The Center for HIV/AIDS Vaccine Immunology (CHAVI) multi-site quality assurance program for cryopreserved Human Peripheral Blood Mononuclear Cells
| Autor: | Melanie Mackay, Jennifer L. Kirchherr, Marcella Sarzotti-Kelsoe, Leila K. Needham, Susan L. Stager, John Bainbridge, Guido Ferrari, Susan A. Fiscus, Takesha McMillion, Thomas N. Denny, Barton F. Haynes, Kristy O. Long, Wendy S. Stevens, Kelly A. Soderberg, Clive M. Gray, Niranjini Moodley, Wes Rountree, Pauline Mokgotho, Raul Louzao, Melissa Kerkau, Whitney Binz |
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| Rok vydání: | 2014 |
| Předmět: |
Quality Control
Laboratory Proficiency Testing Consensus Time Factors Cell Survival International Cooperation Immunology HIV Infections Immunologic Tests Peripheral blood mononuclear cell Article Virus Cryopreservation Specimen Handling Workflow Acquired immunodeficiency syndrome (AIDS) Monitoring Immunologic Predictive Value of Tests medicine Humans Immunology and Allergy Longitudinal Studies Cooperative Behavior Program Development AIDS Vaccines Observer Variation Clinical Trials as Topic business.industry Reproducibility of Results medicine.disease United States Treatment Outcome Biorepository Africa Practice Guidelines as Topic Leukocytes Mononuclear Guideline Adherence Laboratories business Quality assurance Program Evaluation |
| Zdroj: | Journal of Immunological Methods. 409:21-30 |
| ISSN: | 0022-1759 |
| DOI: | 10.1016/j.jim.2014.05.013 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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