title: Leukopak PBMC sample processing for preparing quality control material to support proficiency testing programs.
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.
authors.affiliation: Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA.
authors.forename: Ambrosia
authors.initials: A
authors.lastname: Garcia
authors.affiliation: Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA.
authors.forename: Sarah
authors.initials: S
authors.lastname: Keinonen
authors.affiliation: Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA.
authors.forename: Ana M
authors.initials: AM
authors.lastname: Sanchez
authors.affiliation: Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA; Departments of Surgery, Duke University Medical Center, Durham, NC, USA; Duke Global Health Institute, Duke University Medical Center, Durham, NC, USA.
authors.forename: Guido
authors.initials: G
authors.lastname: Ferrari
authors.affiliation: Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA; Departments of Medicine, Duke University Medical Center, Durham, NC, USA; Duke Global Health Institute, Duke University Medical Center, Durham, NC, USA.
authors.forename: Thomas N
authors.initials: TN
authors.lastname: Denny
authors.affiliation: Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA; Departments of Pediatrics, Duke University Medical Center, Durham, NC, USA. Electronic address: moody007@mc.duke.edu.
authors.forename: M Anthony
authors.initials: MA
authors.lastname: Moody
mesh_terms: D002470:Cell Survival; D002986:Clinical Trials as Topic / Q000592:standards*; D003299:Cooperative Behavior; D015925:Cryopreservation / Q000592:standards*; D019983:Guideline Adherence / Q000592:standards; D015658:HIV Infections / Q000097:blood / Q000175:diagnosis* / Q000276:immunology / Q000821:virology; D015497:HIV-1 / Q000276:immunology; D006801:Humans; D059021:Laboratory Proficiency Testing / Q000592:standards*; D007937:Leukapheresis / Q000592:standards*; D007963:Leukocytes, Mononuclear / Q000276:immunology* / Q000821:virology; D015166:Monitoring, Immunologic / Q000592:standards*; D015588:Observer Variation; D017410:Practice Guidelines as Topic / Q000592:standards; D011237:Predictive Value of Tests; D011786:Quality Control; D019984:Quality Indicators, Health Care / Q000592:standards*; D015203:Reproducibility of Results; D013048:Specimen Handling / Q000592:standards; D013997:Time Factors; D014186:Transportation / Q000592:standards; D057188:Workflow
keywords: Leukapheresis; Leukocytes; PBMC; Proficiency testing