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The Center for HIV/AIDS Vaccine Immunology (CHAVI) multi-site quality assurance program for cryopreserved human peripheral blood mononuclear cells.

dc.contributor.author Bainbridge, John
dc.contributor.author Binz, Whitney
dc.contributor.author Denny, Thomas Norton
dc.contributor.author Ferrari, Guido
dc.contributor.author Fiscus, Susan A
dc.contributor.author Gray, Clive Maurice
dc.contributor.author Haynes, Barton Ford
dc.contributor.author Kerkau, Melissa
dc.contributor.author Kirchherr, J
dc.contributor.author Long, Kristy O
dc.contributor.author Louzao, Raul
dc.contributor.author Mackay, M
dc.contributor.author McMillion, T
dc.contributor.author Mokgotho, P
dc.contributor.author Moodley, N
dc.contributor.author Needham, Leila K
dc.contributor.author Rountree, Wes
dc.contributor.author Sarzotti-Kelsoe, Marcella
dc.contributor.author Soderberg, Kelly
dc.contributor.author Stager, SL
dc.contributor.author Stevens, WS
dc.coverage.spatial Netherlands
dc.date.accessioned 2017-06-01T19:18:14Z
dc.date.available 2017-06-01T19:18:14Z
dc.date.issued 2014-07
dc.identifier https://www.ncbi.nlm.nih.gov/pubmed/24910414
dc.identifier S0022-1759(14)00175-6
dc.identifier.uri http://hdl.handle.net/10161/14681
dc.description.abstract The Center for HIV/AIDS Vaccine Immunology (CHAVI) consortium was established to determine the host and virus factors associated with HIV transmission, infection and containment of virus replication, with the goal of advancing the development of an HIV protective vaccine. Studies to meet this goal required the use of cryopreserved Peripheral Blood Mononuclear Cell (PBMC) specimens, and therefore it was imperative that a quality assurance (QA) oversight program be developed to monitor PBMC samples obtained from study participants at multiple international sites. Nine site-affiliated laboratories in Africa and the USA collected and processed PBMCs, and cryopreserved PBMC were shipped to CHAVI repositories in Africa and the USA for long-term storage. A three-stage program was designed, based on Good Clinical Laboratory Practices (GCLP), to monitor PBMC integrity at each step of this process. The first stage evaluated the integrity of fresh PBMCs for initial viability, overall yield, and processing time at the site-affiliated laboratories (Stage 1); for the second stage, the repositories determined post-thaw viability and cell recovery of cryopreserved PBMC, received from the site-affiliated laboratories (Stage 2); the third stage assessed the long-term specimen storage at each repository (Stage 3). Overall, the CHAVI PBMC QA oversight program results highlight the relative importance of each of these stages to the ultimate goal of preserving specimen integrity from peripheral blood collection to long-term repository storage.
dc.language eng
dc.relation.ispartof J Immunol Methods
dc.relation.isversionof 10.1016/j.jim.2014.05.013
dc.subject Biorepository
dc.subject Cryopreservation
dc.subject HIV
dc.subject Human clinical trials
dc.subject PBMC
dc.subject Vaccine
dc.subject AIDS Vaccines
dc.subject Africa
dc.subject Cell Survival
dc.subject Clinical Trials as Topic
dc.subject Consensus
dc.subject Cooperative Behavior
dc.subject Cryopreservation
dc.subject Guideline Adherence
dc.subject HIV Infections
dc.subject Humans
dc.subject Immunologic Tests
dc.subject International Cooperation
dc.subject Laboratories
dc.subject Laboratory Proficiency Testing
dc.subject Leukocytes, Mononuclear
dc.subject Longitudinal Studies
dc.subject Monitoring, Immunologic
dc.subject Observer Variation
dc.subject Practice Guidelines as Topic
dc.subject Predictive Value of Tests
dc.subject Program Development
dc.subject Program Evaluation
dc.subject Quality Control
dc.subject Reproducibility of Results
dc.subject Specimen Handling
dc.subject Time Factors
dc.subject Treatment Outcome
dc.subject United States
dc.subject Workflow
dc.title The Center for HIV/AIDS Vaccine Immunology (CHAVI) multi-site quality assurance program for cryopreserved human peripheral blood mononuclear cells.
dc.type Journal article
pubs.author-url https://www.ncbi.nlm.nih.gov/pubmed/24910414
pubs.begin-page 21
pubs.end-page 30
pubs.organisational-group Basic Science Departments
pubs.organisational-group Clinical Science Departments
pubs.organisational-group Duke
pubs.organisational-group Duke Cancer Institute
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 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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