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Clinical and Vaccine Immunology, January 2007, p. 52-59, Vol. 14, No. 1
1071-412X/07/$08.00+0     doi:10.1128/CVI.00214-06
Copyright © 2007, American Society for Microbiology. All Rights Reserved.

Substantial Improvements in Performance Indicators Achieved in a Peripheral Blood Mononuclear Cell Cryopreservation Quality Assurance Program Using Single Donor Samples{triangledown}

Wayne B. Dyer,1,2* Sarah L. Pett,3 John S. Sullivan,1,2 Sean Emery,3 David A. Cooper,3 Anthony D. Kelleher,3,4 Andrew Lloyd,5,6 and Sharon R. Lewin7,8

Australian Red Cross Blood Service, Sydney, New South Wales,1 Transfusion Medicine and Immunogenetics Research Unit, Faculty of Medicine, University of Sydney, Sydney, New South Wales,2 National Centre in HIV Epidemiology and Clinical Research, University of NSW, Sydney, New South Wales,3 Centre for Immunology, St. Vincent's Hospital and University of NSW, Sydney, New South Wales,4 Inflammatory Diseases Research Unit, School of Medical Sciences, University of NSW, Sydney, New South Wales,5 Department of Infectious Diseases, Prince of Wales Hospital, Randwick, New South Wales,6 Infectious Diseases Unit, Alfred Hospital, Prahran, Victoria,7 Department of Medicine, Monash University, Melbourne, Victoria, Australia8

Received 8 June 2006/ Returned for modification 31 August 2006/ Accepted 9 October 2006

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.

* Corresponding author. Mailing address: Australian Red Cross Blood Service, 153 Clarence Street, Sydney, NSW 2000, Australia. Phone: 61 2 9229 4557. Fax: 61 2 9229 4521. E-mail: wdyer{at}arcbs.redcross.org.au.

{triangledown} Published ahead of print on 18 October 2006.

Clinical and Vaccine Immunology, January 2007, p. 52-59, Vol. 14, No. 1
1071-412X/07/$08.00+0     doi:10.1128/CVI.00214-06
Copyright © 2007, American Society for Microbiology. All Rights Reserved.



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