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.
External proficiency testing programs designed to evaluate the performance of end-point laboratories involved in vaccine and therapeutic clinical trials form an important part of clinical trial quality assurance.
Here, we describe our experience with a leukapheresis cryopreseration program that has been able to preserve the functionality of cellular subsets and that provides the sample numbers necessary to run an external proficiency testing program.
Participating laboratories are required to complete two External Proficiency (EP) rounds per year.
The program currently monitors 25 domestic and international sites with two external proficiency panels per year.
Here, we report the results of External Proficiency 3 (EP3) where participating sites performed a 7-color ICS assay.
Because this assay has been adopted by multiple laboratories worldwide, an external proficiency testing program was developed to ensure data equivalency across laboratories performing this neutralizing antibody assay for HIV/AIDS vaccine clinical trials.
We developed an external proficiency program for the IFN-γ ELISpot assay that evaluates laboratory performance based on five parameters: timeliness for data reporting; ability to handle cellular samples; detection of background (non-specific) responses; accuracy to consensus of the results; and precision of the measurements.
This study will ultimately provide the scientific community with information on how to organize and implement an external proficiency program to evaluate longitudinally the performance of the participating laboratories and, therefore, fulfill the requirements of the GCLP guidelines for laboratories performing end-point IFN-γ ELISpot assay for clinical trials.
All assays were run with appropriate positive and negative controls and the laboratories participated in external proficiency testing for all available analytes.
In addition to commercial controls run daily with each of the three instruments, the laboratory routinely participates (3 times per year) in external proficiency testing panels distributed by the College of American Pathologists for lymphocyte immunopehnotyping, hematology and clinical chemistry, and the United Kingdom National External Quality Assurance Service for lymphocyte typing.
