Evidence map›Paper›PMID 24838112›Full record

ArticlePloS one2014

External quality assurance of malaria nucleic acid testing for clinical trials and eradication surveillance.

Sean C Murphy, Cornelus C Hermsen, Alexander D Douglas, Nick J Edwards, Ines Petersen, Gary A Fahle, Matthew Adams, Andrea A Berry, Zachary P Billman, Sarah C Gilbert and 9 more

Abstract readValidation Study
In one paragraph

Article in PloS one, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing 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

21 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Searching for Improved Flu Vaccines-The Time Is Now.The Journal of infectious diseases · 2020
    Article
  9. Beyond Blood Smears: Qualification ofThe American journal of tropical medicine and hygiene · 2019
    Article
  10. The Controlled Human Malaria Infection Experience at the University of Maryland.The American journal of tropical medicine and hygiene · 2019
    Article
  11. Article
  12. Article
  13. Review
  14. Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Review
  20. 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

19 authors.

Sean C MurphyDepartment of Laboratory Medicine and Center for Emerging and Re-Emerging Infectious Diseases, University of Washington (UW), Seattle, Washington, United States of America.
Cornelus C HermsenDepartment of Medical Microbiology, Radboud University Medical Center (RUMC), Nijmegen, The Netherlands.
Alexander D DouglasThe Jenner Institute, University of Oxford, Oxford, United Kingdom.
Nick J EdwardsThe Jenner Institute, University of Oxford, Oxford, United Kingdom.
Ines PetersenEuropean Vaccine Initiative (EVI), Heidelberg, Germany.
Gary A FahleDepartment of Laboratory Medicine, Clinical Center, National Institutes of Health (NIH), Bethesda, Maryland, United States of America.
Matthew AdamsCenter for Vaccine Development and Howard Hughes Medical Institute, University of Maryland School of Medicine, Baltimore, Maryland, United States of America.
Andrea A BerryCenter for Vaccine Development and Howard Hughes Medical Institute, University of Maryland School of Medicine, Baltimore, Maryland, United States of America.
Zachary P BillmanDepartment of Laboratory Medicine and Center for Emerging and Re-Emerging Infectious Diseases, University of Washington (UW), Seattle, Washington, United States of America.
Sarah C GilbertThe Jenner Institute, University of Oxford, Oxford, United Kingdom.
Matthew B LaurensCenter for Vaccine Development and Howard Hughes Medical Institute, University of Maryland School of Medicine, Baltimore, Maryland, United States of America.
Odile LeroyEuropean Vaccine Initiative (EVI), Heidelberg, Germany.
Kristen E LykeCenter for Vaccine Development and Howard Hughes Medical Institute, University of Maryland School of Medicine, Baltimore, Maryland, United States of America.
Christopher V PloweCenter for Vaccine Development and Howard Hughes Medical Institute, University of Maryland School of Medicine, Baltimore, Maryland, United States of America.
Annette M SeilieDepartment of Laboratory Medicine and Center for Emerging and Re-Emerging Infectious Diseases, University of Washington (UW), Seattle, Washington, United States of America.
Kathleen A StraussCenter for Vaccine Development and Howard Hughes Medical Institute, University of Maryland School of Medicine, Baltimore, Maryland, United States of America.
Karina TeelenDepartment of Medical Microbiology, Radboud University Medical Center (RUMC), Nijmegen, The Netherlands.
Adrian V S HillThe Jenner Institute, University of Oxford, Oxford, United Kingdom.
Robert W SauerweinDepartment of Medical Microbiology, Radboud University Medical Center (RUMC), Nijmegen, The Netherlands.

Funding

University of Washington/Fred Hutch Center for AIDS ResearchP30AI027757 · NIAID · UNIVERSITY OF WASHINGTON · PI EDWIN ROBERTO ORELLANA · 1988 to 2026
$104.9M
NIAID NIH HHS P30 AI027757Wellcome Trust 090532
6 · The paper itself

Abstract

Nucleic acid testing (NAT) for malaria parasites is an increasingly recommended diagnostic endpoint in clinical trials of vaccine and drug candidates and is also important in surveillance of malaria control and elimination efforts. A variety of reported NAT assays have been described, yet no formal external quality assurance (EQA) program provides validation for the assays in use. Here, we report results of an EQA exercise for malaria NAT assays. Among five centers conducting controlled human malaria infection trials, all centers achieved 100% specificity and demonstrated limits of detection consistent with each laboratory's pre-stated expectations. Quantitative bias of reported results compared to expected results was generally <0.5 log10 parasites/mL except for one laboratory where the EQA effort identified likely reasons for a general quantitative shift. The within-laboratory variation for all assays was low at <10% coefficient of variation across a range of parasite densities. Based on this study, we propose to create a Molecular Malaria Quality Assessment program that fulfills the need for EQA of malaria NAT assays worldwide.

Indexed as

Epidemiological MonitoringDisease EradicationHumansMalariaPlasmodium falciparumPolymerase Chain ReactionQuality Assurance, Health CareReverse Transcriptase Polymerase Chain ReactionSensitivity and Specificity

Identifiers

PMID24838112
PMCPMC4023973

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.