Evidence map›Paper›PMID 24685833›Full record

ArticleJournal of immunological methods2014

The External Quality Assurance Oversight Laboratory (EQAPOL) proficiency program for IFN-gamma enzyme-linked immunospot (IFN-γ ELISpot) assay.

Ana M Sanchez, Wes Rountree, Mark Berrong, Ambrosia Garcia, Alexandra Schuetz, Josephine Cox, Nicole Frahm, Mark Manak, Marcella Sarzotti-Kelsoe, M Patricia D'Souza and 2 more

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 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing 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

13 citing papers in PubMed.

  1. Standard Operating Procedures in Biorepositories and Biobanks.Methods in molecular biology (Clifton, N.J.) · 2026
    Article
  2. Article
  3. Review
  4. Article
  5. Article
  6. A Cytometrist's Guide to Coordinating and Performing Effective COVID-19 Research.Cytometry. Part A : the journal of the International Society for Analytical Cytology · 2021
    Review
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
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

12 authors.

Ana M Sanchez *Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA.
Wes Rountree *Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA.
Mark Berrong *Department of Surgery, Duke University Medical Center, Durham, NC, USA.
Ambrosia GarciaDuke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA.
Alexandra SchuetzDepartment of Retrovirology, USAMC-AFRIMS, Bangkok, Thailand.
Josephine CoxInternational AIDS Vaccine Initiative, New York, New York, USA.
Nicole FrahmFred Hutchinson Cancer Research Center, Seattle, Washington, USA.
Mark ManakDepartment of Diagnostics and Monitoring, US Military HIV Research Program (MHRP), HJF, Walter Reed Army Institute of Research, Silver Spring, MD, USA.
Marcella Sarzotti-KelsoeDuke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA.
M Patricia D'SouzaVaccine Clinical Research Branch, Division of AIDS, NIAID, Bethesda, MD, USA.
Thomas DennyDuke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA.
Guido FerrariDuke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA.

Funding

NIAID NIH HHS HHSN272201000045C
6 · The paper itself

Abstract

The interferon-gamma enzyme-linked immunospot (IFN-γ ELISpot) assay has been developed and used as an end-point assay in clinical trials for infectious diseases and cancer to detect the magnitude of antigen-specific immune responses. The ability to compare data generated by different laboratories across organizations is pivotal to understand the relative potency of different therapeutic and vaccine strategies. We developed an external proficiency program for the IFN-γ ELISpot assay that evaluates laboratory performance based on five parameters: timeliness for data reporting; ability to handle cellular samples; detection of background (non-specific) responses; accuracy to consensus of the results; and precision of the measurements. Points are awarded for each criterion, and the sum of the points is used to determine a numeric and adjectival performance rating. Importantly, the evaluation of the accuracy to the consensus mean for the detection of antigen-specific responses using laboratory-specific procedures informs each laboratory and its sponsor on the degree of concordance of its results with those obtained by other laboratories. This study will ultimately provide the scientific community with information on how to organize and implement an external proficiency program to evaluate longitudinally the performance of the participating laboratories and, therefore, fulfill the requirements of the GCLP guidelines for laboratories performing end-point IFN-γ ELISpot assay for clinical trials.

Indexed as

Clinical Trials as TopicConsensusCooperative BehaviorEnzyme-Linked Immunospot AssayGuideline AdherenceHumansInterferon-gamma Release TestsInternational CooperationLaboratoriesLaboratory Proficiency TestingLongitudinal StudiesMonitoring, ImmunologicObserver VariationPractice Guidelines as TopicPredictive Value of TestsProgram DevelopmentELISpotProficiency testingStandardization

Identifiers

PMID24685833
PMCPMC4138255

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.