M. (2014). Implementation of Good Clinical Laboratory Practice (GCLP) guidelines within the External Quality Assurance Program Oversight Laboratory (EQAPOL). J Immunol Methods, 409, 91–98. https://doi.org/10.1016/j.jim.2013.09.012
Todd, Christopher A., Ana M. Sanchez, Ambrosia Garcia, Thomas N. Denny, and Marcella Sarzotti-Kelsoe. “Implementation of Good Clinical Laboratory Practice (GCLP) guidelines within the External Quality Assurance Program Oversight Laboratory (EQAPOL).J Immunol Methods 409 (July 2014): 91–98. https://doi.org/10.1016/j.jim.2013.09.012.
Todd CA, Sanchez AM, Garcia A, Denny TN, Sarzotti-Kelsoe M. Implementation of Good Clinical Laboratory Practice (GCLP) guidelines within the External Quality Assurance Program Oversight Laboratory (EQAPOL). J Immunol Methods. 2014 Jul;409:91–8.
Todd, Christopher A., et al. “Implementation of Good Clinical Laboratory Practice (GCLP) guidelines within the External Quality Assurance Program Oversight Laboratory (EQAPOL).J Immunol Methods, vol. 409, July 2014, pp. 91–98. Pubmed, doi:10.1016/j.jim.2013.09.012.
Todd CA, Sanchez AM, Garcia A, Denny TN, Sarzotti-Kelsoe M. Implementation of Good Clinical Laboratory Practice (GCLP) guidelines within the External Quality Assurance Program Oversight Laboratory (EQAPOL). J Immunol Methods. 2014 Jul;409:91–98.
Journal cover image

Published In

J Immunol Methods

DOI

EISSN

1872-7905

Publication Date

July 2014

Volume

409

Start / End Page

91 / 98

Location

Netherlands

Related Subject Headings

  • Workflow
  • Specimen Handling
  • Reproducibility of Results
  • Quality Indicators, Health Care
  • Quality Control
  • Program Evaluation
  • Program Development
  • Predictive Value of Tests
  • Practice Guidelines as Topic
  • Observer Variation