Evidence map›Paper›PMID 24928650›Full record

ArticleJournal of immunological methods2014

Leukopak PBMC sample processing for preparing quality control material to support proficiency testing programs.

Ambrosia Garcia, Sarah Keinonen, Ana M Sanchez, Guido Ferrari, Thomas N Denny, M Anthony Moody

Abstract read
In one paragraph

Article in Journal of immunological methods, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

15 citing papers in PubMed.

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  8. Potent, Selective CARs as Potential T-Cell Therapeutics for HPV-positive Cancers.Journal of immunotherapy (Hagerstown, Md. : 1997) · 2021
    Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Ambrosia GarciaDuke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA.
Sarah KeinonenDuke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA.
Ana M SanchezDuke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA.
Guido FerrariDuke 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.
Thomas N DennyDuke 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.
M Anthony MoodyDuke 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.

Funding

Viral Sequencing CoreU19AI067854 · NIAID · DUKE UNIVERSITY · PI BHARDWAJ, NINA · 2006 to 2011
$290.5M
Viral and Host Determinants of HIV-1 TransmissionU01AI067854 · NIAID · DUKE UNIVERSITY · PI HAYNES, BARTON F · 2005 to 2005
$14.9M
IMMUNOLOGY QUALITY ASSURANCE-266995356N01AI095356 · NIAID · UNIV OF MED/DENT OF NJ-NJ MEDICAL SCHOOL · 1999 to 2003
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NIAID NIH HHS AI067854NIAID NIH HHS HHSN272201000045CNIAID NIH HHS N01 AI095356NIAID NIH HHS N01-AI-95356NIAID NIH HHS U01 AI067854NIAID NIH HHS U19 AI067854
6 · The paper itself

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.

Indexed as

Cell SurvivalClinical Trials as TopicCooperative BehaviorCryopreservationGuideline AdherenceHIV-1HIV InfectionsHumansLaboratory Proficiency TestingLeukapheresisLeukocytes, MononuclearMonitoring, ImmunologicObserver VariationPractice Guidelines as TopicPredictive Value of TestsQuality ControlLeukapheresisLeukocytesPBMCProficiency testing

Identifiers

PMID24928650
PMCPMC4138237

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.