Evidence map›Paper›PMID 40652282›Full record

ArticleParasites & vectors2025

Performance and usability evaluation of three LDH-based malaria rapid diagnostic tests in Kédougou, Senegal.

Babacar Souleymane Sambe, Stephanie Zobrist, William Sheahan, Divya Soni, Aissatou Diagne, Ibrahima Sarr, Arona Sabene Diatta, Serigne Ousmane Mbacke Diaw, Allison Golden, Hannah Slater and 10 more

Abstract readEvaluation Study
In one paragraph

Article in Parasites & vectors, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

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

  1. Pooled it
  2. Article
  3. Heme oxygenase-1 and malaria pathogenesis.Frontiers in immunology · 2026
    Review
  4. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors.

Babacar Souleymane Sambe *Institut Pasteur de Dakar, Dakar, Senegal.
Stephanie Zobrist *PATH, Seattle, USA. szobrist@path.org.
William SheahanPATH, Seattle, USA.
Divya SoniPATH, New Delhi, India.
Aissatou DiagneInstitut Pasteur de Dakar, Dakar, Senegal.
Ibrahima SarrInstitut Pasteur de Dakar, Dakar, Senegal.
Arona Sabene DiattaInstitut Pasteur de Dakar, Dakar, Senegal.
Serigne Ousmane Mbacke DiawInstitut Pasteur de Dakar, Dakar, Senegal.
Allison GoldenPATH, Seattle, USA.
Hannah SlaterPATH, Seattle, USA.
Ihn Kyung JangPATH, Seattle, USA.
Nerie RoaPATH, Seattle, USA.
Sampa PalPATH, Seattle, USA.
Fatoumata Diene SarrInstitut Pasteur de Dakar, Dakar, Senegal.
Joseph FayeInstitut Pasteur de Dakar, Dakar, Senegal.
Inès Vigan-WomasInstitut Pasteur de Dakar, Dakar, Senegal.
Yakou DieyePATH, Dakar, Senegal.
Moustapha CissePATH, Dakar, Senegal.
Gonzalo J Domingo *PATH, Seattle, USA.
Makhtar Niang *Institut Pasteur de Dakar, Dakar, Senegal.

Funding

Gates Foundation INV-006979
6 · The paper itself

Abstract

backgroundThe emergence of Plasmodium falciparum (Pf) parasites with deleted histidine-rich protein 2 and 3 (hrp2/hrp3) genes threatens the performance of HRP2-based malaria rapid diagnostic tests (RDTs). RDTs targeting Pf lactate dehydrogenase (LDH) may address current product limitations and improve case management. The objective of this study was to evaluate the performance and usability of three LDH-based RDTs in febrile patients.

methodsA cross-sectional diagnostic accuracy study was conducted in Kédougou, Senegal. Capillary blood was tested using the SD BIOLINE Ag Pf RDT (Abbott Diagnostics Korea Inc., Republic of Korea) and three LDH-based RDTs (BIOCREDIT Malaria Ag Pf [pLDH], BIOCREDIT Pf [pLDH/HRPII] and BIOCREDIT Pf/Pv [pLDH/pLDH]; Rapigen Inc., Republic of Korea). Venous blood was collected and used to repeat the BIOCREDIT RDTs and conduct microscopy. Frozen venous specimens were tested using a reference PCR assay. A quantitative multiplex malaria antigen assay measured antigen concentration. RDT performance was determined and analyzed as a function of antigen concentration distribution. Usability of the Pf-only BIOCREDIT tests was evaluated using a questionnaire.

resultsOf the 220 participants, 154 (70%) were Pf-positive by PCR. The Pf (pLDH/HRPII) test demonstrated the highest sensitivity at 78% (95% confidence interval [CI] 70.9-84.5%); specificity was 89% (95% CI 79.4-95.6%). All RDTs performed better than microscopy (53% sensitivity). Although the HRP2 line on the Pf (pLDH/HRPII) test was more sensitive than the SD BIOLINE HRP2-based test (71%, 95% CI 63.6-78.4%), the sensitivities of the PfLDH lines alone on all three BIOCREDIT tests (61-64%) were lower than that of the SD BIOLINE HRP2 test. RDTs performed better when compared to antigen concentration over PCR results. Improved sensitivity of the Pf (pLDH/HRPII) test was driven by the HRP2 line. Line intensity correlated with antigen concentration. Predicted sensitivity using the analytical limit of detection (LOD) was comparable to the observed sensitivity. RDTs demonstrated acceptable usability.

conclusionsBoth HRP2 and LDH contributed to the sensitivity of the best-performing Pf-RDT. In populations such as this with low rates of hrp2/hrp3 deletions, the PfLDH line alone cannot compensate for the performance of the HRP2 line, even with the improved PfLDH LOD of the BIOCREDIT tests. RDT analytical LODs can be used to predict performance in populations with known antigen concentrations.

Indexed as

Diagnostic Tests, RoutineL-Lactate DehydrogenaseMalaria, FalciparumPlasmodium falciparumAdolescentAdultAgedAntigens, ProtozoanChildChild, PreschoolCross-Sectional StudiesFemaleHumansInfantMaleMiddle AgedAntigens, ProtozoanHRP-2 antigen, Plasmodium falciparumL-Lactate DehydrogenaseProtozoan ProteinsDiagnosisHistidine rich protein 2Lactate dehydrogenaseMalariaRapid diagnostic test

Identifiers

PMID40652282
PMCPMC12255971

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LicenceCC BY
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Registered trials

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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.