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.
journal_name
J Immunol Methodsjournal_title
Journal of immunological methodsauthors
Garcia A,Keinonen S,Sanchez AM,Ferrari G,Denny TN,Moody MAdoi
10.1016/j.jim.2014.05.019subject
Has Abstractpub_date
2014-07-01 00:00:00pages
99-106eissn
0022-1759issn
1872-7905pii
S0022-1759(14)00181-1journal_volume
409pub_type
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journal_title:Journal of immunological methods
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journal_title:Journal of immunological methods
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