Evidence map›Paper›PMID 39226907›Full record

ArticleThe American journal of tropical medicine and hygiene2024

Analytical Sensitivity Analysis and Clinical Impact Modeling of Rapigen Rapid Diagnostic Tests for Malaria.

Allison Golden, Hannah C Slater, Ihn Kyung Jang, Sayali Walke, Thanh T Phan, Greg T Bizilj, Andrew Rashid, Rebecca Barney, Smita Das, Melissa J Rist and 16 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in The American journal of tropical medicine and hygiene, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
–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

10 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Peroxidase-Mimicking Nanozymes for Rapid Detection of Infectious Diseases.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026
    Review
  4. Article
  5. Observational
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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

26 authors.

Allison GoldenPATH, Seattle, Washington.
Hannah C SlaterPATH, Seattle, Washington.
Ihn Kyung JangPATH, Seattle, Washington.
Sayali WalkePATH, Seattle, Washington.
Thanh T PhanPATH, Seattle, Washington.
Greg T BiziljPATH, Seattle, Washington.
Andrew RashidPATH, Seattle, Washington.
Rebecca BarneyPATH, Seattle, Washington.
Smita DasPATH, Seattle, Washington.
Melissa J RistQueensland Institute of Medical Research, Berghofer Medical Research Institute, Brisbane, Australia.
James S McCarthyDepartment of Infectious Diseases, The Peter Doherty Institute for Infection and Immunity, The University of Melbourne, Melbourne, Australia.
Francois NostenShoklo Malaria Research Unit, Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Mae Sot, Thailand.
Jordi LandierShoklo Malaria Research Unit, Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Mae Sot, Thailand.
Mallika ImwongDepartment of Molecular Tropical Medicine and Genetics, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.
Jennifer C C HumeLaboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.
Issaka SagaraMalaria Research and Training Center, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali.
Sara A HealyLaboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.
Patrick E DuffyLaboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.
Henry NtukuMalaria Elimination Initiative, Institute for Global Health Sciences, University of California, San Francisco, California.
Davis MumbengegwiMalaria Operational Research Program, Centre for Research Services at the University of Namibia, Windhoek, Namibia.
Michelle S HsiangMalaria Elimination Initiative, Institute for Global Health Sciences, University of California, San Francisco, California.
Sean C MurphyDepartment of Laboratory Medicine and Pathology, University of Washington, Seattle, Washington.
John RekInfectious Diseases Research Collaboration, Kampala, Uganda.
Katherine TorresDepartamento de Ciencias Celulares y Moleculares, Facultad de Ciencias e Ingeniería, Universidad Peruana Cayetano Heredia, Lima, Peru.
Dionicia GamboaDepartamento de Ciencias Celulares y Moleculares, Facultad de Ciencias e Ingeniería, Universidad Peruana Cayetano Heredia, Lima, Peru.
Gonzalo J DomingoPATH, Seattle, Washington.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Laboratory benchmarking allows objective analysis of the analytical performance of malaria rapid diagnostic tests (RDTs). We present the analytical detection limits of the Rapigen BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH), the Rapigen BIOCREDIT Malaria Ag Pf (pLDH/HRPII), and two best-in-class WHO-prequalified comparator RDTs, generated using standardized panels containing recombinant antigen, in vitro cultured parasites, international standards, and clinical samples. Detection limit antigen concentrations of HRP2, PfLDH, and PvLDH were determined for the Rapigen and comparator RDTs. Detection of antigens in international units (IU)/mL was also evaluated. The Rapigen Ag Pf (pLDH/HRPII) detected 3.9 and 3.9 IU/mL for PfLDH and HRP2, respectively, and the Ag Pf/Pv (pLDH/pLDH) detected 3.9 and 5.0 IU/mL for PfLDH and PvLDH, respectively. The comparator HRP2/PfLDH and HRP2/PvLDH detected 15.6 and 31.3 IU/mL for HRP2 and PfLDH and 15.6 and 50.0 IU/mL for HRP2 and PvLDH, respectively. The RDT clinical sensitivity was predicted through application of analytical detection limits to antigen concentration distributions from clinical symptomatic and asymptomatic cases. Febrile cases would be detected in a majority by both standard and Rapigen RDTs, but incremental increases in sensitivity in the Rapigen RDTs may be important for clinical cases currently missed by microscopy. Rapigen RDTs were predicted to have improved detection of asymptomatic cases and infections with parasites carrying hrp2 deletions through more sensitive PfLDH detection. Through the benchmarking and simulation of clinical sensitivity, a method for rapidly assessing the ability of new RDTs to meet clinical needs using high-sensitivity antigen distribution data is presented.

Indexed as

Antigens, ProtozoanDiagnostic Tests, RoutineMalaria, FalciparumPlasmodium falciparumSensitivity and SpecificityHumansLimit of DetectionMalariaProtozoan ProteinsRapid Diagnostic TestsReagent Kits, DiagnosticAntigens, ProtozoanHRP-2 antigen, Plasmodium falciparumProtozoan ProteinsReagent Kits, Diagnostic

Identifiers

PMID39226907
PMCPMC11542527

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.