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Leukopak PBMC sample processing for preparing quality control material to support proficiency testing programs

dc.contributor.author Denny, Thomas Norton
dc.contributor.author Ferrari, Guido
dc.contributor.author Garcia, Ambrosia
dc.contributor.author Keinonen, Sarah
dc.contributor.author Moody, M Anthony
dc.contributor.author Sanchez, Ana M
dc.date.accessioned 2017-06-01T19:53:24Z
dc.date.available 2017-06-01T19:53:24Z
dc.date.issued 2014-01-01
dc.identifier.issn 0022-1759
dc.identifier.uri http://hdl.handle.net/10161/14707
dc.description.abstract 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. Good clinical laboratory practice (GCLP) guidelines recommend both assay validation and proficiency testing for assays being used in clinical trials, and such testing is facilitated by the availability of large numbers of well-characterized test samples. These samples can be distributed to laboratories participating in these programs and allow monitoring of laboratory performance over time and among participating sites when results are obtained with samples derived from a large master set. The leukapheresis procedure provides an ideal way to collect samples from participants that can meet the required number of cells to support these activities. The collection and processing of leukapheresis samples require tight coordination between the clinical and laboratory teams to collect, process, and cryopreserve large number of samples within the established ideal time of ≤. 8. hours. 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. © 2014 Elsevier B.V.
dc.relation.ispartof Journal of Immunological Methods
dc.relation.isversionof 10.1016/j.jim.2014.05.019
dc.title Leukopak PBMC sample processing for preparing quality control material to support proficiency testing programs
dc.type Journal article
pubs.begin-page 99
pubs.end-page 106
pubs.organisational-group Basic Science Departments
pubs.organisational-group Clinical Science Departments
pubs.organisational-group Duke
pubs.organisational-group Duke Human Vaccine Institute
pubs.organisational-group Immunology
pubs.organisational-group Institutes and Centers
pubs.organisational-group Medicine
pubs.organisational-group Medicine, Duke Human Vaccine Institute
pubs.organisational-group Molecular Genetics and Microbiology
pubs.organisational-group Pediatrics
pubs.organisational-group Pediatrics, Infectious Diseases
pubs.organisational-group School of Medicine
pubs.organisational-group Surgery
pubs.organisational-group Surgery, Surgical Sciences
pubs.publication-status Published
pubs.volume 409
dc.identifier.eissn 1872-7905


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