Evidence map›Paper›PMID 33838672›Full record

ArticleMalaria journal2021

Analytical validation of a real-time hydrolysis probe PCR assay for quantifying Plasmodium falciparum parasites in experimentally infected human adults.

Claire Y T Wang, Emma L Ballard, Zuleima Pava, Louise Marquart, Jane Gaydon, Sean C Murphy, David Whiley, Peter O'Rourke, James S McCarthy

Open access · goldAbstract readValidation Study
In one paragraph

Article in Malaria journal, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
2.2field-weighted citation impact, top 13% of its field
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

6 citing papers in PubMed, 12 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Characterizing the Blood-Stage Antimalarial Activity of Tafenoquine in Healthy Volunteers Experimentally Infected With Plasmodium falciparum.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023
    Article
  5. Article
  6. 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

9 authors at 4 institutions in 2 countries.

Claire Y T WangCentre for Children's Health Research, Children's Health Queensland, Brisbane, Australia. claire.wang@uq.edu.au.ORCID http://orcid.org/0000-0003-2572-0760
Emma L BallardQIMR Berghofer Medical Research Institute, Brisbane, Australia.
Zuleima PavaQIMR Berghofer Medical Research Institute, Brisbane, Australia.
Louise MarquartQIMR Berghofer Medical Research Institute, Brisbane, Australia.
Jane GaydonCentre for Children's Health Research, Children's Health Queensland, Brisbane, Australia.
Sean C MurphyDepartments of Laboratory Medicine and Microbiology, University of Washington, Seattle, WA, USA.
David WhileyCentre for Children's Health Research, Children's Health Queensland, Brisbane, Australia.
Peter O'RourkeQIMR Berghofer Medical Research Institute, Brisbane, Australia.
James S McCarthyQIMR Berghofer Medical Research Institute, Brisbane, Australia.
QIMR Berghofer Medical Research Institute · AUThe University of Queensland · AUChildren's Medical Research Institute · AUUniversity of Washington · US

Funding

Medicines for Malaria Venture OPP1111147
6 · The paper itself

Abstract

backgroundVolunteer infection studies have become a standard model for evaluating drug efficacy against Plasmodium infections. Molecular techniques such as qPCR are used in these studies due to their ability to provide robust and accurate estimates of parasitaemia at increased sensitivity compared to microscopy. The validity and reliability of assays need to be ensured when used to evaluate the efficacy of candidate drugs in clinical trials.

methodsA previously described 18S rRNA gene qPCR assay for quantifying Plasmodium falciparum in blood samples was evaluated. Assay performance characteristics including analytical sensitivity, reportable range, precision, accuracy and specificity were assessed using experimental data and data compiled from phase 1 volunteer infection studies conducted between 2013 and 2019. Guidelines for validation of laboratory-developed molecular assays were followed.

resultsThe reportable range was 1.50 to 6.50 log

conclusionsThe 18S rRNA gene qPCR assay is specific and highly reproducible and can provide reliable and accurate parasite quantification. The assay is considered fit for use in evaluating drug efficacy in malaria clinical trials.

Indexed as

AdultDiagnostic Tests, RoutineHumansHydrolysisMalaria, FalciparumPlasmodium falciparumReal-Time Polymerase Chain ReactionRNA, ProtozoanRNA, Ribosomal, 18SSensitivity and SpecificityRNA, ProtozoanRNA, Ribosomal, 18SHydrolysis probeMIQEPlasmodium falciparumQuantitative PCRValidationVolunteer infection studies

Identifiers

PMID33838672
PMCPMC8035755
OpenAlexW3155045084

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.