Substantial improvements in performance indicators achieved in a peripheral blood mononuclear cell cryopreservation quality assurance program using single donor samples

Dyer, Wayne B., Pett, Sarah L., Sullivan, John S., Emery, Sean, Cooper, David A., Kelleher, Anthony D., Lloyd, Andrew and Lewin, Sharon R. (2007) Substantial improvements in performance indicators achieved in a peripheral blood mononuclear cell cryopreservation quality assurance program using single donor samples. Clinical and Vaccine Immunology, 14 1: 52-59. doi:10.1128/CVI.00214-06


Author Dyer, Wayne B.
Pett, Sarah L.
Sullivan, John S.
Emery, Sean
Cooper, David A.
Kelleher, Anthony D.
Lloyd, Andrew
Lewin, Sharon R.
Title Substantial improvements in performance indicators achieved in a peripheral blood mononuclear cell cryopreservation quality assurance program using single donor samples
Journal name Clinical and Vaccine Immunology   Check publisher's open access policy
ISSN 1556-6811
1556-679X
Publication date 2007-01-01
Year available 2007
Sub-type Article (original research)
DOI 10.1128/CVI.00214-06
Open Access Status DOI
Volume 14
Issue 1
Start page 52
End page 59
Total pages 8
Place of publication Washington, DC, United States
Publisher American Society for Microbiology
Language eng
Abstract Storage of high-quality cryopreserved peripheral blood mononuclear cells (PBMC) is often a requirement for multicenter clinical trials and requires a reproducibly high standard of practice. A quality assurance program (QAP) was established to assess an Australia-wide network of laboratories in the provision of high-quality PBMC (determined by yield, viability, and function), using blood taken from single donors (human immunodeficiency virus [HIV] positive and HIV negative) and shipped to each site for preparation and cryopreservation of PBMC. The aim of the QAP was to provide laboratory accreditation for participation in clinical trials and cohort studies which require preparation and cryopreservation of PBMC and to assist all laboratories to prepare PBMC with a viability of >80% and yield of >50% following thawing. Many laboratories failed to reach this standard on the initial QAP round. Interventions to improve performance included telephone interviews with the staff at each laboratory, two annual wet workshops, and direct access to a senior scientist to discuss performance following each QAP round. Performance improved substantially in the majority of sites that initially failed the QAP (P = 0.002 and P = 0.001 for viability and yield, respectively). In a minority of laboratories, there was no improvement (n = 2), while a high standard was retained at the laboratories that commenced with adequate performance (n = 3). These findings demonstrate that simple interventions and monitoring of PBMC preparation and cryopreservation from multiple laboratories can significantly improve performance and contribute to maintenance of a network of laboratories accredited for quality PBMC fractionation and cryopreservation.
Keyword Peripheral blood mononuclear cells (PBMC)
Quality assurance program (QAP)
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status Non-UQ

Document type: Journal Article
Sub-type: Article (original research)
Collection: Faculty of Medicine
 
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